Canadians being denied life-saving treatments

Common Drug Review says we’re not worth it, patients testify

Attention Parliamentary Press Gallery/News/Health Editors

ISSUED UNDER EMBARGO UNTIL 3:30 P.M. EDT

OTTAWA, May 9, 2007 -- Two of Canada’s most active patient advocates testified today to the Standing Committee on Health that the Common Drug Review (CDR) is blocking access to life-saving medications, sharing poignant examples of how such treatments, once available, changed their lives. Representing the Best Medicines Coalition (BMC), Louise Binder, an HIV positive woman, and Linda Wilhelm, who suffers from severe rheumatoid arthritis, were invited as part of the Committee’s review of the CDR’s effectiveness.

In a submission to the Committee, the BMC outlined how the CDR has rejected treatments that have been proven to provide real benefit to patients, often saving lives. It concluded that the CDR is profoundly compromising the health of Canadians. A total dismantling of the CDR is recommended, preceded by a comprehensive review by an independent working group, with full patient representation.

“The Common Drug Review is a good idea gone wrong. Quite simply, in its present configuration, it’s hard to imagine it being fixed,” stated Louise Binder, chair of the BMC, a national group of organizations whose members represent millions of Canadians living with or affected by chronic diseases. The BMC cited that the CDR is not efficient, has not reduced duplication and is not using comprehensive and progressive models to review evidence.

In her presentation to the Committee, Binder outlined how HIV-positive Canadians rely on being able to choose from a range of treatments. Each individual may not be able to tolerate specific drugs and need options to turn to, describing HIV drugs as being like life-long chemotherapy, often with intolerable side effects.

“I have had to make three drug switches myself, all due to toxicity in my liver. The last switch, just last year, left me too ill to do anything but sleep for three months but I stuck it out because I had few choices left,” Binder recounted to the Committee. “Enter tenofovir, very effective with few side effects and toxicities, allowing HIV-positive people like me to live better lives. Unfortunately, after two submissions, the CDR ruled it was not cost effective and tried to deny it to all treatment-naïve patients.”

Wilhelm, who has suffered from debilitating rheumatoid arthritis for more than twenty years, at times confined to a wheelchair and unable to care for herself or her family, described a long journey of ineffective treatments, surgeries and hospital stays.

“Finally, in 1999 came a breakthrough biologic. I walked out of a three month hospital stay on my own steam and have never looked back,” said Wilhelm. “A recent CADTH report concluded that this drug is not cost effective. According to them, I am not worth it. I disagree with this conclusion and know that there are thousands of Canadians with inflammatory arthritis who would agree with me.”

In its submission, the BMC outlines specific minimum standards which a vastly reformed CDR or, if dismantled, provincial drug review committees must meet:

• Comprehensive and progressive data analysis models, including pharmacoeconomic review, must be adopted which are broader and inclusive in nature, moving away from a narrow cost containment approach. These models must be designed to incorporate a wider definition of costs, including hospitalizations, surgeries and universal healthcare costs. In addition, post approval surveillance activities must be incorporated and enhanced.
• Models of pharmaceutical review must be flexible enough to facilitate, where appropriate, novel and innovative medicines, including those designed for rare disorders, those for previously unmet needs and those where significant therapeutic advance is offered.
• Review processes must be further expedited and improved by involving thorough consultation of national and international experts in each therapeutic area.
• Patients, who are most impacted by decisions, must be significantly involved and consulted. In addition, broader stakeholder groups must participate in the process in a meaningful advisory capacity.
• Transparency and fairness must be integrated, allowing patients and other stakeholders a greater understanding of processes and rationale for actions. An appeal process must allow recourse on all decisions.

Formed in 2002, the BMC is a national alliance of organizations and individuals, representing those living with or affected by chronic disease or illness, who are concerned about drug review reform, treatment access, patient safety and general health policy development.

The BMC is scheduled to testify before the Standing Committee on Health today between 3:30 and 5:30 p.m. (EDT). Copies of the BMC’s submission to the Committee are available on request.