CurrentCignaPolicy IP0044

Isturisa (osilodrostat) — Coverage Criteria for Endogenous Cushing's Syndrome

Defines Cigna's prior authorization and medical necessity criteria for coverage of Isturisa (osilodrostat) for adults with endogenous Cushing's syndrome, including Cushing's disease, and specifies required prescriber specialty and documentation.

Policy Summary

PayerCigna

PolicyIsturisa (osilodrostat) — Coverage Criteria for Endogenous Cushing's Syndrome

Policy CodePolicy IP0044

Change TypeMaterial updates to criteria, step therapy, and prescriber requirement

Effective DateOct 1, 2025

Next Review DateAug 1, 2025

Key ActionObtain prior authorization and document diagnosis, prior therapies, and that medication is prescribed by or in consultation with an endocrinologist or specialist.

SourceLink

POLICY UPDATE CHANGES

Patients awaiting surgery and patients awaiting therapeutic response after radiotherapy were added as options for approval under endogenous Cushing's syndrome.

Employer and Individual/Family plan preferred-product step requirements were updated (preferred product criteria tables introduced).

Added requirement that medication must be prescribed by or in consultation with an endocrinologist or specialist in treatment of endogenous Cushing's syndrome.

≥18minimum patient age for coverage

1 yearinitial approval duration

Prior Auth

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Coverage Criteria for Isturisa (osilodrostat)

FDA-Approved Indication

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, and E):

Main criteria: A. Patient is ≥ 18 years of age;

Main criteria: B. Patient has confirmed diagnosis of Endogenous Cushing's Syndrome [Documentation Required];

Main criteria

ONE of: i. According to the prescriber, the patient is not a candidate for surgery or surgery has not been curative;
ONE of: ii. Patient is awaiting surgery for endogenous Cushing's Syndrome;
ONE of: iii. Patient is awaiting therapeutic response after radiotherapy for endogenous Cushing's Syndrome;

Main criteria: D. Medication is prescribed by or in consultation with an endocrinologist or a physician who specializes in the treatment of endogenous Cushing's syndrome;

Main criteria: E. Preferred product criteria is met for the product(s) as listed in the plan-specific tables;

Approval duration: 1 year

Employer Plans preferred-product criteria

For Employer Plans, approval for specified indications requires one of the following:

Employer plan options: For Cushing's disease (patient ≥ 18 years): A. Patient has tried, or is currently taking, Signifor or Signifor LAR; OR B. Patient has already been started on Isturisa.

Employer plan options: For endogenous Cushing's syndrome (patient ≥ 18 years; includes patients awaiting surgery or awaiting therapeutic response after pituitary radiotherapy): A. Patient has tried and, according to the prescriber, had inadequate efficacy or significant intolerance to, or is currently taking, ONE of oral ketoconazole, Metopirone (metyrapone capsules), or Recorlev; OR B. Patient has already been started on Isturisa.

Individual and Family Plans preferred-product criteria

For Individual and Family Plans, approval for specified indications requires one of the following:

Individual/Family plan options: For Cushing's disease (patient ≥ 18 years): A. Patient has tried, or is currently taking, Signifor or Signifor LAR; OR B. Patient has already been started on Isturisa.

Individual/Family plan options: For endogenous Cushing's syndrome (patient ≥ 18 years; includes patients awaiting surgery or awaiting therapeutic response after pituitary radiotherapy): A. Patient has tried and, according to the prescriber, had inadequate efficacy or significant intolerance to, or is currently taking, one of oral ketoconazole, Metopirone (metyrapone capsules) (Requires Prior Authorization), or Recorlev (Requires Prior Authorization); OR B. Patient has already been started on Isturisa.

Isturisa (osilodrostat) for any use not described in this policy is considered not medically necessary. This includes indications outside of treatment for endogenous Cushing's syndrome and any uses that are not supported by the criteria and documentation requirements in this policy.

Use of Isturisa for indications other than endogenous Cushing's syndrome (including uses not supported by this policy) is considered not medically necessary. Criteria will be updated if new published data become available.

Coding and Age Limits

inv-07: Minimum age

Minimum agePatient must be ≥ 18 years of age for coverage

Approval durationInitial approval for FDA‑approved indication: 1 year

DocumentationAge must be documented as part of the required clinical documentation

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for prescription benefit coverage of Isturisa. Approvals are provided for the duration noted in the policy. Because of the specialized skills required for evaluation and diagnosis of patients treated with Isturisa as well as the monitoring required for adverse events and long-term efficacy, approval requires Isturisa to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Documentation Required

Evidence of Diagnosis and Prior Therapy (Documentation Required)

Documentation is required where noted in the criteria as [Documentation Required]. Documentation may include, but is not limited to, chart notes, laboratory tests, medical test results, claims records, and/or other information to confirm diagnosis and prior therapy.

Acceptable evidence: chart notes, laboratory results, radiology reports, operative reports, prescriptions/medication history, prior authorization records showing previous therapies tried, and clinician documentation of intolerance or inadequate response.

Definitions and Treatment Context

inv-14: Endogenous Cushing's Syndrome

DefinitionEndogenous Cushing's syndrome: hypercortisolism caused by endogenous sources (e.g., Cushing's disease, adrenal tumors)

IncludesCushing's disease (ACTH‑secreting pituitary adenoma) is included within endogenous Cushing's syndrome

Indication scopePolicy covers Isturisa only for endogenous Cushing's syndrome in adults when surgery is not an option or not curative

inv-15: First-line treatment

Primary (first‑line) therapyResection of the causative tumor (e.g., transsphenoidal surgery for pituitary adenoma) is first‑line treatment

When surgery not feasibleMedical therapies (including steroidogenesis inhibitors and pituitary‑directed agents) are second‑line when surgery is not possible or not curative

Background

Cushing's syndrome refers to hypercortisolism that may result from endogenous or exogenous causes. Cushing's disease—caused by an ACTH-secreting pituitary adenoma—is the most common ACTH-dependent form of endogenous Cushing's syndrome. First-line therapy is resection of the causative tumor when feasible; medical therapies, including cortisol synthesis inhibitors such as Isturisa (osilodrostat), are indicated when surgery is not possible or is not curative.

Step Therapy

Plan-Specific Prior Therapy Requirements

Prior therapy requirements vary by plan (Employer vs Individual/Family). Providers must document prior trials, current use, or clinical rationale when a prior trial is not appropriate (for example, patient already started on Isturisa or prescriber determination that surgery/radiation timeline applies).

Employer Plans — Cushing's Disease (≥ 18 years): Approve if patient has tried or is currently taking Signifor or Signifor LAR, OR patient has already been started on Isturisa.
Employer Plans — Endogenous Cushing's Syndrome (≥ 18 years): Approve if patient has tried (and had inadequate efficacy or significant intolerance to), or is currently taking, ONE of oral ketoconazole, metopirone (metyrapone capsules), or Recorlev, OR patient has already been started on Isturisa.
Individual and Family Plans — Cushing's Disease (≥ 18 years): Approve if patient has tried or is currently taking Signifor or Signifor LAR, OR patient has already been started on Isturisa.
Individual and Family Plans — Endogenous Cushing's Syndrome (≥ 18 years): Approve if patient has tried (and had inadequate efficacy or significant intolerance to), or is currently taking, ONE of oral ketoconazole, metopirone (metyrapone capsules) [Requires Prior Authorization], or Recorlev [Requires Prior Authorization], OR patient has already been started on Isturisa.