CurrentCareSourcePolicy N/A

Isturisa (osilodrostat) pharmacy coverage — Prior authorization and criteria

Defines pharmacy benefit coverage and prior authorization criteria for Isturisa (osilodrostat) for members (age and clinical requirements) under CareSource in Arkansas PASSE; affects prescribers and pharmacy staff processing PA requests.

Policy Summary

PayerCareSource

PolicyIsturisa (osilodrostat) pharmacy coverage — Prior authorization and criteria

Policy CodePolicy N/A

Change TypeClarified (removed prescriber specialty requirement)

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and submit required documentation including elevated urinary free cortisol lab report, proof of pituitary surgery status or surgery ineligibility, and evidence of a ≥3-month ketoconazole trial.

SourceLink

POLICY UPDATE CHANGES

Removed prescriber specialty requirement.

PA Requiredcoverage requirement

18+minimum age

6 moinitial approval

12 moreauthorization

30 mg BIDmax dose

Homesite of service

Coverage Criteria for Isturisa (osilodrostat)

Initial Therapy

Covered when ALL of the following are met:

Initial authorization - Cushing's disease: Member is 18 years old or older; AND member had pituitary surgery that was not curative OR is not a candidate for surgery (documentation required); AND member has a diagnosis of Cushing's disease with an elevated urinary free cortisol (UFC) level (lab report required); AND member has tried ketoconazole for at least 3 months with inadequate response.

If all requirements met, approve for 6 months.

Continuation Therapy

Covered when ALL of the following are met for reauthorization:

Reauthorization - Cushing's disease: Labs must show UFC level within normal range; AND chart notes must show improved signs and symptoms of disease (e.g., weight, fasting glucose, blood pressure, or tumor size).

If requirements met, approve for additional 12 months.

Policy Summary

PayerCareSource

PolicyIsturisa (osilodrostat) pharmacy coverage — Prior authorization and criteria

Policy CodePolicy N/A

Change TypeClarified (removed prescriber specialty requirement)

Effective DateJan 1, 2022

Next Review DateN/A

SourceLink

On This Page

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CareSource considers Isturisa (osilodrostat) not medically necessary for the treatment of diseases not listed in this document. Coverage under the pharmacy benefit is limited to the specific indications and criteria detailed in this policy; requests for use in other disease states will be denied as not medically necessary.

Use of Isturisa (osilodrostat) for indications other than Cushing's disease listed in this policy is considered not medically necessary. Isturisa is a non-preferred pharmacy product and requires prior authorization; treatments for diagnoses outside the covered disease state are not eligible for coverage under this policy.

Initial Authorization Criteria

Initial Therapy

Initial authorization conditions

Initial authorization: Age >= 18; pituitary surgery non-curative or not a candidate (documentation required); diagnosis of Cushing's disease with elevated urinary free cortisol (UFC) (lab report required); trial of ketoconazole >= 3 months with inadequate response.

Approve for 6 months; maximum recommended dose 30 mg twice daily.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization requirements

Reauthorization: Labs must show UFC level within normal range; AND chart notes must indicate clinical improvement (weight, fasting glucose, blood pressure, or tumor size).

Approval for 12 months if met.

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required — Non-preferred Pharmacy Product

Prior authorization is required for Isturisa (osilodrostat) as it is a non-preferred pharmacy product. Billing must include a valid NDC code on claims.

Affected product: Isturisa (osilodrostat)
Benefit type: Pharmacy
Billing rule: Must use a valid NDC code

Step Therapy

Step Therapy Requirement — Ketoconazole Trial

Step therapy requires a trial of ketoconazole for at least 3 months with inadequate response documented before Isturisa will be approved for initial authorization.

Required step: Ketoconazole trial ≥ 3 months
Operational note: Documentation of inadequate response to ketoconazole must be provided

Documentation Required

Required Documentation — UFC and Pituitary Workup

Documentation must include a lab report showing elevated urinary free cortisol (UFC) and evidence of pituitary disease workup, including documentation that pituitary surgery was not curative or that the member is not a surgical candidate when applicable.

Required lab: Urinary free cortisol (UFC) report showing elevation
Required clinical documentation: Pituitary surgery history and outcome OR documentation that patient is not a candidate for surgery

Denial Risk

Denial Triggers — Missing Authorization or Documentation

Missing prior authorization or failure to submit the required documentation (e.g., UFC lab report, ketoconazole trial evidence, pituitary surgery documentation) may result in claim denial.

Denial triggers: No prior authorization on file
Denial triggers: Absent or incomplete UFC lab report
Denial triggers: No documentation of ketoconazole trial or pituitary surgery/workup

Billing and Coding

Billing codesNDC

NDC	Must use valid NDC code for billing

inv-06: Maximum recommended dose — 30 mg twice daily

Maximum recommended dose30 mg twice daily (dosage allowed: Max recommended dose is 30 mg as three 10 mg tablets, twice daily)

Per-day limitTotal daily maximum: 60 mg (30 mg twice daily)

Initial authorization notePolicy notes max dose when approving initial therapy for Cushing's disease

Step Therapy Requirements

Step	Requirement
1	Member must have tried ketoconazole for at least 3 months with inadequate response.

Definitions and Terms

inv-12: Elevated UFC — laboratory evidence required for diagnosis confirmation and initial authorization

DefinitionElevated urinary free cortisol (UFC): laboratory evidence required for diagnosis confirmation and initial authorization

Documentation requiredSubmission of lab report showing elevated UFC is required for initial authorization

Role in reauthorizationReauthorization requires UFC level within normal range per chart and labs

inv-13: Non-preferred product — drug covered under pharmacy benefit only with prior authorization

Coverage statusNon-preferred product: Isturisa is covered under the pharmacy benefit only with prior authorization

Billing requirementBilling must use a valid NDC code for the pharmacy claim

Authorization durationsInitial approvals are for 6 months; reauthorization approved for 12 months when criteria met

Quantity and Dose Limits

inv-17: Isturisa (osilodrostat) — Max recommended dose 30 mg

Drug and active ingredientIsturisa (osilodrostat)

Max recommended dose30 mg twice daily (dosage allowed: Max recommended dose is 30 mg as three 10 mg tablets, twice daily)

Quantity guidanceQuantity limits reflect maximum recommended dose of 30 mg per dose, administered twice daily

Allowed Site(s) of Service

Note

Allowed site of service — Home

Site of service for dispensing/administration is allowed at home.

Ensure claim and documentation reflect home as the site of service when applicable.

Background

Isturisa (osilodrostat) is indicated in this policy for the treatment of Cushing's disease. For initial authorization, the policy requires biochemical confirmation with an elevated urinary free cortisol (UFC) level (laboratory report required), documentation that pituitary surgery was non-curative or that the patient is not a surgical candidate, and a trial of ketoconazole for at least 3 months with inadequate response. When initial criteria are met, approval is granted for 6 months; reauthorization requires UFC within the normal range and clinical improvement and may be approved for an additional 12 months.