What Haystack Project does

Haystack Project is a 501(c)(3) nonprofit coalition founded in 2016 and headquartered in Washington, DC, that aggregates 140+ ultra-rare disease patient advocacy organizations to collectively address systemic obstacles to patient access. The organization operates a portfolio of advocacy programs rather than a unified product: the Rare Cancer Policy Coalition (RCPC) for rare cancer reimbursement issues, Health Equity in Access to Treatments (HEAT) for disparities in underserved communities, ROPE BRIDGE for payer engagement, and Patient-Oriented Value (POV©) reports that translate patient perspectives into value framework inputs. It runs a Speaker Series featuring FDA, CMS, and industry officials, and conducts direct congressional engagement including hosting roundtables with Senate HELP & Finance Committees and the Congressional Rare Caucus.

The organization's core recent activities center on legislative and regulatory advocacy: it successfully shepherded HEART Act provisions into the 2022 FDA user fee package, filed a Petition for Rulemaking with the FDA in April 2026 calling for a legally binding context-based evidence framework, and drove bipartisan introduction of the PROTECT Rare Act (S.3551) in the Senate. Haystack Project is funded through donations and contributions from individuals, foundations, and industry partners; participation in the coalition is free for qualifying patient advocacy organizations. The organization is staffed by a small team of 6 employees and operates exclusively within the United States.

Name

Haystack Project

Legal name

The Haystack Project

Website

https://haystackproject.org

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

Haystack Project is a 501(c)(3) nonprofit coalition founded in 2016 that unites 140+ ultra-rare disease patient advocacy organizations to advocate for systemic improvements in healthcare access, FDA regulatory frameworks, payer engagement, and health equity through legislative advocacy, policy initiatives, and educational programming in the United States.

Ownership category

akta.pro rank

Product category

Rare Disease Patient Advocacy

NAICS

Voluntary Health Organizations (813212), Individual and Family Services (6241)

SIC

Services-Social Services (8300), Services-Membership Organizations (8600)

akta.pro primary industry

Rare Disease & Special Needs Support Organizations (BPAGACAM)

akta.pro secondary industry

Global Health Research, Evidence & Technical Assistance Organizations (HLAJAKAN)

Keywords

• Rare disease advocacy
• Patient advocacy coalition
• Ultra-rare diseases
• Healthcare policy advocacy
• Patient access programs

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Donations and Contributions: As a 501(c)(3) nonprofit organization, Haystack Project likely relies on tax-deductible donations from individuals, foundations, and industry partners to fund its operations and advocacy programs.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Haystack Project is a 501(c)(3) non-profit coalition that brings together 140+ ultra-rare disease patient advocacy organizations to address systemic obstacles to patient access. The organization educates policymakers and payers, develops patient-oriented value frameworks, and engages in legislative and regulatory advocacy (including FDA petitions and acts like PROTECT Rare and HEART) to evolve healthcare payment and delivery systems for rare disease therapies.

Product overview

Haystack Project is a non-profit 501(c)(3) coalition of over 140 ultra-rare patient groups that does not offer a unified software product but rather operates a portfolio of advocacy programs and initiatives. The organization connects rare disease patient advocacy organizations to address systemic patient access obstacles through educational outreach, legislative advocacy (PROTECT Rare Act, HEART Act), payer engagement (ROPE BRIDGE), health equity initiatives (HEAT), patient-oriented value assessment frameworks (POV© Reports), and the Rare Cancer Policy Coalition. Key activities include submitting policy petitions to the FDA (Context-Based Evidence Framework), hosting speaker series, producing white papers and reports, and engaging in coalition-building with stakeholders across the healthcare system.

Differentiator

Problem solved

Functional benefit

Brands

• Rare Cancer Policy Coalition (RCPC): A Haystack Project initiative that brings together rare cancer patient organizations focusing on systemic reimbursement barriers and emerging landscape changes impacting new product development and treatment access for rare cancer patients.
• Health Equity in Access to Treatments (HEAT)
• Patient-Oriented Value (POV)
• ROPE BRIDGE

Quantifiable outcome

• Petition for Rulemaking submitted to FDA calling for context-based evidence framework for rare disease therapies
• +2 more outcomes

Named customers2 records

Segments1 record

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Six partnerships are on record, tiered core and minor.

• Rare Cancer Policy Coalition (RCPC)coreStrategic or Co-development PartnerRCPC is a Haystack Project initiative bringing together rare cancer patient organizations. It is the only rare cancer coalition focused specifically on reimbursement, access and value issues. Working within Haystack enables RCPC participants to leverage synergies and common goals to optimize advocacy in disease states where unmet need is high and treatment inadequacies can be catastrophic. National Cancer Institute defines rare cancer as occurring in fewer than 15 out of 100,000 people per year.
• Siegel Rare Neuroimmune Association (SRNA)coreStrategic or Co-development PartnerSRNA is the first organization to leverage Haystack Project's Health Equity in Access to Treatments (HEAT) initiative. The partnership aims to investigate health equity issues in neuroimmune disorders, understand variability in access and disease burden, identify barriers to diagnosis and treatment especially for underserved populations, and assess representativeness of SRNA's outreach and education efforts.
• ROPE BRIDGE Payer Council PartnerscoreStrategic or Co-development PartnerHaystack Project is launching ROPE BRIDGE, a collaborative bi-directional education effort with payers including Medicare Advantage plans, Medicaid managed care plans, and other community, regional, and national plans. The initiative seeks common ground between payers and patients, creating ongoing dialogue about utilization management approaches, documentation requirements, and medical necessity criteria.
• Institute for Clinical and Economic Review (ICER)coreStrategic or Co-development PartnerHaystack Project has engaged extensively with ICER's stakeholder engagement function and secured access to ICER's Analytics and modeling capabilities. Haystack joined ICER's Fair Access Working Group. The organization has spent considerable time educating 80+ rare patient groups about value frameworks and their impact on patient access, and the inadequacy of models used by ICER for extremely rare conditions.
• American Enterprise Institute (AEI)minorGTM or Marketing PartnerAEI logo appears on the Speaker Series page, indicating a partnership for educational programming. Nature of partnership appears to involve joint hosting of speaker series events or educational content related to healthcare policy.
• Alliance of Community Health PlansminorStrategic or Co-development PartnerOrganization represented in Haystack Project speaker series, indicating ongoing dialogue on rare disease policy issues. Nissa Shaffi, Associate Director of Public Policy, presented at October 2023 speaker series.

Scale indicators1 record

Recent moves6 records

Expansion highlights6 records

Direct peers

• Patient Advocate Foundation: Patient Advocate Foundation provides direct case management and access support for patients including those with rare diseases; comparable in patient access mission and payer navigation focus, though service-delivery rather than coalition-based.
• Global Genes: Global Genes is a rare disease patient advocacy organization that builds coalitions, educates patients, and advocates for policy; it is directly comparable to Haystack in mission and constituency, though with broader (rather than ultra-rare) disease coverage.
• National Patient Advocate Foundation: National Patient Advocate Foundation provides case management, policy advocacy, and financial assistance for patients with chronic and rare diseases; it is comparable to Haystack's patient advocacy and payer engagement focus.
• Rare Disease Legislative Advocates (RDLA): RDLA coordinates Congressional advocacy for the rare disease community, including Rare Disease Week on Capitol Hill—an activity that directly overlaps with Haystack's Congressional engagement and Protect Rare Act advocacy.
• EveryLife Foundation for Rare Diseases: EveryLife Foundation is a rare disease public policy advocacy organization that drives federal and state policy on newborn screening, access to therapies, and FDA engagement—directly comparable to Haystack's legislative and regulatory advocacy mission.

Others

• FasterCures (Milken Institute): FasterCures is a policy and advocacy program of the Milken Institute focused on accelerating medical research and patient access; it is adjacent to Haystack in the rare disease policy ecosystem but operates from a think-tank rather than coalition structure.

Broad incumbents

• National Organization for Rare Disorders (NORD): NORD is the largest US rare disease patient advocacy organization representing 300+ disease-specific member organizations; it is a broad incumbent in the same space as Haystack, with deeper resources but broader (rather than ultra-rare-focused) policy agenda.
• National Health Council: National Health Council is a membership organization for patient advocacy groups that engages on value assessment, payer access, and FDA policy; comparable to Haystack as an umbrella advocacy coalition, though broader than ultra-rare.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/haystack-project

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Haystack Project