CAR-T cell therapy has recently arisen as an exciting and innovative therapeutic modality. A wave of new biotechs have been established, several hundreds of clinical trials are underway, and multi-billion-dollar acquisitions have occurred. Despite rapid scientific and clinical advancements, Medicare reimbursement during these initial launch years has been underwhelming, particularly in the in-patient setting where CAR-T therapies are most frequently used.

To characterize the reimbursement challenges to CAR-T therapy today, we spoke with Payers who are covering these therapies, and Pharmacists and Finance VPs at medical institutes providing CAR-T therapies.

We found that inadequate reimbursement coverage for Medicare beneficiaries has led to hospitals with significant financial resources needing to subsidize treatments, while other institutions are not able to provide treatment. We believe that the recent CMS announcement (Feb 15th, 2019) that ties coverage to evidence development may prove to be too burdensome for some providers and could provide a legal route for providers to opt-out of providing CAR-Ts to Medicare patients.

In our white paper presentation, we explore some of the reimbursement solutions that have been proposed by the American Society of Bone Marrow & Transplantation (ASBMT) and the American Society of Hematology (ASH) and assess how these proposals meet the needs of Patients, Providers, Payers, and Manufacturers and their ease of implementation. We also outline a ‘Drop-Ship’ model that could eliminate a provider’s financial burden, and draws parallels to the Spark Therapeutics reimbursement model that has been implemented for the gene therapy Luxturna. We also propose a method to incorporate a 1-year outcomes assessment to address the needs of Payers.

We believe that these reimbursement issues are relevant to any company with a cellular or personalized therapy in development.

A short infographic summary of the paper can be found below. To download a copy of the entire presentation please click on the icon below, or email morris.paterson@groupH.com to arrange an in-person presentation with your team.