Canada Allows Aligned Regulatory Drug Reviews Between Health Canada and HTA Orgs

Health Canada (HC), Canada’s governmental health agency, announced that there is now an option for all biological and pharmaceutical new drug submissions to request aligned regulatory reviews between HC and health technology assessment (HTA) organizations. The HTAs that are collaborating on the aligned review process are the Canadian Agency for Drugs and Technologies in Health (CADTH) and Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS).

The HC notice applies to biosimilars, supplemental new drug submissions for new indications when the sponsor intends to seek a coverage recommendation from HTAs on a pre-Notice of Compliance (NOC) basis. The HC policy, effective immediately, formalizes the timelines, process, and considerations for sponsors with qualifying drug submissions and applies to drug sponsors who are “interested in taking part in aligned reviews between HC and HTAs.” The new joint process furthers efforts to reduce the time between market authorization and reimbursement recommendations for public drug plans in order to support affordability, accessibility, and appropriate use of prescription drugs in Canada.

Sponsors of qualifying submissions will be able to opt in to an aligned review pathway at any stage of the review process by completing the template authorizing, sharing of information, and submitting it to HC. HC encourages sponsors to opt in as early as possible in the review process, however. Sponsors must also comply with the advance notice requirement of HTAs.

Sponsors can also use the principles, which HC will apply to all aligned reviews, as a guide when developing applications, including limitations on the sharing of confidential information, independent decision making, and transparency. These principles include:

• Continuously improving. HC and the HTAs will monitor uptake rate by sponsors and adjust the aligned review process as needed to ensure it provides benefits to HC, HTAs, and industry.
• Consent based. Participation in an aligned review is voluntary and dependent on the submission of consent using the template authorizing the sharing of information.
• Limited in the sharing of confidential information. Although the sponsor authorizes sharing of information, HC and HTAs will make best efforts to limit the sharing of information to those deemed relevant to the alignment of their reviews.

The initiative’s key benefits include reducing delays between HC’s approval of a drug and the recommendations that CADTH and INESSS issue to advise public drug plans about how drugs should be reimbursed, and improving communication between the organizations and allowing for real-time discussions that can help reduce duplication.

HC hopes the new initiative will further the commonly held goal of helping ensure that all Canadians have access to effective therapies that bring value to patients and the health system. Greater collaboration can help close gaps, reduce delays, and enhance the management of pharmaceuticals in Canada.

In the coming months HC, CADTH, and INESSS will release a webinar to provide interested parties with more information about the process.