CurrentNeighborhood Health Plan of Rhode IslandPolicy 2124-A

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

Covers use of Signifor (pasireotide) for adult patients with Cushing's disease when pituitary surgery is not an option or was not curative; defines required documentation for prior authorization and continuation.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySignifor (pasireotide) for Cushing's disease — Coverage Criteria

Policy CodePolicy 2124-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit pretreatment cortisol level by UFC, late-night salivary cortisol, 1 mg DST, or low-dose DST for initial requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

12 mocontinuation authorization duration

4supported cortisol tests

FDA-onlycoverage stance beyond Cushing's

Coverage Criteria for Signifor (pasireotide)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySignifor (pasireotide) for Cushing's disease — Coverage Criteria

Policy CodePolicy 2124-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit pretreatment cortisol level by UFC, late-night salivary cortisol, 1 mg DST, or low-dose DST for initial requests.

SourceLink

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

FDA‑approved indication only.

Initial documentation: For initial request, pretreatment cortisol level measured by one of: urinary free cortisol (UFC), late‑night salivary cortisol, 1 mg overnight dexamethasone suppression test (DST), or longer low‑dose DST (2 mg/day for 48 hours).

Supports baseline biochemical hypercortisolism.

Authorization duration for initial therapy: Authorization of up to 6 months may be granted for initial treatment when surgery was not curative or patient is not a surgical candidate.6 months

Continuation therapy

Continuation covered when ANY of the following are met

Biochemical response: Lower cortisol levels since the start of therapy measured by one of: urinary free cortisol (UFC), late‑night salivary cortisol, 1 mg overnight dexamethasone suppression test (DST), or longer low‑dose DST (2 mg/day for 48 hours).

Clinical response: Improvement in signs or symptoms of Cushing's disease since start of therapy.

Continuation authorization duration: Authorization of 12 months for continuation may be granted when response criteria are met.12 months

Coding and Monitoring

No specific billing codes listedmixed

No codes listed

Cortisol monitoring options — UFC, late-night salivary cortisol, 1 mg overnight DST, or low-dose DST (2 mg/day for 48 hours)"

Urinary free cortisol (UFC)Accepted pretreatment and monitoring test for biochemical hypercortisolism

Late-night salivary cortisolAccepted pretreatment and monitoring test for biochemical hypercortisolism

1 mg overnight dexamethasone suppression test (DST)Accepted pretreatment and monitoring test for biochemical hypercortisolism

Low-dose DST (2 mg/day for 48 hours)Accepted pretreatment and monitoring test for biochemical hypercortisolism

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorizations may be granted for up to 6 months for treatment of Cushing's disease when the member has had pituitary surgery that was not curative or is not a candidate for surgery. Continuation authorizations may be granted for up to 12 months when the member demonstrates ongoing benefit.

Initial authorization duration: up to 6 months
Continuation authorization duration: up to 12 months
PA required for both initial and continuation therapy

Documentation Required

Required Laboratory and Clinical Documentation

For initial prior authorization requests, submit pretreatment cortisol level measured by one of the following: urinary free cortisol (UFC); late‑night salivary cortisol; 1 mg overnight dexamethasone suppression test (DST); or longer low‑dose DST (2 mg per day for 48 hours). For continuation requests, submit current cortisol level measured by one of the same tests and documentation of clinical benefit (e.g., lower cortisol levels since the start of therapy or improvement in signs/symptoms of Cushing's disease). Include relevant clinical notes documenting diagnosis, prior treatments, and rationale if surgery was not performed or was not curative.

Acceptable cortisol tests: UFC; late‑night salivary cortisol; 1 mg overnight DST; longer low‑dose DST (2 mg/day for 48 hours)
Initial request: pretreatment cortisol test result and clinical documentation
Continuation request: recent cortisol test result and documentation of decreased cortisol since therapy start or clinical improvement

Documentation Required

Surgery Requirement / Clinical Context

Treatment is consistent with the FDA‑approved indication for Cushing's disease when pituitary surgery is not an option or has not been curative. Prior authorization should document whether the member has had prior pituitary surgery that was not curative or why the member is not a surgical candidate.

Document prior pituitary surgery and outcome (not curative) OR rationale and supporting clinical notes that the member is not a candidate for surgery

Background on Signifor (pasireotide)

Signifor (pasireotide) is indicated for the treatment of adult patients with Cushing's disease when pituitary surgery is not an option or when surgery has not been curative. Treatment with Signifor should be considered in this specific clinical context; requests for therapy should document that the patient meets the FDA‑approved indication (adult Cushing's disease and non‑surgical candidate or persistent disease after surgery) and include appropriate baseline clinical and biochemical information for prior authorization review.

Definitions and Supported Tests

Supported cortisol tests — UFC; late-night salivary cortisol; 1 mg overnight DST; longer low-dose DST (2 mg/day for 48 hours)"}]}

Urinary free cortisol (UFC)Listed as an FDA-recognized cortisol test for diagnosis and monitoring

Late-night salivary cortisolListed as an FDA-recognized cortisol test for diagnosis and monitoring

1 mg overnight dexamethasone suppression test (DST)Listed as an FDA-recognized cortisol test for diagnosis and monitoring

Longer low-dose DST (2 mg/day for 48 hours)Listed as an FDA-recognized cortisol test for diagnosis and monitoring