Canada To Open Up Priority Review To More New Drugs
Executive Summary
Health Canada has proposed revised criteria that take account of patients' needs and the health care system when deciding whether to fast-track the review of a particular drug.
In a move that should make more new drugs available more quickly, Health Canada is inviting stakeholder feedback on proposed changes to its criteria for triggering an accelerated review of new and promising medicines for patients with serious, life-threatening, or severely debilitating diseases.
The revised priority review criteria – outlined in a draft guideline – take into consideration the needs of Canadian patients and the health care system when deciding whether to fast-track the review of a particular drug.
This represents a significant change from the government department's current priority review process, under which only the first product in a certain class or the first drug for a specific condition can be reviewed on a priority basis.
"The proposed guidance aims to broaden the eligibility criteria for accelerated review, allowing more drugs to go through a fast-track review to get them to the patients who need them sooner, while still ensuring safety," the health ministry said in a statement.
"Canadians with rare diseases already face enough challenges, without having to worry about lengthy approvals and regulatory delays. By streamlining the review process, we will ensure they get can access to treatments they need as quickly as possible," said health minister Ginette Petitpas Taylor.
The revised guideline is an important element of Health Canada's ongoing " Regulatory Review of Drugs and Devices" initiative under which it had consulted on priority review pathways and health care system needs to determine which products could be reviewed under shortened timelines.
Following feedback from stakeholders, the department proposed changes to its policies for "Priority Review of Drug Submissions" and the "Notice of Compliance with Conditions" – both of which are now reflected in the new draft guideline, "Accelerated Review of Human Drug Submissions."
Health Canada is inviting feedback on the overall clarity and content of the draft guideline and is especially keen to get comments on proposed elements relating to: the single pathway for accelerated review; two different options for screening processes; and the eligibility criteria for drug product submissions seeking accelerated review status. Comments on the draft guideline will be accepted until 21 July. Stakeholders wanting to participate in the consultation can request a copy of the draft guideline online.
The guideline, when finalized, will apply to new drug submissions (NDS) and supplement to new drug submissions (SNDS) in support of a prescription pharmaceutical, biologic or radiopharmaceutical product for serious, life-threatening or severely debilitating diseases or conditions. Certain elements of the guidance are also applicable to generic pharmaceuticals where the innovator product has a conditional authorization.
Priority Review: One Of Several Measures
The health ministry noted that the revised guideline on priority review medicines is just one of the several measures in place to accelerate patient access to treatments. Others include:
- Using more information about drugs in real-world settings to build up Health Canada's understanding of their benefit-risk profile and to facilitate the approval of drugs for rare diseases. (Also see "Canada Develops RWE Guide Anticipating Increased Submissions" - Pink Sheet, 26 Apr, 2019.)
- Undertaking more work with international regulators to better understand innovative treatment options even sooner. (Also see "Dual Approval For Verzenio Under International Review Scheme" - Pink Sheet, 18 Apr, 2019.)
- Modernizing the Special Access Program (SAP), which provides access to drugs in extreme situations, to better meet the needs of physicians and patients. A revised SAP guideline is currently under consultation.
- Working with provinces and territories through the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d'excellence en santé et en services sociaux (INESSS) to align reviews and share information to streamline processes.
In addition, Canada’s 2019 budget includes a proposal for a national strategy for high-cost drugs for rare diseases. Under this, the government would work with provinces, territories and other partners to co-develop a plan to ensure that patients with rare diseases have better and more consistent coverage for their treatments. The government has proposed investing up to CAD1bn ($0.74bn) over two years, starting in 2022-23, with up to CAD500 million per year after that.
The government expects that all these measures, taken together, will further improve the availability of treatment options for patients with rare diseases. In the past five years, approximately 30% of the drugs authorized by Health Canada were for rare diseases.