Regulatory Focus™ > News Articles > New Drugs to Undergo Parallel Reimbursement Review Process in Canada

New Drugs to Undergo Parallel Reimbursement Review Process in Canada

Posted 28 November 2012 | By Louise Zornoza

As of 21 November 2012, the Canadian Agency for Drugs and Technologies in Health (CADTH) has implemented a revised Common Drug Review (CDR) deliberative process to guide the Canadian Drug Expert Committee (CDEC) in making cost effectiveness recommendations as to whether a new drug should be eligible for reimbursement. 

The revisions include the removal of an earlier priority review criteria requirement for eligibility for reimbursement review to be undertaken in parallel with the Health Canada's Notice of Compliance (NOC) review. 

Now all new drugs or drugs with new indications will undergo the parallel review process, which can potentially result in shortened timelines between the issuance of the NOC or NOC/c and the final listing decisions by jurisdictions. 

In addition, as of 1 February 2013, manufacturers must submit appropriate pharmacoeconomic (cost benefit) evaluations for the whole patient population for which the new drug is indicated.  Patient population subgroups may also be the subject of such evaluation if such subgroups may uniquely benefit from the drug, or if specific reimbursement criteria has been requested by the manufacturer.


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