ModifiedmhnPolicy CP.PHAR.332

Pasireotide (Signifor, Signifor LAR) clinical policy — medical necessity and coverage criteria

Defines medical necessity, initial and continued coverage criteria, dosing limits, and administration requirements for Signifor and Signifor LAR for Cushing's disease and acromegaly for Centene-affiliated lines of business.

Policy Summary

Payermhn

PolicyPasireotide (Signifor, Signifor LAR) clinical policy

Policy CodePolicy CP.PHAR.332

Change TypeRevised clinical thresholds and approval durationscoding update

Effective Date03.01.17

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating the member meets initial or continued criteria (diagnosis, prescriber specialty, age, prior surgery response or ineligibility, dosing within limits, and treatment response).

SourceLink

POLICY UPDATE CHANGES

For acromegaly, the initial GH threshold was revised from '≥ 1 µg/mL' to '≥ 1 µg/L' per practice guidelines and ACG.

Initial approval duration for acromegaly and Cushing's disease was extended from 6 months to 12 months for certain programs (Medicaid; Cushing's for Medicaid and HIM).

J3490 (unclassified drugs) code was added for Signifor billing.

2FDA-indicated conditions covered

60 mg/4wMax LAR dose (acromegaly)

1.8 mg/dayMax SC dose (Cushing's)

J2502, J3490

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Coverage and Medical Necessity Criteria

Initial Therapy — Acromegaly

Covered when ALL of the following are met:

Acromegaly initial: 1) Diagnosis of acromegaly evidenced by one of the following: (a) pre-treatment IGF-I above the laboratory age- and gender-specific upper limit of normal; OR (b) serum GH ≥ 1 µg/L after a 2-hour oral glucose tolerance test; 2) Request is for Signifor LAR; 3) Prescribed by or in consultation with an endocrinologist; 4) Age ≥ 18 years; 5) Inadequate response to surgical resection or pituitary irradiation, or member is not a candidate for such treatment; 6) Dose does not exceed 60 mg every 4 weeks (1 vial every 4 weeks).see node text

Approval duration varies by line of business

Initial Therapy — Cushing's disease

Covered when ALL of the following are met:

Cushing's initial: 1) Diagnosis of Cushing's disease; 2) Prescribed by or in consultation with an endocrinologist; 3) Age ≥ 18 years; 4) Pituitary surgery was not curative or member is not eligible for pituitary surgery; 5) Dose does not exceed either: (a) Signifor 1.8 mg per day (up to 2 ampules per day), OR (b) Signifor LAR 40 mg every 4 weeks (1 vial every 4 weeks).see node text

Approval duration varies by line of business

Continued Therapy — Acromegaly

Covered when ALL of the following are met:

Acromegaly continued: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria, or continuity of care applies; 2) Request is for Signifor LAR; 3) Member is responding positively to therapy; 4) If request is for a dose increase, the new dose does not exceed 60 mg every 4 weeks (1 vial every 4 weeks).see node text

Approval duration varies by line of business

Continued Therapy — Cushing's disease

Covered when ALL of the following are met:

Cushing's continued: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria, or continuity of care applies; 2) Member is responding positively to therapy; 3) If request is for a dose increase, the new dose does not exceed either: (a) Signifor 1.8 mg per day (up to 2 ampules per day), OR (b) Signifor LAR 40 mg every 4 weeks (1 vial every 4 weeks).see node text

Approval duration varies by line of business

Other indications / Off‑label pathways

Covered when ONE of the following is met:

Other uses: 1) If the drug has had a recent label change (within the last 6 months) not yet reflected in this policy, follow the referenced formulary or non‑formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable); OR 2) If the requested use is not listed under the policy's disallowed indications and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).see node text

References to applicable line‑of‑business policies are required

Selected Revised Criteria and Authorization Durations

Select clinical criteria and authorization durations identified in revision history:

GH threshold for acromegaly: GH level ≥ 1 µg/L as specified by PS/ES practice guidelines and ACG (unit correction recorded in 4Q 2024 review).>= 1 µg/L

Unit correction made in 4Q 2024 review

Initial approval duration (program‑specific): Initial approval duration extended from 6 months to 12 months for Medicaid (acromegaly) and extended from 6 months to 12 months for Medicaid and HIM (Cushing's disease) as recorded in the 4Q 2025 review.12 months for Medicaid (acromegaly); 12 months for Medicaid and HIM (Cushing's disease)

Change recorded in 4Q 2025 review

Requests for use of pasireotide (Signifor or Signifor LAR) for non‑FDA approved indications that are not specifically addressed in this policy will be excluded from coverage unless the provider submits sufficient documentation of efficacy and safety per applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for marketplace, or CP.PMN.53 for Medicaid) or the member’s evidence of coverage supports the indication.

The HCPCS and other billing codes listed in this policy are provided for information only. Inclusion or exclusion of any code does not guarantee coverage. Providers must consult current professional coding guidance and payer billing rules prior to claim submission; the policy notes HCPCS codes including J2502 (injection, pasireotide long acting, 1 mg) and J3490 (unclassified drugs) as referenced examples.

Use of pasireotide for off‑label or non‑FDA indications without adequate supporting documentation of clinical efficacy and safety as required by the applicable off‑label policies is considered not authorized.

The codes shown in this policy are informational only and do not, by themselves, establish whether a particular use is medically necessary or not authorized.

Product Codes, HCPCS, and Dose Limits

Product availability / NDCs (not specified)NDC

NDC not listed

Product availabilities: Signifor single-dose ampules 0.3 mg/mL, 0.6 mg/mL, 0.9 mg/mL; Signifor LAR vials 10 mg, 20 mg, 30 mg, 40 mg, 60 mg

HCPCS Codes referencedHCPCS

J2502	Injection, pasireotide long acting, 1 mg.
J3490	Unclassified drugs

Dose limits — Pasireotide (Signifor / Signifor LAR)

Signifor LAR — AcromegalyMaximum 60 mg every 4 weeks (1 vial)

Signifor LAR — Cushing's diseaseMaximum 40 mg every 4 weeks (1 vial)

Signifor (SC) — Cushing's diseaseMaximum 1.8 mg per day (up to 2 ampules/day)

GH diagnostic threshold

GH diagnostic threshold for acromegaly>= 1 µg/L (serum GH after 2-hour OGTT)

Supporting diagnostic optionPre-treatment IGF-I above age- and sex-adjusted lab ULN can also evidence diagnosis

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit clinical documentation demonstrating that the member meets the applicable initial or continued therapy criteria prior to approval.

Prior authorization required with documentation that initial or continued criteria are met

Documentation Required

Required Documentation

Provider must submit supporting documentation such as office chart notes, relevant laboratory results (including IGF‑I and/or GH with units noted), operative reports or consultation notes demonstrating inadequate response to or ineligibility for surgery, and any other clinical information needed to show the member meets all approval criteria.

Office notes, lab results, operative reports, consultation notes
Document lab units for GH (µg/L) and IGF‑I with lab reference ranges

Clinical Response Definitions and Prescribing References

Treatment response — Cushing's disease

Primary measure of responseReduction in 24-hour urinary free cortisol (UFC) levels

Clinical responseImprovement in signs and symptoms of Cushing's disease

Timing of maximal UFC reductionMaximum UFC reduction typically seen by two months of treatment

Treatment response — Acromegaly

Biochemical responseImprovement or normalization of GH and/or age- and sex-adjusted IGF-I serum concentrations

Tumor responseReduction or control of pituitary tumor mass

Evidence sources

Clinical Background

Pasireotide is a somatostatin analog available in short‑acting and long‑acting formulations (Signifor and Signifor LAR) and is indicated for treatment of certain patients with Cushing’s disease and, for the LAR formulation, acromegaly. Providers seeking coverage must meet the policy’s specified diagnostic and clinical criteria and follow coding guidance when requesting prior authorization; non‑FDA uses require additional off‑label documentation per the referenced policies.

Policy Changes and Material Revisions

2024-07-15unit_correction

GH diagnostic threshold for acromegaly corrected from '≥ 1 µg/mL' to '≥ 1 µg/L' per PS/ES practice guidelines and ACG during 4Q 2024 annual review.

2025-07-10authorization_duration_changeLatest

Initial approval duration extended from 6 months to 12 months for Medicaid (acromegaly) and for Medicaid and HIM (Cushing's disease) during 4Q 2025 annual review.