Synarel (nafarelin acetate) — Highmark

Initial criteria

• Synarel is prescribed by or in consultation with an endocrinologist
• Diagnosis of CPP is confirmed
• Member meets one of the following for onset of secondary sexual characteristics: member is less than 8 years of age if female OR less than 9 years of age if male OR if older, clear medical necessity of further treatment is outlined with clinical documentation
• Advancement of bone age ≥ 12 months beyond chronological age
• MRI or CT scan performed to rule out presence of central nervous system lesions
• Member meets one of the following: elevated basal LH level > 0.2–0.3 mIU/L OR elevated leuprolide-stimulated LH level > 3.3–5.0 mIU/L

Reauthorization criteria

• Synarel is prescribed by or in consultation with an endocrinologist
• Diagnosis of CPP is confirmed
• Member meets one of the following for onset of secondary sexual characteristics: member is less than 8 years of age if female OR less than 9 years of age if male OR if older, clear medical necessity of further treatment is outlined with clinical documentation
• Advancement of bone age ≥ 12 months beyond chronological age
• MRI or CT scan performed to rule out presence of central nervous system lesions
• Member meets one of the following: elevated basal LH level > 0.2–0.3 mIU/L OR elevated leuprolide-stimulated LH level > 3.3–5.0 mIU/L
• Member has experienced positive clinical response to therapy defined as one of the following: pre-pubertal slowing or decline, normalization of FSH, normalization of LH, normalization of bone age, normalization of estradiol level, normalization of testosterone level

Approval duration

Initial: 6 months; Maintenance: 12 months