Korlym denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Korlym 300 mg for treatment of the enrollee’s Cushing’s syndrome. Findings: The physician reviewer found that the current medical evidence supports the requested medication in this clinical setting. Cushing’s syndrome is a collection of signs and symptoms due to prolonged exposure to cortisol. It is associated with poor quality of life, morbidity, and increased mortality. While optimum treatment typically consists of selective and complete resection of the causative tumor, the development of new drugs offers clinicians several choices to treat patients with residual cortisol excess following the surgery. The U.S.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Korlym 300 mg tablets.Cushing’s syndrome, a collection of signs and symptoms due to prolonged exposure to cortisol, is associated with poor quality of life, morbidity, and increased mortality. While optimum treatment typically consists of selective and complete resection of the causative tumor, the development of new drugs offers clinicians several choices to treat patients with residual cortisol excess following the surgery. The U.S. Food and Drug Administration (FDA) has approved the antiprogestin Korlym (mifepristone) for control of hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing’s syndrome who have type 2 diabetes/glucose intolerance and have not responded to, or are not candidates for, surgery.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for Korlym 300 mg.Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. Cushing syndrome results from supraphysiological exposure to glucocorticoids and is associated with significant morbidity and mortality. First-line screening tests, including pituitary magnetic resonance imaging (MRI), a 1 mg dexamethasone suppression test, 24-hour urinary free cortisol excretion, and /or an inferior petrosal sinus sampling (IPSS), should be performed to screen for endogenous Cushing syndrome.

Nature of Statutory Criteria/ Case Summary: The enrollee is requesting authorization and coverage for the medication, Korlym. The enrollee has obesity, uncontrolled diabetes and hypertension. Their blood sugar became difficult to manage with the medication regimen and the endocrinologist suspected they might have hypothyroidism or Cushing’s syndrome. A follow-up thyroid function test (blood work) and a standard 1mg dexamethasone suppression test were ordered. While the enrollee’s thyroid function test resulted in normal values, the enrollee was found to have mildly suppressed cortisol and ACTH levels. The physician indicated the enrollee's dexamethasone suppression test was positive and a CT scan of the adrenal gland was to be performed to see if the enrollee had a tumor; if not, the enrollee was to be put on Korlym.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Korlym, then check the rights and deadlines that apply to your plan.