Signifor (pasireotide) — Blue Cross Blue Shield of Alabama

Initial criteria

• Patient has a diagnosis of Cushing’s disease AND BOTH of the following:
• • Urinary free cortisol levels greater than 1.5 times the upper limit of normal
• • ONE of the following:
• – Inadequate response to pituitary surgical resection OR
• – Not a candidate for pituitary surgical resection OR
• – Patient has another FDA approved indication for the requested agent and route of administration
• If the patient has an FDA approved indication, then ONE of the following:
• • Age is within FDA labeling for the requested indication for the requested agent OR
• • Prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or has consulted with a specialist
• Patient will NOT be using the requested agent in combination with Signifor LAR (pasireotide LAR)
• Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• Patient has had clinical benefit with the requested agent
• Urinary free cortisol levels less than or equal to the upper limit of normal
• Improvements or stabilization from baseline (prior to therapy) as indicated by ONE of the following: Fasting plasma glucose OR Hemoglobin A1c OR Hypertension OR Weight
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or has consulted with a specialist
• Patient will NOT be using the requested agent in combination with Signifor LAR (pasireotide LAR)
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

Cushing’s Disease – 6 months; All other FDA approved diagnoses – 12 months; Renewal – 12 months