Requesting Priority Review

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Priority drug reviews are considered only if submissions meet one or more of the following criteria.

When Priority Review Granted Automatically

Submissions that were granted priority review by CDR (i.e., Pre-NOC or Post-NOC Priority Review) are automatically granted priority review by the province.

If the CDR granted a pre-NOC Priority Review, the submission must receive a NOC before a final PharmaCare listing decision is made.

When Sponsor Must Apply for Priority Review

Sponsors may apply for priority review only if they meet one or both of the following criteria:

  1. When sponsor can demonstrate clinical need and therapeutic benefit

    Clinical criteria: The submission should satisfy an important clinical need and demonstrate substantial therapeutic benefit.
    1. Clinical need is defined as meeting a clinical need in patients suffering from an immediately life-threatening or severely debilitating disease or condition for which there are no other available appropriate therapeutic alternatives (e.g., no other drug or medical intervention is presently available in Canada).
    2. Therapeutic benefit is defined as the ability to substantially improve mortality or other clinically important outcome measures of effectiveness and safety, compared to other available therapies. Therapeutic benefit should be clearly documented by high-quality clinical trial evidence.
    3. At its discretion, the Ministry will determine the eligibility of a drug submitted under the clinical criteria provisions (including clinical need and therapeutic benefit). The Ministry may seek guidance from the Drug Review Resource Committee.
  2. When sponsor can demonstrate drug provides substantial economic benefits.
    1. Substantial economic benefits are defined as the ability to achieve a projected cost avoidance or incremental savings of at least $500,000 per year based upon a budget impact analysis that the Ministry is comfortable with in terms of methodology and input assumptions.
    2. At its discretion, the Ministry may consider as a priority review any submission that provides economic benefits of a lesser amount.

Priority Drug Review Target Timelines

For drugs granted a priority review, the province commits to complete its drug review within a target timeline of six (6) months (standard submission) or nine (9) months (complex submission).

At its discretion, the Ministry may adjust the drug review process to achieve the target timeline.