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Financing and Reimbursement of Cures in the US

The FoCUS Project targets the need for new innovative financing and reimbursement models for curative medicines in the US that ensure (1) patient access for needed treatments; (2) affordability for public and private payers; and (3) the sustainability of innovation by manufacturers.

 
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Financing and Reimbursement of Cures in the US

The FoCUS Project targets the need for new innovative financing and reimbursement models for curative medicines in the US that ensure (1) patient access for needed treatments; (2) affordability for public and private payers; and (3) the sustainability of innovation by manufacturers.

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Research brief

How can self-insured employers prepare for the portfolio impact of high-cost gene therapies coming to market?

Self-insured employers (SIEs) currently rely on traditional stop-loss insurance to protect against unexpected high-cost claims, including those for cell and gene therapies. Given that current approvals are in rare diseases, this approach has succeeded so far. However, as more cell and gene therapies treatments are approved in more prevalent patient populations, this status quo approach may not be sustainable for stop-loss vendors or employers.

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About FoCUS

Medical research is making significant advances toward treatments that cure major diseases, but these treatments will often entail very high up-front costs. The FoCUS Project targets the need for new innovative financing and reimbursement models for curative medicines in the US that ensure (1) patient access for needed treatments; (2) affordability for public and private payers; and (3) the sustainability of innovation by manufacturers.

FoCUS activities center around the design, rapid cycle prototyping, and piloting of financing and reimbursement models for curative therapies in the US, with targeted pilot launches occurring throughout the life of the project. All financing and reimbursement designs will be derived from work done by disease specific multi-stakeholder Target Area Groups (TAGs) in coordination with NEWDIGS team members, MIT Faculty and others. Designs will be rigorously evaluated through modeling and simulation exercises, evaluated through product specific case studies in NEWDIGS Design Labs and vetted. Lessons will be disseminated broadly to inform the stakeholder community, pilot implementations and scale up. Initial priorities for action are curative gene therapies and durable oncology treatments.

Join FoCUS

Successfully meeting the emerging challenges of financing durable/potentially curative therapies will take the hands-on engagement of all stakeholders in the healthcare innovation ecosystem.

Organizations that join FoCUS have the opportunity to shape the immediate and long-term future of both medical innovation and financial solutions to appropriate patient access for durable/curative therapies.

Download the FoCUS Project Prospectus (PDF)

FoCUS Partners

FoCUS partners support the project with financial or in-kind donations. Current partners include:

Beth Israel Deaconess Medical Center (BIDMC)
Bill & Melinda Gates Foundation
Blue Cross Blue Shield Association
bluebird bio
Bristol-Myers Squibb
Canadian Agency for Drugs and Technologies in Health (CADTH)
Canadian Organization for Rare Disorders (CORD)
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Organisation for Rare Diseases (EURORDIS)
European Medicines Agency (EMA)
European network for Health Technology Assessment (EUnetHTA)
Food and Drug Administration (FDA, USA)
Friends of Cancer Research
Harvard Medical School
Harvard School of Public Health
Health Canada
Innovative Medicines Initiative (IMI)
Johnson & Johnson
Massachusetts General Hospital 
Medicines and Healthcare products Regulatory Agency (MHRA)
National Healthcare Institute (ZIN, the Netherlands)
National Organization for Rare Disorders (NORD)
National Institute for Health and Care Excellence (NICE)
Pfizer
Sanofi