The Time is Now: All ALS Therapies should be granted priority review

Health Canada recently began its review of AMX0035 to assess the therapy’s safety, efficacy, and quality. This process began in August when Health Canada accepted the manufacturer’s New Drug Submission (NDS).

There are two timelines under which Health Canada conducts drug reviews:

• Standard Review, which is almost a one-year process (300 days)
• Priority Review, which is a six-month process (180 days)

We were disappointed to learn that Health Canada did not grant AMX0035 a priority review, meaning the therapy is now undergoing the extended review process. Due to the swift progression and terminal nature of the disease, people living with ALS cannot afford to wait almost a year for Health Canada to review a therapy. During this time, people will experience further loss of function, and ultimately, approximately 1,000 Canadians will die of ALS.

Access to innovative therapies is an urgent issue for people living with an ALS diagnosis, and priority review is critical. We believe any new innovative ALS therapy should be granted priority review status. We urge Health Canada to reverse its decision and immediately grant AMX0035 priority review – and set an important precedent for all future ALS therapies.

Health Canada Priority Review:

According to Health Canada, priority review is granted for:

• Effective treatment, prevention or diagnosis of a disease or condition for which no drug is presently marketed in Canada; or
• A significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada.

Given that there are only two approved ALS drugs in Canada, one which has been on the market for over 20 years, and the heterogeneity of the disease, meaning not all therapies work for all people living with ALS, we believe any ALS therapy should be considered to present an overall benefit and be granted priority review status.

You can read our correspondence with Health Canada, and know that we will continue to engage with Health Canada to advocate on this vital issue.

The Time is Now

Our recently published position paper, The Time is Now, considers the complexity of Canada’s drug access processes and proposes two solutions to getting Health Canada approved therapies to Canadians living with ALS in a timeframe that more appropriately reflects the urgency faced by this community. A 300-day review is not aligned with the urgent need of the ALS community.

Furthermore, the 300-day Health Canada review timeframe does not include the time it takes for the pCPA to negotiate with the manufacturer or for individual federal, provincial and territorial drug plans to decide whether they will cover the drug under their public drug plans. These processes can easily take up to two additional years to complete, depending on the jurisdiction. In this prolonged time, Canadians will still not have access to the therapy.

And, while a limited number of Canadians may be able to access the drug through the Special Access Program (SAP), this is not an acceptable mechanism for broad access. The SAP is a temporary measure of access determined on a case-by-case basis. It does not provide equitable access for all Canadians living with ALS and should not be considered a viable alternative for timely access.

Make Your Voices Heard:

Approaching government through a combination of channels at an organizational level and at an individual level means collectively we are in a better position to make our voices heard.

You can maintain pressure on Health Canada to accelerate the review of AMX0035 by tagging the Federal Minister of Health and Health Canada on social media – telling them that all ALS therapies must be granted priority review status.

Here are some template social posts to support you in raising your voice on social media:

• Access to innovative therapies is an urgent issue for people living with an ALS diagnosis. Health Canada must grant #AMX0035 priority review and ensure that ALL future ALS therapies receive priority review status. @GovCanHealth @jyduclos
• Disappointed to learn that Health Canada did not grant #AMX0035 priority review. It is critical that ALL ALS therapies receive priority review status. The ALS community does not have the time to wait for a 300-day review. @GovCanHealth @jyduclos
• In the 300 days that it will take #AMX0035 to move through Health Canada review, nearly 1,000 Canadians will die of ALS. This is unacceptable. ALL ALS therapies must be granted priority review. @GovCanHealth @jyduclos
• ALS is a terminal disease that progresses with devastating swiftness – people living with ALS cannot afford to wait 300 days for Health Canada to review a therapy. #AMX0035 and all future ALS therapies must be granted priority review. @GovCanHealth @jyduclos

Health Minister Social Handles: T: @jyduclos   F: @jyduclosliberal

Health Canada Social Handles: T: @GovCanHealth  F:@HealthyCdns