Strensiq — Medical Mutual

Initial criteria

• Patient was age ≤ 18 years at onset; AND
• Patient has symptoms of hypophosphatasia (if diagnosed in infancy, examples may include short limbs, abnormal shaped chest, soft skull bones, rickets, failure to thrive, respiratory problems, hypercalcemia; if diagnosed in childhood, examples may include early loss of primary teeth, short stature, enlarged waist and ankle joints, abnormal skull shape, osteomalacia, recurrent fractures, joint pain, rickets); AND
• Patient had low baseline alkaline phosphatase (ALP) activity (age adjusted); AND
• Diagnosis of HPP was confirmed by presence of elevated ALP substrate levels (increased serum pyridoxal 5’-phosphate or urinary phosphoethanolamine); AND
• Patient has at least one pathogenic variant in ALPL gene; AND
• Strensiq is prescribed by or in consultation with a geneticist, endocrinologist, metabolic disorder sub-specialist, or a physician who specializes in treatment of hypophosphatasia or related disorders

Reauthorization criteria

• Patient meets all initial criteria; AND
• Patient has responded to therapy with Strensiq with an improvement or stabilization in the clinical signs or symptoms of hypophosphatasia (e.g. improvement in respiratory status, growth, or radiographic findings)

Approval duration

initial 6 months; reauth 1 year