November 1, 2023 • Alpha-1 Canada
Alpha-1 Canada is thrilled to announce that after much deliberation, the Conference of Deputy Ministers of Health authorized an augmentation therapy category for the Canadian Blood Services’ (CBS) Plasma Protein and Related Products Formulary.
It was determined that GLASSIA® (Takeda) will be the brand of augmentation therapy added to the Canadian Blood Services’ Formulary following a competitive RFP, which was open to all eligible Alpha-1-Proteinase Inhibitor products. https://www.blood.ca/en/hospital-services/customer-service/communications/customer-letters
In approximately 12-14 weeks, there will be national access (outside of Quebec) to GLASSIA® for Canadian alpha-1 patients who meet the criteria, per the following:
Prescribing Criteria:
• A respirologist has confirmed the diagnosis of severe A1-PI deficiency and clinical evidence of emphysema and indicated that patient would benefit from treatment with A1-PI product
Eligibility Criteria:
• A1-PI deficiency, defined as serum A1-PI levels <11 μM/L before start of the treatment
• Clinical evidence of emphysema (FEV1 <80%), and patients must be non-smokers for at least 6 months. For patients who have not received a lung transplant.
Alpha-1 Canada would like to thank the patient community for their patience, as governments took the time required to make an informed decision. This has been a lengthy and complicated process, and Alpha-1 Canada would like to thank the Provincial and Territorial Governments, the Canadian Blood Services’ leadership team and Board of Directors, and our industry partners: Takeda, Grifols, and CSL Behring, as well as AlphaNet Canada.
Alpha-1 Canada recognizes that there will be many questions about next steps, especially for those patients who will need to transition to GLASSIA®. We look forward to working with CBS and Takeda to achieve the best possible outcomes for alpha-1 patients in Canada, be it transitioning products, or finally being able to commence treatment for the first time. Alpha-1 Canada will be working with CBS and Takeda’s OnePath® Patient Support Program to ensure we can address as many questions as possible in the coming weeks and months.
A hybrid information session will take place on Saturday, November 25, 2023, at 10 a.m. MST. Patients and stakeholders are welcome to join us in-person for this milestone event, taking place at Hotel Arts in Calgary, Alberta from 10 a.m. – 1 p.m. MST, where we will also be hosting a celebratory reception from 1 p.m. – 3 p.m. MST. If you would like to attend in-person, please RSVP by November 15, 2023, to info@alpha1canada.ca. Alternatively, the webcast link will be sent to everyone registered to receive emails from Alpha-1 Canada; in addition to this, the link will be posted on our social media channels and our website’s homepage.
For patients residing in Quebec, this announcement does not affect your current brand and access to treatment. Alpha-1 Canada will notify the Quebec patient community when access to augmentation therapy in the province of Quebec transitions from Régie de l’assurance maladie du Québec (RAMQ) to Héma-Québec, in 2024.
