CurrentCignaPolicy IP0165

Somatostatin Analogs - Signifor LAR - (IP0165)

Cigna coverage policy for Signifor LAR (pasireotide) prescribing, prior authorization, dosing, FDA-approved and supportive-evidence uses (acromegaly, Cushing's disease, endogenous Cushing's syndrome), and coding/billing guidance for HCPCS J2502.

Policy Summary

PayerCigna

PolicySomatostatin Analogs - Signifor LAR - (IP0165)

Policy CodePolicy IP0165

Change TypeCoverage and criteria revisions (material and administrative)

Effective DateMay 1, 2026

Next Review Date

Key ActionPrior authorization is required; obtain specialist (endocrinologist) consultation and document baseline IGF-1 and adherence to dosing limits and indication-specific approval durations.

SourceLink

POLICY UPDATE CHANGES

Updated coverage policy title from Pasireotide Long-Acting to Somatostatin Analogs - Signifor LAR.

Endogenous Cushing's Syndrome: Updated initial authorization duration from 4 months to 1 year; condition and criteria added under Other Uses with Supportive Evidence.

Endogenous Cushing's Syndrome - Patient Awaiting Surgery and Patient Awaiting Therapeutic Response After Radiotherapy removed as separate conditions and are now addressed under Endogenous Cushing's Syndrome.

Cushing's Disease: Added 'Patient is Currently Receiving Signifor/Signifor LAR' continuation criteria and continuation approval for 1 year if responding to therapy as determined by prescriber.

Employer Plans: For acromegaly, patient must have tried ONE of octreotide ER injectable suspension (Sandostatin LAR Depot, generic), Somatuline Depot, or lanreotide subcutaneous injection; Cipla lanreotide preferred mapping noted as J1930, NDC 69097-0906-67.

Multiple administrative effective/review date updates and preferred product table updates recorded (effective dates 8/1/2024, 7/15/2025, 4/1/2026; review dates include 5/8/2025, 2/5/2026, 5/23/2024).

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Coverage Summary

Coverage stance: covered_with_criteria for Signifor LAR (pasireotide long-acting injection). Scope: Cigna coverage policy for Signifor LAR including prior authorization, specialist prescribing requirement, dosing limits, FDA-approved indications and a selected supportive-evidence use, and coding/billing guidance for HCPCS J2502.

Covered indications: Acromegaly (patients with inadequate response to surgery or not surgical candidates, with required pre-treatment IGF-1 above the laboratory upper limit of normal, prescribed by or in consultation with an endocrinologist, and meeting preferred-product criteria); Cushing's disease (patients not candidates for surgery or with persistent disease — initial therapy may be authorized for a limited duration and continuation for responders); and Endogenous Cushing's syndrome as an other-use with supportive evidence (adult patients not surgical candidates, awaiting surgery, or awaiting radiotherapy response, prescribed by or in consultation with an endocrinologist).

Authorization durations and dates: approvals provided per indication (e.g., Acromegaly and Endogenous Cushing's Syndrome for 1 year; Cushing's disease initial authorization noted as limited with continuation approvals for 1 year when responding per prescriber). Policy effective date: 2026-05-01; last review: 2026-05-23.

Acromegaly — Initial Therapy Criteria

Acromegaly - FDA-Approved Indication

Approve for 1 year if the patient meets ALL of the following (A, B, C and D):

ALL of the following

A) Patient meets ONE of the following
- Patient has had an inadequate response to surgery and/or radiotherapy
- Patient is NOT an appropriate candidate for surgery and/or radiotherapy
- Patient is experiencing negative effects due to tumor size (e.g., optic nerve compression)
B) Pre-treatment IGF-1: Patient has (or had) a pre-treatment (baseline) insulin-like growth factor-1 (IGF-1) level above the upper limit of normal based on age and gender for the reporting laboratoryAbove the upper limit of normal based on age and gender for the reporting laboratory
Pre-treatment refers to the IGF-1 level prior to the initiation of any somatostatin analog (e.g., Mycapssa, octreotide injection products, Signifor LAR, Somatuline Depot, dopamine agonists, Somavert).

Acromegaly - Employer Plans additional requirement

Employer plan variant

For diagnosis of Acromegaly, patient has tried ONE of octreotide ER injectable suspension (Sandostatin LAR Depot, generic), Somatuline Depot or lanreotide subcutaneous injection

May require prior authorization; if requesting a Cipla lanreotide product, preferred product mapping: J1930, NDC 69097-0906-67.

Cushing's Disease — Initial and Continuation Criteria

Other Uses with Supportive Evidence — Endogenous Cushing's Syndrome

Dosing Limits

Billing Rule

Dose frequency limits

Adhere to dosing maximums for J2502: do not exceed 60 mg IM every 28 days for acromegaly; do not exceed 40 mg IM every 28 days for Cushing's disease or endogenous Cushing's syndrome.

Affected code: J2502
Acromegaly limit: 60 mg per 28 days
Cushing's disease / Endogenous Cushing's syndrome limit: 40 mg per 28 days

Exclusions / Not Medically Necessary

Conditions not covered

Signifor LAR for any other use is considered not medically necessary

Applicable Codes

Covered HCPCSHCPCSCovered

J2502

Injection, pasireotide long acting, 1 mg

Preferred product mapping (employer note)mixed

J1930	Not otherwise classified oncology drug -- referenced as preferred product mapping for Cipla lanreotide NDC 69097-0906-67
NDC	69097-0906-67 (Cipla lanreotide product preferred mapping)

Provider Actions & Billing Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for coverage of Signifor (J2502). Approvals are provided for the durations specified per indication: 1 year for acromegaly; for Cushing's disease, 4 months initial therapy and 1 year for continuation if the patient is currently receiving Signifor and responding; 1 year for endogenous Cushing's syndrome when criteria are met.

Code: J2502

Documentation Required

Specialist prescribing requirement

Signifor must be prescribed by or in consultation with an endocrinologist or a physician who specializes in the treated condition (acromegaly, Cushing's disease, or Cushing's syndrome).

Documentation Required

Clinical Evidence & References

Evidence sources include the prescribing information (Recordati Rare Diseases; July 2024) and multiple clinical guidance documents: Endocrine Society Cushing's syndrome guideline (2015), Cushing's disease guideline update (2021), and the Acromegaly Consensus Statement (2025), among other cited updates and consensus documents.

Guidelines summarized in the policy: the Endocrine Society and Cushing's disease guidance frame medical therapies as second-line after surgery for Cushing's disease; the 2025 Acromegaly Consensus reiterates somatostatin analogs as first-line medical therapy for most patients with persistent or non-surgically managed acromegaly and notes specific positions on agents.

Safety and comparative positioning: the policy cites that Signifor LAR provides greater efficacy in some inadequately controlled patients but carries a higher risk of hyperglycemia compared with other somatostatin analogs; guideline documents position Signifor LAR as a second-line option in some contexts because of this hyperglycemia risk and recommend individualized therapy selection.

Background

Signifor LAR (pasireotide long-acting intramuscular injection) is a somatostatin analog indicated for acromegaly in patients with inadequate response to surgery or who are not surgical candidates and for Cushing's disease when pituitary surgery is not an option or not curative.

Compared with other somatostatin analogs, Signifor LAR can provide greater efficacy in some inadequately controlled patients but is associated with a distinct safety profile, notably a higher risk of hyperglycemia relative to octreotide or lanreotide.

Clinical guidance places somatostatin analogs as first-line medical therapy for acromegaly in most patients with persistent or non-surgically managed disease; however, because of the increased hyperglycemia risk, Signifor LAR is often positioned as a second-line option for some patients, with individualized selection and consideration of combination therapy for partial responders.

For acromegaly under employer-plan variants, a prior trial of one injectable somatostatin analog (octreotide LAR, Somatuline Depot, or lanreotide) is required before Signifor LAR may be authorized.

Pre-treatment (baseline) IGF-1 definition and threshold

DefinitionPre-treatment (baseline) IGF-1: IGF-1 level measured prior to initiation of any somatostatin analog therapy; reference ranges vary by laboratory and by age/gender.

Threshold

Revision History

2024-05-23administrative_review

Policy title updated from 'Pasireotide Long-Acting' to 'Somatostatin Analogs - Signifor LAR'; Endogenous Cushing's Syndrome condition and criteria added under Other Uses with Supportive Evidence; awaiting-surgery and awaiting-therapeutic-response conditions consolidated under Endogenous Cushing's Syndrome; initial authorization duration for Endogenous Cushing's Syndrome updated from 4 months to 1 year; 'Patient is Currently Receiving Signifor/Signifor LAR' continuation criteria added for Cushing's disease.

2024-08-01administrative_effective

Administrative effective date recorded (no criteria changes).

2025-04-16