CurrentCignaPolicy N/A

Somavert (pegvisomant) prior authorization

Defines Cigna's prior authorization requirements and medical necessity criteria for Somavert (pegvisomant) for treatment of acromegaly, including prescriber requirements and coverage duration.

Policy Summary

PayerCigna

PolicySomavert (pegvisomant) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document baseline IGF-1 above the lab-specific upper limit of normal; ensure prescription is by or in consultation with an endocrinologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

08/28/2024policy review date

FDA-approvedindication governed

1 yearapproval duration

Coverage Criteria for Somavert (pegvisomant)

FDA-Approved Indication — Acromegaly

Covered when ALL of the following are met:

Main: Approval for 1 year if ALL conditions A, B, and C are met

A: Surgical/radiation response or candidacy: Patient meets ONE of: (i) patient has had an inadequate response to surgery and/or radiotherapy; OR (ii) patient is not an appropriate candidate for surgery and/or radiotherapy; OR (iii) patient is experiencing negative effects due to tumor size (e.g., optic nerve compression)

B: Baseline biomarker: Patient has (or had) a pre-treatment (baseline) insulin-like growth factor-1 (IGF-1) level above the upper limit of normal based on age and gender for the reporting laboratorybaseline IGF-1 > upper limit of normal (age/gender-specific)

Pre-treatment refers to IGF-1 measured prior to initiation of any somatostatin analog, dopamine agonist, or Somavert

Policy Summary

PayerCigna

PolicySomavert (pegvisomant) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document baseline IGF-1 above the lab-specific upper limit of normal; ensure prescription is by or in consultation with an endocrinologist.

SourceLink

On This Page

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C: Prescriber: Medication is prescribed by or in consultation with an endocrinologist

Prior authorization requires specialist involvement due to specialized evaluation and monitoring needs

Somavert (pegvisomant) is considered experimental, investigational, or unproven for any use(s) other than treatment of acromegaly. Examples of non-covered indications include treatment of growth hormone excess associated with McCune-Albright Syndrome. This list is not exhaustive and may be updated as new published data become available.

Coding and Laboratory Criteria

inv-03: Baseline IGF-1

Baseline IGF-1 thresholdAbove the upper limit of normal (ULN) for age and gender as reported by the laboratory

Context for measurementMust be a pre-treatment (baseline) IGF-1 obtained prior to initiation of any somatostatin analog, dopamine agonist, or Somavert

PurposeRequired evidence to meet coverage criteria for Somavert (approval granted for 1 year if all criteria met)

Reporting requirementUse the reporting laboratory’s age- and gender-specific reference range to determine ULN

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Somavert. If all coverage criteria are met, approval is provided for a duration of 1 year.

Step Therapy

Clinical prerequisites before approval

Patient must meet one of the following: inadequate response to surgery and/or radiotherapy; not an appropriate candidate for surgery and/or radiotherapy; or experiencing negative effects due to tumor size (e.g., optic nerve compression).

Documentation Required

Required clinical documentation

Document baseline (pre‑treatment) IGF‑1 level that is above the laboratory-specific upper limit of normal for age and gender, and provide history supporting prior surgery/radiotherapy response or ineligibility and endocrinologist involvement (prescribed by or in consultation with an endocrinologist).

Denial Risk

Non‑acromegaly use considered investigational

Use of Somavert for any indication other than acromegaly is considered experimental, investigational, or unproven and may be denied.

Definitions

inv-09: Pre-treatment (baseline) IGF-1

DefinitionIGF-1 level measured prior to initiation of any somatostatin analog, dopamine agonist, or Somavert

Required levelPre-treatment (baseline) IGF-1 must be above the laboratory-specific upper limit of normal based on age and gender

Examples of therapies that make an IGF-1 non-baselineSomatostatin analogs (e.g., octreotide products, lanreotide, pasireotide), dopamine agonists (e.g., cabergoline, bromocriptine), or prior Somavert exposure

Use in coverage decisionDocumented elevated pre-treatment IGF-1 is a mandatory criterion (Criterion B) for Somavert coverage for acromegaly

Background

Somavert (pegvisomant) is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients with an inadequate response to, or who are unsuitable for, surgery or radiation therapy, or other medical therapies. The therapeutic goal is normalization of serum IGF-1 levels; monitoring of IGF-1 is required with a documented baseline (pre-treatment) IGF-1 level that is above the upper limit of normal for the reporting laboratory by age and gender prior to initiation.