How Classification Of Cell And Gene Therapies As Drugs, Devices Or Procedures Could Have Significant Implications

October 4, 2018 Danielle Twigg

Many countries have different pricing and reimbursement (P&R) processes for prescription drugs, hospital drugs, medical devices, and procedures. Newer transformational technology classes such as CAR-T, cell- and gene-based therapies may not be classified as drugs and thus may be subject to distinct P&R processes. Indeed, CADTH have announced that it will assess Kymriah® (the first CAR-T cell therapy with marketing authorization in Canada), through its HTA process for medical devices and clinical interventions. CAR-T, cell- and gene-based therapies are classified as advanced therapy medicinal products (ATMPs) in Europe; this research examines how ATMPs have been reimbursed in major European markets.

Authors: Macaulay R, Rothwell S, PAREXEL International, London, United Kingdom

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