CurrentCentenePolicy N/A

Clinical Policy: Pegvisomant (Somavert)

Policy governing medical necessity and prior authorization criteria for pegvisomant (Somavert) for treatment of acromegaly for Centene lines of business including Commercial, HIM, and Medicaid in applicable states.

Policy Summary

PayerCentene

PolicyPegvisomant (Somavert) clinical coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2018

Next Review DateN/A

Key ActionProvider must submit office notes, lab results, or other clinical documentation to support that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsTypical initial approval (Commercial)

6 monthsTypical initial approval (Medicaid/HIM)

30 mg/dayMax maintenance dose

J3590HCPCS code listed

NotedState Medicaid precedence

Coverage Criteria

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Initial Therapy Criteria

Covered when ALL of the following are met

Diagnosis

Diagnostic evidence: a) Pre-treatment IGF-I level above the upper limit of normal based on age and gender for the reporting laboratory; OR b) Serum GH level ≥ 1 ug/L after a 2-hour oral glucose tolerance test

Prescriber: Prescribed by or in consultation with an endocrinologist

Prior treatments: Inadequate response to surgical resection or pituitary irradiation, or patient is not a candidate for such treatment; AND failure of a somatostatin analog at up to maximally indicated doses unless contraindicated or intolerant

See Appendix B and Appendix D for therapeutic alternatives and guidance

Age: Patient is ≥ 18 years of age>= 18 years

Dosing limits: Dose does not exceed loading dose of 40 mg once (SC under healthcare provider supervision) and maintenance dose of 30 mg per day40 mg loading; 30 mg/day maintenance

Continuation Therapy Criteria

Covered for continuation when ALL of the following are met

Ongoing use: Member is currently receiving medication via the Centene benefit OR member has previously met initial approval criteria

Clinical response: Member is responding positively to therapy as evidenced by clinical improvement or biochemical measures (examples include improvement or normalization of GH and/or age- and sex-adjusted IGF-I, or tumor mass control)

See Appendix D for examples of treatment response

Dose increase limits: If request is for a dose increase, the new dose does not exceed 30 mg per day<= 30 mg/day

Non‑FDA approved indications that are not specifically addressed by this policy are not authorized unless the request includes sufficient documentation supporting efficacy and safety in accordance with applicable off‑label use policies: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid, or unless the service is covered by the member’s evidence of coverage documents. Providers must submit office chart notes, laboratory results, or other clinical information that justify the off‑label use.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage requirements that may supersede this policy.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for pegvisomant and related therapies in many lines of business; typical approval durations may vary by line of business (for example, Medicaid/HIM: 6 months for initial approval). Providers should verify PA requirements and expected authorization length with the member's specific plan prior to initiating therapy.

Prior authorization required — verify duration by line of business (e.g., Medicaid/HIM: 6 months)
Prescriber or consultation by an endocrinologist typically expected

Billing Rule

Coding impact on prior authorization

The HCPCS/J-code landscape has changed; note the updated J3590 description to 'unclassified biologics' which may affect billing and PA submissions. Ensure claims and PA requests use the appropriate HCPCS/CPT/NDC codes and descriptions accepted by the payer to avoid administrative delays.

Updated J3590 description: 'unclassified biologics' — review billing/PA impacts
Confirm coding with payer-specific billing guidance before submission

Step Therapy

Step therapy expectation

Guideline and policy language position somatostatin receptor ligands (SRLs) such as octreotide LAR and lanreotide as first-line medical therapy for acromegaly; pegvisomant is generally used as second-line therapy when patients do not achieve biochemical control with maximal SRL therapy. Expect documentation of prior SRL trial and inadequate response unless contraindicated.

SRLs (octreotide, lanreotide) are typically first-line
Pegvisomant positioned as second-line after inadequate response to maximal SRL therapy
Documentation of SRL trial (dosing and response) may be requested

Step Therapy

Step therapy (not specified)

No explicit step therapy protocol (e.g., mandatory trial lengths beyond documentation of SRL failure) is specified in the provided excerpts; however, prior authorization criteria reference failure of a somatostatin analog at up to maximally indicated doses unless contraindicated.

No additional formal step therapy requirements specified in excerpts beyond requirement to document SRL failure or contraindication
Providers should supply dosing and response information for prior SRL therapy

Documentation Required

Required clinical documentation

Providers must submit supporting clinical documentation with PA requests (office notes, lab results such as IGF-I and GH/OGTT results, surgical history, imaging, and consultation notes) to demonstrate that the member meets approval criteria.

Office/clinic notes documenting diagnosis and treatment history
Laboratory results: pre-treatment IGF-I and GH levels (e.g., GH ≥1 µg/L after 2-hour OGTT)
Documentation of prior therapies, surgical or radiation history, and endocrinology consultation

Documentation Required

Documentation-dependent authorization

Authorization decisions depend on the completeness and adequacy of submitted documentation. Requests missing required clinical information may be denied or returned for additional information, which will delay care.

Incomplete or absent supporting documentation may lead to denial or request for more information
Submit full medical records and test results to avoid delays

Denial Risk

Administrative denial/coverage risk

Coverage decisions are subject to the plan's terms, conditions, exclusions, and limitations. This policy does not guarantee payment; providers remain responsible for confirming member benefits and are expected to follow applicable coverage documents and administrative requirements.

Coverage subject to evidence of coverage, policy contracts, and state/federal requirements
Health Plan may amend or withdraw clinical policies; verify current policy and plan-level requirements

OpenPayer

Clinical Policy: Pegvisomant (Somavert)

Coverage Criteria

Coding and Dosing

Provider Actions and Prior Authorization

Background

Definitions and Terms