Issuu

Physicians office Resource 2022 | Issue 6

Resources for You, Your Patients, & Your Practice

Comprehensive In-office Diabetes Testing PAGE 4

MEETING THE GOALS OF VALUE-BASED CARE IN CHRONIC DISEASE MANAGEMENT | PAGE 6

A DREAM DESTIN-ATION | PAGE 14

S-COM-ART-02381_R1_Full Page Ad_7.75x10.75_Print.pdf

08/04/2022

14:44

Not all Antigen Tests are Created Equal The LumiraDx SARS-CoV-2 Ag test utilizes next-generation microfluidic technology, bringing lab-comparable performance to the point of care.

• 97.6% positive agreement to RT-PCR • Results in minutes • Authorized for use within 12 days of symptom onset and for asymptomatic screening • Low-waste consumable • CLIA Waived*

1600

Scan to learn more. lumiradx.com

*The LumiraDx SARS-CoV-2 Ag test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. LumiraDx SARS-CoV-2 Ag test has not been cleared or approved by FDA. The LumiraDx SARS-CoV-2 Ag test has been authorized by FDA under an EUA only for the detection of SARS-CoV-2 nucleocapsid protein. The test has not been authorized for use to detect any other viruses or pathogens. The test is authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. S-COM-ART-02381 R1 2022/04

PUBLISHED BY Medical Education Resources, LLC PUBLISHER Aaron R. Medaris amedaris@physiciansofficeresource.com

CEO Andrew C. Nimmo acnimmo@physiciansofficeresource.com

PRESIDENT John D. Pasquale jpasquale@pharmaconnect.com

Getting the most from this guide

BUSINESS MANAGER Marci J. Hills mhills@physiciansofficeresource.com

TRAVEL EDITOR Brandi L. Brower EDITORIAL BOARD Michael Paquin, FHIMSS Barry Craig, MLT (NCA), CLC STAFF WRITER Dylan J. Chadwick

There are two simple ways to request

CREATIVE DIRECTOR PRODUCTION MANAGER Jessica Elmer

information about the products and services

found in Physicians Office Resource. 1. Go to www.PhysiciansOfficeResource.com and enter the four-digit reference number found next to the product or service into the search field, then request additional information, schedule a demo, or speak with a sales agent all with just a simple click of a button. 2. Find the Business Reply Card in this issue, circle the desired reference numbers, complete the form, and drop into any USPS mailbox. A representative will contact you as quickly as possible to answer your questions.

www.PhysiciansOfficeResource.com

To continue your free subscription of Physicians Office Resource magazine, please fill out the Business Reply Card (BRC) located within this magazine and drop in any United States Post Office mailbox. If you are a manufacturer of medical products or provide services to medical professionals and would like to advertise your products or services to the nation’s top physicians doing in-office testing, call 801-380-6094 or visit: POR.io for more information.

2022 · ISSUE 6 | 3

TABLE OF CONTENTS

Comprehensive In-office Diabetes Testing with the DCA Vantage® and CLINITEK Status®+ Analyzers Siemens Healthineers DCA Vantage® and CLINITEK Status® family of analyzers provide hemoglobin A1c (HbA1c) and albumin-to-creatinine ratio (ACR) testing at the point of care. Meet quality measures for A1c control and kidney disease check in minutes with CLIA-waived HbA1c testing and ACR1 ratio. Improve patient experience and overall outcome by providing actionable results in minutes.

1602

1601

1. Moderately complex on the DCA Vantage Analyzer. CLIA-waived on the CLINITEK Status+ Analyzer.

MEETING THE GOALS OF VALUE-BASED CARE IN CHRONIC DISEASE MANAGEMENT

MDecapes: A DREAM DESTIN-ATION

WHY NO ONE RESPONDS TO “WHY DID YOU WANT TO BECOME A DOCTOR?” WITH ANYTHING STARTING WITH “THE SALARY —”

— Chronic diseases are the leading causes of death and disability in the U.S. and major drivers of the nation’s rising healthcare costs.

4 | PHYSICIANS OFFICE RESOURCE

— This luxury boutique hotel is just a year old and has quickly become the place in Northwest Florida to see and be seen. I’m enthralled as I enter the lobby with the expansive ceilings, fresh floral arrangements, extensive marble, curated artwork, modern crystal fixtures, and design concept.

— Money is one of the most influential things in our lives that is simultaneously most difficult to talk about. And the medical field is no exception.

TO X I C O LO G Y S C R E E N I N G

SIMPLIFIED

1603

Comprehensive toxicology menu now with 14 CLIA1 categorized moderately complex assays.

IMMTOX™ 270 BENCHTOP ANALYZER Toxicology screening solutions for physician offices, treatment centers and laboratories. n

25 assay menu

Up to 270 tests per hour

Compact footprint

Quality products, service and reliability

COMPLETE LABORATORY SOLUTIONS From consultation, to licensure and compliance, the Abbott Clinical Lab Solutions team has you covered.

CONTACT ABBOTT CLINICAL LAB SOLUTIONS. CALL 888-831-6850 | EMAIL: CLS_SALES@ABBOTT.COM 1. Clinical Laboratory Improvement Amendments (CLIA) © 2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. Any photos displayed are for illustrative purposes only. MKT52247 REV1 08/20

FEATURE

MEETING THE GOALS OF VALUE-BASED CARE IN CHRONIC DISEASE MANAGEMENT BY SUSAN GARRAMONE, SENIOR CLINICAL MARKETING MANAGER SIEMENS HEALTHINEERS

Chronic diseases are the leading causes of death and disability in the U.S. and major drivers of the nation’s rising healthcare costs.1 Per the Centers for Disease Control and Prevention, the top seven chronic diseases include heart disease, cancer, chronic lung disease, stroke, Alzheimer’s disease, diabetes, and chronic kidney disease (CKD). In the United States, 60% of adults have one chronic disease, and 40% are reported as having two or more.1 The costs of these chronic diseases account for nearly 86% of healthcare costs.2

With these staggering statistics, chronic disease management has become one of the most important priorities for healthcare organizations today and the driving force behind value-based care: the measured improvement in a patient’s health outcomes for the cost of achieving that improvement.3

Value-based Care (VBC) The goal of value-based care is to standardize healthcare processes and develop proactive best practices for patient care to prevent progression and avoid complications of disease before they start. The Value-Based Care (VBC) model centers around patient and provider accountability, shifting emphasis from fee-for-service.5 In this model, physician and hospital payments are based on patient outcomes,

rather than volume-based metrics such as the number of patients seen, or procedures performed. The focus on patient outcomes is intended to help reduce healthcare costs while improving overall patient health and well-being.5

6 | PHYSICIANS OFFICE RESOURCE

Patients seeking care for most of the high-cost chronic conditions, including diabetes and CKD, rely heavily on primary care physicians.6 In fact, primary care physicians

Value-based care may provide earned financial relief to primary care practices while allowing clinicians to strengthen the rewarding patient relationships that are the backbone of primary care.8 In a joint survey by the American Academy of Family Physicians and CompHealth, 87% of providers said the best part of their job was “interacting with

Quality Measures and Quality Payment Programs Quality measures are standards for evaluating performance when caring for patients. They are developed by both private and public-sector organizations and are generally based on the current clinical guidelines or literature reviews. Quality measures are used to not only benchmark individual clinicians and distribute bonus payments, but also to evaluate facilities, health systems, treatments, and care coordination.11 There are several quality-payment programs and performance-measurement sets designed to hold providers accountable for quality, assist in identifying opportunities for improvement, and monitor progress over time. The Centers for Medicare & Medicaid Services (CMS) is the largest payer of healthcare services in the United States.12 CMS is also the primary driver of changes in payment and delivery models and incorporation of value-based purchasing of healthcare services based on incen-

patients and helping patients.”9 Unfortunately, to achieve success in fee-for-service models, providers spend less time with patients, often addressing immediate needs but not underlying causes.9 Value-based care changes this dynamic, as it aligns incentives with the physician’s focus on patient outcomes rather than volume. Additionally, moving from a patient-volume model improves the experience of both the patient and physician, and may allow more time for valuable consultation.9,10 Overall, value-based care helps address the goals of the Quadruple Aim: better outcomes, lower costs, improved patient experience, and improved clinician experience.

FEATURE

treat at least 90% of patients with diabetes in the United States.7 Regular visits with primary care physicians can involve screenings, checkups, monitoring and coordinating treatment, and patient education to help manage chronic conditions.

tives.12 The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established a physician payment system that incentivizes improvements in U.S. healthcare. Under MACRA, physicians participate in the Quality Payment Program (QPP), depending on eligibility, payment impact, and other factors, through the Merit-Based Incentive Payment System (MIPS) or through Advanced Alternative Payment Models (APM), such as risk-bearing accountable care organizations (ACOs).13 All eligible clinicians must choose to participate in either the MIPS or the APMs track and meet eligibility based on specific requirements.13 MIPS is the default program for all providers. In the MIPS program, providers’ performance is measured in four categories: quality, costs, the use of certified EHR, and improvements in clinical practice. Each category is weighted, and providers receive a score between 0 and 100.13,14 This score is then used to adjust payments. Under APMs, there are financial incentives related to the level of provider financial risk and the quality of care provided.14 2022 · ISSUE 6 | 7

FEATURE

In 2022, MIPS scoring is weighted as follows: Quality (30%), Advancing Care Information (25%), Clinical Practice Improvement Activities (15%), and Cost and Resource Use (30%). The maximum payment adjustment for 2022 is ±9%.17 The National Committee for Quality Assurance (NCQA) established a comprehensive set of standardized per-

8 | PHYSICIANS OFFICE RESOURCE

formance measures, the Healthcare Effectiveness Data and Information Set (HEDIS), to give purchasers and consumers a way to reliably compare health plan performance.18 90% of U.S. health plans, including commercial, Medicare, and Medicaid health plans, use HEDIS measurement targets in determining quality incentive payments.18 Several HEDIS measures align with and are included in MIPS criteria.

FEATURE

CHART REFERENCES 13, 18

Quality Measures in Diabetes and CKD Diabetes is an ideal target for prevention strategies, as it is a major risk factor for other serious chronic conditions, including CKD. In the U.S., 37 million people are diagnosed with diabetes.19 This epidemic is responsible for an estimated $327 billion in annual medical and lost productivity costs.20 Additionally, 1 in 3 adults with diabetes also have CKD, responsible for more than $81 billion in annual Medicare costs.21,22 For those at risk for diabetes and CKD, early identification can prevent disease. For those with disease, early identification and treatment and routine monitoring can control disease progression and prevent related complications.23 On this basis, both diabetes and CKD are good targets for value-based care, where there is a desire to positively manage long-term outcomes while containing total cost of care in these growing populations. As such, diabetes and kidney health quality measures are often a focus of quality payment programs. Guidelines call for routine testing of hemoglobin A1c (HbA1c) and urine albumin-creatinine ratio (uACR) for disease monitoring and management.24,25 However, the literature demonstrates that only approximately 70% and

32% of patients with diabetes follow the testing guidelines for HbA1c and uACR, respectively.26,27 Key quality measures in diabetes care are HbA1c control for patients with diabetes and uACR for patients with diabetes and kidney disease.28,29 The population health challenge presented by diabetes, and the need for action, have been recognized for a long time. In 1998, to assess quality of care in diabetes management, the Centers for Medicare & Medicaid Services (CMS), the National Committee on Quality Assurance (NCQA), and the American Diabetes Association (ADA) led the first national effort to develop a set of performance measures for diabetes.30 These quality performance measures have since been widely adopted for assessment in Medicare, Medicaid, and commercial health plans, as a driver toward value-based care.31 Both MIPS and HEDIS quality measures for 2022 include measures for guideline supported HbA1c and uACR testing (Table 1).28,29

2022 · ISSUE 6 | 9

FEATURE

Table 1. HEDIS and MIPS 2022 quality measures for HbA1c and uACR testing.

A Path to Success in Quality Programs with Point-of-care Testing Managing patients diagnosed with diabetes according to clinical guidelines is critically important, yet overall testing compliance is poor.26,27 Point-of-care testing (POCT), clinical laboratory testing at the site of patient care, has been described as a quick, easy, reliable method for monitoring diabetes, and improving test adherence, in the primary care office setting.32 POCT enables the physician to perform diagnostic testing during an office-visit and affords the opportunity for immediate patient-physician consultation and intervention, eliminating potential loss and cost of follow-up associated with traditional laboratory (sendout) testing.32 In fact, the ADA has stated that “The use of point-of-care A1C testing may provide an opportunity for more timely treatment changes during encounters between patients and provider.”24 There is a growing body of evidence supporting the benefits of point-of-care testing to meet goals: • A study by Crocker et al. demonstrated that POC HbA1c testing led to 3.7 times decreased likelihood of missing HbA1c testing.32 • A second study by Crocker demonstrated that pointof-care HbA1c testing “can significantly improve clinical operations with cost reductions through 10 | PHYSICIANS OFFICE RESOURCE

improved practice efficiency,” realizing a potential savings from improved efficiency of $24.64 per patient.33 This savings was achieved through a reduction in the number of calls, letters and additional patient visits required following implementation of POCT. • A recent study by Christofides stated, “Access to uACR testing may be improved by using Clinical Laboratory Improvements Amendments (CLIA)-waived point of care UACR testing options, that is, those approved for use closer to the patient and not necessarily in a central laboratory,” and noted that using a CLIA-waived POC uACR option was a means to optimize test ordering.34 • A study by Schultes et al. found that the implementation of uACR POCT in daily general practice can improve the diagnosis and treatment of diabetic kidney disease (DKD).35 The availability of uACR results at the time of the consultation led physicians to make medication adjustments to 18.5% of the patients enrolled in the study.35 The findings reported in these papers, and others they cite, suggest implementation of POCT may help busy practices achieve quality measures with increased testing adherence while decreasing operating costs through improved practice efficiency.32-35

References

1. https://www.cdc.gov/chronicdisease/about/index.htm#:~:text=Many%20chronic%20diseases%20 are%20caused. Accessed 4-13-22. 2. Holman HR. The relation of the chronic disease epidemic to the health care crisis. ACR Open Rheumatol. 2020 Mar;2(3):16773. doi: 10.1002/acr2.11114. Epub 2020 Feb 19. PMID: 32073759; PMCID: PMC7077778.

Quality measures in both diabetes and CKD are focused on guideline-recommended diagnostic testing. Adoption of point-of-care testing can improve test adherence while bringing increased value to patient office visits. Availability of real-time test results enables immediate consultation and faster intervention and treatment. This facilitation of care may lead to improved patient outcomes and decreased overall diabetes-related healthcare costs, meeting the goals of value-based care.

in the U.S. in 2017. Diabetes Care. 2018;41(5):917-28. doi: 10.2337/ dci18-0007. 21. https://www.cdc.gov/kidneydisease/prevention-risk/ make-the-connection.html. Accessed 4-13-22. 22. https://adr.usrds.org/2020/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd. Accessed 4-13-22.

3. https://www.nachc.org/wp-content/uploads/2017/05/CHFWinter-Spring-2017-Facing-the-Transition.pdf. Accessed 4-13-22.

23. https://www.consultant360.com/articles/diabetes-and-chronic-kidney-disease-prevention-early-recognition-and-treatment. Accessed 4-13-22.

4. Petersen R, et al. Improving population health by incorporating chronic disease and injury prevention into value-based care models. North Carolina Med J. 2016;77(4):257-60. doi: 10.18043/ ncm.77.4.257.

24. American Diabetes Association. Glycemic targets: standards of medical care in diabetes—2021. Diabetes Care. 2021 Jan;44(Suppl 1): S73-S84. Available from: https://doi.org/10.2337/ dc21-S006. Accessed 4-13-22.

5. https://my.clevelandclinic.org/health/articles/15938-value-based-care. Accessed 4-13-22.

25. American Diabetes Association Professional Practice Committee, et al. 11. Chronic kidney disease and risk management: standards of medical care in diabetes-2022. Diabetes Care. 2022;45(Suppl_1): S175-S184. doi: 10.2337/dc22-S011.

6. Sharma MA, et al. Patients with high-cost chronic conditions rely heavily on primary care physicians. J Am Board Fam Med. 2014;27(1):11-2. doi: 10.3122/jabfm.2014.01.130128. 7. Davidson JA. The increasing role of primary care physicians in caring for patients with type 2 diabetes mellitus. Mayo Clin Proc. 2010;85(12 Suppl):S3-S4. doi: 10.4065/mcp.2010.0466 8. https://www.capphysicians.com/articles/overview-value-based-care-primary-care-practices. Accessed 4-13-22. 9. https://www.priviahealth.com/blog/how-the-quadruple-aimand-value-based-care-intersect/. Accessed 4-13-22. 10. Teisberg E, Wallace S, O’Hara S. Defining and implementing value-based health care: a strategic framework. Acad Med. 2020;95(5):682-5. doi: 10.1097/ACM.0000000000003122.

26. https://www.cdc.gov/diabetes/pdfs/library/Diabetes-Report-Card-2019-508.pdf. Accessed 12-17-21. Accessed 4-13-22. 27. Alfego D, et al. Chronic kidney disease testing among at-risk adults in the U.S. remains low: real-world evidence from a national laboratory database. Diabetes Care. 2021;44(9):2025-32. doi:10.2337/dc21-0723. 28. https://www.ncqa.org/wp-content/uploads/2021/12/HEDIS-MY-2022-Measure-Descriptions.pdf. Accessed 4-13-22. 29. https://qpp.cms.gov/mips/explore-measures?tab=qualityMeasures&py=2022#measures. Accessed 4-13-22.

11. https://carejourney.com/physician-quality-and-why-it-is-important/ABCs of Measurement. Accessed 4-13-22.

30. Fleming BB, et al. The Diabetes Quality Improvement Project: moving science into health policy to gain an edge on the diabetes epidemic. Diabetes Care. 2001;24(10):1815-20. doi: 10.2337/ diacare.24.10.1815.

12. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Quality-Programs. Accessed 4-1322.

31. https://diabetesjournals.org/care/article/34/7/1651/38635/ Diabetes-Performance-Measures-Current-Status-and . Accessed 4-13-22.

13. https://www.aapc.com/macra/macra.aspx. Accessed 4-13-22.

32. Crocker JB, et al. The impact of point-of-care hemoglobin A1c testing on population health-based onsite testing adherence: a primary-care quality improvement study. J Diabetes Sc Technol. 2021;15(3):561-7. doi: 10.1177/1932296820972751.

14. https://checkpointehr.com/blog/difference-between-mipsand-apms/. Accessed 4-13-22. 15. https://www.myavls.org/member-resources/macra-resources. html . Accessed 4-13-22. 16. https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1783/QPP%202020%20Participation%20Results%20Infographic.pdf . Accessed 4-13-22. 17. https://mdinteractive.com/mips-blog/cms-releases-2022mips-final-rule-key-takeaways. Accessed 4-13-22. 18. https://healthpayerintelligence.com/news/how-hedis-cmsstar-ratings-cqms-impact-healthcare-payers. Accessed 4-13-22. 19. https://www.cdc.gov/diabetes/basics/quick-facts.html . Accessed 4-13-22. 20. American Diabetes Association. Economic costs of diabetes

FEATURE

Conclusion The goal of value-based care is to cost-effectively improve patient outcomes. Value-based care models reward providers for efficient and effective patient care based on reported quality measures. Chronic conditions such as diabetes and CKD are ideal targets for value-based care because early detection and coordinated intervention can stop disease progression, improve quality of life, and reduce healthcare costs.

33. Crocker JB, Lee-Lewandrowsky E, Lewandrowsky N, et al. Implementation of point-of-care testing in an ambulatory practice of an academic medical center. Am J Clin Pathol. 2014;142(5):640-6. 34. Christofides EA, Desai N. Optimal early diagnosis and monitoring of diabetic kidney disease in type 2 diabetes mellitus: addressing the barriers to albuminuria testing. J Prim Care Community Health. 2021;12:21501327211003683. doi: 10.1177/21501327211003683. 35. Schultes B, Emmerich S, Kistler AD, Mecheri B, Schnell O, Rudofsky G. Impact of albumin-to-creatinine ratio point-of-care testing on the diagnosis and management of diabetic kidney disease. J Diabetes Sci Technol. 2021 Oct 28;19322968211054520. doi: 10.1177/19322968211054520.

2022 · ISSUE 6 | 11

CHEMISTRY ANALYZERS EASY, INTEGRATED WITH-PATIENT TESTING I-STAT SYSTEM

PRODUCT FOCUS

Easy, Integrated With-Patient Testing From Abbott Point of Care i-STAT System from Point of Care at Abbott

The handheld i-STAT System offers a broad menu of diagnostic tests at the patient’s side in just minutes. With just a few drops of blood, The handheld i-STAT offers broad menu of for diagnostic tests at the the i-STAT SystemSystem delivers real time,alab-accurate results a wide chemistries, blood gas,drops coagulation, cardiac patient’srange sideofintests, justincluding minutes. With just a few of blood, the i-STAT more. Minimize delays and wasted time with on-side System markers, deliversand real time, lab-accurate results for a wide range of tests, tests. Easy, intuitive operation.

including chemistries, blood gas, coagulation, cardiac markers, and more. For intended usewasted and complete information, visit pointofMinimize delays and timeproduct with on-site tests. Easy, intuitive operation. 1604

care.abbott.

For intended use anddiagnostic completeuse product information, visit pointofcare.abbott. For in vitro only. This material is intended for a U.S.

For in vitro diagnostic only. This material is intendedofforAbbott. a U.S. audience only. audienceuse only. i-STAT is a trademark Physician Office Rei-STAT is a trademark of Abbott. Physician Office Resource Product08/20 Description – US 3064.REV1 08/20 source i-STAT Product Description — US i-STAT 3064.REV1

View Brochures, Videos & More at POR.io Enter Number 1604 in the Search Area

FULL COMPLEMENT OF CLIA-WAIVED BLOOD CHEMISTRY TESTS PICCOLO XPRESS® CHEMISTRY ANALYZER

Full Complement of Piccolo Xpress® Che

From Abbott Point of Care

The Piccolo Xpress C lab-accurate results fo tests, including metab 1605with just 100 microlite results during a patien efficiency, and suppor every test helps ensu

The Piccolo Xpress Chemistry Analyzer provides physician offices with lab-accurate results for a broad range of CLIAwaived general chemistry tests, including metabolic panels, lipids, live, and kidney function, and more with just 100 microliters of blood. Easy to use, the PIccolo Xpress provides results during a patient’s visit, accelerating treatment decisions, increasing efficiency, and supporting patient satisfaction. Automated quality control on every test helps ensure accuracy.

For in vitro diagnostic use only. T Piccolo Xpress is a registered tra Physician Office Resource Picco

View Brochures, Videos & More at POR.io Enter Number 1605 in the Search Area

1606

ENVOY500+ DELIVERING PROVEN RESULTS IN CLINICAL CHEMISTRY From EliTech The fully automated Envoy500+ is designed to deliver the performance of a large floor model analyzer but provides the cost efficiency of a benchtop analyzer (TPH approx. 490). It enables accurate treatment decisions sooner. Envoy500+ delivers savings the laboratory requires with the following features positive sample and reagent identification, clot detection, liquid level sensing, dry ISE module, reusable glass cuvettes, and many more.

View Brochures, Videos & More at POR.io Enter Number 1606 in the Search Area

POC-22-NAM-3308

Meet the Quadruple Aim in Diabetes Care with In-office HbA1c and uACR Better outcomes. Lower costs. Better patient experience. Better clinician experience.

Comprehensive diabetes-management solutions at the point-of-care Gain key insights into your patient’s current status and drive guideline recommended test adherence: DCA Vantage® Analyzer CLIA-waived HbA1c • Rapid assessment for glycemic control CLINITEK Status® Connect System CLIA-waived analyzer for routine urinalysis • Rapid kidney health assessment: CLINITEK® Microalbumin 2 Strip Albumin-to-creatinine ratio (ACR) Total U.S. Population with Diabetes

54% Increase

The Prevalence of Diabetes Among U.S. Adults is on the Rise1 Help your patients reverse the trend

54,913,000 43,271,000 35,644,000

11.1%

15.3% 13.0%

Customize your patient consultations to enhance physician-patient partnership toward improved outcomes. siemens-healthineers.us/chronicdisease

1607 2015

2020

2030 Projected

1. Rowley, William R et al. “Diabetes 2030: Insights from Yesterday, Today, and Future Trends.” Population health management vol. 20,1 (2017): 6-12. doi:10.1089/pop.2015.0181.

A Dream DESTIN-ATION SANDESTIN GOLF AND BEACH RESORT BY BRANDI NIMMO

Aria greeted me with a smile on her face and my name on a sign she held in her hand, welcoming me to the panhandle paradise. She would be the driver to my Destin-ation, the beautiful emerald waters and white sand beaches of Destin, Florida. “I hope you don’t get a cavity from all the sugar,” she coyly offers, “the sugar-like sand we have down here will give you a toothache.” She gives me a wink and holds the door as I climb into the black SUV. As it turned out, there is no exaggeration in comparing the granularity and whiteness of sugar to the snow-white sand on the beaches of the Emerald Coast. The northwest coastline beaches rank at the top in the Continental US, and it’s easy to see why. This sand is nearly pure quartz crystal making it ultra-soft, with an almost fluffy-like texture. The color is so white that one needs to wear sunglasses from the glare of brightness. In contrast, rushing up upon it is the emerald-colored ocean. The water rivals any Caribbean island; the color is a gorgeous green, transitioning to an ombre of blues - breathtaking. I’m new to this neck of the woods, and there are woods. The lush landscape of palm trees sharing space with the pines and live oaks draped in Spanish moss draws me into my surroundings. Nestled among the mature plantings and abundant wildlife and scenery are meandering golf cart and bike paths, walking trails, and streets that stretch from bay to beach and beyond. Sandestin Golf and Beach Resort offers 2400 acres of natural beauty, from the beaches of the Gulf of Mexico over to

the shores of the Choctawhatchee Bay and everything in between. A contemporary coastal tower appears, with brickwork, hurricane shutters, and wooden beams, all combine to give the structure a friendly facade. Tucked amongst the trees, Hotel Effie Sandestin is the newly built treasure I’m excited to discover. This luxury boutique hotel is just a year old and has quickly become the place in Northwest Florida to see and be seen. I’m enthralled as I enter the lobby with the expansive ceilings, fresh floral arrangements, extensive marble, curated artwork, modern crystal fixtures, and design concept. The receptionist offers a craft cocktail or a sweet tea and shares all the complimentary amenities available during my stay as the bellman whisks away my luggage to my room. There’s a nice balance of refinement and comfort, sophistication, and Southern hospitality -it’s easy to see why this has become a gem of the Emerald Coast. One thing which intrigues me is the name: The Effie. While walking to my room, I come upon a portrait of the hotel’s namesake, Effie Burns, in the main lobby. Below the photograph is a couple of rocking chairs inviting guests to pull up a seat, relax and sit for a spell. Effie was the grandmother to owner and developer Tom Becnel, and she was known for her hospitality and charm, serving as inspiration for what Becnel hopes his hotel will exemplify. The framed picture reminds staff to be exceptional hosts and devoted caretakers. A welcoming emblem to all those entering the property, you are now a part of the family. 2022 · ISSUE 6 | 15

The 250-room hotel features multiple configurations, with some being larger suites but all wrapped in comfortable luxury. Design elements from the lobby continue through to the guest rooms with a soothing coastal color palette like the textures and tones of the natural dunes nearby. Pops of rich jewel tones mimic the blues of the sea out the large black paned windows. Lux linens, overstuffed pillows, cozy robes and throw blankets, illuminated mirrors, and organic bath products add to the indulgence.

in all of Northwest Florida, a popular place to play relaxing games, a giant chessboard and corn hole, or watch the big game on one of the many TVs in the lounge. The spirits are flowing for guests while the DJ spins the beats. As the strung bistro lights come on and the mood softens at dusk, it’s a gorgeous setting to take in the 360-degree panoramic views and watch the sunset. And for a family affair, a weekly movie night by the pool for the little ones - Kung Fu Panda under the moonlight, is a memory maker.

Spa Lilliana, the onsite procurer of pampering, was a perfect place to begin my stay. The carefully appointed space, with comfortable colors, cocoon-like chaise lounges, and low lighting in the relaxation lounge, sets the tone. There are ten treatment rooms for massage therapists to provide therapeutic and rejuvenating services. I’ve received many massages in my years, but Mindy performed some magic on my back that I will be forever grateful. Lovely locker rooms, a spa area for manicures, pedicures, salon services, and a boutique with beachwear round out the facility’s features. A bit of European indulgence with the Parisian skincare line Biologique Recherche and an organic takeaway from the staff, a gift bottle of Osea Undaria Algae body oil, a sweet reminder of my time at Spa Lilliana.

The resort provides a free shuttle to deliver guests to the many popular points in the area; my Destin-ation is a day at the touted beach. It’s a short distance where I’m dropped off at the private beach area, greeted by Hotel Effie staff, who set up a beach chair, towels, and umbrella and offer a menu for lite bites and snacks. Everything was perfect with the sound of the waves and the infamous sugar sand between my toes; my only worry would be if the tide would reach my chair. Thanks to the palm trees, emerald sea, and Florida sun, all my stress evaporated. A perfect day in the panhandle.

Exploring the area on higher ground, I venture up to Hotel Effie’s Ara Rooftop & Pool Lounge. What a beautiful place to soak in the sun and find respite in one of the cool trellised cabanas. It’s a one-of-a-kind experience here, as it’s the only rooftop pool 16 | PHYSICIANS OFFICE RESOURCE

The Sandestin Golf and Beach Resort has many places to eat, but it’s nice to have a lovely place to dine onsite at the Hotel Effie. Ovide, the signature restaurant, lovingly named after Effie’s husband, is not only convenient - it’s cool. The space features significant floral art displayed overhead for dramatic effect, a spacious bar accented with mirrors, and large windows to allow the light to stream in, balancing the dark interior

palate. The interior design is equally laudable with the culinary craftmanship courtesy of celebrity chef Hugh Acheson. Chef Acheson combines the local flavors of the Gulf region, enhancing them with French cooking flare. He is a James Beard Award winner, served as a judge on Top Chef, and is the chef/owner of several top restaurants in the South. Acheson and his team have developed heightened cuisine offerings that make Ovide an exceptional eatery. Sweetbay Coffee is your best bet for grab-and-go sandwiches, pastries, and barista favorites. A search for easy fare, small plates, and creative craft cocktails, pull up a seat to The Lobby Bar. One of the best salads I’ve ever enjoyed was on the light menu at the Ara Rooftop & Lounge. But when you venture out of the Hotel Effie, the Village at Baytowne Wharf is just a stone’s throw away. The 28-acre waterfront town center is a unique collection of award-winning restaurants, specialty merchants, lively nightclubs, and charming boutiques. A jampacked calendar with special events and fun festivals makes this the premier gathering spot for guests and residents of Sandestin. This coastal community has made magical memories for its guests and generations of families for over 45 years, offering every imaginable amenity for visitors to enjoy. Golf: Four topnotch courses, The Raven is a Robert Trent Jones Jr. tract, and Golf Magazine dubs the Burnt Pine course as the “Crown Jewel of Florida Golf.” Whether it is 18 holes from the beach to the

bay or individual instruction from the pros, pure enjoyment is par for these courses. Fitness: a state-of-the-art gym with a wide variety of cardio equipment options and a long list of classes to join in like yoga, turbo kick, and Zumba, to name a few. Tennis: 12 world-class HydroGrid clay and three hard tennis courts, six Pickleball courts with private lessons with pros, fun Round Robin tournaments, and ball machines. Fishing: Destin was discovered and settled by fishermen in 1835, and it’s known for being “The World’s Luckiest Fishing Village.” Charters, overnight fishing trips, and equipment are available at the Baytowne Marina. Water sports: Waverunners, pontoon boats, kayaks, boogie, and paddleboards are a great way to enjoy the Gulf waters. Featured activities that children young and old can enjoy: Floating Water Park, beach bonfires, Baytowne Adventure Zone with zip line, ropes course and tower climb, Blast Arcade and Laser Maze, bicycles, nature trails, treehouse, and carousel are all available for free or a nominal fee. Once you arrive, you never have to get into your vehicle because the Hotel Effie is a self-inclusive world, complete in itself, in that everything you need is right on the Sandestin Golf and Beach Resort property. With the warm hospitality and charm of the South, with so many entertainment activities, and all the opportunities for relaxation and rejuvenation, this dream Destin-ation is one you may never wish to leave.

2022 · ISSUE 6 | 17

PRODUCT FOCUS

COVID-19 TESTING WHY COMPROMISE? FAST AND RELIABLE RESULTS ARE NOW DELIVERED AT THE POINT OF CARE.

1608

From LumiraDx

Introducing the next generation in point-of-care diagnostics. With a growing menu of tests, LumiraDx uses a simple process that allows for more time with your patients by using microfluidic technology that delivers results in minutes. Learn more about rapid COVID-19 diagnostic solutions for your physician office at LumiraDx.com.

View Brochures, Videos & More at POR.io Enter Number 1608 in the Search Area

BIOFIRE® RESPIRATORY 2.1-EZ (RP2.1-EZ)1 PANEL (EUA)1 From BioFire SARS-CoV-2 is everyone’s top suspect, but many other respiratory bugs can cause similar, overlapping symptoms. In your clinic, you can test for 19 common respiratory pathogens, including SARS- CoV-2, with the BioFire RP2.1-EZ Panel (EUA)1—now available under an FDA Emergency Use Authorization. Syndromic testing means all it takes is one test and just 45 minutes to round up SARS-CoV-2—and all the other usual respiratory suspects. 1. This test is not FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories.

View Brochures, Videos & More at POR.io Enter Number 1609 in the Search Area

1609

SOFIA® 2 FLUORESCENT IMMUNOASSAY ANALYZER AND RAPID DIAGNOSTIC TEST KITS 1610

From Quidel

Sofia® 2 Fluorescent Immunoassay Analyzer and Rapid Diagnostic Test Kits Sofia 2 takes rapid testing to a new level. Proven lateral-flow technology and advanced fluorescent chemistry are all integrated into this small benchtop analyzer which can be used in any point-of-care setting. Sofia 2 kits are easy to use and adaptable to any healthcare setting. Excellent performance, objectivity, quality control, LIS capabilities, and an expanding test menu make Sofia 2 the perfect solution for the physician’s office laboratory.

View Brochures, Videos & More at POR.io Enter Number 1610 in the Search Area

18 | PHYSICIANS OFFICE RESOURCE

40 mg tablets 80 mg tablets

NEWLY PUBLISHED DATA

FROM AN XTANDI PIVOTAL TRIAL

Scan this QR code to learn more at XtandiHCP.com

PRODUCT FOCUS

DIABETES

1611

COMPREHENSIVE IN-OFFICE DIABETES TESTING WITH THE DCA VANTAGE® AND CLINITEK STATUS®+ ANALYZERS From Siemens Healthineers Siemens Healthineers DCA Vantage® and CLINITEK Status® family of analyzers provide hemoglobin A1c (HbA1c) and albuminto-creatinine ratio (ACR) testing at the point of care. Meet quality measures for A1c control and kidney disease check in minutes with CLIA-waived HbA1c testing and ACR1 ratio. Improve patient experience and overall outcome by providing actionable results in minutes. 1. Moderately complex on the DCA Vantage Analyzer. CLIA-waived on the CLINITEK Status+ Analyzer.

View Brochures, Videos & More at POR.io Enter Number 1611 in the Search Area

LAB-ACCURATE RESULTS FOR ACR AND HBA1C

1612

From Abbott With its compact size and panel of tests, the Afinion 2 system is ideal for point-of-care testing in physician offices, clinics, community health centers and hospital out-patient clinics. From just a small urine or fingerstick whole blood sample, lab-accurate results for ACR and HbA1c are made available during the consultation.

View Brochures, Videos & More at POR.io Enter Number 1612 in the Search Area

ACCURATE, ACTIONABLE RESULTS FROM THE LEADER IN POINT-OFCARE LIPID TESTING From Abbott The CLIA-waived Alere Cholestech LDX™ Analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in point-of-care lipid profile, cholesterol, and glucose testing. Results are easy to obtain. Fingerstick sampling and a small sample size (40μL) makes results less painful and time consuming.

1613

20 | PHYSICIANS OFFICE RESOURCE

View Brochures, Videos & More at POR.io Enter Number 1613 in the Search Area

1614

1616

1615

PRODUCT FOCUS

FLU AND RESPIRATORY WHY COMPROMISE? FAST AND RELIABLE RESULTS ARE NOW DELIVERED AT THE POINT OF CARE.

1617

From LumiraDx

View Brochures, Videos & More at POR.io Enter Number 1617 in the Search Area

SOFIA® 2 FLUORESCENT IMMUNOASSAY ANALYZER AND RAPID DIAGNOSTIC TEST KITS

1618

From Quidel

View Brochures, Videos & More at POR.io Enter Number 1618 in the Search Area

OSOM ULTRA PLUS FLU A&B TEST From Sekisui Diagnostics 1619

Stronger Clinical Performance Takes Lateral Flow Testing To The Next Level. Providing superior rapid results at the point-of-care. Fast, easy, cost effective so you can test and treat in one visit. • High Performance- Equivalent or exceeding the performance of reader devices, without the need for an instrument • Results in 10 minutes • OSOM® Custom Care- Exceptional Support/Training by licensed medical technologists and experienced healthcare professionals • Made in the USA

View Brochures, Videos & More at POR.io Enter Number 1619 in the Search Area 22 | PHYSICIANS OFFICE RESOURCE

Solid & Glass Door Refrigerators From 1 to 15 Cu.ft.

Refrigerators & Freezers From 23 to 49 Cu.ft. Refrigeration designed and purpose-built for pharmacy, medication, and vaccination applications to support meeting CDC/VFC vaccine storage guidelines

+/-1ºC variation derived from the maximum deviation of an NTC sensor in a 1 oz. vial located nearest the champer geometric center during a 24 hour test period

1620

Advanced Temperature Control & Durable Performance

• Intelligent microprocessor digital temperature controller • Adjustable operating control range from +2 to +8ºC • Digital display of the min/max temperature in Celsius or Fahrenheit • Password protected control parameters beyond setpoitn • Optimized forced air cooling for excellent stability & uniformity with rapid recovery • Open door and high/low temperature alarms • Factory installed lock conveniently located towards the top of each unit • ��

Pharma-Vac Refrigerators Accucold ARS1PV ARG1PV ARS3PV ARG3PV ARS6PV ARG6PV ARS8PV ARG8PV ARS12PV ARG12PV ARS15PV ARG15PV

Capacity 1 cu.ft. 1 cu.ft. 3 cu.ft. 3 cu.ft. 6 cu.ft. 6 cu.ft. 8 cu.ft. 8 cu.ft. 12 cu.ft. 12 cu.ft. 15 cu.ft. 15 cu.ft.

Height 21.5” 21.5” 33.75” 33.75” 32.5” 32.5” 50” 50” 61.75” 61.75” 72” 72”

Width 17.5” 17.5” 18.5” 18.5” 23.5” 23.5” 23.38” 23.38” 23.38” 23.38” 23.5” 23.5”

Depth 19.5” 20” 19” 19.5” 24.5” 25” 24.5” 25” 24.5” 25” 24.5” 25”

Door White Glass White Glass White Glass White Glass White Glass White Glass

790*, 936.00 949.00 1,059.50 1,072.50 1,180.40 1,193.40 1,497.60 1,510.60 2,002.00 2,015.00 2,294.50 2,307.50

Height 83.75 83.75 83.75 83.75

Width 27.5 27.5 55.25 55.25

Depth 31 31 31 31

Door (1) Stainless (1) Glass (2) Stainless (2) Glass

790*, 2,762.50 3,113.50 4,413.50 4,771.00

Height 83.75 83.75

Width 27.5 55.25

Depth 31 31

Door (1) Stainless (2) Stainless

790*, 3,178.50 5,063.50

Pharma-Lab Refrigerators Accucold ARS23ML ARG23ML ARS49ML ARG49ML

Capacity 23 cu.ft. 23 cu.ft. 49 cu.ft. 49 cu.ft.

Pharma-Lab Freezers Accucold AFS23ML AFS49ML

Capacity 23 cu.ft. 49 cu.ft.

Choosing the Right Sized Unit Below are a few handy steps for determining the ideal Accucold refrigerator size for your clinic:

Estimate the maximum number of doses of publicly-provided vaccine and privately purchased vaccine that will be in your refrigerator.

Refrigerator: Public Vaccine

Add the number of doses on hand (current inventory) from your last order form. ________________

Match your maximum doses with the minimum cubic feet needed to safely store your vaccine

Max. Doses

Minimum Cubic Ft.

2,000+ doses

may need more than one refrigerator

1000-2000

40 cu.ft 36 cu.ft 21-23 cu.ft

Private Vaccine

+ ________________

900-1000 801-900

Total doses

= ________________

701-800

17-19.5 cu.ft

Multiply (max inventory) Maximum doses

x 1.25 = ________________

400-700

11-16.7 cu.ft

100-399

4.9-6.1 cu.ft

2022 · ISSUE 6 | 23

PRODUCT FOCUS

STREP TESTS 1621

OSOM® ULTRA STREP A TEST From Sekisui Diagnostics

The OSOM® Ultra Strep A test is a color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. Shown to be not statistically different than single swab culture. Sensitivity 95.7% and 100% Specificity. Includes two additional test sticks for External QC. CLIA Waived..

View Brochures, Videos & More at POR.io Enter Number 1621 in the Search Area

SOFIA® 2 FLUORESCENT IMMUNOASSAY ANALYZER AND RAPID DIAGNOSTIC TEST KITS

1622

From Quidel

View Brochures, Videos & More at POR.io Enter Number 1622 in the Search Area

TOXICOLOGY TOXICOLOGY SCREENING SIMPLIFIED ABBOTT’S IMMTOX 270 BENCHTOP ANALYZER NOW WITH 14 ASSAYS CLIA CATEGORIZED AS MODERATE COMPLEXITY From Abbott

The ImmTox270 benchtop analyzer offers comprehensive toxicology screening solutions for physician offices, treatment centers and independent laboratories. Broad test menu with over 20 assays to choose from including 14 that are now available as moderately complex.

1623

With complete laboratory solutions from consultation to licensure, and compliance the Abbott Clinical Laboratory Solutions team has you covered.

View Brochures, Videos & More at POR.io Enter Number 1623 in the Search Area 24 | PHYSICIANS OFFICE RESOURCE

Choice without compromise. Soa 2 delivers automated, objective, and accurate results across a growing menu of assays from respiratory infectious diseases to Lyme disease and GI infections. With its unique “Advance Result Technology” (ART), Soa 2 can provide results in as few as 3 minutes, helping you get through increasingly heavier workloads.

With Soa 2, you no longer have to choose between accuracy and speed.

For more information, contact Quidel Inside Sales at 858.431.5814. 1624

*THESE TESTS ARE AVAILABLE FOR SALE IN THE USA UNDER EMERGENCY USE AUTHORIZATION. These tests have not been FDA cleared or approved, but have been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. These assays are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner. AD10102100EN00 (03/22)

WOMEN’S HEALTH PRODUCT FOCUS

OSOM® BVBLUE® 1625

From Sekisui Diagnostics The OSOM® BVBLUE® detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella and Mobiluncus. OSOM® BVBLUE® is more sensitive than Amsel criteria providing physicians with a more accurate diagnosis to treat and minimize serious health consequences such as early spontaneous preterm births and miscarriage.

View Brochures, Videos & More at POR.io Enter Number 1625 in the Search Area

OSOM® TRICHOMONAS RAPID TEST From Sekisui Diagnostics The OSOM® Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis antigens from vaginal swabs or from the saline solution. The OSOM® Trichomonas Rapid Test is a CLIA-waived rapid test available today. OSOM® Trichomonas is more sensitive than wet mount due to the assay being able to detect viable and non-viable organisms which offers significant benefits to the patient and clinician alike.

View Brochures, Videos & More at POR.io Enter Number 1626 in the Search Area

1627

1626

ULTRA HCG COMBO TEST From Sekisui Diagnostics The OSOM® Ultra hCG Combo test is a simple immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Internal studies have confirmed that the OSOM® Ultra hCG Combo test does not have a false negative result from hCG variants providing physicians with a higher level of confidence.

View Brochures, Videos & More at POR.io Enter Number 1627 in the Search Area

26 | PHYSICIANS OFFICE RESOURCE

LIBTAYO is indicated for the ﬁrst-line treatment of patients with non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations, and is1: • Locally advanced where patients are not candidates for surgical resection or deﬁnitive chemoradiation or1 • Metastatic1

A FIRST-LINE TREATMENT OPTION IN

ADVANCED NSCLC

NCCN Guidelines ® for Non-Small Cell Lung Cancer recommend cemiplimab-rwlc (LIBTAYO) as a Category 1* (preferred) systemic therapy option for advanced NSCLC2† *Category 1 recommendation is based upon high-level evidence and uniform NCCN consensus that the intervention is appropriate.2

Category 1* (preferred) recommendation2

See the NCCN Guidelines for the detailed recommendations, including other preferred options.

†

PD-L1–POSITIVE (≥50%) ADVANCED NSCLC A preferred PD-1 inhibitor2

CATEGORY 1*

NCCN PREFERRED

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.

Negative for actionable molecular markers and no contraindications to PD-1 or PD-L1 inhibitors2

OPTION FOR ADVANCED NSCLC2

ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; NCCN=National Comprehensive Cancer Network; PD-1=programmed death receptor-1; PD-L1=programmed death ligand 1; ROS1=ROS proto-oncogene 1, receptor tyrosine kinase.

Approved in patients with advanced NSCLC‡ with PD-L1 ≥50% and no EGFR, ALK, or ROS1 aberrations1

LIBTAYO significantly EXTENDED SURVIVAL vs platinum-based chemotherapy in EMPOWER-Lung 11,3 32% Median OS: 22.1 months 70% 12-mo OS rate

1.0 0.9

(95% CI, 64%-75%)

Probability of OS

ITT population (N=710)

0.8

49% 24-mo OS rate

0.7

(95% CI, 39%-57%)

0.6

0.1 0

Median OS LIBTAYO: 22.1 months (95% CI, 17.7-NE) Chemotherapy: 14.3 months (95% CI, 11.7-19.2) 0

30%

304 303

254 254

48 41

37 27

27 12

18 7

8 4

3 3

1 0

0 0

Month

Number of subjects at risk 356 LIBTAYO Chemotherapy 354

LIBTAYO (n=356) Chemotherapy (n=354)

(95% CI, 19%-41%)

223 205

198 172

147 126

120 93

Study design

87 73

71 52

(95% CI, 17.7-NE) with LIBTAYO vs 14.3 months (95% CI, 11.7-19.2) with chemotherapy1

• Number of deaths: 30% of patients (108 out of 356 patients) with LIBTAYO and 40% of patients (141 out of 354 patients) with chemotherapy1 • Nearly 3 out of 4 patients (74%) who progressed on platinum-based chemotherapy crossed over to LIBTAYO treatment1

(95% CI, 49%-62%)

0.4 0.2

(95% CI, 0.53-0.87) P=0.0022

56%

0.5 0.3

Reduction in risk of death HR=0.68

Patients with locally advanced NSCLC who are not candidates for surgical resection or deﬁnitive chemoradiation or who have metastatic NSCLC.1

‡

HR=hazard ratio; NE=not evaluable; OS=overall survival.

EMPOWER-Lung 1 was a large, phase 3, randomized, open-label, multicenter study that included patients with locally advanced NSCLC who were not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC. Key eligibility criteria included PD-L1 expression ≥50% and ECOG PS 0 or 1. Patients with type 1 diabetes mellitus or hypothyroidism only requiring hormone replacement were eligible. Patients with brain metastases that were treated and clinically stable (neurologically returned to baseline) for at least 2 weeks prior to randomization were permitted. Radiological confirmation of stability or response was not required. Patients were excluded if they had EGFR, ALK, or ROS1 aberrations, a medical condition that required systemic immunosuppression, uncontrolled infections with hepatitis B, hepatitis C, or HIV, autoimmune disease that required systemic therapy within 2 years of treatment, and never-smokers.1,3,4 Patients were randomized 1:1 to receive LIBTAYO 350 mg IV Q3W for up to 108 weeks or investigator’s choice of the following platinum-doublet chemotherapy regimens for 4 to 6 cycles: paclitaxel + cisplatin or carboplatin; gemcitabine + cisplatin or carboplatin; or pemetrexed + cisplatin or carboplatin followed by optional pemetrexed maintenance in patients with nonsquamous histology. Treatment with LIBTAYO continued until RECIST 1.1-defined progressive disease, unacceptable toxicity, or for up to 108 weeks. Patients who experienced IRC-assessed RECIST 1.1-defined progressive disease on therapy with LIBTAYO were permitted to continue treatment with LIBTAYO 350 mg Q3W for up to 108 additional weeks, along with the addition of histology-specific chemotherapy for 4 cycles until further progression was observed. Patients who experienced IRC-assessed RECIST 1.1-defined progressive disease on chemotherapy were permitted to receive treatment with LIBTAYO monotherapy until further progression, unacceptable toxicity, or for up to 108 weeks.1,3 The primary efficacy endpoints were OS and PFS. Secondary endpoints included ORR (key), DOR, and safety and tolerability.1,4 The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.1 DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; IRC=independent review committee; IV=intravenous; ORR=objective response rate; PFS=progression-free survival; PS=performance status; Q3W=every 3 weeks; RECIST=Response Evaluation Criteria in Solid Tumors.

Important Safety Information Warnings and Precautions

Severe and Fatal Immune-Mediated Adverse Reactions While immune-mediated adverse reactions usually occur during treatment, Immune-mediated adverse reactions, which may be severe or fatal, can they can also occur after discontinuation. Immune-mediated adverse occur in any organ system or tissue at any time after starting treatment. reactions affecting more than one body system can occur simultaneously. Please see additional Important Safety Information and Brief Summary of full Prescribing Information on the following pages.

The EMPOWER-Lung 1 study was designed to enroll patients with PD-L1 ≥50%.4 • A total of 710 patients were enrolled and randomized. For some patients, it was later determined that PD-L1 biomarker testing was not conducted according to the instructions for use, and required retesting4 • An analysis was conducted in a subset of patients with known PD-L1 ≥50% (n=563). The analysis excluded 91 patients from the overall population whose PD-L1 status was unknown because their tumors could not be retested, and 56 patients from the overall population who had <50% PD-L1 expression4 (LIBTAYO is not indicated in patients with <50% PD-L1 expression)

In an analysis of the subset of patients with advanced NSCLC* who had no EGFR, ALK, or ROS1 aberrations and known PD-L1 ≥50% (n=563):

Overall survival with LIBTAYO vs platinum-based chemotherapy in EMPOWER-Lung 13-5 43% Median OS: Not Reached 72% 12-mo OS rate

0.9

Reduction in risk of death HR=0.57

(95% CI, 66%-78%)

0.8

Probability of OS

Known PD-L1 ≥50% population (n=563)

1.0

(95% CI, 0.42-0.77) P=0.0002

0.7 0.6 0.5

54%

0.4

(95% CI, 46%-61%)

0.3 0.2 0.1 0

Median OS LIBTAYO: Not Reached (95% CI, 17.9-NE) Chemotherapy: 14.2 months (95% CI, 11.2-17.5) 0

LIBTAYO (n=283) Chemotherapy (n=280) 10

244 239

203 198

24 15

18 11

15 6

10 4

6 2

3 1

1 0

0 0

• Number of deaths: 25% of patients (70 out of 283 patients) with LIBTAYO and 38% of patients (105 out of 280 patients) with chemotherapy4,5 • 72% of patients who progressed on platinum-based chemotherapy crossed over to LIBTAYO treatment6

Month

Number of subjects at risk 283 LIBTAYO Chemotherapy 280

(95% CI, 17.9-NE) with LIBTAYO vs 14.2 months (95% CI, 11.2-17.5) with chemotherapy4,5

177 153

154 125

108 87

83 57

55 41

42 25

Adapted with permission from Sezer et al, Lancet 2021.4 *Patients with locally advanced NSCLC who were not candidates for surgical resection or deﬁnitive chemoradiation or who had metastatic NSCLC.4

Clinical safety data1 • LIBTAYO was permanently discontinued due to adverse reactions in 6% of patients; • Adverse reactions resulting in permanent discontinuation in at least 2 patients were pneumonitis, pneumonia, ischemic stroke, and increased aspartate aminotransferase • Serious adverse reactions occurred in 28% of patients receiving LIBTAYO; • The most frequent serious adverse reactions in at least 2% of patients were pneumonia and pneumonitis

Important Safety Information (continued) Warnings and Precautions (continued)

Severe and Fatal Immune-Mediated Adverse Reactions (continued) Early identification and management are essential to ensuring safe use of PD-1/PD-L1–blocking antibodies. The definition of immune-mediated adverse reactions included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. No dose reduction for LIBTAYO is recommended. In general, withhold LIBTAYO for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue LIBTAYO for life-threatening (Grade 4) immunemediated adverse reactions, recurrent severe (Grade 3) immune-mediated adverse reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone equivalent per day within 12 weeks of initiating steroids. Withhold or permanently discontinue LIBTAYO depending on severity. In general, if LIBTAYO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or

equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroids. Immune-mediated pneumonitis: LIBTAYO can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.2% (26/810) of patients receiving LIBTAYO, including Grade 4 (0.5%), Grade 3 (0.5%), and Grade 2 (2.1%). Pneumonitis led to permanent discontinuation in 1.4% of patients and withholding of LIBTAYO in 2.1% of patients. Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 58% of the 26 patients. Of the 17 patients in whom LIBTAYO was withheld, 9 reinitiated after symptom improvement; of these, 3/9 (33%) had recurrence of pneumonitis. Withhold LIBTAYO for Grade 2, and permanently discontinue for Grade 3 or 4. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiating steroids.

Please see additional Important Safety Information and Brief Summary of full Prescribing Information on the following pages.

For more information, scan this QR code with your phone, or visit LIBTAYOhcp.com/NSCLC

• Hypophysitis: LIBTAYO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue depending on severity. Hypophysitis occurred in 0.4% (3/810) of patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.1%) adverse reactions. Hypophysitis led to permanent discontinuation of LIBTAYO in 1 (0.1%) Important Safety Information (continued) patient and withholding of LIBTAYO in 1 (0.1%) patient. Systemic corticosteroids were required in 67% (2/3) of patients with hypophysitis. Warnings and Precautions (continued) Hypophysitis had not resolved in any patient at the time of data cutoff Severe and Fatal Immune-Mediated Adverse Reactions (continued) • Thyroid disorders: LIBTAYO can cause immune-mediated thyroid Immune-mediated colitis: LIBTAYO can cause immune-mediated colitis. disorders. Thyroiditis can present with or without endocrinopathy. The primary component of immune-mediated colitis was diarrhea. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement Cytomegalovirus (CMV) infection/reactivation has been reported in patients or medical management of hyperthyroidism as clinically indicated. with corticosteroid-refractory immune-mediated colitis treated with PD-1/ Withhold or permanently discontinue LIBTAYO depending on severity PD-L1–blocking antibodies. In cases of corticosteroid-refractory immune• Thyroiditis: Thyroiditis occurred in 0.6% (5/810) of patients receiving mediated colitis, consider repeating infectious workup to exclude alternative LIBTAYO, including Grade 2 (0.2%) adverse reactions. No patient etiologies. Immune-mediated colitis occurred in 2.2% (18/810) of patients discontinued LIBTAYO due to thyroiditis. Thyroiditis led to withholding of receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (1.1%). Colitis led LIBTAYO in 1 patient. Systemic corticosteroids were not required in any to permanent discontinuation in 0.4% of patients and withholding of patient with thyroiditis. Thyroiditis had not resolved in any patient at the LIBTAYO in 1.5% of patients. Systemic corticosteroids were required in all time of data cutoff. Blood thyroid stimulating hormone increased and patients with colitis. Colitis resolved in 39% of the 18 patients. Of the blood thyroid stimulating hormone decreased have also been reported 12 patients in whom LIBTAYO was withheld, 4 reinitiated LIBTAYO after • Hyperthyroidism: Hyperthyroidism occurred in 3.2% (26/810) of patients symptom improvement; of these, 3/4 (75%) had recurrence. Withhold receiving LIBTAYO, including Grade 2 (0.9%). No patient discontinued LIBTAYO for Grade 2 or 3, and permanently discontinue for Grade 4. Resume treatment and LIBTAYO was withheld in 0.5% of patients due to in patients with complete or partial resolution (Grade 0 to 1) after hyperthyroidism. Systemic corticosteroids were required in 3.8% (1/26) corticosteroid taper. Permanently discontinue if no complete or partial of patients. Hyperthyroidism resolved in 50% of 26 patients. Of the resolution within 12 weeks of initiating steroids or inability to reduce 4 patients in whom LIBTAYO was withheld for hyperthyroidism, 2 patients prednisone to less than 10 mg per day (or equivalent) within 12 weeks of reinitiated LIBTAYO after symptom improvement; of these, none had initiating steroids. recurrence of hyperthyroidism Immune-mediated hepatitis: LIBTAYO can cause immune-mediated • Hypothyroidism: Hypothyroidism occurred in 7% (60/810) of patients hepatitis. Immune-mediated hepatitis occurred in 2% (16/810) of patients receiving LIBTAYO, including Grade 2 (6%). Hypothyroidism led to permanent receiving LIBTAYO, including fatal (0.1%), Grade 4 (0.1%), Grade 3 (1.4%), discontinuation of LIBTAYO in 1 (0.1%) patient. Hypothyroidism led to and Grade 2 (0.2%). Hepatitis led to permanent discontinuation of LIBTAYO withholding of LIBTAYO in 1.1% of patients. Systemic corticosteroids were in 1.2% of patients and withholding of LIBTAYO in 0.5% of patients. not required in any patient with hypothyroidism. Hypothyroidism resolved in Systemic corticosteroids were required in all patients with hepatitis. 8.3% of the 60 patients. Majority of the patients with hypothyroidism Additional immunosuppression with mycophenolate was required in 19% required long-term thyroid hormone replacement. Of the 9 patients in whom (3/16) of these patients. Hepatitis resolved in 50% of the 16 patients. Of the LIBTAYO was withheld for hypothyroidism, 1 reinitiated LIBTAYO after 5 patients in whom LIBTAYO was withheld, 3 reinitiated LIBTAYO after symptom improvement; 1 required ongoing hormone replacement therapy symptom improvement; of these, none had recurrence. For hepatitis with no tumor involvement of the liver: Withhold LIBTAYO if AST • Type 1 diabetes mellitus, which can present with diabetic ketoacidosis: Monitor for hyperglycemia or other signs and symptoms of diabetes. Initiate or ALT increases to more than 3 and up to 8 times the upper limit of normal treatment with insulin as clinically indicated. Withhold LIBTAYO depending (ULN) or if total bilirubin increases to more than 1.5 and up to 3 times the on severity. Type 1 diabetes mellitus occurred in 0.1% (1/810) of patients, ULN. Permanently discontinue LIBTAYO if AST or ALT increases to more than including Grade 4 (0.1%). No patient discontinued treatment due to type 1 8 times the ULN or total bilirubin increases to more than 3 times the ULN. diabetes mellitus. Type 1 diabetes mellitus led to withholding of LIBTAYO in For hepatitis with tumor involvement of the liver: Withhold LIBTAYO if 0.1% of patients baseline AST or ALT is more than 1 and up to 3 times ULN and increases to Immune-mediated nephritis with renal dysfunction: LIBTAYO can cause more than 5 and up to 10 times ULN. Also, withhold LIBTAYO if baseline AST immune-mediated nephritis. Immune-mediated nephritis occurred in 0.6% or ALT is more than 3 and up to 5 times ULN and increases to more than (5/810) of patients receiving LIBTAYO, including fatal (0.1%), Grade 3 (0.1%), 8 and up to 10 times ULN. Permanently discontinue LIBTAYO if AST or ALT and Grade 2 (0.4%). Nephritis led to permanent discontinuation in 0.1% of increases to more than 10 times ULN or if total bilirubin increases to more patients and withholding of LIBTAYO in 0.4% of patients. Systemic corticosteroids than 3 times ULN. If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue LIBTAYO based on recommendations for were required in all patients with nephritis. Nephritis resolved in 80% of the 5 patients. Of the 3 patients in whom LIBTAYO was withheld, 2 reinitiated hepatitis with no liver involvement. LIBTAYO after symptom improvement; of these, none had recurrence. Withhold Resume in patients with complete or partial resolution (Grade 0 to 1) after LIBTAYO for Grade 2 or 3 increased blood creatinine, and permanently corticosteroid taper. Permanently discontinue if no complete or partial discontinue for Grade 4 increased blood creatinine. Resume in patients with resolution within 12 weeks of initiating steroids or inability to reduce complete or partial resolution (Grade 0 to 1) after corticosteroid taper. prednisone to less than 10 mg per day (or equivalent) within Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids. 12 weeks of initiating steroids or inability to reduce prednisone to less than Immune-mediated endocrinopathies: For Grade 3 or 4 endocrinopathies, 10 mg per day (or equivalent) within 12 weeks of initiating steroids. withhold until clinically stable or permanently discontinue depending on severity. Immune-mediated dermatologic adverse reactions: LIBTAYO can cause • Adrenal insufficiency: LIBTAYO can cause primary or secondary adrenal immune-mediated rash or dermatitis. Exfoliative dermatitis, including insufficiency. For Grade 2 or higher adrenal insufficiency, initiate Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and symptomatic treatment, including hormone replacement as clinically drug rash with eosinophilia and systemic symptoms (DRESS) has indicated. Withhold LIBTAYO depending on severity. Adrenal insufficiency occurred with PD-1/PD-L1–blocking antibodies. Immune-mediated occurred in 0.4% (3/810) of patients receiving LIBTAYO, including Grade 3 dermatologic adverse reactions occurred in 1.6% (13/810) of patients (0.4%). Adrenal insufficiency led to permanent discontinuation of LIBTAYO receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (0.6%). in 1 (0.1%) patient. LIBTAYO was not withheld in any patient due to Immune-mediated dermatologic adverse reactions led to permanent adrenal insufficiency. Systemic corticosteroids were required in all patients discontinuation in 0.1% of patients and withholding of LIBTAYO in 1.4% with adrenal insufficiency; of these, 67% (2/3) remained on systemic of patients. Systemic corticosteroids were required in all patients with corticosteroids. Adrenal insufficiency had not resolved in any patient at the immune-mediated dermatologic adverse reactions. Immune-mediated time of data cutoff dermatologic adverse reactions resolved in 69% of the 13 patients. Of Please see additional Important Safety Information and Brief Summary of full Prescribing Information on the following pages.

Important Safety Information (continued)

Warnings and Precautions (continued)

Severe and Fatal Immune-Mediated Adverse Reactions (continued) Immune-mediated dermatologic adverse reactions (continued): the 11 patients in whom LIBTAYO was withheld for dermatologic adverse reactions, 7 reinitiated LIBTAYO after symptom improvement; of these, 43% (3/7) had recurrence of the dermatologic adverse reaction. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold LIBTAYO for suspected SJS, TEN, or DRESS. Permanently discontinue LIBTAYO for confirmed SJS, TEN, or DRESS. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiating steroids. Other immune-mediated adverse reactions: The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 810 patients who received LIBTAYO or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions. • Cardiac/vascular: Myocarditis, pericarditis, and vasculitis. Permanently discontinue for Grades 2, 3, or 4 myocarditis • Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, and autoimmune neuropathy. Withhold for Grade 2 neurological toxicities and permanently discontinue for Grades 3 or 4 neurological toxicities. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiating steroids • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss • Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis, stomatitis • Musculoskeletal and connective tissue: Myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica • Endocrine: Hypoparathyroidism • Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection

Infusion-related reactions

Severe infusion-related reactions (Grade 3) occurred in 0.1% of patients receiving LIBTAYO as a single agent. Monitor patients for signs and symptoms of infusion-related reactions. The most common symptoms of infusion-related reaction were nausea, pyrexia, rash, and dyspnea. Interrupt or slow the rate of infusion for Grade 1 or 2, and permanently discontinue for Grade 3 or 4.

Complications of allogeneic HSCT

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1–blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT.

Embryo-fetal toxicity

LIBTAYO can cause fetal harm when administered to a pregnant woman due to an increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose.

Adverse Reactions

• In the pooled safety analysis of 810 patients, the most common adverse reactions (≥15%) with LIBTAYO were musculoskeletal pain, fatigue, rash, and diarrhea • In the pooled safety analysis of 810 patients, the most common Grade 3-4 laboratory abnormalities (≥2%) with LIBTAYO were lymphopenia, hyponatremia, hypophosphatemia, increased aspartate aminotransferase, anemia, and hyperkalemia

Use in Specific Populations

• Lactation: Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO • Females and males of reproductive potential: Verify pregnancy status in females of reproductive potential prior to initiating LIBTAYO Please see Brief Summary of full Prescribing Information on the following pages. References: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) for Non-Small Cell Lung Cancer V.5.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed June 16, 2021. To view the most recent and complete version of the guidelines, go online to NCCN.org. 3. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274)(suppl):1-178. 4. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274):592-604. 5. PD-L1 IHC 22C3 pharmDx [instructions for use]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2021. 6. Data on file. Regeneron Pharmaceuticals, Inc.

LIBTAYO® (cemiplimab-rwlc) injection, for intravenous use Brief Summary of Prescribing Information 1 INDICATIONS AND USAGE 1.3 Non-Small Cell Lung Cancer LIBTAYO is indicated for the first-line treatment of patients with non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test [see Dosage and Administration (2.1) in the full prescribing information] ), with no EGFR, ALK or ROS1 aberrations, and is: • locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or • metastatic. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Severe and Fatal Immune-Mediated Adverse Reactions LIBTAYO is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting PD-1/PD-L1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue LIBTAYO depending on severity [see Dosage and Administration (2.3) in the full prescribing information]. In general, if LIBTAYO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroids. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis LIBTAYO can cause immune-mediated pneumonitis. The definition of immune-mediated pneumonitis included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. In patients treated with other PD-1/PD-L1 blocking antibodies the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.2% (26/810) of patients receiving LIBTAYO, including Grade 4 (0.5%), Grade 3 (0.5%), and Grade 2 (2.1%) adverse reactions. Pneumonitis led to permanent discontinuation of LIBTAYO in 1.4% of patients and withholding of LIBTAYO in 2.1% of the patients. Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 58% of the 26 patients. Of the 17 patients in whom LIBTAYO was withheld for pneumonitis, 9 reinitiated LIBTAYO after symptom improvement; of these, 3/9 (33%) had recurrence of pneumonitis.

Immune-Mediated Colitis LIBTAYO can cause immune-mediated colitis. The definition of immunemediated colitis included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. The primary component of the immune-mediated colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1 blocking antibodies. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 2.2% (18/810) of patients receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (1.1%) adverse reactions. Colitis led to permanent discontinuation of LIBTAYO in 0.4% of patients and withholding of LIBTAYO in 1.5% of patients. Systemic corticosteroids were required in all patients with colitis. Colitis resolved in 39% of the 18 patients. Of the 12 patients in whom LIBTAYO was withheld for colitis, 4 reinitiated LIBTAYO after symptom improvement; of these, 3/4 (75%) had recurrence of colitis. Immune-Mediated Hepatitis LIBTAYO can cause immune-mediated hepatitis. The definition of immunemediated hepatitis included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. Immune-mediated hepatitis occurred in 2% (16/810) of patients receiving LIBTAYO, including fatal (0.1%), Grade 4 (0.1%), Grade 3 (1.4%), and Grade 2 (0.2%) adverse reactions. Hepatitis led to permanent discontinuation of LIBTAYO in 1.2% of patients and withholding of LIBTAYO in 0.5% of patients. Systemic corticosteroids were required in all patients with hepatitis. Nineteen percent (19%) of these patients (3/16) required additional immunosuppression with mycophenolate. Hepatitis resolved in 50% of the 16 patients. Of the 5 patients in whom LIBTAYO was withheld for hepatitis, 3 patients reinitiated LIBTAYO after symptom improvement; of these, none had recurrence of hepatitis. Immune-Mediated Endocrinopathies Adrenal Insufficiency LIBTAYO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold LIBTAYO depending on severity [see Dosage and Administration (2.3) in the full prescribing information]. Adrenal insufficiency occurred in 0.4% (3/810) of patients receiving LIBTAYO, including Grade 3 (0.4%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of LIBTAYO in 1 (0.1%) patient. LIBTAYO was not withheld in any patient due to adrenal insufficiency. Systemic corticosteroids were required in all patients with adrenal insufficiency; of these 67% (2/3) remained on systemic corticosteroids. Adrenal insufficiency had not resolved in any patient at the time of data cutoff. Hypophysitis LIBTAYO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue LIBTAYO depending on severity [see Dosage and Administration (2.3) in the full prescribing information]. Hypophysitis occurred in 0.4% (3/810) of patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.1%) adverse reactions. Hypophysitis led to permanent discontinuation of LIBTAYO in 1 (0.1%) patient and withholding of LIBTAYO in 1 (0.1%) patient. Systemic corticosteroids were required in 67% (2/3) patients with hypophysitis. Hypophysitis had not resolved in any patient at the time of data cutoff. Thyroid Disorders LIBTAYO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue LIBTAYO depending on severity [see Dosage and Administration (2.3) in the full prescribing information]. Thyroiditis: Thyroiditis occurred in 0.6% (5/810) of patients receiving LIBTAYO, including Grade 2 (0.2%) adverse reactions. No patient discontinued LIBTAYO due to thyroiditis. Thyroiditis led to withholding of LIBTAYO in 1 patient. Systemic corticosteroids were not required in any patient with thyroiditis. Thyroiditis had not resolved in any patient at the time of data cutoff. Blood thyroid stimulating hormone increased and blood thyroid stimulating hormone decreased have also been reported.

Hyperthyroidism: Hyperthyroidism occurred in 3.2% (26/810) of patients receiving LIBTAYO, including Grade 2 (0.9%) adverse reactions. No patient discontinued treatment due to hyperthyroidism. Hyperthyroidism led to withholding of LIBTAYO in 0.5% of patients. Systemic corticosteroids were required in 3.8% (1/26) of patients with hyperthyroidism. Hyperthyroidism resolved in 50% of the 26 patients. Of the 4 patients in whom LIBTAYO was withheld for hyperthyroidism, 2 patients reinitiated LIBTAYO after symptom improvement; of these, none had recurrence of hyperthyroidism. Hypothyroidism: Hypothyroidism occurred in 7% (60/810) of patients receiving LIBTAYO, including Grade 2 (6%) adverse reactions. Hypothyroidism led to permanent discontinuation of LIBTAYO in 1 (0.1%) patient. Hypothyroidism led to withholding of LIBTAYO in 1.1% of patients. Systemic corticosteroids were not required in any patient with hypothyroidism. Hypothyroidism resolved in 8.3% of the 60 patients. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. Of the 9 patients in whom LIBTAYO was withheld for hypothyroidism, 1 reinitiated LIBTAYO after symptom improvement; 1 required ongoing hormone replacement therapy. Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold LIBTAYO depending on severity [see Dosage and Administration (2.3) in the full prescribing information]. Type 1 diabetes mellitus occurred in 0.1% (1/810) of patients, including Grade 4 (0.1%) adverse reactions. No patient discontinued treatment due to Type 1 diabetes mellitus. Type 1 diabetes mellitus led to withholding of LIBTAYO in 0.1% of patients. Immune-Mediated Nephritis with Renal Dysfunction LIBTAYO can cause immune-mediated nephritis. The definition of immunemediated nephritis included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. Immune-mediated nephritis occurred in 0.6% (5/810) patients receiving LIBTAYO, including fatal (0.1%), Grade 3 (0.1%) and Grade 2 (0.4%) adverse reactions. Nephritis led to permanent discontinuation of LIBTAYO in 0.1% of patients and withholding of LIBTAYO in 0.4% of patients. Systemic corticosteroids were required in all patients with nephritis. Nephritis resolved in 80% of the 5 patients. Of the 3 patients in whom LIBTAYO was withheld for nephritis, 2 reinitiated LIBTAYO after symptom improvement; of these, none had recurrence of nephritis. Immune-Mediated Dermatologic Adverse Reactions LIBTAYO can cause immune-mediated rash or dermatitis. The definition of immune-mediated dermatologic adverse reaction included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and DRESS (Drug Rash with Eosinophilia and Systemic Symptoms), has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue LIBTAYO depending on severity [see Dosage and Administration (2.3) in the full prescribing information]. Immune-mediated dermatologic adverse reactions occurred in 1.6% (13/810) of patients receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (0.6%) adverse reactions. Dermatologic adverse reactions led to permanent discontinuation of LIBTAYO in 0.1% of patients and withholding of LIBTAYO in 1.4% of patients. Systemic corticosteroids were required in all patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions resolved in 69% of the 13 patients. Of the 11 patients in whom LIBTAYO was withheld for dermatologic adverse reaction, 7 reinitiated LIBTAYO after symptom improvement; of these 43% (3/7) had recurrence of the dermatologic adverse reaction. Other Immune-Mediated Adverse Reactions The following clinically significant immune-mediated adverse reactions occurred at an incidence of < 1% in 810 patients who received LIBTAYO or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome / myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy

Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-KoyanagiHarada like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss. Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis, stomatitis Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica Endocrine: Hypoparathyroidism Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection 5.2 Infusion-Related Reactions Severe infusion-related reactions (Grade 3) occurred in 0.1% of patients receiving LIBTAYO as a single agent. Monitor patients for signs and symptoms of infusion-related reactions. The most common symptoms of infusion-related reaction were nausea, pyrexia, rash and dyspnea. Interrupt or slow the rate of infusion or permanently discontinue LIBTAYO based on severity of reaction [see Dosage and Administration (2.3) in the full prescribing information]. 5.3 Complications of Allogeneic HSCT Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT. 5.4 Embryo-Fetal Toxicity Based on its mechanism of action, LIBTAYO can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose [see Use in Specific Populations (8.1, 8.3)]. 6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling. • Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)] • Infusion-Related Reactions [see Warnings and Precautions (5.2)] • Complications of Allogeneic HSCT [see Warnings and Precautions (5.3)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in Warnings and Precautions reflect exposure to LIBTAYO as a single agent in 810 patients in three open-label, single-arm, multicohort studies (Study 1423, Study 1540 and Study 1620), and one open-label randomized multi-center study (Study 1624). These studies included 219 patients with advanced CSCC (Studies 1540 and 1423), 132 patients with advanced BCC (Study 1620), 355 patients with NSCLC (Study 1624), and 104 patients with other advanced solid tumors (Study 1423). LIBTAYO was administered intravenously at doses of 3 mg/kg every 2 weeks (n=235), 350 mg every 3 weeks (n=543), or other doses (n=32; 1 mg/kg every 2 weeks, 10 mg/kg every 2 weeks, 200 mg every 2 weeks). Among the 810 patients, 57% were exposed for ≥ 6 months and 25% were exposed for ≥ 12 months. In this pooled safety population, the most common adverse reactions (≥15%) were musculoskeletal pain, fatigue, rash, and diarrhea. The most common Grade 3-4 laboratory abnormalities (≥2%) were lymphopenia, hyponatremia, hypophosphatemia, increased aspartate aminotransferase, anemia, and hyperkalemia.

Non-Small Cell Lung Cancer (NSCLC) The safety of LIBTAYO was evaluated in 355 patients with locally advanced or metastatic NSCLC in Study 1624 [see Clinical Studies (14.3) in the full prescribing information]. Patients received LIBTAYO 350 mg every 3 weeks (n=355) or investigator’s choice of chemotherapy (n=342), consisting of paclitaxel plus cisplatin or carboplatin; gemcitabine plus cisplatin or carboplatin; or pemetrexed plus cisplatin or carboplatin followed by optional pemetrexed maintenance. The median duration of exposure was 27.3 weeks (9 days to 115 weeks) in the LIBTAYO group and 17.7 weeks (18 days to 86.7 weeks) in the chemotherapy group. In the LIBTAYO group, 54% of patients were exposed to LIBTAYO for ≥ 6 months and 22 % were exposed for ≥ 12 months. The safety population characteristics were: median age of 63 years (31 to 79 years), 44% of patients 65 or older, 88% male, 86% White, 82% had metastatic disease and 18% had locally advanced disease and ECOG performance score (PS) of 0 (27%) and 1 (73%). LIBTAYO was permanently discontinued due to adverse reactions in 6% of patients; adverse reactions resulting in permanent discontinuation in at least 2 patients were pneumonitis, pneumonia, ischemic stroke and increased aspartate aminotransferase. Serious adverse reactions occurred in 28% of patients. The most frequent serious adverse reactions in at least 2% of patients were pneumonia and pneumonitis. Table 6 summarizes the adverse reactions that occurred in ≥ 10% of patients and Table 7 summarizes Grade 3 or 4 laboratory abnormalities in patients receiving LIBTAYO. Table 6: Adverse Reactions in ≥ 10% of Patients with Locally Advanced or Metastatic NSCLC Receiving LIBTAYO in Study 1624 Adverse Reactions

LIBTAYO N=355 All Grades %

Chemotherapy N=342

Grades 3-4 %

All Grades %

Grades 3-4 %

Musculoskeletal and connective tissue disorders Musculoskeletal paina

0.6

1.5

1.4

3.4

1.1

0.6

0.3

Skin and subcutaneous tissue disorders Rashb

Blood and lymphatic system disorders Anemia

General disorders and administration site conditions Fatiguec

Metabolism and nutrition disorders Decreased appetite Infections and infestations Pneumoniad

Respiratory, thoracic and mediastinal disorders Coughe

Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03 a. Musculoskeletal pain is a composite term that includes back pain, arthralgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, bone pain, myalgia, neck pain, spinal pain, and musculoskeletal stiffness b. Rash is a composite term that includes rash, dermatitis, urticaria, rash maculopapular, erythema, rash erythematous, rash pruritic, psoriasis, autoimmune dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, drug eruption, dyshidrotic eczema, lichen planus, and skin reaction c. Fatigue is a composite term that includes fatigue, asthenia, and malaise d. Pneumonia is a composite term that includes atypical pneumonia, embolic pneumonia, lower respiratory tract infection, lung abscess, paracancerous pneumonia, pneumonia, pneumonia bacterial, and pneumonia klebsiella e. Cough is a composite term that includes cough and productive cough

Table 7: Grade 3 or 4 Laboratory Abnormalities Worsening from Baseline in ≥1% of Patients with Locally Advanced or Metastatic NSCLC Receiving LIBTAYO in Study 1624 Laboratory Abnormality

LIBTAYO N=355

Chemotherapy N=342 Grades 3-4a %

Chemistry Increased aspartate aminotransferase Increased alanine aminotransferase Increased alkaline phosphatase Increased blood bilirubin Hypoalbuminemia Increased creatinine Hematology Lymphopenia Anemia

3.9

1.2

2.7

0.3

2.4

0.3

2.1 1.8 1.2

0.3 1.3 1.6

2.7

Electrolytes Hyponatremia

Hyperkalemia

4.2

1.9

Hypocalcemia

3.9

3.4

Hypophosphatemia

2.4

4.1

Hypermagnesemia

2.1

1.6

Hypokalemia

1.5

2.2

Hypercalcemia

1.2

2.2

Toxicity graded per NCI CTCAE v. 4.03 a. Percentages are based on the number of patients with at least 1 post-baseline value available for that parameter.

6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to cemiplimab-rwlc in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. Anti-drug antibodies (ADA) were tested in 823 patients who received LIBTAYO. The incidence of cemiplimab-rwlc treatment-emergent ADAs was 2.2% using an electrochemiluminescent (ECL) bridging immunoassay; 0.4% were persistent ADA responses. In the patients who developed anti-cemiplimab-rwlc antibodies, there was no evidence of an altered pharmacokinetic profile of cemiplimab-rwlc. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Based on its mechanism of action, LIBTAYO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) in the full prescribing information]. There are no available data on the use of LIBTAYO in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immunemediated rejection of the developing fetus resulting in fetal death (see Data). Human IgG4 immunoglobulins (IgG4) are known to cross the placenta; therefore, LIBTAYO has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with LIBTAYO to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering LIBTAYO during pregnancy include increased rates of abortion or stillbirth. As reported in the literature, there were no malformations related to the

blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to cemiplimab-rwlc may increase the risk of developing immune-mediated disorders or altering the normal immune response. 8.2 Lactation Risk Summary There is no information regarding the presence of cemiplimab-rwlc in human milk, or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating LIBTAYO [see Use in Specific Populations (8.1)].

8.4 Pediatric Use The safety and effectiveness of LIBTAYO have not been established in pediatric patients. 8.5 Geriatric Use Of the 810 patients who received LIBTAYO in clinical studies, 32% were 65 years up to 75 years and 22% were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients. Of the 219 patients with mCSCC or laCSCC who received LIBTAYO in clinical studies, 34% were 65 years up to 75 years and 41% were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients. Of the 132 patients with BCC who received LIBTAYO in Study 1620, 27% were 65 years up to 75 years, and 32% were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients.

Contraception LIBTAYO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].

Females Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose.

The Adview 2 is still the only truly modular diagnostic station that grows with your needs. Start with blood pressure and choose temperature or pulse oximetry option at the time of purchase.

Bionet CardioTouch 3000: $1,495.00 Schiller FT-1: $2,961.00 Burdick ELI 280: $4,294.00 Welch Allyn CP150 w/ Interp: $3,645.00

1628

1630

1631

1629

1632

1635

1634

1633

Coaxial Ophth, Fiber Optic Oto, Speucla Dispenser, Aneroid BP, Wall Transformer and Wall Board without Thermometer: $1,121.00 with Thermometer: $1,474.00 1637

1636

1639

1640

1638

FEATURE

WHY NO ONE RESPONDS TO “WHY DID YOU WANT TO BECOME A DOCTOR?” WITH ANYTHING STARTING WITH “THE SALARY —” BY MIRIAM SWEENEY

36 | PHYSICIANS OFFICE RESOURCE

Money is one of the most influential things in our lives that is simultaneously most difficult to talk about. And the medical field is no exception. In my unique situation, I’ve had the opportunity to talk with an abnormally high number of doctors-to-be about their finances.

As I worked with premeds to articulate why they wanted to go to medical school, it surprised me how infrequently people would tell me that one of their motivations for going to medical school was financial. When talking with bright young people who are midway through their undergraduate degrees and sincerely contemplating the next decade of their lives and stating (not only with a straight face, but with excessive volunteer and shadowing hours and effort to get great grades) that they think that going back to school and staying in it for years to come is actually a fantastic idea, very few talked me about how much money they hope to make.

FEATURE

It started when I began to edit friends’ personal statements with them before their applications to medical school. Editing one friend’s statement led to editing their friend’s statement, and soon enough, I had a small seasonal editing side gig on my hands.

In fact, as part of my personal statement editing process, I’ll ask everyone why they want to go to med school. I never let them give me just one simple answer. I encouraged everyone I worked with to brainstorm a list of responses in the style of “there are no wrong answers here.” Of course, I didn’t tell them they needed or even should include all the reasons in their personal statement, but I wanted to see their minds were open and they were willing to be honest with themselves. And not one of the dozens of students who I worked with ever mentioned compensation until after I prodded them and indicated that money and lifestyle are also valid reasons for enormous career decisions. Once prompted, everyone would chuckle, loosen up a bit, and agree that they wanted to be compensated well for hard work in their career. But we don’t talk about this. We don’t talk about how much money we make or how much money we wish we made. Or, if we do, perhaps we fear being lumped together with money-hungry ladder climbing go-getters who want nothing more than to increase their salary and die someday on a king-sized bed built of hundred dollar bills. No one wants to be lumped into a category with that guy. But that stigma is keeping us from conversations that could potentially truly benefit us and help us in continuing our education of how to navigate the world as professionals, providers, family members, members of various communities, and adults in general. When exploring the need for a physician personal finance education platform, I had as many conversations with medical students, residents, and early-in-their-attending-years physicians as I could. I want to know the same thing from all of them: I wanted to better understand their experience and relationship with money and how those have shaped their decisions and experiences in relation to their careers. In a field as demanding and highly intellectual as medicine, I was surprised by the enormous variety I found when people talked through their relationship with money. Some people I talked to were extremely debt-tolerant, going into more debt than strictly necessary to ensure that their undergraduate medical school and residency experiences were not just livable, but top-notch. Others had been raised in families where they were taught that maintaining a monthly 2022 · ISSUE 6 | 37

FEATURE

balance on their credit cards would improve their credit scores (in case you fall into this category, know that it doesn’t). Still others would readily confess (and sometimes proudly brandish) their utter and complete ignorance to all things financial — whether we were discussing simple monthly budgets or complex investing and retirement plans — and wave to me in the direction of a significant other, a cousin, or, in many cases, a tired and caring member of their physician faculty who had somehow earned himself or herself the reputation for being the go-to money person on staff for generations of medical students, residents, and attending physicians. In stages as demanding and vertical as medical school and residency, it is a blessing, I’m sure, to have someone in your life who is willing to take on the mental load of finances. In fact, in my informal research, I discovered it was more common than not for a medical student’s partner to be not just in charge of household finances, but the primary go to person for matters of their own educational debt and repayment. In other words, we find ourselves with a system that is not only so demanding and rigorous that it’s leading to increasingly poor health outcomes for its own people, but that it leaves individuals so flabbergasted as to how to navigate its financial implications that those individuals are left to resort to the patient research of their loved ones to understand their own options for how to pay for their medical education. Such a system, combined with the trend of not talking about finance, also creates an uncomfortable inequality between professionals. According to recent statistics, 25% of medical students graduate without debt from medical school. That means that if you as a medical student are looking to your peers for an example of what a suitable, sustainable lifestyle is like for yourself, then a quarter of the time, you may be looking at someone who is not dealing with the mental load and pressure of debt in the way you are dealing with it. Even something as simple as seeing your friends take vacations or make arguably unnecessary purchases may create subliminal pressure for you to also indulge in things that appear to be affordable for a fellow medical student, whether or not you have determined that they are personally affordable for you. This tendency to avoid discussing personal finances has also led to extreme oversimplification from a systemic perspective. I was again surprised in my conversations with medical students and residents to hear how generally unhelpful many of their interactions with their financial aid offices at their respective institutions have been. One person recounted being told (for the entirety of a lecture, mind you, that was advertised as designed to help them to make a plan for budgeting on a limited residence budget) that their financial situation was their fault because their generation was likely to be buying fancy coffee daily instead of brewing their own. Such oversimplification and condescension was, I’m sorry to say, much more common than one would hope in these conversations with medi38 | PHYSICIANS OFFICE RESOURCE

cal students, residents, and attending physicians. Such an experience, even this one in its extreme, produces droplets of shame that are bound to fester and prevent otherwise productive conversations, whether formal or spontaneous, from happening in the first place. It could prevent an individual physician from learning something about money management or investing that could change their lives – and, by extension, the lives of their patients and families – for the better. For most people, it is unthinkable to get through a full medical education without any debt. And that’s not necessarily a bad thing; modern society allows for investments of time and money into the promise of future value, and the existence of student loans is one of the things helping to ensure that we have the best providers being trained and not just the providers who happen to come from families who can afford to make them doctors. But if we don’t reevaluate our own relationship with money and openly revisit the stigma of talking about money and one another, I’m afraid that we will create a stagnant environment where needed change – whether that change is needed on administrative levels to ensure the sustainability and financial viability of healthcare organizations, or needed on individual levels to sustain and promote good mental health for hard-working physicians– is entirely inaccessible. You can start today. If you have a solid knowledge of personal finance, complete with a robust retirement and investing plan and debt payoff strategies, then bring up something you’ve learned or heard recently about personal finance with your colleagues. If they see you’re willing to discuss finances, they may also be willing to open up. Conversely, if you don’t feel confident in your own understanding of your options and personal finances — or even if you just recognize that there’s no way to know what you don’t know — then make a plan to learn something. There are plenty of podcasts and Youtubers who discuss personal finance at length, and some of us even focus specifically on physician personal finance. If you want a bite sized, free way to start that educational experience, I would love to hear if the app that my team and I built in response to those dozens of conversations I had scratches that itch for you. What is perhaps most important is remembering that money is just a tool. If we treat it like a tool and not like a prize to be won on one end of the spectrum or an unknown, unfeeling god to fear on the other, then we’ll be more likely to be personally in control of our money. We’ll be more able to be a source of positive change where changes are needed to make the world safer, healthier, and more prone to thrive.

1. MedSchoolInsiders: https://medschoolinsiders.com/pre-

med/the-real-cost-of-medical-school/#:~:text=Approxi mately%2012%25%20graduate%20 with%20%24300%2C000,just%20a%20few%20years%20 ago.

POP QUIZ: What percentage of doctors actually have to use their disa ility insurance during their career? We’re not selling insurance. We’re actually not selling anything. We’re o(ering free foundatonal personal Nnance educaton to physicians because we know that this is part of what it will take to help reduce burnout and help doctors live the lives we want to while taking great care of our patents. he answer, by the way,, is 25%, according to Medscape. And while many physicians already know that, there’s always the issue that $@>! 7 6>J7 $>$ /6>$@>! 7 6>J7 $. Eeef up your basic physician personal Nnance knowledge today. Get our mobile app for free. @scrubmoneyorg scrubmoney.org

1641

2022 · ISSUE 6 | 39

Resilience + Passion

We make diagnostics that

matter

We recognize your passion for providing the best care to your patients and helping them lead a long and healthy life, but we also know you must navigate through daily challenges in your practice which requires resilience. At SEKISUI Diagnostics we are committed to providing high quality, US-made women’s health rapid tests which are accurate and easy-to-use so you can get the answers fast and your patients back to doing what they love. Like you, we understand there is a patient behind every answer—and that’s what matters most. For more information, call 888-616-0537, or visit us at osomtests.com

OSOM® TRICHOMONAS RAPID TEST

OSOM® BVBLUE® TEST

1642

1643

© 2022 SEKISUI Diagnostics, LLC. All rights reserved. OSOM® is a registered trademark of SEKISUI Diagnostics, LLC. Because every result matters™ is a trademark of SEKISUI Diagnostics, LLC. BVBLUE® is a registered trademark of Gryphus Diagnostics, LLC.