Health Equity and the Cost of Novel Treatments for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (R61/R33 Clinical Trial Not Allowed) | RFA AG 24 050

Opportunity Information: Apply for RFA AG 24 050

The National Institutes of Health (NIH) funding opportunity RFA-AG-24-050, titled "Health Equity and the Cost of Novel Treatments for Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) (R61/R33 Clinical Trial Not Allowed)," supports research focused on the real-world equity implications of emerging Alzheimer’s drug treatments. The core purpose is to understand how the arrival of novel therapeutics (and repurposed drugs) may affect access, affordability, and patient-centered value for people living with AD/ADRD, with a specific emphasis on racial and ethnic minority communities that have historically faced barriers in diagnosis, treatment access, and quality care.

This opportunity uses a phased R61/R33 grant mechanism. The R61 is a study development phase meant to lay a strong foundation for the main project by conducting rigorous stakeholder engagement. In practice, this means applicants are expected to work closely with racial and ethnic minority individuals living with AD/ADRD, along with caregivers, community organizations, clinicians, payers, and other relevant stakeholders, to identify what matters most to patients and families when considering pharmacologic treatment. The R61 phase should produce well-justified measures and study approaches that can credibly capture treatment preferences, perceived benefits and risks, and the practical realities that shape demand for new or repurposed AD/ADRD drugs. If the milestones for the R61 phase are met, the project can transition into the R33 implementation phase.

The R33 phase is designed for executing the main analytic work: rigorous modeling of drug-related costs and health outcomes, paired with dissemination of findings. A central expectation is that the funded work will quantify expenditures and health-related quality of life (HRQoL) for people who are interested in receiving novel or repurposed AD/ADRD therapies. This can include examining out-of-pocket costs, insurance coverage dynamics, and the broader cost picture associated with treatment (for example, monitoring requirements, infusion or administration costs, additional testing, specialist visits, or care management). The modeling is also expected to explore whether cost barriers to pharmacological care exist for racial and ethnic minority groups and how those barriers may shape who is able to start and continue treatment.

Across both phases, the NOFO highlights three major research aims that strong applications should address. First, investigators should identify pharmacological treatment preferences among racial and ethnic minority people living with AD/ADRD, capturing what attributes drive decision-making (such as expected benefits, side effects, treatment burden, route of administration, monitoring requirements, and costs). Second, investigators should assess whether cost barriers exist for these communities, which can involve evaluating affordability, coverage, and financial toxicity, as well as structural barriers that translate costs into reduced access. Third, applicants should quantify expenditures and HRQoL among people interested in receiving new or repurposed AD/ADRD drugs, linking economic outcomes to patient-centered measures of well-being and daily functioning rather than focusing only on clinical endpoints.

Importantly, this NOFO is explicitly "Clinical Trial Not Allowed," meaning the intent is not to fund interventional trials that test the safety or efficacy of a drug. Instead, the emphasis is on health services research, patient and community engagement, preference elicitation, economic evaluation, and modeling approaches that can inform policy, payer decisions, and equitable implementation strategies as new treatments enter the market. A key deliverable is actionable evidence that can guide how health systems and policymakers anticipate and reduce inequities in access to costly AD/ADRD therapeutics.

Eligibility is broad and includes many types of organizations that can credibly conduct community-engaged and policy-relevant research. Eligible applicants include state, county, city, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities. The NOFO also specifically calls out additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, eligible federal agencies, and even non-U.S. (foreign) entities, reflecting an intent to include institutions with deep ties to underserved communities and expertise in equity-focused work.

Key administrative details provided include that the funding instrument is a grant, the activity category is health, and the CFDA number is 93.866. The original closing date listed is 2023-10-31, and an award ceiling of $200,000 is provided in the source data (noting that total budget structure can depend on NIH policy, the phased design, and project-specific scope). Overall, the opportunity is aimed at generating practical, stakeholder-informed evidence on how drug pricing, affordability, and implementation realities may affect equitable uptake of next-generation AD/ADRD treatments, and at producing models and disseminated findings that can support more equitable decision-making across healthcare and policy settings.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Health Equity and the Cost of Novel Treatments for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (R61/R33 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
• This funding opportunity was created on 2023-07-19.
• Applicants must submit their applications by 2023-10-31. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $200,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AG 24 050

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