With the news that manufacturer MT Pharma is pursuing the regulatory channels necessary to bring the drug edaravone to Canada, the ALS community in this country finds itself facing the possibility of a second treatment option nearly 20 years after riluzole was approved. But how does any new drug become approved in Canada – and what exactly does approval mean? This blog post is intended to help orient you to the steps involved, their purpose, the milestones along the way and the timelines involved.
Working with our partner ALS Societies across the country, ALS Canada will advocate for an expedited review process for any potential new ALS therapies and voice the need for timely and affordable access. We look forward to working with the ALS community in support of our shared goals and will connect via social media about opportunities to advocate together. Approaching government through a combination of channels at an organization level and at an individual level means collectively we are in a better position to make our voices heard.
Health Canada must authorize the drug to be sold in Canada
How it works
- Health Canada conducts a review of the drug to assess its safety, efficacy and quality.
- The process begins when the drug manufacturer files a New Drug Submission (NDS) with Health Canada.
- If Health Canada concludes the benefits of the drug outweigh the known risks they will issue a Drug Identification Number (DIN) and a Notice of Compliance (NOC). This means the drug is officially approved to market in Canada and physicians can begin prescribing it. At this stage the drug must be paid for out-of-pocket or through private insurance.
- If the drug does not receive a notice of compliance or a drug identification number, the drug’s manufacturer has the option of providing additional information, re-submitting the application at a later date with additional supporting data, or asking Health Canada to reconsider its decision.
How long it takes
Standard review is one year; Priority Review is 180 days.
What it means for Canadians living with ALS
As our community knows all too well, Canadians living with ALS do not have the luxury of time, which means that regulatory processes never move quickly enough. We believe any potential ALS therapies should automatically be granted priority review, ideally faster than the standard timelines so that people can access new treatments as quickly as possible.
Publicly-funded drug plans must determine if they will cover any costs associated with the drug
How it works
- The drug manufacturer makes a submission to the Common Drug Review, which is administered by a federal agency called the Canadian Agency for Drugs and Technologies in Health, or CADTH. (In Quebec, this process is managed by the Institut national d’excellence en santé et en services sociaux, or INESSS.)
- The Common Drug Review examines the clinical effectiveness, safety and cost-effectiveness of the drug. It results in recommendations and advice that are used by federal, provincial, and territorial drug plans to make decisions about whether the drug costs will be covered through publicly-funded programs.
- Patient input is a key part of the Common Drug Review. Patient groups are invited to share their experiences, perspectives and expectations for the drug under review.
- At the conclusion of the Common Drug Review, one of the following recommendations is made:
– That the drug be reimbursed;
– That the drug be reimbursed with clinical criteria and/or conditions; or
– That the drug not be reimbursed.
The final recommendation is shared with participating drug plans and the manufacturer and is posted on cadth.ca.
- Following the completion of the Common Drug Review, provinces and territories can choose to work together through the pan-Canadian Pharmaceutical Alliance (pCPA) to determine what public reimbursement could look like within each jurisdiction based on negotiation with the manufacturer.
- Each jurisdiction then does its own independent review to determine if and how the drug will be covered by public drug plans. Once the review is complete, the jurisdiction’s health authority (e.g. Ministry of Health) will make the final decision about provincial drug plan coverage.
How long it takes
- The Common Drug Review has a target timeline of approximately six months. However, there are multiple variables that can affect the process and extend it upwards of one year or more.
- Timelines associated with the pan-Canadian Pharmaceutical Alliance and each jurisdiction’s independent review can take up to two years complete, depending on the jurisdiction. However, throughout the process there are often ways for patients, patient groups and caregivers to push for an expedited process.
What it means for Canadians living with ALS
Patient input
When patient input is sought for potential new ALS therapies as part of the Common Drug Review process, ALS Canada will make a submission on behalf of the ALS community. We will engage people living with ALS along with caregivers and family members in order to ensure that lived experience is reflected in the submission.
Timelines
ALS Canada will work with key government officials to push for not only greater transparency into the process and more opportunities for meaningful consultation, but also highlighting the importance of public drug coverage for any potential ALS treatment. Where possible we will work with our provincial partners to keep our community informed about opportunities to advocate provincially for expedited review processes given the lengthy time they are known to take. For those living with ALS, the timelines associated with regulatory reviews should not be a barrier to equitable access to promising therapies.
The price of the drug is set
How it works
- While Health Canada approval and reimbursement decisions are in process, and throughout the duration of the drug’s patent, the drug is subject to price controls, which fall under the authority of the Patented Medicine Prices Review Board (PMPRB). The PMPRB is a federal agency that regulates the price at which companies sell their drug products to distributors across the country (e.g. hospitals and pharmacies).
- Drug manufacturers must submit specific pricing information to the PMPRB when the drug is first introduced and then on a semi-annual basis. PMPRB publishes information on its price reviews on its website.
What it means for Canadians living with ALS
It’s important that the PMPRB process strikes a balance between ensuring the price isn’t so high that public drug plans will be unable to provide reimbursement, but also not so low that manufacturers won’t want to bring their drugs to Canada. We want drug manufactures to see the value in bringing new treatment options to Canada, especially those that demonstrate promise for people living with ALS.
Health Canada has proposed a number of amendments to the PMPRB process that are currently under review. In partnership with other health charities, we are actively following these developments in order to ensure that any reforms support the needs of Canadians living with ALS.