Product Details
Strensiq
Asfotase alfa40 mg/1 mL
Solution for Subcutaneous Injection
Single-Use Vial (Preservative-Free)
DIN/PIN/NPN
02444631
Manufacturer
Alexion Pharma GmbH
Formulary Listing Date
2018-06-06
Unit Price
3019.2000
Amount MOH Pays
3019.2000
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
A16AB13
Interchangeable Products
NOLU Clinical Criteria
NOEAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Metabolic/Genetic Modifiers | Asfotase alfa
Initiation Criteria: For the treatment of perinatal/infantile, childhood, or juvenile-onset hypophosphatasia (HPP) in patients who meet the following criteria:
Approval duration for initial requests: 6 months Renewal Criteria: Renewals of reimbursement will be considered in patients meeting the following criteria:
First renewal: 6 months Subsequent renewals: 1 year Stopping Criteria:
Notes: 1Normal range as informed by the Canadian Laboratory Initiative on Paediatric Reference Intervals (CALIPER) can be used as a reference for this information. Below upper limit of normal refers to 2 or lower standard deviations above the mean. 2Incoming Requests should address the following:
Assessments such as the Radiographic Global Impressive of Change (RGIC) score and/or the Thacher score for evaluating rickets may be provided at baseline and at the time of renewal of coverage (as applicable) as a measure of response and benefit from therapy. 3Specific patient treatment goals should be developed on a case-by-case basis and may include some of the following: Healing of rickets, improved bone mineralization, fewer fractures, reduced pain, improved growth, mobility, improvement in respiratory status, attainment of age-appropriate growth milestones, improvement in gait or deformities, improved quality of life measures. Documentation of improvement from baseline is to be provided at the time of renewal. Please note that effective April 8, 2021, foreign labelled Strensiq (generic name: asfotase alfa) has been added as a temporary Exceptional Access Program benefit due to drug shortage. PIN: 9857647
PIN: 9857648
PIN: 9857649
PIN: 9857650
EAP Drug Request Form: |