Product Details

Strensiq

Asfotase alfa
28 mg/0.7 mL
Solution for Subcutaneous Injection
Single-Use Vial (Preservative-Free)

DIN/PIN/NPN

02444623

Manufacturer

Alexion Pharma GmbH

Formulary Listing Date

2018-06-06  

Unit Price

2113.4400

Amount MOH Pays

2113.4400

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

A16AB13

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Metabolic/Genetic Modifiers

Asfotase alfa

  • Brand(s): Strensiq
  • Dosage Form/Strength: 18mg/0.45mL, 28mg/0.7mL, 40mg/1mL, 80mg/0.8mL

Initiation Criteria: 

For the treatment of perinatal/infantile, childhood, or juvenile-onset hypophosphatasia (HPP) in patients who meet the following criteria: 

  1. Diagnosis is confirmed by genetic testing (i.e. documented tissue-nonspecific alkaline phosphatase gene mutations); AND

  2. Serum alkaline phosphatase (ALP) level is below the age-adjusted normal range1 using age and gender adjusted norms; AND

  3. Plasma pyridoxal-5-phosphate (PLP) above the upper limit of normal; AND

  4. Radiologically confirmed HPP-related skeletal abnormalities; AND

  5. Diagnosis occurred before the patient’s 12th birthday with documented onset of signs/symptoms2 of HPP prior to their 12th birthday; AND

  6. Patient is younger than 18 years of age at the time the treatment is initiated; AND

  7. Patient does not have odonto- or pseudo- HPP (i.e., craniosynostosis alone, premature loss of deciduous teeth alone and vitamin D deficiency to be ruled out); AND

  8. The patient’s treatment plan and goals of therapy is provided prior to the initiation of therapy; AND

  9. Patient is under the care of a metabolic specialist with expertise in the diagnosis and management of HPP. 

Approval duration for initial requests: 6 months 

Renewal Criteria: 

Renewals of reimbursement will be considered in patients meeting the following criteria: 

  • Patient continues to be under the care of a metabolic specialist; AND 

  • Patient has demonstrated compliance to the treatment and monitoring schedule: AND 

  • Pre-specified goals3 based on the patient’s clinical status at initiation of treatment are met and the patient is deemed to continue to benefit from treatment. (Note: The request must include information about the treatment responses and milestones) 

First renewal: 6 months

Subsequent renewals: 1 year

Stopping Criteria:

  • Discontinuation to be considered after growth is completed based on objective measure of height, weight and closure of bone growth plates as confirmed radiologically. 

  • Babies with perinatal/infantile HPP who fail treatment trials of 6 months 

  • If pre-specified goals are not met at reassessment, the treatment should not be continued. 

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:

  • baseline skeletal symptoms including age and dates of for those assessments 

  • abnormalities of skeletal mineralization 

  • fracture history 

  • growth plate irregularities and bone and skeletal growth 

  • description of growth and developmental milestones 

  • Signs, symptoms, and history of seizures 

  • respiratory function including need for ventilator support 

  • Activity and mobility 

  • Laboratory markers that include vitamin D levels, calcium levels 

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 

  • MA (EU) Number: EU/1/15/1015/006
  • Strength: 18mg/0.45mL
  • Pack: Single Use Vial 

 PIN: 9857648 

  • MA (EU) Number: EU/1/15/1015/008
  • Strength: 28mg/0.7mL
  • Pack: Single Use Vial

PIN: 9857649 

  • MA (EU) Number: EU/1/15/1015/010
  • Strength: 40mg/1mL
  • Pack: Single Use Vial

PIN: 9857650 

  • MA (EU) Number: EU/1/15/1015/004
  • Strength: 80mg/0.8mL
  • Pack: Single Use Vial

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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