Feds Seek Input on National PrEP Coverage

The federal government is seeking public input concerning whether its Medicare department should cover HIV pre-exposure prophylaxis and PrEP medication nationwide, including a new injectable drug that has been developed.

Centers for Medicare and Medicaid Services (CMS) is considering whether it will cover HIV prevention pre-exposure prophylaxis drugs (PrEP) such as Apretude, a prescription injectable given every two months to individuals at risk of contracting HIV.

As part of the analysis, CMS seeks comments from the public, particularly those that include scientific evidence.

As of 2020, Medicare coverage for PrEP varies by state or county, but the average cost of the prevention is $2276 to $2430 per year, Endpoints News reports.

For a service to qualify for national coverage, it must be rated an A or B by the U.S. Prevention Services Task Force (USPSTF). The task force gave long-acting injectable PrEP an A rating last month. Oral PrEP received an A rating in 2019.

Under the Affordable Care Act, health insurance plans and private insurers that the ACA approves are required to cover preventive services that receive an A or B rating.

According to CMS, this analysis comes at the same time as the U.S. Preventive Services Task Force updated a recommendation for prescribing PrEP with effective antiretroviral therapy to HIV-infected individuals last month and gave the proposal an A.

ViiV Healthcare, a subsidiary of GSK, formally requested a national coverage determination last February after FDA approval in December 2021. Apretude is approved for use in adults and adolescents who weigh at least 77 pounds. Initiation injections for Apretude are given one month apart, followed by two monthly injections.

Representatives for the drug manufacturer asked government regulators to issue the passing certificate quickly.

“Given that the USPSTF’s current Grade A recommendation, by its terms, broadly applies to all PrEP therapies (even if it was based on clinical evidence supporting daily oral tenofovir disoproxil fumarate-emtricitabine), it is appropriate to apply the USPSTF’s current Grade A recommendation for PrEP to APRETUDE,” wrote Andrew Zolopa, head of ViiV North America Medical Affairs, in a letter to CMS. “Finally, provider-administered PrEP is appropriate for individuals enrolled under Medicare Part B. Data show that the Medicare program covers approximately 10% of individuals who could benefit from PrEP, including primarily younger individuals who are eligible for Medicare based on disability.”

Zolopa closes by noting, “We urge CMS to initiate a National Coverage Analysis for provider-administered PrEP as soon as possible.”

Anyone wishing to contribute to the comments can access the CMS website.

In September, The Advocate was the first to report that a federal judge in Texas had ruled partially in favor of plaintiffs who argued that requiring insurance companies to cover medications for HIV pre-exposure prophylaxis, or PrEP, violates their rights on religious grounds.

The judge, in that case, did not rule on a remedy, and the government has indicated its intent to appeal that ruling.

The comment period ends February 11.