Prior authorization criteria for Cushing syndrome agents (coverage criteria)
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Form and clinical criteria for prior authorization of medications used to treat Cushing syndrome and related hypercortisolemia for Anthem/Blue Cross Blue Shield Indiana lines of business; applies to prescribers requesting coverage for listed agents.
No material clinical or coverage changes in this revision.
Agent-specific Coverage Criteria
Isturisa (osilodrostat) - Initial authorization
Covered when ALL of the following are met
Korlym (mifepristone) - Initial authorization
Covered when ALL of the following are met
Lysodren (mitotane) - Initial authorization
Covered when ALL of the following are met
Metopirone (metyrapone) - Initial authorization
Covered when ALL of the following are met
Recorlev (levoketoconazole) - Initial authorization
Covered when ALL of the following are met
Signifor (pasireotide diaspartate) - Initial authorization
Covered when ALL of the following are met
Signifor LAR (pasireotide pamoate) - Initial authorization
Covered when ALL of the following are met
Use of listed agents is excluded when the specific contraindications called out on the agent section of the prior authorization form are present. Examples include the gynecologic and drug-concomitant exclusions for mifepristone (Korlym) — such as endometrial carcinoma, endometrial hyperplasia with atypia, unexplained vaginal bleeding, and concomitant use of certain strong CYP3A substrates or other specified interacting drugs — and the hepatic, QT, and prior-azole–injury exclusions for levoketoconazole (Recorlev) — including prior azole-induced liver injury, acute or poorly controlled liver disease, baseline AST/ALT >3× ULN, baseline QTcF >470 msec, cirrhosis, and use of drugs that prolong QT or are sensitive CYP3A4/P-gp substrates. Prescriber attestation that none of the agent-specific contraindications apply is required per the form.
Requests that do not meet the agent-specific criteria on the prior authorization form will not meet medical necessity. The form requires completion of all sections and documentation (including age and diagnosis fields, required attestations, pregnancy testing where applicable, and the requested dose within the listed limit); incomplete forms or missing required information will be returned per the submission instructions.
Agent Listing and Dosing Information
| Isturisa (osilodrostat phosphate) | Agent name and PA criteria |
| Korlym (mifepristone) | Agent name and PA criteria |
| Lysodren (mitotane) | Agent name and PA criteria |
| Metopirone (metyrapone) | Agent name and PA criteria |
| Recorlev (levoketoconazole) | Agent name and PA criteria |
| Signifor (pasireotide diaspartate) | Agent name and PA criteria |
| Signifor LAR (pasireotide pamoate) | Agent name and PA criteria |
| Isturisa (osilodrostat phosphate) | Agent name and PA criteria |
| Korlym (mifepristone) | Agent name and PA criteria |
| Lysodren (mitotane) | Agent name and PA criteria |
| Metopirone (metyrapirone) | Agent name and PA criteria |
| Recorlev (levoketoconazole) | Agent name and PA criteria |
| Signifor (pasireotide diaspartate) | Agent name and PA criteria |
| Signifor LAR (pasireotide pamoate) | Agent name and PA criteria |
Prior Authorization Requirements and Submission Instructions
Isturisa (osilodrostat) PA requirements
Prior authorization required. Member must be ≥18 years old, have a diagnosis of endogenous hypercortisolemia/Cushing's syndrome for whom surgery is not an option or has not been curative, and the requested dose must be 60 mg/day or less.
Korlym (mifepristone) PA requirements
Prior authorization required. Member must be ≥18 years old with hyperglycemia secondary to hypercortisolism in endogenous Cushing's syndrome (type 2 diabetes mellitus or glucose intolerance) who have failed or are not candidates for surgery; prescriber must attest no listed contraindications, confirm a negative pregnancy test within 30 days, document counseling on conception risks and non-hormonal contraception, and the requested dose must be 1200 mg/day or less.
Lysodren (mitotane) PA requirements
Prior authorization required. Selected diagnosis must be Cushing's syndrome or inoperable adrenocortical cancer, member must be ≥18 years old, provide a negative pregnancy test within 30 days when applicable, and the requested dose must be 12 g/day or less.
Metopirone (metyrapone) PA requirements
Prior authorization required. Indication must be Cushing's syndrome, pituitary-dependent hypercortisolism, or for diagnostic HPA testing; member must be ≥18 years old for treatment indications, prescriber must attest the member does not have adrenal cortical insufficiency, and the requested dose must be 6 g/day or less.
Recorlev (levoketoconazole) PA requirements
Prior authorization required. Member must be ≥18 years old, have endogenous hypercortisolemia/Cushing's syndrome for whom surgery is not an option or has not been curative, the requested dose must be 1.2 g/day or less, and prescriber must attest that none of the listed hepatic, QT, drug-interaction, or other contraindications are present.
Signifor (pasireotide diaspartate) PA requirements
Prior authorization required. Diagnosis must be Cushing's syndrome in members for whom pituitary surgery is not an option or has not been curative; member must be ≥18 years old and the requested dose must be 2.4 mg/day or less.
Signifor LAR (pasireotide pamoate) PA requirements
Prior authorization required. Selected diagnosis must be Cushing's syndrome (pituitary surgery not an option or not curative) or acromegaly (inadequate response to or not candidate for surgery); member must be ≥18 years old and the requested dose must match the indication: 40 mg every 4 weeks for Cushing's syndrome or 60 mg every 4 weeks for acromegaly.
No step therapy specified
No step therapy sequencing or prior medication failure hierarchy is specified on the form; no sequencing of listed agents is required prior to PA consideration.
Required documentation and attestations
Prescriber must complete all sections of the prior authorization form, include dates and documentation of negative pregnancy tests where required, and sign attestations regarding contraindications when requested.
Submission instructions — fax numbers
Fax the completed prior authorization form to the Prior Authorization of Benefits Center: 844-864-7860 for retail prior authorizations or 888-209-7838 for medical injectable prior authorizations.
Incomplete form will be returned
The prescribing provider must complete all sections of the form; incomplete or missing sections will result in the request being returned.
Denial risk for failure to meet agent-specific criteria
Requests that do not meet agent-specific criteria (including age requirements, specified diagnosis, requested dose limits, prescriber attestations of absence of contraindications, or required negative pregnancy-test documentation) risk denial.
Terms and Required Documentation
Policy Background
This prior authorization form exists to support coverage of medical therapies for endogenous hypercortisolemia/Cushing's syndrome in clinical scenarios where surgery is not an option or has not been curative. Several agents (for example, Recorlev) explicitly reference use when surgery is not feasible or curative, and the form collects the clinical attestations and safety screening (age, pregnancy testing when applicable, liver and QTc considerations, and drug-interaction checks) necessary to authorize medical management in these non-surgical situations.
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