Once a new therapy is approved by the Health Canada, the Common Drug Review (CDR) and the Ontario government's own Committee to Evaluate Drugs (CED) determines whether it should be listed as a benefit under Ontario's public drug plan. Usually drugs have to be listed on the provincial formulary to be covered, however, a special process -- called Individual Clinical Review or Section 16 (previously Section 8) -- provides coverage for drugs that have not been listed as a benefit on the provincial formulary, but have been approved by the federal government and reviewed by the CED.
For neuroapthic pain therapies, Lyrica™ (pregabalin) have been approved by Health Canada and reviewed by the CED, but are not listed on the provincial formulary. For this reason, people who need assistance with the cost of this medication must apply for Section 16 coverage and be approved before they are eligible to receive assistance through Ontario's Drug Benefit program.
The following information provides additional details about the criteria for access and reimbursement process for the neuroapthic pain therapies in Ontario. Individuals who need assistance with the application process should ask their physician.