Prescription status of edaravone and personal importation: Notice of update
Updated: September 29, 2022
As of October 1, 2022, Health Canada will no longer use enforcement discretion to allow the personal import of edaravone (brand name Radicava). This measure is no longer necessary to enable access to edaravone in Canada. There will be a grace period of 30 days, until October 31, 2022, to give patients with amyotrophic lateral sclerosis (ALS) time to transition. Patients should speak with their health care provider to access edaravone in Canada. Those without private insurance coverage should contact the applicable provincial/territorial health ministry about coverage.
Updated: March 31, 2022
Health Canada is extending the personal importation of edaravone (brand name Radicava) for patients with amyotrophic lateral sclerosis (ALS) to October 1, 2022. Given that the provinces/territories have updated their drug formularies to include edaravone as part of their health care coverage considerations, this is likely to be the last extension granted for personal importation of edaravone. We will continue to monitor the situation up to October 1, 2022, to determine whether access via personal importation is still required. Patients should speak with their health care provider to access the drug in Canada. Those without private insurance coverage should contact the applicable provincial/territorial health ministry about coverage.
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- Current coverage
- Health Canada authorization
- Prescription status
- Transition to the Special Access Program
- Personal importation
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Organizations and the provinces/territories continue to make progress in the marketing and reimbursement of edaravone (brand name Radicava). Currently, all provinces with the exception of Prince Edward Island (PEI) have updated their drug formularies to include edaravone for public reimbursement. The territories are still in the process of establishing full coverage.
Decisions about coverage in these 2 jurisdictions are not expected to be completed by October 1, 2021.
Health Canada wants to ensure the continued supply of edaravone in Canada. We are extending the personal importation (by mail/courier or individuals) of this needed medication from October 1, 2021, until April 1, 2022.
Health Canada authorization
Patients with amyotrophic lateral sclerosis (ALS), their families and health care providers want continued access to the latest treatment options available to them.
Health Canada authorized edaravone for the treatment of ALS on October 4, 2018, following a thorough scientific review. As there were limited treatment options available for patients living with ALS, we granted a priority review to Mitsubishi Tanabe Pharma Canada Inc. (MTPC Inc.) on its request. Following this review, we issued a notice of compliance so it could be sold legally in Canada.
MTPC Inc. began marketing edaravone in Canada in November 2019. Since the safe use of this drug requires the supervision of a health care practitioner, it was added to the prescription drug list (PDL). This helps ensure that the health and safety of patients in Canada is protected.
The intent of the PDL is to inform health care providers and the public on when a substance requires a prescription to be sold in Canada.
Listing a drug on the PDL may also generate discussions on health care coverage by publicly and privately funded insurance programs. Health Canada and the Canada Border Services Agency also use the PDL to verify a product’s classification and take the applicable regulatory action at the border.
Once edaravone was added to the PDL and came onto the Canadian market, health care providers were able to begin prescribing it as of November 5, 2019.
Transition to the Special Access Program
In the past, a limited number of patients accessed this drug through a program administered by the manufacturer and authorized by Health Canada’s Special Access Program (SAP). MTPC Inc. informed health care providers of its intent to transition the distribution of edaravone from SAP to its own patient support program as of November 5, 2019, with no interruption in supply.
Health Canada wants to ensure the continued supply of this needed medication during the transition of edaravone to the Canadian market. Thus, we are allowing individuals to continue to import edaravone until April 1, 2022. Individuals may import the drug personally or have it sent to them by mail or courier.
To be imported personally, the drug must be shipped/carried in appropriate packaging (hospital or pharmacy-dispensed packaging, retail packaging or with the original label). Supporting documentation provided by the patient’s doctor must accompany the package. It must also indicate that the drug is for the individual's own use or for someone whom they are responsible for and travelling with. The quantity for import must not exceed a 90-day supply or a single course of treatment based on the directions for use, whichever is less.
Patients and their families who have been importing edaravone for their own use should speak with their health care provider about continued access.
Health Canada will continue to monitor the situation up to April 1, 2022, to determine whether access via personal importation discretion is still required. We are committed to working with the company, patients and health care providers to help patients access the medications they need.
For more information on the personal importation policy, please contact email@example.com.
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