Provincial & Territorial Drug Coverage – HPP

Hypophosphatasia (HPP) is a rare, inherited metabolic disorder caused by mutations in the ALPL gene. The resulting deficiency of tissue-nonspecific alkaline phosphatase (TNSALP) impairs normal bone and tooth mineralization. Severity varies widely, from mild adult-onset forms to severe perinatal cases that can be life-threatening.

Asfotase alfa is a pharmacological treatment option for HPP. It is an enzyme replacement therapy (ERT), a recombinant form of TNSALP, that helps restore the missing enzyme activity in patients with HPP. It is administered by subcutaneous injection.

In Canada, Asfotase alfa is marketed under the brand name Strensiq by Alexion Pharmaceuticals. It was approved by Health Canada in August 2015 for the treatment of patients with pediatric-onset HPP.

Swipe left to view full table.

Province/Territory	Access	Clinical Requirements	Residency	Source
Alberta	via Special Authorization	Must have confirmed ALPL gene mutation. X-ray evidence of skeletal abnormalities. Lab work must show low ALP and elevated PLP levels. Must be prescribed by Metabolic Specialist.	Must be an Alberta Health Care Insurance Plan registrant for at least 1 year.	Alberta Health – Drug Benefit List Asfotase Alfa Consent Form Asfotase Alfa Special Authorization Request Form
British Columbia	via Expensive Drugs for Rare Diseases	No explicit requirements; each case is handled on a case-by-case basis. Patient must obtain an EDRD form from their physician and submit it to their physician. Provincial Health Service Authority performs an individual patient review via several advisory and clinical subcommittees.	Must be a resident of British Columbia and registered with Medical Services Plan (MSP).	Exceptional Funding of EDRDs
Saskatchewan	via Exception Drug Status	Confirmed diagnosis of perinatal, infantile, or juvenile-onset HPP via genetic testing. Documented onset of signs and symptoms must occur before age 12. Treatment must be initiated before the patient is 18 years of age. Must be prescribed by a Metabolic Specialist with expertise in HPP. Initial request must include baseline clinical data: radiologic findings, pain severity, and respiratory findings.	Must be a resident of Saskatchewan and have a valid Saskatchewan Health Services number.	Exception Drug Status Exception Drug Status Appendix A Exception Drug Status Request Form
Manitoba	via Special Circumstance Review (case by case)	Note: Asfotase alfa is not explicitly named on the public Exception Drug Status (EDS) list or the provincial formulary. It is accessed through a specific “Special Circumstances” review process. The prescriber must apply for coverage via Exception Drug Status Process.	Must be a resident of Manitoba and registered with Manitoba Pharmacare.	Manitoba Drug Formulary
Ontario	via Exceptional Access Program	Confirmed diagnosis of pediatric onset of hypophosphatasia via genetic testing. Documentation of onset of signs and symptoms must occur before age 12. Must be prescribed by a metabolic specialist. Initial request must include baseline data.	Must be a resident of Ontario with a valid OHIP card and eligibility for the Ontario Drug Benefit program.	Reimbursement Criteria
Quebec	via Patient d’exception	Note: Asfotase alfa is not listed on the standard RAMQ formulary. Access may be requested through the Patient d’exception process on a case-by-case basis. The prescriber must apply for coverage via the Patient d’exception process.	Must be a resident of Quebec and registered with RAMQ.	Patient d’exception
New Brunswick	via Special Authorization	For the treatment of perinatal, infantile or juvenile onset hypophosphatasia. Eligibility is determined by the Canadian HPP Clinical Expert Committee. Must be prescribed by a metabolic specialist.	Must be a resident of New Brunswick and enrolled in the New Brunswick Drug Plan.	New Brunswick Drug Formulary Special Authorization Application Asfotase Alfa Special Authorization Criteria
Nova Scotia	via Exception Status Drug	For the treatment of perinatal, infantile, or juvenile onset hypophosphatasia. Eligibility is determined by the Canadian HPP Clinical Expert Committee.	Must be a resident of Nova Scotia and enrolled in Nova Scotia Pharmacare.	Criteria for Exception Drug Status Coverage Standard Exception Status Drug Request Form
Prince Edward Island	via Special Authorization	Note: Asfotase alfa is not listed on the PEI Pharmacare Formulary. Coverage may be requested through a Special Authorization on a case-by-case basis. The prescriber must submit a Special Authorization Request to PEI Pharmacare.	Must be a resident of PEI with a valid PEI Health Card.	PEI Pharmacare Special Authorization Form
Newfoundland and Labrador	via Special Authorization	Confirmed diagnosis of perinatal, infantile, or juvenile-onset hypophosphatasia via genetic testing. Diagnosis and documented onset of signs and symptoms must occur before age 12. Lab work must show low ALP and elevated PLP levels. Must be prescribed by a Metabolic Specialist. Treatment must be initiated before the patient is 18 years of age.	Must be a resident of Newfoundland and Labrador and enrolled in NL Prescription Drug Program.	Prescription Drug Program – Special Authorization Drug Products Special Authorization Drugs
Yukon	via Exception Drug Status (case by case)	Note: Asfotase alfa is not listed on the Yukon Drug Formulary. Coverage may be requested through Exception Drug Status on a case-by-case basis. The prescriber must apply for coverage to Yukon Pharmacare on a patient’s behalf. Specific criteria are not posted publicly.	Must be a resident of Yukon with a valid Yukon Health Care Card.	Yukon Drug Formulary Yukon Government – Department of Health and Social Services Call: 867-667-3096
Nunavut	via Non Formulary Request (case by case)	Note: Asfotase alfa is not listed on the Government of Nunavut Formulary. Non-formulary drugs can be requested by a physician through Director of Pharmacy with the Government of Nunavut. Specific criteria are not posted publicly. Prescribing physician must submit a non-formulary drug request on a patient’s behalf.	Must be a resident of Nunavut.	Government of Nunavut Formulary
Northwest Territories	via Exception Drug Status (case by case)	Note: Asfotase alfa is not listed on the Government of Northwest Territories formulary. Non-formulary drugs can be requested by a physician through pharmacies located in Northwest Territories. Prescribing physician must submit a non-formulary drug request on a patient’s behalf.	Must be a resident of Northwest Territories.	Government of Northwest Territories Pharmacare Formulary Call: 1(800) 661 0830

Disclaimer: This document is intended as a general guide to help patients, families, and advocates navigate public drug coverage for rare diseases in Canada. It is not a substitute for medical advice, nor a definitive statement of coverage eligibility.

Coverage criteria, application processes, and program details change over time, and individual eligibility depends on each patient’s clinical situation and residency. People living with these conditions should work directly with their physicians and care team, to navigate application process, and contact their provincial or territorial drug directly to confirm current criteria and documentation requirements.

The links and sources provided here are meant to point readers in the right direction – not replace direct consultation with health providers or government drug programs.

BACK TO HPP MAIN PAGE

Provincial and Territorial Drug Coverage – HPP