Isturisa — Blue Cross Blue Shield of New Mexico

Initial criteria

• Target Agent will be approved when ALL of the following are met:
• 1. BOTH of the following:
• A. ONE of the following:
• 1. The patient has a diagnosis of Cushing’s syndrome AND
• A. ONE of the following:
• 1. The patient had an inadequate response to surgery OR
• 2. The patient is NOT a candidate for surgery AND
• 2. The patient’s disease is persistent or recurrent as evidenced by ONE of the following:
• A. Mean of three 24-hour urine free cortisol >1.3 × upper limit of normal OR
• B. Morning plasma ACTH above the lower limit of normal AND
• 3. ONE of the following:
• A. (Cancer use) The prescriber has stated or provided documentation that the patient has stage 4 advanced metastatic cancer and agent used to treat the cancer or associated condition AND use is consistent with FDA approval and evidence-based literature OR
• B. The patient is currently being treated with the requested agent and is stable [chart notes required] OR
• C. BOTH of the following:
• 1. ONE of the following:
• A. The request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR
• B. The patient has tried and had an inadequate response to ≥1 of: mifepristone; Signifor/Signifor LAR (pasireotide); Recorlev (levoketoconazole); cabergoline; metyrapone; Lysodren (mitotane) OR discontinued due to lack of efficacy/adverse event OR has intolerance/hypersensitivity/FDA-labeled contraindication OR expected to be ineffective or medically not in best interest based on chart notes OR tried another agent with same mechanism discontinued for inefficacy/adverse event
• AND
• 2. ONE of the following: the request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR the patient has tried, failed, or cannot tolerate ketoconazole tablets with same rationale options as above (inadequate response, discontinued for AE, contraindication, expected to be ineffective, medically not in best interest, or tried another in same class discontinued for AE/inefficacy)
• D. The patient has another FDA labeled indication for the requested agent and route of administration
• B. If FDA labeled indication, ONE of:
• A. Patient age within FDA labeling for indication OR
• B. There is support for use for the patient’s age
• 2. The prescriber is an endocrinologist or has consulted with one
• 3. The patient will NOT be using the agent in combination with glucocorticoid replacement therapy
• 4. The patient does NOT have any FDA labeled contraindications to the agent
• Length of Approval: BCBSOK 36 months; BCBSIL and BCBSMT 12 months; all other plans 6 months.
• Alternate approval for Ohio residents (Fully Insured or HIM Shop): no contraindications AND one of FDA-label, compendia support, or two peer-reviewed journal articles supporting proposed use (study designs include randomized, double-blind, placebo-controlled).
• Length of Approval: BCBSOK 36 months; others 12 months.

Reauthorization criteria

• Target Agent approved when ALL of:
• 1. Patient previously approved for requested agent through PA process
• 2. Patient has had clinical benefit with requested agent
• 3. Prescriber is endocrinologist or has consulted with endocrinologist
• 4. Patient will NOT use requested agent with glucocorticoid replacement therapy
• 5. Patient has no FDA labeled contraindications to requested agent
• Length of Approval: BCBSOK 36 months; all other plans 12 months

Approval duration

6–36 months (plan-dependent)