Health Canada, CADTH, and Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) have officially launched efforts to align regulatory and health technology assessment (HTA) drug reviews for eligible submissions, effective immediately.

Background

The new process stems from Health Canada and HTAs recognizing the need for greater coordination of the review processes within the drug approval and market access pathways. The change is expected to reduce time between Health Canada’s market authorization and HTA recommendations (where possible) by allowing for earlier submissions to each CADTH and INESSS (180 days prior to anticipated Health Canada approval) announced earlier this year and improving communication among the organizations throughout their reviews.

Former Health Minister Jane Philpott first announced the plan to align regulatory and HTA reviews in Spring 2017 and Health Canada has since conducted a pilot project to better align reviews and enhance information sharing procedures among the organizations.

Details

Manufacturers must opt into an aligned review by consenting to information sharing among the organizations after completing their Health Canada submission. Subsequently, and to optimally take advantage of the aligned processes, manufacturers are encouraged to submit for HTA soon after the Health Canada submission has been accepted for review:

• within 4 months for standard Health Canada submissions (which are targeted for completion in 300 days)
• within 3 weeks for a drug reviewed via the NOC/c pathway (which are targeted for completion in 200 days)
• immediately for drugs reviewed through Health Canada’s priority review pathways (which are targeted for completion in 180 days)

For more details on the new process please consult Health Canada’s Notice to Industry.

Implications for Industry

• Overall, the aligned process should be good news for industry and patients alike – it is expected to result in shorter delays between regulatory approval and HTA recommendation (which would mean quicker public reimbursement)
• With potentially shorter times to reimbursement, industry members will need to be very nimble and forward thinking about their reimbursement strategy. For example, strategic planning for the clinical and economic value, and the overall negotiation strategy will need to begin even earlier than current practice to capitalize on this new integrated review process, and to increase the probability of favourable reimbursement.
• Despite the clearly positive quicker-to-reimbursement result, manufacturers pursuing this pathway may have to do so by undertaking significant uncertainty, as any unforeseen changes to the anticipated Health Canada approved product monograph or indication could affect the optimal HTA and reimbursement strategy. This uncertainty will have to be weighed against the potential benefits of earlier access when manufacturers decide whether and how they can best take advantage of an aligned review.

To discuss how the new process could affect your product launches and reimbursement strategy contact us at info@pdci.ca.