FDA

Letter to Delaware legislature suggesting amendments to strengthen PrEP bills under consideration

We have some concerns with the current language that we believe can be addressed as the bill moves forward. In particular, we are concerned that the “medical necessity” coverage standard creates unnecessary ambiguity that could limit access to the full range of PrEP options and may be weaker than current federal guidance. To strengthen the bill and ensure comprehensive, durable access, we recommend three targeted changes: clarifying the coverage standard to require all FDA-approved PrEP medications, strengthening the scope of covered services, and restoring the original 2027 effective date.

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HIV Groups letter to CVS Health on not covering Yeztugo

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.

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Comments on Medicare national coverage determination for long-acting injectable PrEP

On behalf of the HIV+Hepatitis Policy Institute, an organization dedicated to promoting quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions, we thank you for this opportunity to comment on a National Coverage Determination (NCD) by the Centers for Medicare and Medicaid Services (CMS) on the use of provider-administered pre-exposure prophylaxis (PrEP). The first provider-administered medication for HIV pre-exposure prophylaxis (Apretude or cabotegravir as PrEP) was approved by the Food and Drug Administration in January 2022. In August 2022, we wrote to you on behalf of 64 organizations to request that CMS quickly and efficiently evaluate provider-administered PrEP for a National Coverage Determination, which is the only pathway to coverage under Medicare Part B. We commend CMS on moving forward with the NCD process and urge CMS to approve the NCD for provider-administered PrEP.

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