Posted by Michael Wonder on 27 Mar 2018
Gene therapy: international regulatory and health technology assessment activities and reimbursement status
28 March 2018 - There is widespread variation in the definition of gene therapy used by international regulatory bodies and a lack of definitions specific to reimbursement bodies.
In Canada, gene therapies are classified as drugs by Health Canada.
There is a lack of gene therapy-specific guidelines or frameworks from health technology assessment bodies.
Several gene therapies have received international regulatory approvals and/or reimbursement recommendations funding in recent years.
Regulatory and reimbursement challenges include limited data and uncertainty around efficacy, long-term safety, and cost-effectiveness.
