Augmentation therapy
Learn about the approved augmentation therapy options in Canada and the criteria for patient eligibility.
Augmentation Therapy
In 2024, the Conference of Deputy Ministers of Health authorized an augmentation therapy category for the Canadian Blood Services’ (CBS) Plasma Protein and Related Products Formulary.
Following a competitive RFP, which was open to all eligible Alpha-1-Proteinase Inhibitor products, it was determined that Takeda’s GLASSIA® would be the brand of augmentation therapy added to the Canadian Blood Services’ Formulary.
GLASSIA® product monograph is available HERE .
Glassia can be requested for adult patients (outside of Quebec) with severe A1-PI deficiency and clinical evidence of emphysema who meet the following criteria*:
- 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.
- A1-PI deficiency, defined as serum A1-PI levels <11 μmol/L or < 57 mg/dL before start of the treatment.
- Clinical evidence of obstruction (FEV1 <80%).
- Patients must be nonsmokers for at least six months.
- For patients who have not received a lung transplant.
*Criteria are based on recommendations from the Canadian Agency for Drugs and Technologies in Health (CADTH)
Patients should contact their respirologist to determine if Glassia is an appropriate treatment option and whether they meet the required eligibility criteria.
As Glassia is listed on the PPRP formulary with specific eligibility criteria, the treating prescriber (a respirologist) must complete and submit a Request for Patient Designated PPRP form to Canadian Blood Services. The request will be reviewed to confirm that eligibility criteria are met. If the patient is approved, a Named Patient Contract (NPC) will be created and provided to the prescriber.
Like other products on the Canadian Blood Services PPRP Formulary, patients will receive the product through hospital transfusion medicine laboratories. In the province of Alberta only, Glassia will be dispensed and delivered to patients by Bayshore Pharmacy (as part of a new Canadian Blood Services pilot project).
Respirologists can download the Request for Patient Designated PPRP Form HERE .
Health Care Providers can view an instructional video on how to complete PPRP Form HERE.
Most patients will have Glassia administered at Innomar infusion clinics. Patients will also have the option of being trained to infuse at home. Once enrolled, patients will be contacted by Takeda’s Patient Support Program (PSP), OnePath, to arrange appointments and receive instructions on how to transport their products for infusion appointments.
Prescribers can enroll patients by submitting enrollment form to OnePath. Any questions regarding the program should be directed to OnePath through the following contact information:
Tel: (844) 691-7284
Fax: (844) 951-7284
E-mail: support@onepathprogram.ca
Respirologists can download the Glassia Consent and Enrollment Form HERE.
GLASSIA in Alberta
Canadian Blood Services is piloting a program for home delivery to eligible patients in Alberta using Bayshore Pharmacy, a specialty pharmacy. The purpose of this pilot is to demonstrate that this is a feasible option for providing home care PPRP to patients while increasing Canadian Blood Services’ access to product use data. Getting data from Bayshore Pharmacy on the use of PPRP will allow Canadian Blood Services to better manage PPRP access, demand planning, and inventory management. This pilot is being implemented through financial support from the Alberta Ministry of Health.
Glassia prescriptions can be sent to Bayshore Pharmacy via electronic fax to (855) 307-2929 through your electronic medical record (EMR). Alternatively, the Glassia Bayshore Enrolment form can be found HERE and faxed to Bayshore Pharmacy at (855) 307-2929.
PROLASTIN-C
Patients receiving ministry-funded Prolastin-C who meet the eligibility criteria are expected to transition to Glassia. Patients with Prolastin-C coverage through a private insurer are encouraged to contact their insurer and/or Prolastin-Direct for further information at (877) 325-7421 or at ProlastinDirect@innomar-strategies.com.
For patients residing in Quebec, access to Glassia through Canadian Blood Services does not affect their current access to Prolastin-C.
CADTH looked at a non-inferiority trial comparing Glassia to Prolastin-C. This trial showed that Glassia is non-inferior to Prolastin-C and that no claim can be made that there is any difference between these products. Based on expert opinion and the non-inferiority trial, Prolastin-C and Glassia were found to be comparable.
