Addressing the global Pegasys® shortage
We understand and empathize that the global peginterferon, Pegasys® shortage has been stressful. The Leukemia & Lymphoma Society of Canada and the Canadian MPN Network have been working alongside the clinicians, pharmaceutical manufacturers and Health Canada to find a solution.
In order to help address the situation Health Canada has granted ropeginterferon, BESREMi®, Exceptional Importation status. If you are someone who needs Pegasys®, please connect with your doctor to develop a plan.
About the shortage
About Pegasys®
About BESREMi®
- What is BESREMi®?
- Does exceptional importation mean for Health Canada approval?
- I have heard of BESREMi® as an alternative; when will it be available?
- Will BESREMi® be available to me regardless of the type of MPN I have?
- What happens if I am put on BESREMi® and Pegasys® becomes available again?
- I’m scared that my Pegasys® will run out before BESREMi is available.
Pegasys® shortage FAQs
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When the original manufacturer sold the rights to a new company in 2017, they had stockpiled what was predicted to be a 10-year global supply. This was done in order to allow the new manufacturer time to establish the new line. Due to increased demand across many diseases, the stockpile has run out much earlier than anticipated.
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There is a very limited supply of Pegasys® in Canada. If you are experiencing difficulty filling your prescription, you should work with your doctor and pharmacist to find a pharmacy with supply and ask them to initiate a pharmacy to pharmacy transfer.
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When the original manufacturer sold the rights to a new company in 2017, they had stockpiled what was predicted to be a 10-year global supply. This was done in order to allow the new manufacturer time to establish the new line. Due to increased demand across many diseases, the stockpile has run out much earlier than anticipated.
About Pegasys®
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There is still a limited supply of Pegasys® in Canada. If you are experiencing difficulty filling your prescription, you should work with your doctor and pharmacist to find a pharmacy with supply and ask them to initiate a pharmacy to pharmacy transfer.
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Contact your specialist and he/she will work with you to develop a plan. There is still limited supply of Pegagys® in Canada. You should work with your doctor and pharmacist to find a pharmacy with supply and ask them to initiate a pharmacy to pharmacy transfer.
About BESREMi®
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BESREMi® is ropeginterferon and it has received Exceptional Importation status from Health Canada and will be imported into Canada to address the Pegasys® shortage.
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Exceptional importation does not equal what we traditionally consider to be Health Canada approval. Exceptional Importation is a process that can be used to address a shortage. It allows a drug to be imported from a foreign market but has been manufactured according to quality standards similar to those required in Canada. It still undergoes a rigorous review to ensure safety. They are only permitted to be imported for sale for a limited period of time in order to address the shortage. Health Canada approval is a review process that allows for a treatment to be sold and marketed in Canada. There is no time restriction on how long the treatment can be sold in Canada.
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As of February 11, Health Canada has granted as of February 11, BESREMi® Exceptional Importation status. Meetings are planned with the provinces and territories to work out how BESREMi® will be reimbursed and distribution. The clinician community has also been working on guidance and plans to safely switch their patients onto BESREMi®.
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Yes. BESREMi® will be available to you regardless of the form of MPN you have. Speak to your doctor to formulate a plan that is suitable for you.
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It is important to talk to your doctor to develop a plan that is suitable for you. We encourage you to talk to your medical team.
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We understand the anxiety the Pegasys® shortage has caused. BESREMi® has received Exceptional Importation status and we are all working with the provinces and territories on reimbursement and distribution. In the meantime, there is still limited supply of Pegasys® in Canada. Talk to you doctor to develop a plan.
We are here to help. If there is additional support we can provide, please connect with:
Please watch this short video explaining the situation from Dr Shireen Sirhan, President of the MPN Group, Hematologist and Medical Oncologist, Assistant Professor at McGill University.