RECORLEV (levoketoconazole)

RECORLEV (levoketoconazole) 

Self-administration – oral

Diagnosis considered for coverage:

• Cushing’s syndrome - a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.
  • Recorlev is not approved for the treatment of fungal infections.

Coverage Criteria:

For diagnosis of Cushing's syndrome:

• Dose does not exceed 600 MG by mouth twice daily (1200 MG total per day); AND
• Prescribed by or in consultation with an endocrinologist; AND
• Medical record documents the patient is being treated for endogenous hypercortisolemia (e.g., pituitary adenoma, ectopic tumor, adrenal adenoma, etc.); AND
• Medical record documents one of the following:
  • Patient is not a candidate for surgery
  • Surgery has not been curative and the patient still requires a cortisol synthesis inhibitor; AND
• Patient has tried and failed or intolerance at least one of the following cortisol synthesis inhibitors:
  • ketoconazole
  • mitotane (Lysodren)

Reauthorization Criteria:

For diagnosis of Cushing's syndrome:

• Dose does not exceed 600 MG by mouth twice daily (1200 MG total per day); AND
• Documentation of positive clinical response to therapy (e.g., normalization of urinary free cortisol (UFC); at least a 50% decrease in UFC levels).

Coverage Duration:

• Initial: 6 months
• Reauthorization: 1 year

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Endogenous glucocorticoid overproduction or hypercortisolism that is independent of adrenocorticotropic hormone (ACTH) is usually due to a primary adrenocortical neoplasm - most commonly an adenoma and rarely a carcinoma.
• Cases of hepatotoxicity with fatal outcome or requiring liver transplantation have been reported with oral ketoconazole. Some patients had no obvious risk factors for liver disease. Recorlev is associated with serious hepatotoxicity. Evaluate liver enzymes prior to and during treatment.
• Recorlev is associated with dose-related QT interval prolongation. QT interval prolongation may result in life-threatening ventricular dysrhythmias such as torsades de pointes. Perform ECG prior to and during treatment.
• Recorlev is contraindicated for patients with cirrhosis, acute liver disease or poorly controlled chronic liver disease, baseline AST or ALT > 3 times the upper limit of normal, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease.
• Recorlev is contraindicated for patients taking drugs that cause QT prolongation associated with ventricular arrhythmias including torsades de pointes, prolonged QTcF interval > 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or prolonged QT syndrome.

Policy Updates:

• 05/17/2022 – New policy approved by P&T.

References:

1. Fleseriu M, Auchus R, Bancos I, Ben-Shlomo A, Bertherat J, Biermasz NR, Boguszewski CL, Bronstein MD, Buchfelder M, Carmichael JD, Casanueva FF. Consensus on diagnosis and management of Cushing's disease: a guideline update. The Lancet Diabetes & Endocrinology. 2021 Dec 1;9(12):847-75.
2. Recorlev Prescribing Information. Xeris Pharmaceuticals, Inc. Chicago, IL. December 2021.