Surprise! The Copay for PrEP Just Disappeared

Carl Schmid and his colleagues got more than they bargained for — in a good way — when they requested that Medicare cover long-acting physician-administered HIV pre-exposure prophylaxis (PrEP) drugs under its Part B program.

Oral PrEP drugs had been paid for under Medicare’s Part D drug program, but Part D doesn’t normally cover physician-administered drugs. And although some Part D plans had been paying for the long-acting PrEP anyway, others had not been, explained Schmid, who is executive director of the HIV+Hepatitis Policy Institute in Washington, D.C. The most recent data, which are a couple of years old, suggested that “several hundred” Medicare beneficiaries were on the long-acting drugs, but “that has probably gone up to a couple thousand” since, he added.

So, 2 years ago, Schmid’s group, as well as other organizations and affected drugmakers, asked Medicare for a National Coverage Analysis that would allow long-acting PrEP to be covered under Medicare Part B, which covers physician-administered drugs. “We needed a way to cover the injectable HIV prevention drugs, and that’s what necessitated the ask for the coverage determination,” Schmid said in a phone interview. “What we didn’t know was they would move the oral PrEP to Part B at the same time.”

CMS officials told Schmid that the agency can’t split up coverage of drugs to prevent or treat a specific disease between different parts of the Medicare program; the drugs all have to be covered under the same program. And that change, which took effect under Medicare’s National Coverage Determination issued on Monday, has an unexpected benefit for the approximately 45,000 Medicare enrollees taking the daily oral medications: they will go from having a copay under Part D to no copay under Part B.

Schmid said although he’s pleased about that surprise bonus, the transition to Part B is not without complications. “The issue is that pharmacies are not signed up to bill for drugs in Part B,” he said. “They have to apply — it’s a 50-page document to apply — get a site review, and then they have to have a diagnosis code to get reimbursed.”

In addition, “there’s [a] different reimbursement” system under Part B — “you have PBMs [pharmacy benefit managers] who are involved in Part D, with rebates and all that,” Schmid said. “That does not exist with Part B; the PBMs are out of it. It’s a reimbursement model, so the pharmacists have to buy the drug first, and they’re worried they may not get proper reimbursement from Medicare. And since it’s going to be in the Part B schedule, they don’t even know when their reimbursement is going to be.”

The good news is that so far, “payers and plans and pharmacies are being flexible,” he said. Notices have been sent out to plans informing them of the change, technical assistance webinars have been held for pharmacies, “and we’re trying to get the word out to clinics,” especially to remind patients to bring their Medicare cards when they get their prescriptions filled.

Schmid expects that as time goes on, more and more people will be opting for the long-acting PrEP — which is administered every 6 months — rather than the less convenient daily oral medications.

He noted that Gilead has recently been making progress on lenacapavir (Sunlenca), its twice-yearly injectable PrEP medication. In the phase III randomized PURPOSE 2 trial involving 3,200 cisgender men, transgender men, transgender women, and gender non-binary individuals in seven countries who have sex with partners assigned male at birth, there were only two incident cases of HIV among the 2,180 participants taking lenacapavir, the company said in a September 12 press release.

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