CurrentNeighborhood Health Plan of Rhode IslandPolicy 2097-A

Somavert (pegvisomant) for acromegaly — Prior Authorization and Coverage Criteria

Policy governs prior authorization and coverage criteria for Somavert (pegvisomant) for treatment of acromegaly, including initial and continuation approval requirements for affected members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySomavert (pegvisomant) for acromegaly — Prior Authorization and Coverage Criteria

Policy CodePolicy 2097-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit a lab report showing high pretreatment IGF-1 and documentation of inadequate/partial response to surgery or radiotherapy when seeking initial approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

FDA-onlycoverage scope

IGF-1 requireddocumentation

Coverage Criteria for Somavert (pegvisomant)

Initial Therapy

Covered when ALL of the following are met:

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Initial therapy for acromegaly: Member has a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference rangeIGF-1 above lab reference for age/gender

Document with laboratory report

Prior surgery/radiotherapy requirement: Member had an inadequate or partial response to surgery or radiotherapy OR there is a clinical reason why the member has not had surgery or radiotherapyN/A

Documented in chart notes

Indication is acromegaly (FDA‑approved); other indications are considered experimental/investigational and not medically necessaryN/A

Refer to FDA indication

Laboratory and Clinical Coding Guidance

IGF-1

Pretreatment IGF-1 statusHigh pretreatment IGF-1: IGF-1 level above the laboratory reference range for the patient's age and/or gender (document with laboratory report).

Required change for continuationDecrease or normalization of IGF-1: Member's IGF-1 level must have decreased or normalized since initiation of therapy (document with current lab report or chart notes).

Documentation for initial approvalLaboratory report showing high pretreatment IGF-1 for age/gender and chart notes documenting inadequate/partial response to surgery or radiotherapy or clinical reason for not having these therapies.

Documentation for continuation approvalLaboratory report showing current normal IGF-1 or chart notes documenting decreased/normalized IGF-1 since therapy initiation.

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Somavert (pegvisomant). Approvals may be granted for up to 12 months when the coverage criteria are met.

Prior authorization required; approvals may be issued for up to 12 months when all criteria are satisfied.

Documentation Required

Required Documentation

For initial therapy, documentation must show a pretreatment IGF-1 elevated for the patient’s age/gender and chart notes documenting an inadequate or partial response to surgery or radiotherapy, or a clinical reason why surgery/radiation is not appropriate. For continuation of therapy, provide laboratory report showing current normal IGF-1 or chart notes documenting that IGF-1 has decreased or normalized since starting therapy.

Initial: laboratory report with high pretreatment IGF-1 and chart notes documenting inadequate/partial response to surgery or radiotherapy, or documented clinical reason surgery/radiation not appropriate.
Continuation: laboratory report showing current normal IGF-1 or chart notes documenting a decrease or normalization of IGF-1 since treatment initiation.

Denial Risk

Indication-Based Denial Risk

Per the FDA‑approved indication, Somavert is indicated only for acromegaly in patients with inadequate response to surgery or radiation therapy, or for whom those therapies are not appropriate. Use for any other diagnosis/indication is considered experimental/investigational and is not medically necessary.

Somavert is FDA‑approved for acromegaly only (patients with inadequate response to, or inappropriate candidates for, surgery or radiotherapy).
All other indications are experimental/investigational and will be denied as not medically necessary.

Note

Surgery/Radiotherapy Requirement and Approval Period

Authorization for acromegaly may be granted for 12 months when the following are met: (1) pretreatment IGF‑1 is elevated for age/gender per laboratory reference range, and (2) member had inadequate/partial response to surgery or radiotherapy OR there is a documented clinical reason why surgery/radiotherapy was not performed or is not appropriate.

Authorization duration: up to 12 months when criteria are satisfied.
Clinical requirement: inadequate/partial response to surgery or radiotherapy, or documented clinical reason surgery/radiotherapy not appropriate.

Background

Somavert (pegvisomant) is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. Treatment decisions rely on measurement of IGF-1 to establish elevated pretreatment levels and to monitor response. Uses outside the FDA-approved acromegaly indication are considered experimental/investigational and not medically necessary.

Definitions

High pretreatment IGF-1 (definition)

DefinitionHigh pretreatment IGF-1 is an insulin-like growth factor-1 (IGF-1) level above the laboratory reference range for the patient's age and gender, as documented in a laboratory report.

How to documentProvide the laboratory report that shows the IGF-1 result and the lab's age- and gender-specific reference range.

Context for coverageHigh pretreatment IGF-1 is required as part of initial authorization criteria for acromegaly treatment with Somavert.

Evidence for other indicationsUse of Somavert for indications other than FDA‑approved acromegaly is considered experimental/investigational and not medically necessary.