How We Developed The Haystack Group
- Collaborate with relevant patient groups and manufacturers on identified need for a voice for the ultra rare community;
- Develop Haystack Project, The Voice of the Ultra Rare entity and infrastructure;
- Conduct needs and priorities assessment with interested members;
- Develop initial goals and priorities with interested members;
- Facilitate the consensus-building process toward a unified set of goals and priorities; and
- Assess and communicate to members the potential trade-offs and negotiation strategies for activities identified as high priority or time-sensitive.
- Develop advocacy strategy on the Hill and with relevant regulatory agencies;
- Draft, or facilitate the drafting of, any white papers, position papers, talking points, and other advocacy materials;
- Create grassroots initiatives through patient organizations, specialty societies and other relevant ultra-orphan drug stakeholders on behalf of the Haystack Project, The Voice of Ultra Rare; and
- Develop an effective messaging strategy to promote recognition of ultra-orphan drugs and biologicals as a distinct, unique, and vulnerable subset of orphan products;
- Explore existing incentives for R&D and commercialization of orphan products, their value, and the potential risk of their reduction, limitation, or elimination;
- Assess the adequacy of existing incentives for ultra-orphan drugs and biologicals, and identify opportunities to “level the playing field” for individuals with ultra-rare disorders for which there are no FDA-approved treatment options;
- Execute advocacy strategy;
- Deploy messaging and other materials developed for the Haystack Project;
- Initiate grassroots initiatives; and
- Identify champions and assess opposition.
- Assess progress toward initial goals, and evaluate emerging priorities, risks, and/or opportunities;
- Assess and address gaps in patient advocacy partnerships; and
- Identify risks and opportunities in upcoming CMS annual regulatory proposals, craft and execute strategic initiatives.
- Continue to evaluate and pivot as socialization of a differentiated ultra-orphan reality develops and succeeds.
- Evolve “asks” in response to emerging vehicles.
- Kick off Hill meetings
- Kick off stakeholder meetings
- Website developed and launched at members’ request
- Facebook page developed and launched at members’ request
- Kick off of weekly calls