CVS Caremark Plays Kicks-the-Can on Yeztugo; Undermines HIV Prevention Efforts

By: Ranier Simons, ADAP Blog Guest Contributor

Benjamin Franklin is credited with the phrase, ‘An ounce of prevention is worth a pound of cure.’ In simple terms, it is easier to prevent a negative outcome from happening than to expend energy repairing damage that has already occurred. This is especially true regarding HIV. Given that there is currently no cure for the virus, it is imperative to prevent HIV transmission. Recent innovations, especially long-acting injectable agents, have expanded the toolbox of HIV prevention. Consequently, the mere existence of life-saving tools is not beneficial if the people who need them are denied access. CVS Caremark recently announced that it will not be adding coverage for Yeztugo (lenacapavir), Gilead Sciences' bi-annual HIV PrEP injectable, to its commercial plans (Beasley, 2025).

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Yeztugo was approved by the U.S. Food and Drug Administration (FDA) in June 2025, following the successful outcomes of its Phase 3 clinical trials, PURPOSE 1 and PURPOSE 2. Approximately 99.9% of participants remained HIV negative, proving Yeztugo in the trial to be more effective than daily Truvada administered as PrEP (Gilead, 2025). Out of the 2,179 participants in the PURPOSE 2 trial, only two people contracted HIV.

Medicare, Veterans’ Administration, and some Medicaid plans are already covering Yeztugo. In contrast, CVS Caremark has stated that it will not cover the drug in its commercial plans, nor in any of its Affordable Care Act (ACA) formularies. CVS follows the recommendations of the U.S. Preventive Services Task Force (USPSTF) for HIV prevention medications. Presently, USPSTF only recommends daily Truvada (Gilead), Descovy (Gilead), and the bimonthly injectable Apretude (ViiV). Prevention measures recommended by the USPSTF must be covered without any patient cost-sharing. Many in the HIV care community are concerned about Yeztugo ever being recommended by the USPSTF, given the current paradigm of the embattled JFK Jr.-led U.S. Department of Health and Human Services (HHS) (Beasley, 2025).

Photo Source: Metro Weekly

In a statement emailed to the publication Fierce Pharma, a CVS spokesperson explained, “As is typical with new-to-market products, we undergo a careful review of clinical, financial, and regulatory considerations, under the guidance of our external Pharmacy and Therapeutics (P&T) Committee of independent medical experts” (Kansteiner, 2025). Given that Medicare, Veterans’ Administration, and some state Medicaid plans (including California and New York) are already covering Yeztugo, and it has had stellar results in its clinical trials, it is unclear what clinical, financial, and regulatory considerations are of concern. Those in the HIV care community feel CVS’s decision is based on Yeztugo’s list price of $28,000 per year for the two injections. The average lifetime cost of treating a person living with HIV ranges from $420,285.00 to over $1 million (Bingham et al., 2021). Thus, in the long term, preventative treatment would appear cost-effective.

Notably, CVS Caremark is currently embroiled in legal disputes. Chief Judge Mitchell Goldberg, a Philadelphia federal judge, issued a ruling ordering CVS Caremark to pay a $289.9 million judgment for fraudulent prescription drug charges to Medicare. Initially, the penalty issued was $95 million (Stempel, 2025). In 2014, a former head actuary for Medicare Part D at Aetna initiated a whistleblower case, accusing CVS Caremark of causing health insurers to file false and inflated claims to the Centers for Medicare and Medicaid Services (CMS), while paying Rite Aid and Walgreens pharmacies less. The judge explained that CVS knowingly manipulated drug pricing to its financial benefit. Due to the motivations and intent of CVS, Judge Goldberg, using the False Claims Act, tripled the $95 million and added a $4.87 million civil fine. 

CVS is being admonished for causing fiscal harm to the government via CMS, as well as weakening public trust in the CMS. Judge Goldberg wrote, “CMS relies on companies like Caremark to truthfully and accurately report Part D drug prices," he wrote. "Caremark's conduct broke CMS's trust, and as a result, the public's trust in CMS." In the decision, Judge Goldberg specifically spelled out, “ Caremark devised a scheme to earn hidden spread or indirect profit on Part D purchases, and in the process, caused CMS to over-subsidize prescription drug costs to the tune of some $95 million. When CMS and other industry participants asked questions, Caremark consistently concealed the true nature of its scheme”. In addition to this case, CVS is appealing a separate $948.8 million judgment against its Omnicare unit, issued by a Manhattan federal judge in July, over allegations of fraudulent billing.

Photo Source: Review of Optometric Business

This pattern of profit-motivated questionable behavior is additional reasoning for why CVS’s initial decision not to cover Yeztugo is causing concern among many stakeholder groups. Yeztugo is a way to ensure adherence, given that it is only administered twice a year. It is crucial to increase the possibility of preventing HIV acquisition among those at high risk, not reduce it. Prevention reduces health care expenditures for the system and the individual. 

Stakeholders like Brian Hujdich, Executive Director at HealthHIV, explain the quandary: “It’s hard to reconcile Franklin’s wisdom together with CVS’s decision. Long-acting PrEP injectables could prevent unnecessary transmission, medical costs, and sick days, while reducing the time and effort required to stay protected. They can also help minimize situations where stigma commonly shows up — whether internal, like the stress of daily pill-taking, or external, like repeated pharmacy pickups and clinic visits — while supporting people to stay healthy.”

[1] Beasley, D. (2025, August 21). CVS holds off adding Gilead’s new HIV prevention shot to drug coverage lists. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/cvs-holds-off-adding-gileads-new-hiv-prevention-shot-drug-coverage-lists-2025-08-20/

[2] Bingham, A., Shrestha, R. K., Khurana, N., Jacobson, E. U., & Farnham, P. G. (2021). Estimated Lifetime HIV-Related Medical Costs in the United States. Sexually transmitted diseases, 48(4), 299–304. https://doi.org/10.1097/OLQ.0000000000001366

[3] Gilead Sciences. (2025, June 18). Press Release: Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection. Retrieved from https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection#:~:text=In%20the%20PURPOSE%202%20trial,with%20once%2Ddaily%20oral%20Truvada

[4] Kansteiner, F. (2025, August 21). For now, CVS declines to cover Gilead's long-acting HIV PrEP treatment Yeztugo. Retrieved from https://www.fiercepharma.com/pharma/now-cvs-declines-cover-gileads-twice-yearly-hiv-prep-treatment-yeztugo

[5] Stempel, J. (2025, August 20). CVS unit must pay $290 million in drug whistleblower lawsuit, judge rules. Retrieved from https://www.reuters.com/legal/government/cvs-unit-must-pay-290-million-drug-whistleblower-lawsuit-judge-rules-2025-08-20/#:~:text=In%20a%20Tuesday%

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.