By Richard Hughes IV, Managing Director, Avalere Health
The potential to end the HIV epidemic looks more promising today than it has in the 40 years since the virus was discovered – yet the landscape giving rise to that promise is fraught with potential for a level of confusion capable of stymying an HIV-free future.
As we mark and celebrate HIV Vaccine Awareness Day, it is important to first review the promise:
More than 25 companies and organizations currently have in various phases of development HIV vaccines or monoclonal antibodies (mAbs), including a Phase III candidate, making the possibility of eliminating the risk of HIV infection more realistic now than ever before.
The Trump Administration is launching in 2020 the 10-year initiative “Ending the HIV Epidemic: A Plan for America,” which aims to reduce the current (and stalled) rate of new HIV infections from approximately 40,000 per year to less than 3,000 per year by 2030.
To date, the Food and Drug Administration (FDA) has approved more than 45 antiretroviral and treatment medications for HIV/AIDS, providing numerous preventive and therapeutic options for those at risk for and living with HIV.
As increasingly successful progression of therapies for those living with HIV has given way to options for preventing transmission through pre-exposure prophylaxis (PrEP). As options for PrEP increase, the promise of a vaccine is nearer to becoming reality.
These innovations, however, encounter fragmented governance of preventive recommendations, impairing clarity for payers, providers, and – most concerning – patients. Furthermore, HIV/AIDS carries a pervasive stigma that may further complicate access to life-saving preventive interventions once vaccines and mAbs are brought to market.
For example, the US Preventive Services Task Force (USPSTF), an independent, volunteer panel of national experts in disease prevention and evidence-based medicine whose recommendations affect standard best practices nationwide, recommended in 2019 the use of PrEP, which is more than 90% effective in preventing the spread of HIV when taken daily by high-risk populations in combination with safe-sex practices. USPSTF also renewed its recommendation for routine HIV screening for adolescents and adults. These USPSTF’s Grade A recommendations promote expanded access by guaranteeing coverage without cost sharing through individual and group markets and state Medicaid expansion programs.
Still, lack of clarity exists with respect to which PrEP products are entitled to first dollar coverage under the USPSTF recommendation. As new, innovative oral and injectable PrEP products enter the marketplace, patients will have increasing options for protection against HIV. Further clarity from the federal government for payers and providers on the coverage and management, as well as application of patient protections from out-of-pocket liabilities for these products, would ensure better access.
With respect to an HIV vaccine, the US Advisory Committee on Immunization Practices (ACIP) develops recommendations on the use of vaccines. All ACIP-recommended vaccines are entitled to the same coverage requirements as the USPSTF A- or B-rated services. The responsibility to make a recommendation for a US-licensed, HIV-preventive vaccine would presumably fall to the ACIP. But, overlapping authorities could generate confusion and slow eradication efforts: the USPSTF’s role in recommending PrEP, a therapeutic product with a prophylactic indication, and the ACIP’s historical role in recommending vaccines and mAbs used in conjunction with vaccines.
The onus to avoid the very real potential for misaligned or conflicting recommendations as HIV vaccines and mAbs are brought to market is likely to require multi-stakeholder attention. In particular, USPSTF and ACIP could prepare to issue coordinated recommendations for PrEP and future vaccinations to guide clinician, patient, and payer decision making and reduce the potential for marketplace confusion.
However, the more likely and feasible approach for encouraging the establishment of clear, consistent, evidence-based guidelines across organizations is for vaccine/mAb developers and their stakeholders to proactively work toward these ends as they move through clinical trials. Just as there are multiple HIV treatments, potential treatments and educational imperatives, there are multiple strategies that can be deployed by developers and their stakeholders to ensure smooth market entry, such as:
- Payer and Provider Strategy that includes establishing and maintaining relationships with, and providing clear clinical guidance to, vaccinating providers; developing individualized strategies for each payer market to pull-through first dollar coverage; focusing on coverage for HIV risk groups while engaging ACIP on the importance of a broad recommendation; and leveraging existing HIV-payment and purchasing programs to provide vaccine access and reimbursement.
- Federal Vaccine Policy that helps grantees use Section 317 funds to support programs that provide access to and information about HIV vaccines; ensures clarity for payers and providers on coverage requirements; and engages in advocacy efforts to reduce barriers to vaccines in Medicare.
- State Vaccine Policy that broadens existing HIV awareness efforts to include vaccines; considers opportunities for states to expand facility requirements to include HIV vaccines; improves pharmacy and other immunizer reimbursement for vaccine administration; engages state Medicaid agencies to ensure coverage of HIV vaccines without cost sharing; and supports advocacy efforts to reduce HIV vaccine hesitancy and misinformation.
- Advocacy and Stakeholder Engagement that aligns policy and advocacy strategies to include the HIV vaccine; engages HIV/AIDS stakeholders to support HIV vaccine policy, awareness, and access; and engages immunization stakeholders to support HIV policy development, awareness, and access.
In these ways, developers and stakeholders who are committed to a future without HIV/AIDS can ensure that this future is defined by coordinated care, access, and education – for all who are currently at risk for contracting HIV and the for the providers and advocates who serve them.