HIV is a high-cost category with an increasing number of competitors, 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 both commercial and Medicare lives said that managing HIV is an average priority for them. Those covering more than one-third of lives rated it a high priority. Payers representing around one-third of lives said they aggressively manage the condition. Commercial payers with almost three-fourths of lives said they were highly satisfied with the treatment options for HIV, and more than half of physicians said the same. Still, payers with more than half of commercial lives said there is moderate unmet need in treating HIV.
Payers representing three-fourths of commercial lives perceive a high to very high disease burden for people with HIV. Almost half of physicians considered it a high burden. Payers with more than half of commercial lives and less than half of Medicare lives said that HIV therapies have a high budget impact. More than one-third of providers said that people with HIV have an average out-of-pocket spend for their treatments.
Social Determinants of Health
Among payers covering Medicare lives, the top social determinants of health initiatives for disadvantaged members with HIV are greater access to telehealth — which is offered by payers with almost all lives — partnerships with housing authorities or community organizations and transportation to and from medical appointments. Commercial payers said they also prioritize these partnerships and greater access to telehealth, as well as services to assist in health/medicine language barriers. Physicians cited socioeconomic status, education and health literacy, and housing and transportation resources as the top non-medical factors impacting the ability of people with HIV to access health care services and therapy.
Gilead Sciences, Inc. said on Aug. 22, 2022, that the European Commission granted marketing authorization to its first-in-class capsid inhibitor lenacapavir, which will be marketed as Sunlenca. The agent is an every-six-months therapy for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multidrug-resistant HIV infection for whom it is otherwise not possible to construct a suppressive antiviral regimen. The company said in the prior month that the FDA had accepted its resubmission for the therapy, which has an action date of Dec. 27, 2022. Approximately half of physicians said the drug would have some impact on their treatment of both new and current patients. With the availability of the medication, payers covering almost half of commercial lives said there is a high disease burden for people with HIV.
PrEP Access and Coverage Act
On Dec. 1, 2021, Rep. Adam Schiff (D-Calif.) introduced the PrEP Access and Coverage Act. The bill is aimed at increasing access to pre-exposure prophylaxis (PrEP) in order to reduce HIV transmission and would, among other things, require all public and private insurance plans to cover the costs of HIV prevention pills and related services, with no patient out-of-pocket costs. Payers with more than three-fourths of Medicare lives and almost two-thirds of commercial lives said they already are compliant with the act. Among those that are apprehensive about the proposed mandate for no cost sharing, the top concerns were financial and operational issues.
Message: “Discussion and update regarding the status of Gilead’s lenacapavir as a treatment option in the management of HIV infection. Lenacapavir is a first-in-class/novel long-acting HIV-1 capsid inhibitor targeted for patients with multidrug-resistant HIV and heavily treated individuals and dosing subcutaneously twice yearly. The drug can be used in combination with other antiretroviral agents. Clinical efficacy studies as demonstrated in the CAPELLA Phase II and III trials demonstrated improvement in CD4 counts in patients that have tried/failed other agents due to multidrug resistance. The drug is currently classified as investigational and under review by the FDA. Additional information will be forthcoming and published as available.”
Payer Thoughts: “Overall, lenacapavir provides for not only improved efficacy and compliance due to the twice-yearly dosing, but an option in addressing an unmet need in patients that have experienced multidrug resistance.”
SCAN Aims to Serve Aging LGBTQ+ Population With Affirm Product
Long Beach, Calif.-based SCAN Health Plan is gaining attention for launching a novel product specifically geared toward LGBTQ+ older adults. Company executives tell AIS Health, a division of MMIT, that the nonprofit insurer spent more than a year carefully shaping the product to ensure that it would meet the needs of the LGBTQ+ community, and it will continue to tweak the product as it gathers feedback from enrollees. Layered on top of the same benefits available through other SCAN plans, SCAN Affirm features care navigation services provided by Included Health; lower copayments on specialty tier drugs including HIV treatments and gender-affirming hormone treatment; and $0 copays for PrEP and HIV testing.
Federal Judge Strikes Down ACA’s Coverage Mandate for PrEP Drugs
A federal judge on Sept. 7, 2022, ruled that the Affordable Care Act’s requirement that individual and group health plans must cover pre-exposure prophylaxis (PrEP) medications to prevent HIV violates the religious freedom of objecting employers. The ruling is not likely the final salvo in a case that challenged the ACA’s entire preventive service coverage mandate, but it did spark outcry from one advocacy group representing HIV-positive patients.