CADTH Common Drug Review Will Accept Submissions Up to Six Months Pre-Notice of Compliance (NOC)

Operational change can help reduce the time between regulatory approval and reimbursement recommendations for prescription drugs in Canada

Today CADTH is pleased to announce an operational change to our Common Drug Review (CDR) program that will further align our health technology assessment process with Health Canada’s regulatory approval process for new prescription drugs in Canada.

In the CDR’s current process, a drug manufacturer can submit a drug for review up to three months (90 days) before it has been formally approved by Health Canada and received its Notice of Compliance (NOC) or Notice of Compliance with Conditions (NOC/c). Effective April 2, 2018, CADTH will now double this time horizon and accept drug submissions to the CDR up to six months (180 days) before the anticipated receipt of Health Canada’s NOC or NOC/c.

“This is an important change that can help CADTH improve the accessibility of treatments that are proven to be effective and will bring value to patients and the health system,” says Heather Logan, Vice-President (Acting) of Pharmaceutical Reviews. “By accepting a drug manufacturer’s submission earlier, we can potentially eliminate delays between Health Canada’s regulatory approval and the reimbursement recommendations CADTH issues to the 18 public drug plans that participate in the CDR.”

Beyond enhancing alignment with Health Canada’s process, this change also ensures greater consistency between CDR and CADTH’s pan-Canadian Oncology Drug Review (pCODR) program, which currently accepts submissions up to six months before the anticipated receipt Health Canada’s NOC or NOC/c.

For complete details, please see CDR Update – Issue 134.

What led to this change?

For some time, CADTH, Health Canada and the provincial, territorial, and federal public drug plans have been working together to improve the affordability, accessibility, and appropriate use of prescription drugs in Canada.

The operational update announced today is the result of work that is happening under the umbrella of Health Canada’s “Regulatory Review of Drugs and Devices” (R2D2) initiative. This initiative brings together key organizations to improve collaboration and information sharing. Through the R2D2 initiative, CADTH identified our pre-NOC submission process as an area where a small change could have an important impact on the timely access to new drugs.

There are several reasons why this change to our pre-NOC submission rule is important:

• It means that CDR assessments can potentially proceed concurrently with Health Canada reviews.
• It may help eliminate major delays between Health Canada’s approval and our final reimbursement recommendation.
• It further aligns the processes of our CDR and pCODR programs.

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