CurrentHealth NetPolicy CP PHAR.332

Clinical Policy: Pasireotide (Signifor, Signifor LAR)

Clinical coverage policy for pasireotide (Signifor and Signifor LAR) for treatment of Cushing's disease and acromegaly, specifying initial and continued therapy criteria, dosing limits, prescriber requirements, and approval durations for Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyPasireotide (Signifor, Signifor LAR) clinical coverage policy

Policy CodePolicy CP PHAR.332

Change TypeAnnual review - no material change

Effective DateMar 1, 2017

Next Review Date

Key ActionObtain prior authorization with documentation that initial or continued therapy criteria are met, including diagnosis, prescriber specialty, prior treatments, dosing, and evidence of response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Q 2024Most recent annual review

60 mg/4wkMax Signifor LAR dose (acromegaly)

40 mg/4wkSignifor LAR dose (Cushing's)

1.8 mg/dayMax Signifor (SC) dose

J2502, J3490HCPCS codes referenced

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Coverage Criteria for Pasireotide (Signifor, Signifor LAR)

Initial Approval — Acromegaly (Signifor LAR)

Covered when ALL of the following are met

Initial Acromegaly Criteria: Member has a diagnosis of acromegaly evidenced by either (a) pre-treatment IGF‑I above the laboratory upper limit of normal for age and gender OR (b) serum growth hormone (GH) >= 1 µg/L after a 2‑hour oral glucose tolerance test; request is for Signifor LAR; prescribed by or in consultation with an endocrinologist; age >= 18 years; inadequate response to resection or pituitary irradiation OR member is not a candidate for such treatment; dose does not exceed 60 mg every 4 weeks (or 1 vial every 4 weeks where applicable).

Initial Approval — Cushing's Disease (Signifor or Signifor LAR)

Covered when ALL of the following are met

Initial Cushing's Criteria: Member has a diagnosis of Cushing's disease; prescribed by or in consultation with an endocrinologist; age >= 18 years; pituitary surgery was not curative OR member is not eligible for pituitary surgery; dosing limits do not exceed either Signifor (subcutaneous) 1.8 mg per day OR Signifor LAR 40 mg every 4 weeks (1 vial every 4 weeks).

Continued Therapy — Acromegaly and Cushing's Disease

Covered when ALL of the following are met

Continued Therapy: Member is currently receiving medication via the Centene benefit OR has previously met initial approval criteria (or is covered under applicable continuity of care regulations); request is for Signifor LAR where applicable; member is responding positively to therapy per Appendix D; if a dose increase is requested, the new dose does not exceed the specified maximums (acromegaly: Signifor LAR 60 mg every 4 weeks or 1 vial every 4 weeks; Cushing's disease: Signifor SC 1.8 mg per day or Signifor LAR 40 mg every 4 weeks).

Other Diagnoses/Indications — Use exceptions and off-label guidance

Use exceptions and off-label guidance

Other Indications: For requests for diagnoses or uses not specifically covered by this policy, apply the applicable formulary, non‑coverage, non‑formulary, or off‑label use policy for the member's line of business (references: CP.CPA.190, HIM.PA.33, HIM.PA.103, CP PMN.255, CP CPA.09, HIM.PA.154, CP PMN.16, CP PMN.53 as appropriate).

Initial criteria (acromegaly) - note

Policy updates/criteria notes

Acromegaly initial criteria revision: Initial GH threshold for acromegaly diagnosis/initial therapy was revised to GH >= 1 µg/L per PS/ES practice guidelines and ACG as of the 4Q 2024 annual review.GH >= 1 µg/L

Full logical criteria set for this revision is recorded in the policy annual review notes.

Coverage is not authorized for non‑FDA approved indications unless the provider supplies sufficient documentation demonstrating the efficacy and safety of the requested off‑label use in accordance with the applicable off‑label use policies: CP.CPA.09 for commercial lines of business, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid, or unless other evidence of coverage applies.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Providers should refer to the applicable state Medicaid manual for specific coverage requirements and any state‑level deviations from this policy.

The HCPCS codes listed in this policy are provided for informational purposes only. Inclusion or exclusion of any code does not guarantee coverage. Providers must use current professional coding guidance when submitting claims and should not infer coverage solely from the presence or absence of a code in this document.

Coding, Dosing Limits, and Clinical Thresholds

Covered CPT/HCPCS/ICD-10 Codesmixed

N/A	No specific CPT/HCPCS/ICD-10 codes listed in this document part.

HCPCS Codes referencedHCPCS

J2502	Injection,pasireotide long
J3490	Unclassified drugs

Signifor LAR — Acromegaly dosing limits

Maximum dose (Signifor LAR, acromegaly)60 mg every 4 weeks (do not exceed 1 vial every 4 weeks)

Applicable indicationAcromegaly (for patients with inadequate response to surgery or not candidates for surgery)

Prescriber requirementPrescribed by or in consultation with an endocrinologist

Signifor LAR — Cushing's disease dosing option

Signifor LAR dose option (Cushing's disease)40 mg every 4 weeks (do not exceed 1 vial every 4 weeks)

Applicable indicationCushing's disease when pituitary surgery was not curative or patient is not eligible for surgery

Provider Requirements, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for pasireotide (Signifor, Signifor LAR). Providers must submit documentation demonstrating that initial or continued therapy criteria are met, including chart notes, laboratory results (e.g., IGF‑I, GH, oral glucose tolerance test results), and other pertinent clinical information. Requests should indicate diagnosis, prescriber specialty (endocrinologist or consultation documented), dose and formulation, and prior treatments (e.g., pituitary surgery or irradiation) when applicable.

Affected HCPCS: J2502 (Injection, pasireotide long-acting) and J3490 (Unclassified drugs) — inclusion of codes is informational and does not guarantee coverage; verify current coding guidance prior to claim submission.
Submit supporting documentation: chart notes, labs, imaging, operative reports, and prior treatment documentation.
For acromegaly and Cushing's disease, document prior surgical or irradiation status (e.g., pituitary resection attempted and outcome, or documented candidacy contraindicating surgery/irradiation).
Continuation/step notes: to approve ongoing therapy, show positive clinical response per Appendix D or prior meeting of initial approval criteria; dose increases must not exceed policy-specified maximums (e.g., Signifor LAR 60 mg every 4 weeks for acromegaly; Signifor/Signifor LAR dosing limits for Cushing's as listed in policy).

Background on Pasireotide and Indications

Pasireotide (Signifor; Signifor LAR) is a somatostatin analog indicated for the treatment of patients with Cushing's disease when pituitary surgery is not an option or was not curative, and for acromegaly in patients for whom surgery is inadequate or not an option. Clinical response for acromegaly is defined as improvement or normalization of growth hormone (GH) and/or age‑ and sex‑adjusted insulin‑like growth factor‑I (IGF‑I) levels or tumor control; for Cushing's disease response is reduction in 24‑hour urinary free cortisol (UFC) and improvement in signs and symptoms, with most UFC reduction typically observed by two months of treatment. Dosing limits referenced in this policy include a maximum of 60 mg every 4 weeks for Signifor LAR in acromegaly, a Signifor LAR option of 40 mg every 4 weeks for Cushing's disease, and a maximum daily dose of 1.8 mg per day for subcutaneous Signifor in Cushing's disease; product availability and prescribing information are detailed in the manufacturer prescribing information and references.

Definitions and Treatment Response Criteria

Treatment response — Acromegaly

Definition of treatment response (acromegaly)Improvement from baseline or normalization of GH and/or age‑ and sex‑adjusted IGF‑I serum concentrations, or tumor mass control.

Examples of response measuresSerum GH and IGF‑I levels; radiographic tumor size reduction or stabilization

Context for useUsed to determine continued therapy eligibility per policy Appendix D

Treatment response — Cushing's disease

Definition of treatment response (Cushing's disease)Reduction in 24‑hour urinary free cortisol (UFC) levels and/or improvement in signs and symptoms of the disease; maximum UFC reduction typically seen by two months of treatment.

Examples of response measures24‑hour UFC concentration; clinical symptom improvement