Health Equity and the Cost of Novel Treatments for Alzheimers Disease and Related Dementias (R61/R33 Clinical Trial Not Allowed) | RFA AG 23 005

Opportunity Information: Apply for RFA AG 23 005

This National Institutes of Health (NIH) funding opportunity, RFA-AG-23-005, supports research focused on health equity issues tied to the pricing and access challenges surrounding new and repurposed drug treatments for Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD). It uses an R61/R33 phased innovation award mechanism and is explicitly "Clinical Trial Not Allowed," meaning applicants should propose observational, survey, qualitative, economic, or modeling work rather than interventional studies that assign participants to receive treatments. The central aim is to understand how the arrival of novel therapeutics affects different populations, particularly whether racial and ethnic minority communities face distinct barriers, preferences, or financial burdens that could worsen existing inequities in dementia care.

The FOA emphasizes three closely linked research targets. First, applicants are expected to identify treatment preferences for pharmacological approaches among racial and ethnic minority people living with AD/ADRD. This can include what outcomes matter most to patients and caregivers, how people weigh potential benefits versus risks and side effects, and how trust, prior experiences with the healthcare system, and cultural context shape willingness to try new or repurposed drugs. Second, the opportunity calls for assessing whether cost barriers to pharmacological care exist for these groups, which could include issues like out-of-pocket costs, insurance coverage limitations, access to specialists, transportation burdens, prior authorization requirements, and uneven availability of diagnostic services that often gate access to treatment. Third, applicants should quantify both expenditures and health-related quality of life (HRQoL) among people who are interested in receiving these novel or repurposed therapies, tying financial impacts to patient-centered outcomes rather than examining costs in isolation.

A defining feature of this announcement is the two-phase structure. The R61 phase is a study development period designed to ensure the eventual research is grounded in rigorous stakeholder engagement. In practice, this means meaningful, structured input from the communities most affected, including racial and ethnic minority individuals living with AD/ADRD, their caregivers, and potentially community leaders, clinicians, payers, and advocacy organizations. The goal of this phase is to refine research questions and measures, validate that proposed approaches reflect real-world decision-making and lived experience, and identify how to measure "demand" for new and repurposed drugs in a way that is credible and culturally appropriate. If the R61 milestones are met, the project transitions to the R33 phase, which supports implementation of robust economic and outcomes modeling, estimation of costs and HRQoL impacts, and dissemination of findings so they can inform policy, coverage decisions, and equitable access strategies.

The work supported in the R33 phase is oriented toward rigorous modeling and communication of results. That typically implies analytic approaches such as decision-analytic modeling, cost or cost-effectiveness frameworks, budget impact analysis, and other methods that link treatment uptake scenarios to expected spending and quality-of-life changes. Although the FOA does not prescribe a single methodology, it makes clear that the end products should help quantify what people pay, what systems spend, and what patients experience in terms of HRQoL when novel or repurposed treatments are sought or used, especially under conditions where costs and access constraints differ by race and ethnicity. Equally important is the expectation that investigators disseminate model findings, meaning results should not remain purely academic but be shared in forms that stakeholders can use, such as policy briefs, community-facing summaries, or guidance relevant to health systems and payers.

Eligibility is broad and includes many organization types that could credibly carry out community-engaged health equity and health economics research. Eligible applicants include state, county, city, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights interest in participation from institutions and organizations closely connected to underserved communities, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American and Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and regional organizations. In terms of international participation, non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization, but foreign components of U.S. organizations are allowed, consistent with NIH policy definitions.

Administratively, the opportunity is categorized as a discretionary grant under the NIH, with the activity tied to health (CFDA 93.866). The original closing date listed is July 1, 2022, and the FOA was created on February 17, 2022. While the summary does not include an award ceiling or the number of expected awards, the structure and scope indicate NIH is looking for projects that can move from early, community-grounded study design into a well-justified, quantitative assessment of how drug costs and access dynamics affect equity in AD/ADRD care. Overall, the FOA is aimed at producing evidence that clarifies what communities want from emerging treatments, what stands in the way of equitable access, and what the cost and quality-of-life consequences are likely to be as new therapies enter real-world practice.

• 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 and Related Dementias (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 2022-02-17.
• Applicants must submit their applications by 2022-07-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 23 005

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