HIV is a high-cost category with an increasing number of therapies, even as the number of generics grows as well. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for HIV, Zitter Insights surveys a leading panel of pharmacy and therapeutics (P&T) decision makers at payers and integrated delivery networks. The Managed Care Biologics and Injectables Index: HIV combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading specialty brands.
Payers with almost half of commercial lives and more than one-third of Medicare lives said that managing HIV is an average priority for them. Payers representing around four-fifths of commercial lives and almost three-quarters of Medicare beneficiaries said they somewhat aggressively or aggressively manage the condition. More than two-thirds of payers expressed high satisfaction with available treatment options for HIV, and more than half of physicians said the same. Still, payers with approximately half of commercial lives said there is moderate unmet need in treating HIV.
Payers representing almost three-fifths of both commercial and Medicare lives perceive a high disease burden for people with HIV. Slightly fewer physicians considered it an average or high burden. Payers with almost three-fifths of commercial and Medicare beneficiaries said that HIV therapies have a high budget impact. Almost two-fifths of providers responded that people with HIV have an average or high out-of-pocket spend for their treatments.
Payers, physicians and practice managers were asked to rate manufacturers of HIV medications on six different metrics: overall commitment to the disease, account representative support, patient/family support resources, patient copay assistance, physician education/support and hub services. Payers rated ViiV Healthcare the top company in five categories and named Johnson & Johnson Innovative Medicine first in hub services. Physicians ranked J&J the best in four categories, with ViiV taking the top spots for account representative support and patient/family support programs and resources. Gilead Sciences, Inc. was named the No. 1 company in five categories by practice managers, tying with Merck & Co., Inc. for physician education and support, while J&J was rated first in patient copay assistance.
On Dec. 22, the FDA approved Gilead’s Sunlenca (lenacapavir) for the treatment, in combination with other antiretroviral(s), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The agency gave the first-in-class capsid inhibitor priority review, fast track and breakthrough therapy designations. Three-fifths of physicians said they expect some impact from the new agent, with their treatment approach likely to stay mostly unchanged except they possibly might alter it with some patients. Among the payers that had conducted a P&T review, those with almost two-thirds of commercial lives said they expected Sunlenca would have some impact on other products to treat HIV, meaning that they would not change coverage or tiering, but some utilization management criteria may change.
On March 30, 2023, a U.S. district court judge struck down certain preventive services coverage mandated by the Affordable Care Act (ACA). If upheld, the decision could upend access to potentially life-saving services, including pre-exposure prophylaxis (PrEP) for the prevention of HIV, that have been provided for free for more than a decade. About half of payers said they were moderately familiar with the ruling. More than four-fifths of payers said they expect there to be no change to beneficiary cost sharing for PrEP following the ruling. The steps taken by payers that said they will try to manage a potential increase in costs include encouraging generics over brand drugs, pushing members to use manufacturer coupons and leveraging generics to boost contracting for brand medications.
Message: “We are looking at our HIV preferred brands. Gilead has many preferred HIV products for us, including Genvoya. Genvoya has been an important agent for new starts with very good adherence success. We expect to continue to prefer many of the Gilead combination products that are still under patent protection.”
Payer Thoughts: “We like the Gilead HIV combos in general but feel a need to maintain competition with ViiV products to help with contract leverage. Genvoya is highly successful and preferred by prescribers, so it is kind of a no brainer that we would continue to contract for this agent.”
Gilead’s First-in-Class HIV Drug Sunlenca Offers Much-Needed Option
The FDA recently approved a new HIV drug for a small patient population desperately in need of treatments. And the twice-yearly medication’s annual price is below the level that respondents to a Zitter Insights poll said they would consider a good value. The medication comes with both potential advantages and disadvantages for patients, providers and payers, say industry experts.
Federal Watchdog: One Quarter of HIV-Positive Medicaid Enrollees Missed Care
More than a quarter of HIV-positive Medicaid enrollees did not receive at least one of three necessary services for viral suppression in 2021, according to a new report from the HHS Office of Inspector General (OIG). According to one expert, that missed care is certain to rebound to Medicaid managed care organizations (MCOs) in the form of a heavy cost burden: If HIV isn’t continually treated with antiretroviral therapy (ART) drugs and patients are not monitored by practitioners, the virus will cause a patient to develop AIDS — and patients are more likely to transmit the virus to others.