Asfotase alfa (Strensiq ®) for the treatment of hypophosphatasia (HPP)
The National Health Care Institute has completed its assessment whether asfotase alfa (Strensiq®) is interchangeable with a medicinal product that has been included in the Medication Reimbursement System (GVS). The National Health Care Institute's advice is to include asfotase alfa (Strensiq®) in Appendix 1B and Appendix 2 of the Health Insurance Regulation and to impose additional conditions.
Registered indication
Asfotase alfa is an orphan drug and is registered for exceptional circumstances for the indication ‘long-term enzyme replacement therapy in patients with paediatric- onset hypophosphatasia to treat bone manifestations of the disease.’
Assessment
Based on the criteria for interchangeability, asfotase alfa (Strensiq®) is not interchangeable with the other products included in the GVS.
The National Health Care Institute's advice
Based on the considerations mentioned in the report, the National Health Care Institute advises the Minister to include asfotase alfa (Strensiq®) in Appendix 1B and Appendix 2 (with additional conditions).
Condition for asfotase alfa
Only for an insured person with hypophosphatasia whose initial symptoms occurred in the womb (before birth) or before the age of 6 months.
This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.