PMPRB Hearing Panel issues final Order in Soliris case

From: Patented Medicine Prices Review Board Canada

News release

August 2, 2022

Ottawa, ON — Patented Medicine Prices Review Board

A Patented Medicine Prices Review Board (PMPRB) Hearing Panel has issued an Order relating to the medicine Soliris, manufactured and marketed in Canada by Alexion Pharmaceuticals Inc.  

In 2017, the Hearing Panel issued a Decision and Order regarding the pricing of Soliris. The decision was judicially reviewed in 2019 and subsequently appealed to the Federal Court of Appeal. In 2021, following a decision of the Federal Court of Appeal, the matter was remitted back to the Board for redetermination.

The Hearing Panel has issued a final Order that the redetermination proceeding be discontinued, based on a joint request by the parties. The final Order outlines the terms for the proceeding to be discontinued. 

Soliris is the first and only treatment for patients with Paroxysmal Nocturnal Hemoglobinuria – a rare and life-threatening blood disorder characterized by excessive destruction of red blood cells – and Atypical Hemolytic Uremic Syndrome, a rare and life-threatening genetic disorder characterized by blood clots in small vessels.

Quick facts

  • The Patented Medicine Prices Review Board (PMPRB) is an independent quasi-judicial body that protects the interests of Canadian consumers by ensuring the prices of patented medicines sold in Canada are not excessive, and provides stakeholders with price, cost, and utilization information to help them make timely and knowledgeable drug pricing, purchasing, and reimbursement decisions.

  • Patentees must file price and sales information with the PMPRB at introduction, and twice a year afterward, for each strength of each dosage form of each patented medicine sold in Canada.

  • PMPRB staff review the prices patentees charge for each individual patented drug product sold in Canadian markets on an ongoing basis to ensure their prices are not excessive.

  • If the PMPRB Hearing Panel finds a patentee to be in breach of its reporting requirements, the Panel may order the patentee to provide the PMPRB with the required pricing and sales information.

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Contacts

PMPRB Media Relations
PMPRB.MediaCentre-CentreMedias.CEPMB@pmprb-cepmb.gc.ca

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