Strensiq (asfotase alfa subcutaneous injection – Alexion) — Cigna

Initial criteria

• Diagnosis is supported by ONE of the following (i, ii, or iii): i. Molecular genetic testing documenting pathogenic tissue non-specific alkaline phosphatase (ALPL) gene variants; OR ii. Low baseline serum alkaline phosphatase activity; OR iii. An elevated level of a tissue non-specific alkaline phosphatase substrate (i.e., serum pyridoxal 5’-phosphate, serum or urinary inorganic pyrophosphate, urinary phosphoethanolamine); AND
• Patient meets ONE of the following (i or ii): i. Patient currently has, or had a history of, clinical manifestations consistent with hypophosphatasia; OR ii. Patient has a family history (parent or sibling) of hypophosphatasia without current clinical manifestations of hypophosphatasia; AND
• Disease onset < 18 years of age; AND
• The medication is prescribed by or in consultation with a geneticist, endocrinologist, a metabolic disorder sub-specialist, or a physician who specializes in the treatment of hypophosphatasia or related disorders.

Approval duration

1 year