CAMBRIDGE, Mass., Oct. 27, 2016 — Patient advocates, healthcare payers, industry, and academic stakeholders gathered today at the Massachusetts Institute of Technology (MIT) to map out a new strategy for designing and piloting innovative financing and reimbursement models for promising, and possibly curative, new medicines. The project is called Financing and Reimbursement of Cures in the US (FoCUS).

FoCUS will initially target three urgent medical areas—Curative Gene Therapies, Durable Oncology Treatments, and Antibiotics for Multi-Drug Resistant Infections. Working groups will use components of a dynamic design “toolkit” to tailor innovative finance and reimbursement models that address different characteristics of curative therapy types.

The science and technology for new therapies is advancing in exciting ways, but the medical products leveraging that science often lags behind urgent patient needs. Peter Saltonstall, President and CEO of the National Organization of Rare Disorders (NORD), a leading patient-advocacy group, said “Once [new therapies are] developed, each player in the healthcare system bears responsibility in ensuring access and affordability.”

FoCUS is an undertaking of the MIT Center for Biomedical Innovation (CBI) NEWDIGS (NEW Drug Development ParadIGmS) Initiative, which focuses on re-engineering drug development and delivery processes to optimize benefit and access to new medicines for patients, while also ensuring the sustainability of pharmaceutical innovation.

MIT NEWDIGS works with key stakeholders to develop and promote ‘adaptive’ strategies that help innovative biomedical products more reliably reach appropriate patients quickly and affordably.

Much of the translation challenge lies in how new drugs are financed in development and paid for once in use. “Prescription drug benefit plan coverage policies and utilization management programs in place today were not designed to accommodate the high costs of the curative treatments on the horizon or the sustained costs of durable cancer treatments already in use. And, they can’t,” said J. Russell Teagarden, former VP, Clinical Practices & Therapeutics at Medco Health Solutions. “New coverage policy designs and new financing mechanisms are required if there is to be any hope that these new treatments will be available to all the people who will need them.”

Tanisha Carino, Vice President, US Public Policy at GlaxoSmithKlein, and participant in the FoCUS project, agreed. “Our health care system has evolved to pay for relatively predictable and stable costs, which may be the right approach in financing the care of chronic conditions. However, as we are now experiencing a significant period of transformative scientific advance and discovery, we need to ensure we have a system that will deliver the value of these new innovations,” she said.

In addition to the three main workgroups, the FoCUS project will involve a number of cross-functional teams, including a steering committee to set goals and evaluate outcomes, a design team to plan pilot projects, a research team to refine models through rigorous quantitative simulations, as well as ad hoc groups with specific content expertise like law and policy.

“We need to innovate how we innovate,” said Dr Gigi Hirsch, Executive Director of CBI. “The FoCUS project will help develop realistic solutions to a key problem: how do we provide timely access for patients to potentially curative treatments, in ways that are affordable to payers and also provide adequate incentives to manufacturers to ensure the sustainability of innovation?”

FoCUS collaborators will start by designing financing and reimbursement pilots for high cost but potentially curative treatments. In the meeting at MIT, participants agreed on initial opportunities for pilot projects and began the work they will carry out over the next three years.

According to Hirsch, “FoCUS will give us a platform to iterate solutions that are practical for all those involved in the pharmaceutical innovation chain. It’s a ‘think and do tank’ for designing, evaluating, piloting, and implementing effective system changes.”

The FoCUS project team aims to have more than theoretical impact. “By engaging a truly diverse and representative set of healthcare innovation stakeholders, we intend to drive real change that benefits everyone, especially patients” said Hirsch. “Working together we can drive new financing and payment models that enable patient-centered, sustainable innovation.”

Contact
MIT NEWDIGS
Deborah Young
Operations Director
debyoung@mit.edu
617-324-7756

About MIT NEWDIGS
MIT NEW Drug Development ParadIGmS (NEWDIGS) is an international “think and do tank” dedicated to helping biomedical innovation benefit all healthcare stakeholders faster and reliably. NEWDIGS designs, evaluates, and initiates advancements that are too complex and cross-cutting to be addressed by a single organization or market sector. Its members include global leaders in research, development, insurance, regulation, and patient advocacy. For more information, visit http://newdigs.mit.edu.