ModifiedHealth NetPolicy N/A

Pegvisomant (Somavert) — Coverage Criteria

Defines medical necessity criteria, prior authorization expectations, dosing limits, and coverage duration for pegvisomant (Somavert) for members with acromegaly across Health Net/Centene lines of business.

Policy Summary

PayerHealth Net

PolicyPegvisomant (Somavert) — Coverage Criteria

Policy CodePolicy N/A

Change TypeDiagnostic threshold and coding updates

Effective Date12.01.18

Next Review Date

Key ActionSubmit prior authorization with documentation (office notes, labs) showing member meets all approval criteria, including serum GH ≥ 1 µg/L after a 2-hour oral glucose tolerance test or elevated IGF‑I.

SourceLink

POLICY UPDATE CHANGES

For acromegaly, revised initial criteria to specify serum GH level ≥ 1 µg/L per PS/ES practice guidelines and ACG.

Removed inactive HCPCS code C9399 and updated J3590 HCPCS code description to 'unclassified biologics'.

30 mg/daymaximum maintenance dose

40 mgrecommended loading dose

6 monthsinitial approval duration (Medicaid/HIM)

J3590HCPCS code referenced

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HCPCS description updated

Coverage Criteria for Pegvisomant (Somavert)

Initial Approval Criteria

Covered when ALL of the following are met:

Initial acromegaly criteria

ALL of the following
- ONE of: Pre-treatment IGF-I level above the upper limit of normal based on age and gender for the reporting laboratory.
- ONE of: Serum growth hormone (GH) level >= 1 μg/L after a 2-hour oral glucose tolerance test.
Prescribed by or in consultation with an endocrinologist.
Inadequate response to surgical resection or pituitary irradiation, or patient is not a candidate for such treatment.
Patient is age 18 years or older.
Failure of a somatostatin analog at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced.
ALL of the following
- Loading dose: 40 mg once (administered subcutaneously under healthcare provider supervision).
- Maintenance dose: 30 mg per day.

Administrative

Prior authorization is required as indicated by plan billing/coding guidance (see coding section).
Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

Continued Therapy

Continued therapy is covered when:

Continuation criteria

Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria.
Member is responding positively to therapy, demonstrated by improvement or normalization of GH and/or age- and sex-adjusted IGF-I or tumor mass control.
If the request is for a dose increase, the new dose does not exceed 30 mg per day.
Approval duration: Medicaid/HIM: 12 months; Commercial: 6 months or to the member's renewal date, whichever is longer.

Monitoring and documentation

Non‑FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or unless coverage is established in other evidence of coverage documents.

This clinical policy does not supersede or modify state Medicaid coverage provisions. If any conflict exists between this policy and state Medicaid requirements, the state Medicaid provisions take precedence and govern coverage and claims adjudication.

Requests for use of pegvisomant for indications that are not FDA‑approved and are not covered by this policy will be considered not authorized unless the request includes adequate supporting documentation per the Health Plan off‑label use policies. Providers should submit office notes, laboratory results, and any other clinical evidence needed to demonstrate efficacy and safety per the off‑label requirements; absence of such documentation may result in denial.

Coding and Diagnostic Thresholds

HCPCS Codes referencedHCPCS

J3590

Unclassified biologicals

Updated HCPCS descriptionHCPCS

J3590

unclassified biologics

inv-08: Serum GH after oral glucose tolerance test threshold — diagnostic threshold value

Diagnostic thresholdSerum GH >= 1 µg/L measured after a 2-hour oral glucose tolerance test

Context in criteriaOne of two diagnostic evidences required for acromegaly (other is pre-treatment IGF‑I above lab-specific ULN)

Source guidance updateThreshold revised in 4Q 2024 annual review per PS/ES practice guidelines and ACG

inv-09: P&T Approval Date placeholder referenced in coding section

P&T approval date statusReferenced in coding section but not specified in the document content

Related coding note

Provider Responsibilities, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for pegvisomant (Somavert). Submit a prior authorization request before dispensing or administration.

Prior authorization required for pegvisomant (Somavert).
Reference HCPCS code: J3590.

Billing Rule

Billing / HCPCS Coding Update

HCPCS coding guidance: use J3590 (description updated to 'Unclassified biologics') when submitting claims for pegvisomant when no specific HCPCS code applies. Verify current coding guidance prior to claim submission.

HCPCS J3590 — description updated to 'Unclassified biologics'.

Background on Pegvisomant and Clinical Context

Pegvisomant (Somavert) is a growth hormone receptor antagonist indicated for the treatment of acromegaly when surgery or radiotherapy are inadequate or inappropriate, with the therapeutic goal of normalizing serum IGF‑I. Somatostatin receptor ligands (e.g., octreotide, lanreotide) are commonly used as first‑line medical therapy; pegvisomant is generally reserved for patients who have not achieved biochemical control with maximally indicated SRL therapy or who cannot tolerate or are contraindicated for SRLs. Dosing guidance in this policy includes a single loading dose up to 40 mg and a maximum maintenance dose of 30 mg per day.

Definitions and Abbreviations

inv-19: Somavert (pegvisomant) definition — growth hormone receptor antagonist indication summary

DefinitionSomavert (pegvisomant) is a growth hormone receptor antagonist indicated for treatment of acromegaly in patients with inadequate response to surgery or radiation or when those therapies are not appropriate

Treatment goalNormalization of serum insulin‑like growth factor‑I (IGF‑I) levels

Place in therapyGenerally used when surgery/radiation are inadequate or inappropriate; considered when patients fail somatostatin analogs at maximally indicated doses unless contraindicated

inv-20: SRL definition — somatostatin receptor ligand examples

DefinitionSRL (somatostatin receptor ligand): a class of medications used as first‑line medical therapy for acromegaly

Examples

Policy Summary

PayerHealth Net

PolicyPegvisomant (Somavert) — Coverage Criteria

Policy CodePolicy N/A

Change TypeDiagnostic threshold and coding updates

Effective Date12.01.18

Next Review Date

SourceLink

On This Page

Ongoing documentation required: submit relevant clinic notes and laboratory results showing biochemical response (GH and/or IGF-I) and clinical status.

Providers should follow applicable continuity-of-care regulations for members enrolled in states/products with such provisions.

Dose limits reminder

Maintenance dose should not exceed 30 mg per day; loading dose limited to a single 40 mg subcutaneous administration under provider supervision.

Prior authorization and coding

Prior authorization remains required for continuation as per plan policy; follow HCPCS coding guidance for billing.

Requests lacking documentation that the member has met continuation criteria may be denied.

Operational note

Coding section entries list P&T Approval Date fields in revision history but the latest P&T Approval Date value is not provided in the coding block

Revision history entriesMultiple P&T Approval Date entries appear in the coding implications history (e.g., 11.20, 11.21, 11.22, 11.23) but the coding section P&T Approval Date field is blank

Codes are provided for informational purposes and inclusion does not guarantee coverage.

Step Therapy

Step Therapy Requirement

Step therapy applies: pegvisomant is generally second-line. Members must have failed, had contraindication to, or experienced clinically significant adverse effects from somatostatin receptor ligands (SRLs) such as octreotide LAR or lanreotide, unless contraindicated.

Failure of an SRL at maximally indicated doses is required unless contraindicated.
Pegvisomant is typically used when biochemical control is not achieved with SRL therapy.

Documentation Required

Required Documentation to Support PA

Providers must submit supporting clinical documentation with the authorization request. Acceptable documentation includes office chart notes, lab results (IGF‑I and GH including oral glucose tolerance test results), operative and pathology reports, consultation notes, and evidence of prior SRL therapy or contraindication.

Office chart notes and consultation notes.
Laboratory results showing pre‑treatment IGF‑I above the lab upper limit of normal and GH ≥ 1 µg/L after a 2‑hour oral glucose tolerance test, when applicable.
Documentation of SRL trial (doses and response) or documentation of contraindication/adverse effects.
Operative, pathology, or radiation therapy records if applicable.

Note

Provider Responsibilities and Coverage Context

Coverage determinations are based on this clinical policy and applicable benefit contracts. This policy is not a guarantee of payment; coverage is subject to all terms, conditions, exclusions, and limitations of the member's evidence of coverage or contract. Providers must exercise professional judgment in patient care; the policy is not intended to dictate treatment.

This clinical policy does not guarantee payment — refer to the member's coverage documents for benefits and limitations.
Providers are independent and must use professional medical judgment when treating members.

Denial Risk

Denial Risk for Nonconformance

Requests lacking required documentation, requests for non‑FDA or unsupported off‑label indications without evidence per the applicable off‑label use policy, or requests that do not conform to coverage criteria may be denied.

Denial risk if documentation of diagnosis, lab values, SRL trial, or specialist consultation is missing.
Denial risk for non‑FDA indications without sufficient evidence per off‑label policies (commercial, marketplace, Medicaid as applicable).
Coverage subject to plan terms and limitations; nonconformance may result in denial.

Octreotide (Sandostatin, Sandostatin LAR) and Lanreotide (Depot) are listed as SRL examples in Appendix B

Role in policyFailure of an SRL at up to maximally indicated doses is required prior to pegvisomant unless contraindicated or intolerant

inv-21: Health Plan definition — terminology for the insurer

Term definitionHealth Plan: a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC or an affiliate, as applicable

Policy purposeProvides guidance to assist in coverage decisions and administration of benefits; not a contract or guarantee of payment

ApplicabilityCoverage decisions are subject to terms, conditions, exclusions, limitations of coverage documents and applicable legal/regulatory requirements