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.Apply for RFA AG 24 050
- 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.
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FAQs: NIH RFA-AG-24-050 - Health Equity and the Cost of Novel Treatments for Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) (R61/R33 Clinical Trial Not Allowed)
What is the funding opportunity?
This is a National Institutes of Health (NIH) funding opportunity announcement (FOA) 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)." The FOA number is RFA-AG-24-050.
What is the main purpose of this grant?
The core purpose is to study the real-world equity implications of emerging Alzheimer’s therapeutics (including novel drugs and repurposed drugs). The work is focused on access, affordability, and patient-centered value for people living with AD/ADRD, with special emphasis on racial and ethnic minority communities that have historically faced barriers in diagnosis, treatment access, and quality care.
What does "Health Equity and the Cost of Novel Treatments" mean in this context?
It means examining whether new or repurposed AD/ADRD drug options may widen or reduce inequities, especially through pricing, coverage, out-of-pocket costs, treatment logistics, and other practical requirements that affect who can start and stay on treatment.
What grant mechanism does this opportunity use?
This opportunity uses a phased R61/R33 mechanism. The R61 phase supports study development, and the R33 phase supports the main implementation and analytic work if the R61 milestones are met.
What is the R61 phase intended to support?
The R61 is a study development phase. It is meant to build a strong foundation for the main project through rigorous stakeholder engagement and the development of well-justified measures and study approaches.
What does NIH expect applicants to do during the R61 phase?
Applicants are expected to engage stakeholders closely, including racial and ethnic minority individuals living with AD/ADRD, caregivers, community organizations, clinicians, payers, and other relevant stakeholders. The goal is to identify what matters most to patients and families when considering pharmacologic treatment and to develop credible ways to measure preferences, perceived benefits and risks, and real-world factors that shape demand for treatment.
What kinds of outputs should come from the R61 phase?
The R61 phase should produce stakeholder-informed and well-justified measures and study approaches that can capture treatment preferences, perceived benefits and risks, and practical realities influencing interest in novel or repurposed AD/ADRD drugs. These outputs are intended to support a successful transition into the R33 phase if milestones are achieved.
How does a project move from R61 to R33?
Transition is expected to occur if the project meets the R61 milestones. The FOA describes the R61 as a development phase that must demonstrate readiness for the main analytic and dissemination work of the R33.
What is the R33 phase intended to support?
The R33 phase supports execution of the main analytic work, including rigorous modeling of drug-related costs and health outcomes, along with dissemination of findings.
What does "rigorous modeling" refer to in the R33 phase?
It refers to analytic approaches that quantify expenditures and health-related outcomes (including health-related quality of life) for people who are interested in receiving novel or repurposed AD/ADRD therapies, and that can examine how cost barriers may affect equitable uptake and continuation of treatment.
What cost components can be included in the analysis?
The FOA indicates the cost picture can include out-of-pocket costs and insurance coverage dynamics, as well as broader treatment-associated costs such as monitoring requirements, infusion or administration costs, additional testing, specialist visits, and care management.
What is the role of health-related quality of life (HRQoL) in this opportunity?
A central expectation is to quantify HRQoL for people interested in receiving novel or repurposed AD/ADRD therapies and connect economic outcomes to patient-centered measures of well-being and daily functioning, rather than focusing only on clinical endpoints.
What populations are prioritized in this funding opportunity?
The FOA places specific emphasis on racial and ethnic minority communities affected by AD/ADRD, particularly because these groups have historically experienced barriers to diagnosis, treatment access, and quality care.
What are the major research aims NIH highlights for strong applications?
The FOA highlights three major aims: (1) identify pharmacological treatment preferences among racial and ethnic minority people living with AD/ADRD; (2) assess whether cost barriers exist for these communities (including affordability, coverage, financial toxicity, and structural barriers); and (3) quantify expenditures and HRQoL among people interested in receiving new or repurposed AD/ADRD drugs, linking costs to patient-centered outcomes.
What kinds of treatment attributes should preference research capture?
The FOA specifically notes attributes that may drive decision-making, including expected benefits, side effects, treatment burden, route of administration, monitoring requirements, and costs.
What does the FOA mean by "cost barriers"?
Cost barriers can include affordability challenges, insurance coverage dynamics, financial toxicity, and structural barriers that translate costs into reduced access, resulting in differences in who can start and continue pharmacological treatment.
Does this opportunity fund clinical trials?
No. This FOA is explicitly "Clinical Trial Not Allowed." It is not intended to fund interventional trials that test drug safety or efficacy.
If clinical trials are not allowed, what types of research does NIH want here?
The FOA emphasizes 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.
What is meant by "patient-centered value" in this opportunity?
Based on the FOA description, patient-centered value refers to understanding treatment value through what matters to patients and families (preferences, perceived benefits/risks, burden, and practical realities), and by linking economic outcomes to HRQoL and daily functioning rather than only clinical metrics.
What is an example of a key deliverable for this funding opportunity?
A key deliverable is actionable evidence that helps health systems and policymakers anticipate and reduce inequities in access to costly AD/ADRD therapeutics as these treatments enter real-world use.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include various government entities (state, county, city, special district), public and state-controlled institutions of higher education, private institutions of higher education, federally recognized tribal governments and other tribal organizations, public housing authorities, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses) and small businesses, and other entities.
Are specific institution types explicitly encouraged or included as eligible?
Yes. The FOA also calls out additional eligible applicants such as HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, eligible federal agencies, and non-U.S. (foreign) entities.
Are non-U.S. (foreign) entities allowed to apply?
Yes. The information provided states that non-U.S. (foreign) entities are included among eligible applicants.
What is the funding instrument and activity category?
The funding instrument is a grant, and the activity category is health.
What is the CFDA number for this opportunity?
The CFDA number listed is 93.866.
What is the closing date listed in the source information?
The original closing date provided is 2023-10-31.
What is the award ceiling listed?
An award ceiling of $200,000 is provided in the source data, with a note that total budget structure can depend on NIH policy, the phased design, and project-specific scope.
How does this opportunity connect research to real-world implementation?
The FOA is centered on real-world equity implications, meaning applicants are expected to consider practical access and affordability factors (coverage, out-of-pocket spending, treatment logistics, monitoring, administration, and related services) and produce findings that can guide policy, payer decisions, and equitable implementation strategies.
Why is stakeholder engagement emphasized so strongly?
Because the R61 phase is designed to ensure the main study is built around what patients, caregivers, and communities consider important. The FOA expects engagement to help define meaningful outcomes and measures of preferences, benefits/risks, and treatment realities, especially for racial and ethnic minority communities that face historical and structural barriers.
What types of stakeholders are mentioned?
The FOA mentions racial and ethnic minority individuals living with AD/ADRD, caregivers, community organizations, clinicians, payers, and other relevant stakeholders.
What is the overall goal across both phases?
Across R61 and R33, the goal is to generate practical, stakeholder-informed evidence and models about drug costs, affordability, and health outcomes (including HRQoL) so decision-makers can better anticipate and reduce inequities in access to novel or repurposed AD/ADRD treatments.
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