Health Canada Approves Tepezza
TEPEZZA from Amgen Canada “reduces eye bulging and double vision. It also improves the signs and symptoms of Thyroid Eye Disease (TED), including eye pain, redness, and swelling.” Approval by Health Canada is the first step in a four-step process. See product information.
Tepezza Progress within Canada’s Drug Approval/Reinbursment Process
- Health Canada reviews drugs for safety, efficacy and quality before authorizing them for sale in Canada. This authorization results in a Notice of Compliance (NOC) – Approved for Tepezza.
- CDA and INESSS in Quebec provide a recommendation to public drug plans on whether or not a drug should be reimbursed for public funding – Est. May 2025 for Tepezza.
- The pan-Canadian Pharmaceutical Alliance (pCPA) uses the recommendations from the CDA and INESSS and other factors to determine whether or not it will enter into a negotiation for a drug. Following a successful negotiation, pCPA will issue a letter of intent which sets the terms of the agreement between the pCPA and the drug manufacturer.
- Public drug plans make a final decision to fund a drug once a negotiation has been successfully completed and enter into a product listing agreement with the drug manufacturer.
Steps 3 and 4 will take 12 or more months to complete. TFC will provide updates for TED patients as additional steps are completed.
