Crenessity (crinecerfont) oral solution — Point32Health

Initial criteria

• Documented diagnosis of classic congenital adrenal hyperplasia as evidenced by a 21-hydroxylase deficiency confirmed by one (1) of the following: elevated serum 17-hydroxyprogesterone level OR genetic testing confirming presence of mutations in the 21-hydroxylase gene OR positive newborn screen with confirmatory second-tier testing OR cosyntropin stimulation test assessed by an endocrinologist
• Patient age ≥ 4 years
• Prescribed by endocrinologist or physician specializing in treatment of adrenal hyperplasia
• Documentation of use as adjunctive treatment with glucocorticoids
• Documentation of one (1) of the following: patient requires a supraphysiologic glucocorticoid dose to control disease (defined as >12 mg/m2/day in hydrocortisone dose equivalents for pediatrics and >13 mg/m2/day in hydrocortisone dose equivalents for adults) OR patient has uncontrolled androgen levels despite maximally tolerated glucocorticoid dose
• If requesting oral suspension, documentation of one (1) of the following: patient weight <55 kg OR (patient weight ≥55 kg AND patient has a swallowing disorder)

Reauthorization criteria

• Documented diagnosis of classic congenital adrenal hyperplasia as evidenced by a 21-hydroxylase deficiency
• Patient age ≥ 4 years
• Prescribed by endocrinologist or physician specializing in treatment of adrenal hyperplasia
• Documentation of use as adjunctive treatment with glucocorticoids
• Documentation of therapeutic response to Crenessity as evidenced by one (1) of the following: reduction in daily glucocorticoid dose OR improved androgen control
• For the oral suspension, documentation of one (1) of the following: patient weight <55 kg OR (patient weight ≥55 kg AND patient has a swallowing disorder)

Approval duration

initial 6 months; reauth 12 months