HIV Groups letter to CVS Health on not covering Yeztugo

September 18, 2025

J. David Joyner, President and CEO
CVS Health
1 CVS Drive
Woonsocket RI 02895

Dear Mr. Joyner:

We, the undersigned 64 organizations, on behalf of people and communities affected by HIV, their care providers, public health practitioners, and community-based organizations, write in response to statements made by CVS Health to the media that it does not intend to cover Yeztugo (lenacapavir), a twice-yearly long-acting injectable drug recently approved by the FDA as pre-exposure prophylaxis (PrEP) for the prevention of HIV.[1] We urge you to reconsider this decision and cover Yeztugo without delay.

CVS Health plans must cover Yeztugo without delay
Yeztugo is no “me too” drug. It is the first in a new class of antiretroviral drugs known as capsid inhibitors. Yeztugo’s recent FDA approval is based on the overwhelmingly successful results of two clinical trials, including one in which it demonstrated zero HIV infections, the first PrEP drug to achieve this in a Phase III trial. The study results were so groundbreaking that Science magazine named Yeztugo its 2024 “Breakthrough of the Year”—a distinction previously awarded to the momentous discovery of combination antiretroviral therapy in 1996. [2]

The CDC has published just today a strong new clinical recommendation for the use of Yeztugo in a Policy Note in the Morbidity and Mortality Weekly Report (MMWR).[3] It is already recommended by the International Antiviral Society-USA,[4] the World Health Organization,[5] and the New York State Department of Health.[6]

Federal requirements mandate the coverage of any FDA-approved PrEP drug without cost-sharing or utilization management by all non-grandfathered commercial insurance plans. We have learned that many commercial payers have already stepped forward to comply with this requirement by covering Yeztugo, including plans offered by major PBMs such as Express Scripts and Optum, and large insurers such as Blue Cross Blue Shield of California.

Zero-cost coverage of Yeztugo has been available in Medicare Part B since the day the drug was approved by FDA.[7] Several state Medicaid programs have already moved to cover Yeztugo as a preferred drug without cost-sharing or prior authorization, including New York and California.

Many states also recognize the importance of covering all FDA-approved PrEP drugs without copay or utilization management in state-specific legislation, including in the state of Rhode Island[8] where CVS is headquartered, along with Illinois,[9] Maine,[10] New York,[11] and many others.

The United States Preventive Services Task Force PrEP recommendation is not drug-specific
The United States Preventive Services Task Force (USPSTF) recommends the prescription of PrEP using “effective antiretroviral therapy” to individuals at increased risk of acquiring HIV.[12] It is important to recognize that the recommendation is not specific to particular PrEP medications; they do not endorse specific drugs. USPSTF recommendations, which are typically updated on a five-year cycle, are based on systematic review of the cumulative evidence to date on a preventive intervention, not on specific products, which are evaluated by the FDA. If we relied on USPSTF recommendations to determine insurance coverage of specific preventive products, it could take two to six years for coverage of a new preventive medication or service to begin. Delaying access to the latest scientific advances in preventive health in this way would be extraordinarily harmful.

Federal insurance regulators have consistently made clear that the USPSTF recommendation is not drug specific. At the time of the first USPSTF PrEP recommendation in 2019, only one PrEP drug—Truvada—had been approved, but when the federal government issued coverage guidance implementing the recommendation in 2021,[13] it also encompassed Descovy, which had been approved after the 2019 recommendation statement. Similarly, at the time of the second USPSTF PrEP recommendation in 2023,[14] three PrEP drugs were available and cited.

The CMS National Coverage Determination for PrEP for Medicare approved in 2024[15] demonstrates that CMS understood the USPSTF recommendation to encompass PrEP in general and requires coverage of all drugs approved by FDA as PrEP, including all future drugs.

Everyone benefits from increased PrEP uptake and adherence
Increased PrEP uptake and adherence yield important benefits to people and communities affected by HIV. Eliminating barriers to PrEP uptake is of particular urgency to overcome the stark racial, gender, and geographical disparities in PrEP uptake. Society as a whole benefits when wider PrEP access results in reduced HIV transmission and lowers long-term health costs.

It is important to note that private insurers benefit from increased PrEP uptake, especially from long-acting formulations that improve adherence, and help avoid the high cost of lifetime HIV treatment. Additionally, CMS now accounts for PrEP use in risk adjustment payments made to Marketplace insurers, meaning that insurers now benefit financially by covering PrEP.[16]

CVS Health should update coverage of new PrEP medications and guidelines proactively
All four FDA-approved PrEP medications are highly effective, but that does not mean they are interchangeable for people using PrEP or people who would benefit from PrEP. There is an active drug development pipeline that could make several new long-acting PrEP formulations available in the next few years. As new PrEP medications are approved, we call on CVS Health to comply with existing coverage requirements and make them available to beneficiaries immediately without barriers such as cost-sharing or prior authorization.

We also call on CVS Health to ensure that laboratory testing and other ancillary services integral to PrEP are covered promptly and without restrictions in accordance with PrEP clinical guidelines.

Finally, CVS Health should take immediate steps to eliminate impermissible copays that many PrEP users still report being charged for their medications and related services. Ensuring comprehensive, zero-cost PrEP access is both a legal requirement and a critical public health imperative.

If you have any questions or comments, please contact Carl Schmid, Executive Director, HIV+Hepatitis Policy Institute at cschmid@hivhep.org or (202) 462-3042; Kevin Herwig, Health Policy Manager, HIV+Hepatitis Policy Institute at kherwig@hivhep.org or (617) 666-6634; Harold Phillips, CEO-Elect, NMAC at HPhillips@nmac.org or (202) 853-1846; or Joe Huang-Racalto, Director, Strategic Partnerships and Policy, NMAC, at JHuang-Racalto@nmac.org or (202) 321-1935.

HIV+Hepatitis Policy Institute
NMAC
Act Now: End AIDS (ANEA) Coalition
ADAP Advocacy Association
Advocates for Youth
AIDS Action Baltimore
AIDS Alabama
AIDS Foundation of Chicago
AIDS United
American Academy of HIV Medicine
amfAR
APLA Health
Association of Nurses in AIDS Care
AVAC
CenterLink: The Community of LGBTQ Centers
Chicago Black Gay Men’s Caucus
Chicago Women’s AIDS Project
Coai, Inc
Community Access National Network
Community Health Center, Inc., Middletown CT
Community Resource Initiative
Compass LGBTQ Community Center
DAP Health
Equality California
Fenway Health
Five Horizons Health Services
Georgia AIDS Coalition
Georgia Equality
HealthHIV
Health Imperatives, Inc.
Health Justice
Health Services Center, Inc.
HIV Dental Alliance
HIV Medicine Association
IDEA Exchange Syringe Services Program
Illinois Public Health Association
International Association of Providers of AIDS Care
Latino Commission on AIDS
Latinos in the South
Lavender Rights Project
Los Angeles LGBT Center
Multicultural AIDS Coalition
National Alliance for HIV Education and Workforce Development
National HIV Aging Advocacy Network
National LGBTQ Task Force Action Fund
National Working Positive Coalition
Neelyx Labs
North Carolina AIDS Action Network
PlusInc
POWER Atlanta, Inc.
Rhode Island Public Health Institute
RxEACH Initiative
Red Ribbon Consultants
SAGE
San Francisco AIDS Foundation
Southern AIDS Coalition
Structural Health Dynamics, LLC
TaskForce Prevention and Community Services
The AIDS Institute
The Center for HIV Law and Policy
The Reunion Project
Transgender Excellence Academy
Treatment Action Group
Valley AIDS Council

cc: Edward DeVaney, Executive Vice President

[1] https://www.reuters.com/business/healthcare-pharmaceuticals/cvs-holds-off-adding-gileads-new-hiv-prevention-shot-drug-coverage-lists-2025-08-20/

[2] Science Magazine, Vol 386, Issue 6727. 2024 Breakthrough of the Year. Jon Cohen. The long shot, https://www.science.org/content/article/breakthrough-2024

[3] https://www.cdc.gov/mmwr/volumes/74/wr/pdfs/mm7435a1-H.pdf

[4] https://jamanetwork.com/journals/jama/fullarticle/2827545

[5] https://www.who.int/publications/i/item/9789240111608

[6] https://www.hivguidelines.org/wp-content/uploads/2025/07/NYSDOH-AI-Interim-Guideline-on-the-Use-of-Twice-Yearly-LEN-for-HIV-Prevention_7-9-2025_HG.pdf

[7] https://www.cms.gov/medicare/coverage/prep

[8] https://law.justia.com/codes/rhode-island/title-27/chapter-27-20/section-27-20-79/

[9] https://www.ilga.gov/Legislation/BillStatus?DocNum=1344&GAID=17&DocTypeID=SB&LegId=145644&SessionID=112&GA=103

[10] https://legislature.maine.gov/statutes/24-a/title24-Asec4317-D.html

[11] https://www.nysenate.gov/legislation/bills/2023/S9842

[12] https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/prevention-of-human-immunodeficiency-virus-hiv-infection-pre-exposure-prophylaxis

[13] https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf

[14] https://www.cms.gov/files/document/faqs-implementation-part-68.pdf