Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in AIS Health, in “Preventive Services Recommendation May Not Increase Injectable PrEP Access,” by Peter Johnson. (Read the full version – subscription required.)
Following is an excerpt:
A federal panel of medical experts on Aug. 22 recommended that pre-exposure prophylaxis be prescribed to people at increased risk of HIV infection, and included long-lasting, physician-administered injectable forms of PrEP in its guidance. However, a leading vaccine expert says the decision by the U.S. Preventive Services Task Force (USPSTF) is unlikely to increase access to PrEP, especially given an ongoing conservative-led legal battle that threatens to overturn the preventive services mandate included in the Affordable Care Act.
USPSTF granted PrEP an “A” grade, its highest rating. In the rating, USPSTF experts “recommend[ed] that healthcare professionals prescribe PrEP to people at increased risk for HIV to help prevent HIV.” Notably, the new rating mentions injectable PrEP, Apretude (cabotegravir extended-release injectable suspension), which had not been included in USPSTF PrEP recommendations before. In a 2019 PrEP endorsement, the task force only mentioned oral PrEP. …
Richard Hughes IV, partner at Epstein Becker Green LLP and adjunct professor at George Washington University’s law school, tells AIS Health, a division of MMIT, that adherence to daily oral PrEP is much more likely to slip than adherence to injectables. Hughes has called for increased access to injectable PrEP in op-eds published by Health Affairs and Stat earlier this year.
“Injectable PrEP is a complete game changer,” Hughes says. Since it is administered on a multi-month basis, rather than taken as a daily pill, Hughes says, “it improves adherence, and it increases effectiveness."
Despite those advantages, the recommendation is unlikely to change the market access picture for injectable PrEP, Hughes says.
“Under the ACA’s rules, if the task force is not specific about which items and services it’s recommending, that means payers have discretion about how they cover” a given treatment, Hughes says. After the 2019 recommendation, CMS issued guidance saying “payers get to choose — as long as they cover at least one product without cost sharing, they can subject these [other PrEP] products to formulary management.”