CurrentCentenePolicy CP.PHAR.332

Pasireotide (Signifor, Signifor LAR) (PDF)

Defines medical necessity criteria, dosing limits, prior authorization and approval durations for pasireotide (Signifor and Signifor LAR) for acromegaly and Cushing's disease across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyPasireotide (Signifor, Signifor LAR) (PDF)

Policy CodePolicy CP.PHAR.332

Change TypeRevised (diagnostic criteria, durations, coding)

Effective Date03.01.17

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

4Q 2024: revised acromegaly initial GH criterion from '≥ 1 µg/mL' to '≥ 1 µg/L'.

4Q 2022: added confirmatory diagnostic requirements (IGF-I or GH) for acromegaly.

4Q 2025: extended initial approval duration for acromegaly from 6 to 12 months for Medicaid; extended initial approval duration for Cushing's disease from 6 to 12 months for Medicaid and HIM.

4Q 2023: added J3490 code for Signifor.

2Covered Indications

18+References Cited

J2502,J3490HCPCS Codes

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Coverage Summary

Policy stance: Covered with criteria for pasireotide (Signifor, Signifor LAR). Scope: defines medical necessity criteria, dosing limits, prior authorization and approval durations for Signifor and Signifor LAR for FDA-indicated adult Cushing's disease and adult acromegaly (Signifor LAR) when medical necessity criteria are met. Lines of business: Commercial, HIM, and Medicaid. The policy aligns coverage to FDA indications and specialty-society diagnostic and response criteria per the brief.

Initial Therapy 20— Acromegaly (must meet all)

Covered when ALL of the following are met:

ALL of the following

ANY of the following
- Pre-treatment insulin-like growth factor-I (IGF-I) level above the upper limit of normal based on age and gender for the reporting laboratory.
- Serum growth hormone (GH) level ≥ 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 (refer to Appendix D).
ALL of the following
- Lanreotide (Somatuline Depot).
- ALL of the following
  - Generic octreotide acetate LAR (generic Sandostatin LAR Depot), unless octreotide acetate LAR is unavailable due to shortage.
  - If member is unable to use generic octreotide acetate LAR due to shortage: Sandostatin LAR Depot.
ALL of the following
- 60 mg every 4 weeks.
- 1 vial every 4 weeks.

Step Therapy

Step therapy / Documentation

Step therapy and documentation requirements (action required by provider): - Prior authorization may be required for lanreotide, generic octreotide acetate LAR (generic Sandostatin LAR Depot), and Sandostatin LAR Depot. Providers must document trials and failures (or contraindications/intolerances) of the required somatostatin analogs before approval of Signifor LAR for acromegaly, unless the member has clinically significant adverse effects or contraindications to these agents. - For continuation/renewal requests, provider must document positive clinical response to therapy (examples include improvement or normalization of GH and/or age- and sex-adjusted IGF-I serum concentrations, or tumor mass control) per Appendix D.

Prior authorization may be required for lanreotide, octreotide acetate LAR, and Sandostatin LAR Depot.
Document trials and failures (or contraindications/intolerances) of required step agents.
For continuation, document positive response to therapy (improved/normalized GH and/or IGF-I, or tumor mass control).

Initial Therapy — Cushing's Disease (must meet all)

Initial Therapy - Cushing's Disease (must meet all)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of Cushing's disease
Prescriber: Prescribed by or in consultation with an endocrinologist
Age ≥ 18 yearsAge ≥ 18
Surgery status

Other diagnoses / Indications

Other diagnoses/indications

If requested use is not described above or there is a recent label change:

ANY of the following

Recent label change: If this drug has had a recent label change within the last 6 months not reflected in this policy, refer to formulary/no coverage or non-formulary policies per line of business (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)within 6 months
Off-label: If requested use is not specifically listed and the above 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)

Referenced line-of-business policies for label changes: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16. For off-label use references: CP.CPA.09, HIM.PA.154, CP.PMN.53.

Continued Therapy — Acromegaly (must meet all)

Continued Therapy - Acromegaly (must meet all)

Covered when ALL of the following are met:

ALL of the following

Continuity of care
- Currently receiving via Centene: Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- State continuity: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
  Refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B
Product: Request is for Signifor LAR

Continued Therapy — Cushing's Disease (must meet all)

Continued Therapy - Cushing's Disease (must meet all)

Covered when ALL of the following are met:

ALL of the following

Continuity of care
- Currently receiving via Centene: Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- State continuity: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
  Refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B
Response: Member is responding positively to therapy (see Appendix D)

Diagnoses / Indications Not Authorized

Diagnoses/Indications Not Authorized

Not covered when:

Not authorized: Non‑FDA approved indications that are not addressed in this policy are not covered unless sufficient documentation per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents is provided

Applicable Codes

Relevant J-codesHCPCS

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

Billing Rule

Dose exceedance will not meet criteria (J2502, J3490)

Requests exceeding the specified dose limits will not meet criteria. Relevant billing codes include J2502 (pasireotide long acting, 1 mg) and J3490 (unclassified drugs); these codes are referenced for enforcement of dose thresholds.

Enforcement: requests above listed dose thresholds will not meet criteria
Relevant J-codes: J2502 and J3490

Provider Actions / Prior Authorization

Prior Authorization

Documentation submission required for prior authorization

Providers must submit supporting documentation with the prior authorization request, including office chart notes, laboratory results, and other clinical information demonstrating the member meets all approval criteria.

Submit office notes, labs, and other clinical information to show criteria are met

Step Therapy

Acromegaly step therapy requirement

Initial acromegaly therapy requires failure of both lanreotide (Somatuline Depot) and generic octreotide acetate LAR (generic Sandostatin LAR Depot). If generic octreotide acetate LAR is unavailable due to shortage, Sandostatin LAR Depot may be used instead. Exceptions apply for clinically significant adverse effects or contraindications.

Required failures: lanreotide and generic octreotide acetate LAR
If generic is unavailable due to shortage: Sandostatin LAR Depot
Exceptions allowed for adverse effects or contraindications

Clinical Evidence & References

Evidence and guideline sources cited: Signifor and Signifor LAR Prescribing Information, July 2024 and guideline support from the ACG/Endocrine Society and the Pituitary Society which were used to set diagnostic and response criteria.

Background

Background: Pasireotide is a somatostatin analog with FDA approvals for Signifor and Signifor LAR in adults with Cushing's disease when pituitary surgery is not an option or not curative; Signifor LAR is also FDA-approved for acromegaly in patients with inadequate response to or who are not candidates for surgery. The policy is aligned to those FDA indications and to specialty society diagnostic and response criteria for acromegaly and Cushing's disease.

Revision History

4Q 2025duration_extension_and_formulary_updateLatest

Extended initial approval duration: acromegaly initial approval extended from 6 months to 12 months for Medicaid; Cushing's disease initial approval extended from 6 months to 12 months for Medicaid and HIM. Added redirection to lanreotide, generic octreotide acetate LAR (Sandostatin LAR Depot) and brand Sandostatin LAR Depot if generic is unavailable due to shortage; removed Signifor LAR from non-formulary list.

4Q 2024threshold_revision

Revised acromegaly initial GH threshold from '≥ 1 µg/mL' to '≥ 1 µg/L' per Pituitary Society/Endocrine Society practice guidelines and ACG.

Policy Summary

PayerCentene

PolicyPasireotide (Signifor, Signifor LAR) (PDF)

Policy CodePolicy CP.PHAR.332

Change TypeRevised (diagnostic criteria, durations, coding)

Effective Date03.01.17

Next Review Date

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

SourceLink

On This Page

Pituitary surgery was not curative

Not eligible for surgery: Member is not eligible for pituitary surgery

Dose limit

Signifor (SC): Signifor: 1.8 mg per day; 2 ampules per day1.8 mg per day; 2 ampules per day
Signifor LAR: 40 mg every 4 weeks; 1 vial every 4 weeks40 mg every 4 weeks; 1 vial every 4 weeks

Documentation Required

Cushing's - specialist involvement and documentation submission

Prescriptions must be by or in consultation with an endocrinologist. Providers must submit documentation (office chart notes, lab results or other clinical information) supporting that the member meets all approval criteria for initial Cushing's requests.

Specialist involvement: prescribed by or in consultation with an endocrinologist
Documentation required: office notes, labs, and other clinical information to show criteria are met

Response: Member is responding positively to therapy (see Appendix D)

Response definitions in Appendix D: GH/IGF-I improvement or tumor control

Dose increase limit: If request is for a dose increase, new dose does not exceed: 60 mg every 4 weeks; 1 vial every 4 weeks60 mg every 4 weeks; 1 vial every 4 weeks

Documentation Required

Continued therapy response and dose limits (acromegaly)

For continued therapy requests, providers must document a positive clinical response (see Appendix D) — e.g., GH/IGF-I improvement or tumor control for acromegaly. Dose increases are subject to dose limits; new doses must not exceed 60 mg every 4 weeks or 1 vial every 4 weeks for Signifor LAR in acromegaly.

Continued therapy: documentation of positive response required (GH/IGF-I improvement or tumor control)
Dose limit for acromegaly Signifor LAR: 60 mg every 4 weeks (1 vial every 4 weeks)
Dose increases must not exceed the listed thresholds

Appendix D: UFC reduction or improvement in signs/symptoms for Cushing's

Dose increase limit

Signifor (SC): Signifor: 1.8 mg per day; 2 ampules per day1.8 mg per day; 2 ampules per day
Signifor LAR: 40 mg every 4 weeks; 1 vial every 4 weeks40 mg every 4 weeks; 1 vial every 4 weeks

Documentation Required

Continued therapy response and dose limits (Cushing's)

For continued therapy in Cushing's disease, providers must document positive response such as reduction in 24-hour urinary free cortisol (UFC) and/or improvement in signs or symptoms. Dose increases are limited; for Signifor the maximum is 1.8 mg per day (2 ampules per day) and for Signifor LAR the maximum is 40 mg every 4 weeks (1 vial every 4 weeks).

Response metrics: UFC reduction and/or clinical improvement in signs/symptoms
Signifor dose limit (Cushing's): 1.8 mg per day (2 ampules per day)
Signifor LAR dose limit (Cushing's): 40 mg every 4 weeks (1 vial every 4 weeks)

Documentation Required

Specialist involvement required

Prescriptions for both acromegaly and Cushing's disease must be written by or in consultation with an endocrinologist per the policy requirements.

Prescriber requirement: by or in consultation with an endocrinologist

Billing Rule

Dose limits enforced — product and indication thresholds

Dose limits are enforced and vary by product and indication. Specified thresholds include: acromegaly Signifor LAR — 60 mg every 4 weeks (1 vial every 4 weeks); Cushing's Signifor — 1.8 mg per day (2 ampules per day); Cushing's Signifor LAR — 40 mg every 4 weeks (1 vial every 4 weeks). Requests exceeding these thresholds will not meet criteria.

Acromegaly Signifor LAR limit: 60 mg every 4 weeks (1 vial every 4 weeks)
Cushing's Signifor limit: 1.8 mg/day (2 ampules/day)
Cushing's Signifor LAR limit: 40 mg every 4 weeks (1 vial every 4 weeks)

Continuity of care: continued therapy criteria include an allowance for members who are currently receiving medication via the Centene benefit or who previously met initial approval criteria, and for members enrolled in states/products with continuity of care regulations. State-specific addendums referenced for continuity of care are CC.PHARM.03A and CC.PHARM.03B.

4Q 2023coding_update

Added HCPCS code J3490 (Unclassified drugs) for Signifor; references reviewed and updated.

4Q 2022diagnostic_requirement_added

Added confirmatory diagnostic requirements for acromegaly (pre-treatment IGF-I or GH) per Pituitary Society/Endocrine Society practice guidelines; template changes applied to other sections.