ModifiedmhnPolicy CP.PHAR.389

Pegvisomant (Somavert)

Medical necessity criteria, dosing, and coverage guidance for pegvisomant (Somavert) for treatment of acromegaly for Centene-affiliated health plans across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyPegvisomant (Somavert)

Policy CodePolicy CP.PHAR.389

Change TypeClinical clarifications and coding/authorization updates

Effective Date12.01.18

Next Review Date

Key ActionSubmit prior authorization with supporting documentation and use updated HCPCS J3590 coding; note IL HIM step therapy bypass per IL HB 5395 when applicable.

SourceLink

POLICY UPDATE CHANGES

Revised diagnostic GH threshold formatting from 'µg/mL' to 'µg/L' per practice guidelines.

Added step therapy bypass for Illinois HIM per IL HB 5395.

Extended initial approval duration from 6 months to 12 months for HIM and Medicaid.

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

Added step therapy bypass for IL HIM per IL HB 5395.

Extended initial therapy duration from 6 months to 12 months for HIM and Medicaid.

Age ≥ 18minimum age for initial approval

IGF-I or OGTTconfirmatory diagnostic requirement options

12 monthsinitial therapy duration for HIM and Medicaid

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Coverage Criteria for Pegvisomant (Somavert)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Acromegaly Approval: 1. Diagnosis of acromegaly evidenced by either: (a) pre-treatment IGF-I above the upper limit of normal based on age and gender for the reporting laboratory OR (b) serum growth hormone (GH) ≥ 1 µg/L after a 2-hour oral glucose tolerance test; 2. Prescribed by or in consultation with an endocrinologist; 3. Age ≥ 18 years; 4. Inadequate response to surgical resection or pituitary irradiation, or member is not a candidate for such treatment (see Appendix D); 5. Failure of a somatostatin analog at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced (see Appendix B); 6. Dose does not exceed both: (a) loading dose 40 mg once; and (b) maintenance dose 30 mg per day.see text

All numbered criteria must be met

Continuation Therapy — Covered for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met

Continued Therapy - Acromegaly: 1. Member currently receiving medication via Centene benefit or member has previously met initial approval criteria OR member is receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy (see Appendix D); 3. If request is for a dose increase, the new dose does not exceed 30 mg per day.see text

All numbered criteria must be met

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the referenced off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or as otherwise specified in the member’s evidence of coverage.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage requirements or exceptions.

Use of pegvisomant for non‑FDA approved indications without sufficient documentation of efficacy and safety per the referenced off‑label use policies is not authorized. Providers must follow CP.CPA.09, HIM.PA.154, or CP.PMN.53 as applicable when requesting coverage for off‑label uses.

Coding and Diagnostic Thresholds

HCPCS Codes referencedHCPCS

J3590

Unclassified biologicals

HCPCS updatesHCPCS

C9399	inactive HCPCS code (removed)
J3590	unclassified biologics (updated description)

inv-08: GH threshold after OGTT — ≥ 1 µg/L

GH threshold after 2-hour OGTTSerum growth hormone (GH) level ≥ 1 µg/L

Source contextListed as diagnostic option for acromegaly confirmation in initial approval criteria

Guideline alignmentRevised units from µg/mL to µg/L per PS/ES practice guidelines and ACG (4Q 2024 review)

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for pegvisomant (Somavert) per this policy. Providers must obtain prior authorization before initiating therapy and ensure submitted documentation supports that the member meets all approval criteria.

Prior authorization required for Somavert/pegvisomant
Prescriptions should be submitted by or in consultation with an endocrinologist when applicable

Billing Rule

Billing and Coding — Use Updated HCPCS Code

Providers must use the updated HCPCS coding guidance when submitting claims. Use HCPCS code J3590 (Unclassified biologics) as applicable; failure to follow the updated HCPCS coding or to reference current professional coding guidance may impact claims processing and reimbursement.

Definitions and Key Terms

inv-18: Key terms and diagnostic thresholds — IGF-I, GH, diagnostic confirmation options including IGF-I or GH ≥ 1 µg/L after OGTT

IGF-IInsulin-like growth factor I (IGF-I); elevated pre-treatment IGF-I above lab-specific upper limit of normal (age/gender) can confirm diagnosis

GH after OGTTSerum growth hormone (GH) level ≥ 1 µg/L after a 2-hour oral glucose tolerance test can confirm diagnosis

Diagnostic confirmation optionsDiagnosis may be confirmed by either elevated pre-treatment IGF-I or GH ≥ 1 µg/L after 2-hour OGTT (per initial approval criteria and updated practice guidance)

inv-19: Health Plan — Health Plan identifier/value

Health PlanThis clinical policy is the property of the Health Plan and effective as determined by the Health Plan; plan retains right to change, amend, or withdraw the policy

Background

Pegvisomant (Somavert) is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients for whom surgical resection or radiation therapy have been inadequate or are not appropriate. The therapeutic goal is normalization of serum IGF‑I; pegvisomant is typically used when somatostatin receptor ligand therapy has failed to achieve biochemical control.

Revision History and Policy Changes

2025-07-10policy_revisionLatest

Added step therapy bypass for Illinois HIM per IL HB 5395 and extended initial therapy duration from 6 months to 12 months for HIM and Medicaid.

2024-07-15coding_and_threshold_update

Revised GH diagnostic threshold formatting from 'µg/mL' to 'µg/L' per practice guidelines and removed inactive HCPCS code C9399 while updating J3590 description to 'unclassified biologics'.

2021-08-12coding_section_added

Added coding implications section and updated cross-reference from HIM.PHAR.21 to HIM.PA.154 during 4Q 2021 annual review.