CurrentNeighborhood Health Plan of Rhode IslandPolicy 2124-A

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

Covers prior authorization and medical necessity criteria for Signifor (pasireotide) in adults with Cushing's disease when surgery is not an option or was not curative; applies to members of Neighborhood Health Plan of Rhode Island as implemented from the CVS Caremark policy content.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

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

Policy CodePolicy 2124-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with pretreatment cortisol level (late-night salivary cortisol, UFC, 3 mg overnight DST, or low-dose DST) and documentation that pituitary surgery is not an option or was not curative.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial auth

12 monthscontinuation auth

FDA-onlycovered indications

Other indicationsnot covered

Coverage Criteria for Signifor (pasireotide)

Initial Therapy

Covered when ALL of the following are met

Initial therapy for Cushing's disease: 1) Patient is an adult with Cushing's disease (FDA‑approved indication: Signifor is indicated for adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative); 2) Pituitary surgery is not an option or prior pituitary surgery was not curative (documentation of surgical status should be provided); 3) Pretreatment cortisol level is provided, measured by one of: late‑night salivary cortisol; urinary free cortisol (UFC); 3 mg overnight dexamethasone suppression test (DST); or low‑dose DST (2 mg per day for 48 hours); 4) No exclusions to the prescribed therapy apply (see exclusions).

Authorization duration: up to 6 months for initial therapy

Continuation Therapy

Covered when ALL of the following are met

Continuation of therapy: 1) Current cortisol level is provided, measured by one of: late‑night salivary cortisol; urinary free cortisol (UFC); 3 mg overnight dexamethasone suppression test (DST); or low‑dose DST (2 mg per day for 48 hours); 2) Demonstrated clinical benefit defined as lower cortisol levels since the start of therapy per one of the listed tests and/or improvement in signs or symptoms of Cushing's disease;

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

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

Policy CodePolicy 2124-A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Signifor (pasireotide) for Cushing's disease. Initial authorizations may be granted for up to 6 months. Continuation authorizations may be granted for up to 12 months when clinical response and monitoring criteria are met.

Initial authorization: up to 6 months
Continuation authorization: up to 12 months

Documentation Required

Required Laboratory and Clinical Data

For initial prior authorization requests submit documentation of pretreatment cortisol level measured by one of the following: late‑night salivary cortisol; urinary free cortisol (UFC); 1 mg overnight dexamethasone suppression test (DST) or low‑dose DST (2 mg per day for 48 hours). For continuation requests submit a current cortisol level using one of the same tests and documentation of clinical improvement in signs or symptoms.

Accepted tests: late‑night salivary cortisol; urinary free cortisol (UFC); 1 mg overnight DST; low‑dose DST (2 mg/day for 48 hours)
For continuation: current cortisol level by one of above tests and evidence of clinical improvement

Documentation Required

Surgical Candidacy Requirement

Signifor is indicated only for adult patients with Cushing's disease for whom pituitary surgery is not an option or was not curative. Documentation of surgical candidacy (or documentation that surgery was attempted and not curative) is required with the initial prior authorization request.

Provide documentation that the member is not a surgical candidate OR surgical treatment was performed and was not curative

OpenPayer

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

Coverage Criteria for Signifor (pasireotide)

Laboratory Measures and Coding Considerations

Provider Requirements and Prior Authorization

Background

Definitions and FDA-Approved Indication