The CDC made a strong recommendation based on a high certainty of evidence to use the long-acting injectable lenacapavir (Yeztugo) for HIV pre-exposure prophylaxis (PrEP), but will that ensure the treatment’s place in the nation’s health plan formularies?
“[Lenacapavir] is a highly effective and safe PrEP option administered every 6 months, which provides the potential to improve PrEP adherence and thus enhance HIV prevention in the United States,” the CDC’s PrEP Guidelines Work Group stated in its clinical recommendation, published last week in the Morbidity and Mortality Weekly Report.
Even so, the CDC’s new position on lenacapavir won’t necessarily convince all U.S. private and public health insurers to cover the PrEP drug.
“Just because an injectable is in the CDC clinical guidelines doesn’t mean all insurance companies have to pay for it,” Monica Gandhi, MD, of the University of California San Francisco and the HIV Clinic at Ward 86, told MedPage Today.
Is the Price Right?
At roughly $14,000 per 6-month dose in the U.S. — $28,000 per year — Gandhi said lenacapavir’s annual cost essentially matches that of competing PrEP injectable cabotegravir (Apretude), after adding up the annual cost of cabotegravir’s 2-month doses. Both cost more than competing, clinically recommended daily oral options. Even with cabotegravir’s earlier addition to the CDC’s guidelines and its more-convenient dosing, its uptake remains low relative to the daily oral treatments.
FDA’s recent approval for lenacapavir hasn’t led to universal coverage within a fractured U.S. health system, explained Gandhi, who was an external reviewer on the CDC’s lenacapavir recommendation.
Some private pharmacy benefit managers (PBMs) have added it to their formularies, and some state Medicaid programs such as California’s are paying for lenacapavir as well. However, one of the nation’s three largest PBMs, CVS Caremark, has declined to add lenacapavir to its list of covered PrEP therapies, which includes cabotegravir. In August, CVS Health announced it would not include the drug in its commercial or Affordable Care Act plans.
In a Sept. 18 letter to CVS Health President and CEO J. David Joyner, a group of 64 advocacy organizations led by the HIV+Hepatitis Policy Institute called on the PBM giant to rethink that stance. “Ensuring comprehensive, zero-cost PrEP access is both a legal requirement and a critical public health imperative,” the group stated.
Thus, from an insurance coverage standpoint, it’s critically important that the CDC and other guidelines (e.g., those from the World Health Organization) endorse lenacapavir, said Allison Agwu, MD, of Johns Hopkins University in Baltimore. “That helps put the fingers on the scale to say, ‘Hey, we really should be covering it.'”
Lenacapavir Brings More Choice to PrEP
The FDA approved lenacapavir in June for PrEP in adults and adolescents weighing at least 77 lb at risk of HIV infection.
Lenacapavir is now one of four FDA-approved PrEP therapies on the market, oral options being emtricitabine in combination with tenofovir disoproxil fumarate (Truvada; F/TDF) for men and women, or emtricitabine combined with tenofovir alafenamide (Descovy; F/TAF) for men and transgender women.
“It’s incredibly meaningful to have lenacapavir added, because it expands the armamentarium,” Agwu told MedPage Today. With lenacapavir as another long-acting option, “hopefully, we can get to have coverage for everybody who needs PrEP in a way that they want to take it.”
While head-to-head studies of lenacapavir and cabotegravir haven’t been done, Gandhi said, the two injectable treatments are both likely to be more effective than the oral options.
“We are very eager to use the long-acting injectables in our patient populations that are vulnerable and face a lot of challenges,” she explained. That said, “we’re happy to give patients a choice in the clinical setting.”
Choice means patients can find a PrEP regimen that works for them. For example, patients who aren’t comfortable with the post-injection nodules that can persist with long-acting shots can continue to choose daily oral therapy, Gandhi noted.
The Evidence for Lenacapavir
The CDC’s lenacapavir recommendation rests on two phase III clinical trials, PURPOSE 1 and PURPOSE 2.
PURPOSE 1 compared HIV incidence among HIV-negative girls and women ages 16 to 25 years in South Africa and Uganda with sexual risk factors for HIV infection. In that group, 5,338 participants were randomized 2:1:1 to receive lenacapavir every 6 months, daily oral F/TAF, or F/TDF.
Over 52 weeks of follow-up in PURPOSE 1, lenacapavir was 100% efficacious, with no new HIV infections, compared with the background HIV incidence among all 8,094 people screened for the study (2.41 cases per 100 person-years) and those taking F/TAF (2.02 events per 100 person-years) or F/TDF (1.69 events per 100 person-years).
PURPOSE 2 included 4,634 HIV-negative males ages 16 to 80 years in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the U.S. PURPOSE 2 followed PURPOSE 1’s risk-based participation requirements and randomization regimen and showed that compared with no PrEP use, lenacapavir had an efficacy of 96% for HIV prevention. Lenacapavir had an efficacy of 89% when compared with F/TDF.
Adverse event rates were similar in all groups across both trials, and pregnancy-associated adverse event rates were similar between the treatment groups and no-PrEP groups.
“[Lenacapavir] PrEP may be used in pregnant women or continued in women who become pregnant while receiving injections, considering the woman’s risk for HIV without PrEP,” the CDC work group said.
Please enable JavaScript to view the