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Updates from CADTH: Improvements to CADTH reimbursement review process, increased fees and new Formulary Management Expert Committee pilot

Authored byUrszula Wojtyra

The Canadian Agency for Drugs and Technologies in Health (CADTH) announced upcoming improvements to its Reimbursement Review process. CADTH will review its current process to identify efficiency and process improvements over the coming year. Examples of such improvements include the addition of presubmission pipeline meetings with drug sponsors (effective immediately), development of a budget impact analysis template, and piloting a new formulary management committee (described below). To enable these changes, CADTH is adjusting its application fee structure for drug submissions filed by industry sponsors. Effective July 17, 2023, the fee for CADTH Pharmaceutical Reviews will be $98,670 for an application reviewed through the standard review process (up from $75,900), and the fee for the CADTH Scientific Advice service will range from $80-125,000 (up from $65-100,000).

CADTH also announced a 1-year pilot program of a new Formulary Management Expert Committee to support decision-making across the drug life cycle. The Committee assesses various types of evaluations requested by participating public payers, for example, non-sponsored single drug reviews and reviews across therapeutic categories or drug classes. According to CADTH, “The objectives of this pilot project are twofold. The first is to respond to the need of public payers for evidence and recommendations that will help them maximize the value of drugs across their lifespan. The second is to create a controlled test-and-learn environment where CADTH can introduce innovative approaches to reviews, methods, deliberative processes, stakeholder inputs, and the communication of outputs.”

Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.