Leqembi Receives Positive Public Reimbursement Recommendation in Canada
BioArctic announced that CDA-AMC has issued a final recommendation supporting public reimbursement of Leqembi (lecanemab) for eligible patients with MCI or mild dementia due to early Alzheimer’s disease. The recommendation follows reconsideration by CDA-AMC and moves Leqembi closer to broader public access in Canada, with price negotiations through the pCPA followed by reimbursement decisions from provincial and territorial drug plans. With more than 770,000 Canadians estimated to be living with dementia in 2025 and the number projected to reach 1.7 million by 2050, the recommendation could strengthen Leqembi’s position in the growing early Alzheimer’s treatment market.
Fujirebio Expands Blood-Based Neurology Testing in Canada
Fujirebio received Health Canada Class II Medical Device Licenses for its Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays, expanding access to blood-based neurological biomarkers in Canada. The NfL assay quantitatively measures neurofilament light chain in serum and plasma to support assessment of neuro-axonal injury, disease monitoring, prognosis, and treatment response, while the pTau 217 assay helps identify amyloid pathology associated with Alzheimer’s disease in patients aged 50 and older with cognitive decline. Both assays run on Fujirebio’s fully automated LUMIPULSE G immunoassay platform, strengthening the company’s neurology diagnostics portfolio.
PixCell Medical Expands HemoScreen Access in Canada
PixCell Medical entered the Canadian market after receiving a Health Canada Class III Medical Device License for HemoScreen™, its point-of-care hematology analyzer, alongside a distribution partnership with Inter Medico. HemoScreen enables rapid, lab-quality 5-part differential CBC testing from a drop of venous or capillary blood using AI-powered digital imaging and proprietary Viscoelastic Focusing technology in a disposable cartridge. With no maintenance, calibration, external reagents, or liquid waste required, the analyzer supports decentralized testing across hospitals, community clinics, oncology centers, and rural or remote settings, establishing a foundation for broader near-patient hematology testing across Canada.
Yorvipath Receives Conditional Reimbursement Recommendation in Canada
Pendopharm and Ascendis Pharma announced that CDA-AMC has recommended reimbursement with conditions for Yorvipath (palopegteriparatide) for eligible adults with chronic hypoparathyroidism inadequately controlled with conventional therapy. Authorized by Health Canada in January 2026, Yorvipath is a parathyroid hormone replacement therapy supported by Phase 3 PaTHway trial data. The recommendation moves the therapy closer to public reimbursement, with final listing decisions to be made independently by participating federal, provincial, and territorial drug plans, potentially expanding access for patients who remain inadequately controlled on oral calcium and active vitamin D.
