CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Isturisa (osilodrostat) coverage for Cushing's disease

Defines medical necessity criteria, authorization limits, and monitoring requirements for coverage of Isturisa (osilodrostat) for members with Cushing's disease under Neighborhood Health Plan of Rhode Island Medicaid.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIsturisa (osilodrostat) coverage for Cushing's disease

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization for 6 months and document age ≥18, diagnosis of Cushing's disease, prior pituitary surgery failure or contraindication, endocrinologist involvement, and prior failure/contraindication/intolerance to ketoconazole and Signifor LAR.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization duration

18+min age (yrs)

mUFC ≤ ULNcontinuation lab criterion

1mg:8;5mg:12quantity limits

Coverage Criteria for Isturisa (osilodrostat)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIsturisa (osilodrostat) coverage for Cushing's disease

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2021

Next Review DateN/A

SourceLink

On This Page

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Initial approval criteria: Member is 18 years of age or older

Initial approval criteria: Documented diagnosis of Cushing's Disease

Initial approval criteria: Documentation of failed pituitary surgery or a contraindication to pituitary surgery

Initial approval criteria: Medication is prescribed by or in consultation with an endocrinologist

Initial approval criteria: Member has experienced a failure, contraindication, or intolerance to ketoconazole and Signifor LAR

Authorization of 6 months may be granted when all criteria are met.

Continuation Therapy

Continuation of therapy is covered when ALL of the following are met:

Continuation criteria: Meets all initial approval criteria (see Initial Therapy)

Continuation criteria: Documentation of a positive clinical response after at least 6 months of therapy with Isturisaat least 6 months of therapy

Continuation criteria: Mean urinary free cortisol level less than or equal to the upper limit of normal≤ upper limit of normal

Continuation criteria: Improvement in overall signs and symptoms of the condition

Continuation criteria: Ongoing monitoring for severe adverse reactions (e.g., hypocortisolism, QTc prolongation, hypokalemia)

Authorization of 6 months may be granted for members meeting these continuation criteria.

No additional exclusions beyond the stated approval criteria are specified in the policy. Patients who do not meet all elements of the initial or continuation criteria — including being at least 18 years of age, having a documented diagnosis of Cushing’s disease, documentation of failed or contraindicated pituitary surgery, prescription by or in consultation with an endocrinologist, and prior failure/contraindication/intolerance to both ketoconazole and Signifor LAR — are not eligible for authorization.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. An authorization of 6 months may be granted when all initial criteria are met; renewals follow the continuation criteria and may also be authorized for 6 months.

Authorization duration: 6 months when initial criteria are met; continuation authorizations also 6 months when continuation criteria are satisfied.
Required prescriber: Medication must be prescribed by or in consultation with an endocrinologist.

Step Therapy

Step Therapy Requirement

Step therapy must be documented before approval. Members must have experienced failure, contraindication, or intolerance to both ketoconazole and Signifor LAR prior to authorization.

Step therapy requirement: documented failure, contraindication, or intolerance to ketoconazole and Signifor LAR.
Failure documentation should include treatments tried, durations, and reason for discontinuation (inefficacy, adverse event, or contraindication).

Documentation Required

Required Documentation

Providers must supply complete documentation to support the prior authorization request. Missing or incomplete documentation increases the risk of denial.

Documentation must include the member's age (≥ 18 years) and a documented diagnosis of Cushing's disease.
Evidence of failed pituitary surgery or a documented contraindication to pituitary surgery (operative reports, clinician notes, or clear rationale).
Documentation of specialist involvement: prescription by or consultation with an endocrinologist (consult note, referral, or co-signature).
Records showing failure, contraindication, or intolerance to ketoconazole and Signifor LAR (medication trials, durations, response, and adverse effects).
For continuation requests, documentation of positive clinical response after at least 6 months of therapy (mean urinary free cortisol ≤ upper limit of normal and improvement in signs/symptoms).
Monitoring documentation for adverse reactions (hypocortisolism, QTc prolongation, hypokalemia) as clinically appropriate.

Denial Risk

Documentation Risks for Denial

Applications lacking required elements may be denied. Verify all items before submission to avoid delays or denials.

Denial risks: missing documentation of age ≥ 18, absence of a documented diagnosis of Cushing's disease, or no evidence of failed pituitary surgery or contraindication to surgery.
Denial risks: lack of documentation showing failure/contraindication/intolerance to both ketoconazole and Signifor LAR.
Denial risks: prescription not from or not in consultation with an endocrinologist, or missing consultation/prescriber notes.
Denial risks: for continuation, no evidence of clinical response after ≥ 6 months (no mean urinary free cortisol ≤ ULN or no documented symptom improvement).

Background

Isturisa (osilodrostat) is an oral steroidogenesis inhibitor used to treat endogenous Cushing’s disease. The policy prioritizes use in adult patients (age ≥ 18) with a documented diagnosis of Cushing’s disease who have either failed pituitary surgery or have a contraindication to surgery, and who have experienced failure, contraindication, or intolerance to other steroidogenesis inhibitors such as ketoconazole and Signifor LAR. Prior authorization may be granted for 6 months when all initial criteria are met.

OpenPayer

Isturisa (osilodrostat) coverage for Cushing's disease

Coverage Criteria for Isturisa (osilodrostat)

Coding, Limits, and Laboratory Targets

Prior Authorization, Documentation, and Step Therapy

Background

Definitions and Clinical Response