A Statement from the Executive Officer of the Ontario Public Drug Programs on behalf of the pCPA

TORONTO, Feb. 16, 2016 /CNW/ - "The Pan Canadian Pharmaceutical Alliance (pCPA), on behalf of participating provinces and territories, has ended negotiations with the drug manufacturer Alexion for the listing of Soliris for the treatment of atypical hemolytic uremic syndrome (aHUS).

Atypical hemolytic uremic syndrome is a rare genetic disease that affects approximately one in a million people worldwide - and approximately 166 Canadians - that result in clots in small vessels, destruction of red blood cells and impaired kidney function. Up to one third of patients with aHUS also develop end-stage kidney disease.

Negotiations ended with the manufacturer as Alexion and the pCPA could not reach an agreement on funding criteria - specifically in the determination of which instances there is some evidence to support the use of Soliris. There was also a disagreement of financial terms.

The conclusion of negotiations without an agreement between pCPA and a manufacturer is not common. As of December 31, 2015, pCPA completed 89 negotiations, with 86 negotiations ending with a decision to proceed with listing the drug. There are another 24 negotiations ongoing.

The pCPA made every effort to expedite a decision on Soliris and negotiated for six months in good faith with Alexion to try and reach an agreement on clinical criteria.

The decision to end the negotiations is supported by Canadian Agency for Drugs and Technologies in Health, the original recommendation and subsequent advice from the Canadian Agency for Drugs and Technologies in Health (CADTH) - an independent, not-for-profit organization responsible for providing health care decision-makers with objective evidence to help make informed decisions about the optimal use of health technologies, including drugs.

In addition, the Patented Medicine Prices Review Board, an agency of the Government of Canada that works to ensure that the prices of patented medicines sold in Canada are not excessive, is considering whether the price being charged for Soliris is too high.

In the face of rising drug costs, provinces and territories have a responsibility to review drug funding requests and to consider clinical effectiveness, safety, cost effectiveness and affordability, and the impact on other health services. This diligence is necessary to continue to provide adequate care while sustaining a publicly funded drug system for generations to come.

Patients and physicians want to try anything that may work to help them cope with their disease. We understand that and we can empathize with patients. However, public drug plans cannot provide coverage for all individuals who may wish to try Soliris or any drug – regardless of its cost - where the clinical evidence does not demonstrate improved health outcomes.

Despite the current decision to close negotiations without an agreement to list Soliris, the pCPA remains willing to re-engage in negotiations with Alexion on Soliris should the manufacturer be able to address the clinical and financial concerns raised by the pCPA. In addition, the pCPA is committed to working with Alexion to consider other drug products in the future.

Individual provinces or territories will be considering funding options based on the circumstances in each jurisdiction.

In Ontario, the province will utilize the advice from CADTH to inform its funding criteria."

Suzanne McGurn
Executive Officer, The Pan Canadian Pharmaceutical Alliance

SOURCE Pan Canadian Pharmaceutical Alliance

For more information (media): David Jensen, Ministry of Health and Long-Term Care, Ontario, 416-314-6197