CurrentmhnPolicy CP.PHAR.332

Clinical Policy: Pasireotide (Signifor, Signifor LAR)

Defines medical necessity, authorization criteria, dosing limits, and approval durations for pasireotide (Signifor and Signifor LAR) for treating Cushing's disease and acromegaly for covered lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Pasireotide (Signifor, Signifor LAR)

Policy CodePolicy CP.PHAR.332

Change TypeNo material change

Effective DateMar 1, 2017

Next Review DateN/A

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA‑approved indications covered

60 mgMax LAR dose (acromegaly)

1.8 mg/dayMax SC dose (Cushing's)

12 monthsTypical Medicaid approval

J2502, J3490HCPCS codes referenced

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Initial Therapy — Acromegaly

Covered when ALL of the following are met

Acromegaly initial therapy criteria: Member has diagnosis of acromegaly evidenced by one of the following: (a) pre-treatment IGF-I above the laboratory upper limit of normal for age and gender, OR (b) serum 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 surgical resection or pituitary irradiation or member is not a candidate for such treatment; failure of both lanreotide (Somatuline Depot) and octreotide acetate LAR (generic Sandostatin LAR Depot) — or Sandostatin LAR Depot if generic octreotide LAR is unavailable — unless clinically significant adverse effects or contraindications; dose does not exceed 60 mg every 4 weeks (1 vial).

Initial Therapy — Cushing's Disease

Covered when ALL of the following are met

Cushing's disease initial therapy criteria: Member has 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; dose does not exceed one of the following: (a) Signifor SC initial regimen 0.6–0.9 mg twice daily up to 1.8 mg/day (≤ 2 ampules/day), OR (b) Signifor LAR 10–40 mg IM every 4 weeks (maximum 40 mg/4 weeks, 1 vial).

Continued Therapy — Acromegaly

Covered when ALL of the following are met

Acromegaly continuation criteria: Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria, OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; request is for Signifor LAR; member is responding positively to therapy (examples include improvement or normalization of GH and/or age- and sex-adjusted IGF-I or tumor control); if request is for a dose increase, new dose does not exceed 60 mg every 4 weeks (1 vial).

Continued Therapy — Cushing's Disease

Covered when ALL of the following are met

Cushing's disease continuation criteria: Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria, OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; member is responding positively to therapy (e.g., reduction in 24-hour urinary free cortisol and/or improvement in signs or symptoms); if request is for a dose increase, new dose does not exceed one of the following: (a) Signifor up to 1.8 mg/day (≤ 2 ampules/day), OR (b) Signifor LAR up to 40 mg every 4 weeks (1 vial).

Coverage does not extend to non‑FDA approved indications that are not specifically addressed in this policy unless the request includes sufficient documentation of efficacy and safety per the applicable off‑label use policies. For commercial lines of business, refer to CP.CPA.09; for the Health Insurance Marketplace, refer to HIM.PA.154; and for Medicaid, refer to CP.PMN.53 when submitting supporting clinical evidence for an off‑label indication.

Signifor LAR was previously listed on a non‑formulary list but has been removed. When Signifor LAR is not on the formulary for the applicable line of business, requests should follow the Health Insurance Marketplace formulary exception process where applicable: HIM.PA.103.

Requests for use of pasireotide (Signifor or Signifor LAR) for indications not approved by the FDA and not covered in this policy must include clinical documentation demonstrating efficacy and safety consistent with the plan’s off‑label use policies. Follow the referenced off‑label policies (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) when preparing justification to avoid denial as not authorized or not medically necessary.

Prior Authorization, Step Therapy, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Signifor LAR. Approval duration varies by line of business: Medicaid — 12 months; HIM — refer to HIM.PA.103 for Signifor LAR; Commercial — 6 months or to the member's renewal date, whichever is longer. Prior authorization may also be required for lanreotide, octreotide acetate LAR, and Sandostatin LAR Depot.

Approval durations: Medicaid = 12 months; Commercial = 6 months or to member renewal date, whichever is longer; HIM = refer to HIM.PA.103
Prior authorization may be required for J2502 (pasireotide long acting) and related agents such as lanreotide and octreotide LAR

Billing Rule

J‑Codes and Billing

Use the following HCPCS/J‑code guidance when submitting claims: J2502 describes pasireotide long acting (1 mg). Unclassified drug code J3490 may be used when appropriate. Inclusion or exclusion of codes in this policy does not guarantee coverage.

J2502 — Injection, pasireotide long acting, 1 mg
J3490 — Unclassified drugs
Providers should verify the correct J‑code and billing guidance prior to claim submission

Denial Risk

Off‑label / Non‑FDA Indications

Coverage does not extend to non‑FDA approved indications unless sufficient supporting documentation for the off‑label use is provided per the applicable off‑label policies: CP.CPA.09 (Commercial), HIM.PA.154 (HIM), and CP.PMN.53 (Medicaid) or as allowed in the member's evidence of coverage.

Non‑FDA indications require documentation of efficacy and safety per off‑label policies
Absent sufficient off‑label documentation, requests for non‑FDA uses may be denied

Documentation Required

Coding Implication — Verify Before Submission

Codes referenced in this policy are for informational purposes only. Inclusion or exclusion of any code does not guarantee coverage. Improper or outdated coding may result in claim denial. Providers must reference the most up‑to‑date professional coding guidance prior to submitting claims for reimbursement.

Coding implication: inclusion/exclusion of codes in policy does not guarantee coverage; incorrect coding may lead to denial
Providers should confirm current coding and billing guidance before claim submission

Documentation Required

Required Clinical Documentation

Providers must submit clinical documentation supporting that the member meets all approval criteria. Acceptable documentation includes office chart notes, relevant laboratory results (e.g., IGF‑I, GH, oral glucose tolerance test results), surgical/radiation history, and documentation of prior therapies and responses.

Examples of required documentation: office chart notes, lab results (IGF‑I, GH), ORT results, surgical/pathology reports, prior therapy records
Documentation must demonstrate failure or intolerance of required prior therapies when step therapy applies

Step Therapy

Step Therapy Requirement for Acromegaly

Step therapy applies for acromegaly: members must have failed both (a) lanreotide (Somatuline Depot) and (b) generic octreotide acetate LAR (generic Sandostatin LAR Depot). If generic octreotide acetate LAR is unavailable due to shortage, Sandostatin LAR Depot may be required. Exceptions apply when contraindications or clinically significant adverse effects prevent use. For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395.

Required trial failures for acromegaly: lanreotide AND generic octreotide acetate LAR (or Sandostatin LAR Depot if generic is unavailable due to shortage)
Illinois HIM: step therapy waived for HIM as of 1/1/2026 (IL HB 5395)

Note

Therapeutic Redirection During Shortages

During drug shortages or unavailability of a required agent, therapeutic redirection to alternative somatostatin analogs is permitted per this policy and formulary guidance. Acceptable alternatives include lanreotide, generic octreotide acetate LAR (generic Sandostatin LAR Depot), and brand Sandostatin LAR Depot when the generic is unavailable. Providers should document shortage-based rationale and prior attempts to obtain the unavailable product.

Permitted redirections during shortages: lanreotide; octreotide acetate LAR (generic Sandostatin LAR Depot); Sandostatin LAR Depot when generic is unavailable
Document the shortage and reason for therapeutic redirection when submitting PA requests

Definitions and Reference Terms

insulin-like growth factor I (IGF-I)

DefinitionInsulin-like growth factor I (IGF-I): a serum marker used to assess acromegaly activity; pre-treatment IGF-I above the laboratory upper limit of normal for age and sex supports diagnosis.

Clinical useTreatment response assessment: improvement or normalization of age‑ and sex‑adjusted IGF‑I concentrations indicates positive response to acromegaly therapy.

Diagnostic roleAn elevated pre-treatment IGF‑I level is one of the diagnostic criteria for acromegaly per policy requirements.

growth hormone (GH)

DefinitionGrowth hormone (GH): pituitary hormone measured for diagnosis and monitoring of acromegaly; a serum GH ≥ 1 µg/L after a 2‑hour oral glucose tolerance test meets the policy diagnostic threshold.

Clinical useGH reduction or normalization is an example of treatment response to acromegaly therapy (including somatostatin analogs).

Diagnostic roleA GH ≥ 1 µg/L after a 2‑hour oral glucose tolerance test is accepted as diagnostic evidence of acromegaly in the policy.

Signifor — prescribing information reference

Prescribing information (Signifor)Signifor Prescribing Information. Novartis Pharmaceuticals Corporation; July 2024. URL: https://www.signifor.com/pdf/signifor-pi.pdf (accessed July 10, 2025).

Indications referencedSignifor indicated for treatment of Cushing's disease (adult patients) as cited in the referenced prescribing information.

Source citationPolicy references Signifor prescribing information in the policy reference list (VII. References).

Signifor LAR — prescribing information reference

Prescribing information (Signifor LAR)Signifor LAR Prescribing Information. Novartis Pharmaceuticals Corporation; July 2024. URL: https://signiforlar.com/.../signifor-lar-pi.pdf (accessed July 10, 2025).

Indications referencedSignifor LAR indicated for treatment of acromegaly in patients not controlled by or not candidates for surgery, per the referenced prescribing information.

Source citationPolicy references Signifor LAR prescribing information in the policy reference list (VII. References).

OpenPayer

Clinical Policy: Pasireotide (Signifor, Signifor LAR)

Coverage Criteria for Pasireotide (Signifor, Signifor LAR)

Coding, Codes and Dose Limits

Prior Authorization, Step Therapy, and Provider Requirements

Background

Definitions and Reference Terms