Korlym — Medical Mutual

Initial criteria

• Patient is age ≥ 18 years; AND
• Baseline urinary free cortisol is elevated; AND
• Mifepristone is prescribed by or in consultation with an endocrinologist or a physician who specializes in the treatment of Cushing’s syndrome; AND
• Mifepristone is being used to control hyperglycemia secondary to hypercortisolism in patients who have type 2 diabetes mellitus or glucose intolerance; AND
• Patient meets ONE of the following: (i) According to the prescriber, the patient is not a candidate for surgery or surgery has not been curative; OR (ii) Patient is awaiting surgery for endogenous Cushing’s syndrome; OR (iii) Patient is awaiting therapeutic response after radiotherapy for endogenous Cushing’s syndrome; AND
• The patient has tried ketoconazole tablets, Metopirone (metyrapone capsules), Lysodren (mitotane tablets), or Signifor/Signifor LAR for the treatment of Cushing’s syndrome; AND
• If brand Korlym is prescribed, the patient has previously failed or is intolerant to generic mifepristone; AND brand Korlym is being requested due to a formulation difference in inactive ingredient(s) that has or would result in significant allergy or serious adverse reaction

Reauthorization criteria

• Patient is age ≥ 18 years; AND
• Mifepristone is prescribed by or in consultation with an endocrinologist or a physician who specializes in the treatment of Cushing’s syndrome; AND
• Mifepristone is being used to control hyperglycemia secondary to hypercortisolism in patients who have type 2 diabetes mellitus or glucose intolerance; AND
• According to the prescriber, the patient is not a candidate for surgery or surgery has not been curative; AND
• The patient has tried ketoconazole tablets, Metopirone (metyrapone capsules), Lysodren (mitotane tablets), or Signifor/Signifor LAR; AND
• The patient has experienced improved glucose tolerance or stable glucose tolerance while on Korlym; AND
• If brand Korlym is prescribed, the patient has previously failed or is intolerant to generic mifepristone; AND brand Korlym is being requested due to a formulation difference in inactive ingredient(s) that has or would result in significant allergy or serious adverse reaction

Approval duration

initial 6 months; reauth 1 year