CurrentNeighborhood Health Plan of Rhode IslandPolicy 2124-A

Pasireotide (Signifor) for Cushing's disease — Coverage Criteria

Policy governs prior authorization, documentation, and duration of coverage for pasireotide (Signifor) when used to treat adult patients with Cushing's disease for whom pituitary surgery is not an option or was not curative; applies to Neighborhood Health Plan of Rhode Island members covered under the referenced products.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPasireotide (Signifor) for Cushing's disease — Coverage Criteria

Policy CodePolicy 2124-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with a pretreatment cortisol level (UFC, LNSC, or 1 mg overnight DST) and request up to 6 months initial authorization; provide documentation of cortisol reduction or clinical improvement for renewal up to 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA-approvedIndication limited to adult Cushing's disease when surgery not an option or not curative

6 monthsInitial authorization duration

12 monthsContinuation authorization duration

3 test typesAccepted cortisol measures

Coverage Criteria for Pasireotide (Signifor)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPasireotide (Signifor) for Cushing's disease — Coverage Criteria

Policy CodePolicy 2124-A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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Initial therapy coverage

Covered when ALL of the following are met

FDA-approved indication: Patient is an adult with Cushing's disease and pituitary surgery is not an option or was not curative.

Based on FDA indication; all other indications are experimental/investigational and not covered.

Initial documentation: Pretreatment cortisol level must be provided as measured by one of: urinary free cortisol (UFC), late-night salivary cortisol (LNSC), or 1 mg overnight dexamethasone suppression test (DST).

Required to initiate prior authorization.

Authorization eligibility: Member is either post‑pituitary surgery that was not curative or is not a candidate for pituitary surgery.

If met, prior authorization of up to 6 months may be granted.

Continuation therapy coverage

Continuation covered when ANY of the following are met

Biochemical response: Current cortisol level has decreased from baseline as measured by urinary free cortisol (UFC), late‑night salivary cortisol (LNSC), 1 mg overnight dexamethasone suppression test (DST), or a longer low‑dose DST (2 mg/day for 48 hours).decrease vs baseline

Supports renewal/extension of authorization up to 12 months.

Clinical response: Documented improvement in signs or symptoms of Cushing's disease since starting pasireotide therapy.

Also supports renewal/extension of authorization up to 12 months.

Coverage for pasireotide (Signifor) is limited to the FDA‑approved indication: treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. Prior authorization is required and approval is contingent on submission of the documentation and response monitoring specified elsewhere in this policy.

Use of pasireotide (Signifor) for any indication other than the specified adult Cushing's disease population (patients for whom pituitary surgery is not an option or was not curative) is considered experimental/investigational and not medically necessary and will be denied.

Coding and Drug Reference

Referenced drugmixed

Signifor / pasireotide

Drug referenced (brand and generic)

Authorization response criteria — decrease in cortisol from baseline measured by UFC, LNSC, or DST

Authorization response criterionDecrease in cortisol from baseline as measured by urinary free cortisol (UFC)

Authorization response criterionDecrease in cortisol from baseline as measured by late-night salivary cortisol (LNSC)

Authorization response criterionDecrease in cortisol from baseline as measured by 1 mg overnight dexamethasone suppression test (DST)

Authorization response criterion (alternate DST)Decrease in cortisol from baseline as measured by longer low‑dose DST (2 mg/day for 48 hours)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization durations and renewal criteria vary by clinical scenario — see durations below. Requests for continuation must include evidence of clinical benefit or biochemical response.

Prior authorization required
Include required documentation (see Documentation callout)

Prior Authorization

Prior Authorization Duration — 6 months

Authorization may be granted for 6 months for members who have had pituitary surgery that was not curative or for members who are not candidates for surgery.

Duration: up to 6 months
Applies to: post-surgical non-curative or non-surgical candidates

Prior Authorization

Prior Authorization Duration and Renewal Criteria — 12 months

Authorization may be granted for 12 months for members who demonstrate biochemical response or clinical improvement. Acceptable evidence includes decreased cortisol from baseline or improvement in signs/symptoms.

Duration: up to 12 months
Renewal criteria (one or both): decreased cortisol from baseline by UFC, LNSC, 1 mg overnight DST, or longer low-dose DST (2 mg/day for 48 hours); or documented improvement in signs or symptoms of Cushing's disease

Documentation Required

Required Documentation for Initial and Continuation Requests

For initial requests submit a pretreatment cortisol level measured by one of the following tests. For continuation (renewal) requests submit a laboratory report showing current cortisol has decreased from baseline by one of the following tests.

Acceptable tests: Urinary free cortisol (UFC); Late-night salivary cortisol (LNSC); 1 mg overnight dexamethasone suppression test (DST); Longer, low-dose DST (2 mg per day for 48 hours)
Initial request: include pretreatment cortisol level (one of the tests above)
Continuation/renewal request: include current cortisol level showing decrease from baseline (one of the tests above) and/or documentation of clinical improvement

Denial Risk

Indication Limits / Not Medically Necessary

Signifor is indicated only for adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. Requests for other indications are considered not medically necessary.

Non‑covered: indications other than Cushing's disease per FDA label

OpenPayer

Pasireotide (Signifor) for Cushing's disease — Coverage Criteria

Coverage Criteria for Pasireotide (Signifor)

Coding and Drug Reference

Provider Actions, Authorization, and Documentation

Definitions and Accepted Measures

Background