CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Somavert (pegvisomant) — Coverage Criteria for Acromegaly

Policy governs prior authorization and coverage criteria for Somavert (pegvisomant) for treatment of acromegaly for members of Neighborhood Health Plan of Rhode Island; it defines required documentation, indications, and continuation criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySomavert (pegvisomant) — Coverage Criteria for Acromegaly

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of high pretreatment IGF-1 and evidence of inadequate response to or inappropriateness of surgery/radiation for initial approval; submit IGF-1 showing decrease/normalization for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauth duration

IGF-1required marker

FDA-onlyindication scope

Coverage Criteria for Somavert (pegvisomant)

Initial Therapy (Acromegaly)

Covered when ALL of the following are met for acromegaly (initial therapy):

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Initial therapy criteria: A. Diagnosis of acromegaly (FDA‑approved indication: treatment for patients with inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate).

Initial therapy criteria: B. Laboratory report showing a high pretreatment IGF-1 level for the member's age and/or gender based on the laboratory reference range.IGF-1: high pretreatment per laboratory reference range

Initial therapy criteria: C. Documentation of inadequate or partial response to surgery or radiotherapy, OR clinical documentation explaining why surgery or radiotherapy was not done or is not appropriate for the member.

Authorization of 12 months may be granted when criteria are met

Continuation Therapy (Acromegaly)

Covered when ALL of the following are met for continuation of therapy:

Continuation criteria: IGF-1 level has decreased or normalized since initiation of therapy, documented by laboratory report or chart notes.IGF-1: decreased or normalized

Authorization of 12 months may be granted for continuation

All indications other than the FDA‑approved indication for acromegaly and recognized compendial uses are excluded from coverage as experimental/investigational. The policy follows the FDA‑approved labeling which limits Somavert (pegvisomant) to acromegaly in patients with an inadequate response to, or for whom surgery or radiation therapy are not appropriate; uses outside of this scope will not be covered.

Coding and Laboratory Requirements

No explicit billing or diagnosis codes listed in policymixed

No codes listed

inv-06: IGF-1 — pretreatment high for age/gender; decreased or normalized for continuation

ThresholdHigh pretreatment IGF-1 level for age and/or gender based on the laboratory reference range

ContextRequired for initial authorization for acromegaly treatment

MeasurementIGF-1 compared to lab-specific age/gender reference range

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required — Initial Approval

Prior authorization is required for Somavert (pegvisomant) for the treatment of acromegaly. Authorization of up to 12 months may be granted when approval criteria are met, including documentation of a high pretreatment IGF-1 for the member's age and gender.

Authorization duration: up to 12 months
Required: high pretreatment IGF-1 documented in laboratory report

Prior Authorization

Prior Authorization Required — Continuation

Continuation prior authorization of up to 12 months may be granted when there is documentation that the member's IGF-1 level has decreased or normalized since initiation of therapy.

Authorization duration for continuation: up to 12 months
Required: laboratory report showing decreased or normalized IGF-1 since treatment start

Prior Authorization

Prior Surgery/Radiation Requirement

For initial approval, the plan requires documentation of an inadequate or partial response to surgery or radiation therapy, or documentation that these therapies are not appropriate for the member, consistent with the FDA‑approved indication.

Acceptable documentation: chart notes describing inadequate/partial response to surgery or radiotherapy
Or: chart notes documenting clinical reasons why surgery or radiotherapy are not appropriate

Documentation Required

Required Documentation for Prior Authorization

Submit the following documentation to initiate prior authorization review.

Initial approval: laboratory report showing high pretreatment IGF-1 for age/gender and chart notes documenting inadequate or partial response to surgery or radiotherapy or clinical reason these therapies were not appropriate
Continuation: laboratory report showing current IGF-1 has decreased or normalized since initiation of therapy, and relevant chart notes

Denial Risk

Non‑FDA Indications / Coverage Exclusion

Use of Somavert for indications other than FDA‑approved acromegaly (in patients who had an inadequate response to or are not appropriate for surgery/radiation) is considered experimental/investigational and not medically necessary.

Non‑FDA indications are not covered

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 those therapies are not appropriate. The policy requires documentation of the acromegaly diagnosis and prior treatment history as part of prior authorization review and uses monitoring of insulin‑like growth factor‑1 (IGF‑1) to assess need for initiation and continuation of therapy.

Definitions

inv-13: IGF-1 — Insulin-like growth factor-1; lab measurement required to document pretreatment elevation and subsequent decrease or normalization

DefinitionInsulin-like growth factor-1 (IGF-1) — laboratory measurement used to document pretreatment elevation and subsequent response

Initial documentation requirementSubmit laboratory report showing high pretreatment IGF-1 for age/gender

Continuation documentationSubmit laboratory report showing IGF-1 has decreased or normalized since initiation of therapy

inv-14: Indicated population — Patients with acromegaly who had inadequate response to or are unsuitable for surgery or radiotherapy

PopulationPatients with acromegaly who have had an inadequate response to surgery or radiation therapy

Alternative eligibilityPatients for whom surgery or radiation therapy are not appropriate

Coverage scopeFDA‑approved indication: Somavert covered for acromegaly when criteria met; other indications considered experimental/investigational and not medically necessary

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySomavert (pegvisomant) — Coverage Criteria for Acromegaly

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

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