CMS proposes coverage for pre-exposure prophylaxis regimens to prevent HIV

The Centers for Medicare and Medicaid Services on Wednesday proposed coverage for pre-exposure prophylaxis (PrEP) using antiretroviral therapy to prevent HIV infections.

The news comes nearly six months after CMS initiated a national coverage analysis for PrEP. Medicare coverage for PrEP currently varies by plan, though many patients are left with high out-of-pocket costs. According to one 2020 study that analyzed a variety of Medicare plans in the Ann Arbor, MI area, the average annual cost for someone with a prescription drug plan was between $2,276 and $2,430, including deductibles, monthly premiums, copays and coinsurance.

On Wednesday, CMS proposed coverage for both oral and long-acting injectable forms of PrEP using antiretroviral therapy in individuals at high risk of infection. The agency also proposed coverage for the administration of injectable PrEP, up to seven counseling visits annually, HIV screening up to seven times per year for those who are taking or being assessed for PrEP using antiretroviral therapy, and a screening for hepatitis B virus.

Carl Schmid

That’s important because PrEP is more than just the drug, HIV+Hepatitis Policy Institute executive director Carl Schmid told Endpoints News on Thursday. CMS noted that counseling can include HIV risk assessment, risk reduction and medication adherence.

“There’s a lot of barriers in accessing PrEP, but this gets rid of some of those barriers, the cost barrier,” Schmid said. “That’s a big barrier, but we still need a lot of work to be done to get people who need PrEP to be on it.”

GSK’s ViiV Healthcare requested the national coverage determination in February 2022, following the December 2021 approval of its PrEP treatment Apretude (cabotegravir). The drug is administered every two months, after two initiation injections one month apart. In its letter to CMS, ViiV said two years ago that Medicare covered about 10% of individuals who could benefit from PrEP, including younger people on Medicare because of a disability.

“Despite the availability of daily oral PrEP for over a decade, its effectiveness can be limited by inconsistent adherence as well as structural and cultural barriers that lead to underutilization in key populations, perpetuating health disparities,” ViiV wrote.

The Joint UN Programme on HIV/AIDS set a goal back in 2019 to end the HIV epidemic by 2030. However, some advocates have warned that progress is slowing. There were an estimated 39 million HIV cases worldwide at the end of 2022, according to the World Health Organization.

The US Preventive Services Task Force previously issued a grade A recommendation for prescribing PrEP with antiretroviral therapy, meaning “there is high certainty that the net benefit is substantial.”

healthcare
health
prescription
aids