CurrentNeighborhood Health Plan of Rhode IslandPolicy 2097-A

Pegvisomant (Somavert) for acromegaly — Coverage Criteria

Covers prior authorization and medical necessity criteria for pegvisomant (Somavert) for treatment of acromegaly for members of Neighborhood Health Plan of Rhode Island when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPegvisomant (Somavert) for acromegaly — Coverage Criteria

Policy CodePolicy 2097-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with pretreatment IGF-1 lab report and documentation of inadequate or partial response to surgery/radiotherapy (or clinical rationale for not performing surgery/radiotherapy).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period for initial and continuation therapy

IGF-1 documentedlaboratory requirement (pretreatment and for continuation)

FDA-approved indication onlyother indications considered experimental/not medically necessary

Coverage Criteria for Pegvisomant (Somavert)

Initial Therapy (Acromegaly)

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Initial Therapy Criteria: 1) Diagnosis of acromegaly (FDA‑approved indication: treatment for patients with inadequate response to surgery or radiotherapy, or for whom these therapies are not appropriate). 2) Laboratory report showing a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range. 3) Member had an inadequate or partial response to surgery or radiotherapy OR there is a documented clinical reason why the member has not had surgery or radiotherapy.Pretreatment IGF-1: elevated for age/gender per lab reference range

Authorization may be granted for 12 months if all criteria are met.

Continuation Therapy

Covered when ALL of the following are met:

Continuation Therapy Criteria: 1) Member is currently receiving pegvisomant (Somavert) for acromegaly. 2) Laboratory report demonstrating that the member's IGF-1 level has decreased or normalized since initiation of therapy (or chart notes documenting normalization).IGF-1: decreased or normalized since initiation of therapy

Authorization may be granted for 12 months if criteria are met.

Coding and Laboratory Requirements

Referenced drugNDC | mixed

Somavert / pegvisomant

Product referenced (brand and generic)

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

Pretreatment IGF-1 requirementLaboratory report must show a high (elevated) pretreatment IGF-1 level for the member's age and/or gender based on the laboratory reference range.

Continuation IGF-1 monitoringFor continuation, submit laboratory report showing the member's IGF-1 level has decreased or normalized since initiation of therapy.

Documentation to support initial requestChart notes documenting an inadequate or partial response to surgery or radiotherapy, or a clinical rationale for not undergoing surgery/radiotherapy, must accompany the pretreatment IGF-1 result.

Reference for approval periodWhen the IGF-1 pretreatment and continuation criteria are met, authorization may be granted for up to 12 months.

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization duration

Authorization of 12 months may be granted for the treatment of acromegaly when all required criteria are met. The initial and continuation approval period is 12 months.

Initial approval: 12 months
Continuation approval: 12 months

Prior Authorization

Surgery/radiotherapy requirement

Member must have had an inadequate or partial response to surgery or radiotherapy, OR there must be a documented clinical reason why surgery or radiotherapy are not appropriate or were not performed. This requirement applies to initial authorization decisions.

Applies to initial therapy: inadequate/partial response to surgery or radiotherapy, OR documented reason surgery/radiotherapy not appropriate

Documentation Required

Initial approval documentation

For initial approval, submit laboratory report showing elevated pretreatment IGF-1 (for age and gender per lab reference range) and chart notes documenting inadequate or partial response to surgery or radiotherapy or a clinical reason for not having surgery or radiotherapy.

Required: pretreatment IGF-1 lab report
Required: chart notes documenting inadequate/partial response to surgery/radiotherapy or clinical reason for not undergoing those therapies

Documentation Required

Continuation documentation

For continuation approval, submit a laboratory report demonstrating that the member’s IGF-1 level has decreased or normalized since initiation of therapy, or chart notes documenting clinical benefit (e.g., decreased IGF-1 or clinical improvement).

Required: follow-up IGF-1 lab report showing decreased/normalized levels since treatment initiation OR chart notes documenting clinical benefit

Denial Risk

Non‑approved indications

Use of this therapy for indications other than FDA‑approved acromegaly (in patients with inadequate response to or inappropriate for surgery/radiotherapy) is considered experimental/investigational and not medically necessary.

Non‑approved indications are not covered

Definitions

inv-13: Inadequate or partial response to surgery or radiotherapy — clinical/biochemical evidence per chart notes

Clinical/biochemical evidence requiredChart notes must document clinical or biochemical evidence that prior surgery or radiotherapy produced an inadequate or partial response for acromegaly control.

Alternative to prior surgery/radiotherapyIf surgery or radiotherapy was not performed, documentation must provide a clinical reason explaining why these therapies were not done.

Connection to coverage decisionAn inadequate or partial response to surgery or radiotherapy (or documented reason for not performing them) is required as part of initial approval criteria for pegvisomant.

inv-14: IGF-1 requirement — lab measurement required pretreatment (elevated for age/gender) and for continuation monitoring

Pretreatment laboratory requirementA laboratory report demonstrating a high pretreatment IGF-1 level for age and/or gender (per laboratory reference range) is required for initial approval.

Ongoing monitoring requirementFor continuation of therapy, a laboratory report showing that IGF-1 has decreased or normalized since initiation must be submitted.

Acceptable alternative documentationChart notes documenting IGF-1 normalization or decrease may be used when laboratory reports are not available, provided they clearly document the change since therapy initiation.

Background

Pegvisomant (Somavert) 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. Clinical management is guided by measurement of insulin‑like growth factor‑1 (IGF‑1) to document pretreatment elevation and to monitor response during therapy.