ModifiedmhnPolicy CP.PHAR.389

Clinical Policy: Pegvisomant (Somavert)

Policy governing medical necessity and prior authorization criteria for pegvisomant (Somavert) for treatment of acromegaly for members of Centene-affiliated health plans across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyPegvisomant (Somavert) clinical coverage criteria

Policy CodePolicy CP.PHAR.389

Change TypeCriteria revisionsstep therapy and duration updates

Effective Date12.01.18

Next Review Date

Key ActionSubmit prior authorization with documentation showing failure of required somatostatin analogs (lanreotide and octreotide acetate LAR or brand Sandostatin LAR Depot if generic unavailable) or indication for step therapy bypass per IL HB 5395.

SourceLink

POLICY UPDATE CHANGES

For acromegaly, revised initial criteria from '(GH) level ≥ 1 µg/mL' to '(GH) level ≥ 1 µg/L' per PS/ES practice guidelines and ACG.

Removed inactive HCPCS code C9399 and updated J3590 HCPCS code description to 'unclassified biologics'.

Added step therapy bypass for Illinois HIM per IL HB 5395.

For initial therapy, extended approval duration from 6 months to 12 months for HIM and Medicaid.

Somatostatin analog redirection revised to require failure of lanreotide, generic octreotide acetate LAR, and brand Sandostatin LAR Depot if generic is unavailable due to shortage.

>=18minimum age for initial approval

12 monthsinitial therapy duration (HIM/Medicaid)

J3590billing code

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IL HB 5395IL legislation

Load 40 mg; Maint 30 mg/daydosing limits

Coverage Criteria

Initial Therapy - Acromegaly

Covered when ALL of the following are met for Initial Approval (Acromegaly):

Acromegaly initial approval: 1. Diagnosis of acromegaly as evidenced by one of the following: (a) pre-treatment IGF-I level above the upper limit of normal based on age and gender for the reporting laboratory; OR (b) serum growth hormone (GH) level ≥ 1 µg/L after a 2-hour oral glucose tolerance test; 2. Prescribed by or in consultation with an endocrinologist; 3. Age ≥ 18 years; 4. Inadequate response to surgical resection or pituitary irradiation, or member is not a candidate for such treatment; 5. Failure of both of the following unless clinically significant adverse effects occur or all are contraindicated: (a) lanreotide (Somatuline Depot); AND (b) both: (i) generic octreotide acetate LAR (generic Sandostatin LAR Depot), unless unavailable due to shortage; (ii) if generic octreotide acetate LAR is unavailable due to shortage, Sandostatin LAR Depot; 6. Dose does not exceed both: (a) loading dose 40 mg once; AND (b) maintenance dose 30 mg per day.

Step therapy requirement does not apply for Illinois HIM requests as of 1/1/2026 per IL HB 5395.

Continuation Therapy - Acromegaly

Covered when ALL of the following are met for Continued Therapy (Acromegaly):

Acromegaly continued therapy: 1. Member currently receiving medication via Centene benefit or member has previously met initial approval criteria; OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy (see Appendix D); 3. If request is for a dose increase, new dose does not exceed 30 mg per day.

Approval durations differ by line of business (Medicaid/HIM 12 months; Commercial 6 months or to member renewal).

Non‑FDA approved indications that are not specifically addressed in this policy will only be considered when the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace (HIM), and CP.PMN.53 for Medicaid, or when covered by applicable evidence of coverage documents.

When a conflict exists between this clinical policy and state Medicaid coverage provisions for a Medicaid member, the state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage rules and requirements that supersede this policy.

Requests for use of pegvisomant (Somavert) for non‑FDA approved indications that do not include sufficient documentation of efficacy and safety per the referenced off‑label use policies will not be authorized.

Coding and Clinical Thresholds

HCPCS Codes referencedHCPCS

J3590	Unclassified biologicals
J3590	Unclassified biologicals

inv-07: GH after 2-hour oral glucose tolerance test

GH after 2-hour OGTT (numeric threshold)>= 1 µg/L

ContextUsed as diagnostic criterion for acromegaly (serum GH >= 1 µg/L after a 2-hour oral glucose tolerance test).

Source guidanceSpecified in Initial Approval Criteria for acromegaly.

inv-08: Age for initial approval

Minimum age for initial approval>= 18 years

ContextAge requirement appears in Initial Approval Criteria for acromegaly (must be 18 years or older).

Provider Actions and Authorization Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for Somavert (pegvisomant) and related somatostatin analogs. Providers must obtain prior authorization where applicable before initiation of therapy.

Prior authorization may be required for lanreotide, octreotide acetate LAR (generic Sandostatin LAR Depot), and Sandostatin LAR Depot.

Documentation Required

Requests must include supporting clinical documentation such as office chart notes, laboratory results (e.g., IGF‑I, GH, oral glucose tolerance test), imaging, and notes from endocrine consultations. Lack of sufficient documentation may result in denial.

Include office notes, labs, and any other clinical information supporting that the member meets all approval criteria.

Background

Pegvisomant (Somavert) is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation, or who are not candidates for those treatments. The therapeutic goal is biochemical control, typically normalization of serum IGF‑I. Somatostatin receptor ligands (SRLs) such as octreotide LAR and lanreotide are considered first‑line medical therapy; pegvisomant is generally used as second‑line therapy for patients who do not achieve adequate biochemical control with surgery, radiation, or SRLs.

Definitions and Key Terms

inv-18: Key terms

IGF-IInsulin-like growth factor I; used to assess biochemical control of acromegaly (pre-treatment IGF-I above lab-specific ULN is diagnostic criterion).

GHGrowth hormone; serum GH >= 1 µg/L after a 2-hour oral glucose tolerance test is an alternative diagnostic criterion for acromegaly.

SRLSomatostatin receptor ligand; examples include octreotide LAR and lanreotide, considered first-line medical therapy for acromegaly.

inv-19: Health Insurance Marketplace / HIM definition

HIM (Health Insurance Marketplace)Health Insurance Marketplace; referenced for policy-specific provisions such as step therapy bypass for Illinois HIM per IL HB 5395 and extended initial approval duration to 12 months for HIM and Medicaid.

Policy implications

Policy Summary

Payermhn

PolicyPegvisomant (Somavert) clinical coverage criteria

Policy CodePolicy CP.PHAR.389

Change TypeCriteria revisionsstep therapy and duration updates

Effective Date12.01.18

Next Review Date

SourceLink

On This Page

Initial therapy requests for pegvisomant (Somavert).

Denial Risk

Non‑FDA Use / Documentation Insufficiency — Denial Risk

Non‑FDA (off‑label) indications are not covered by this policy unless sufficient evidence of efficacy and safety is provided per the applicable off‑label use policies. Insufficient or absent evidence for non‑FDA use places the request at risk for denial.

Non‑FDA approved indications require documentation of efficacy/safety per the referenced off‑label use policies.
Commercial: CP.CPA.09; Health Insurance Marketplace: HIM.PA.154; Medicaid: CP.PMN.53.

Documentation Required

Document Step Therapy and Prior Therapy Duration

Document the member’s step therapy history and prior therapy durations where applicable. For initial therapy decisions, include dates and outcomes of prior somatostatin analog trials and note any adverse effects or contraindications.

Record prior agents tried, start/stop dates, doses, and reason for discontinuation (lack of efficacy, adverse events, or contraindication).
For HIM and Medicaid initial therapy, note the extended initial approval duration (12 months) when applicable.

Step Therapy

Somatostatin Analog Step Therapy and IL HIM Bypass

Step therapy for somatostatin analogs requires failure of specified agents prior to approval of pegvisomant except where an IL HIM bypass applies. Per policy updates, the required sequence is failure of lanreotide and octreotide acetate LAR (generic Sandostatin LAR Depot); if generic octreotide acetate LAR is unavailable due to shortage, failure of brand Sandostatin LAR Depot is required. Illinois HIM requests are exempt from the step therapy requirement per IL HB 5395 effective 1/1/2026.

Required failures: Lanreotide (Somatuline Depot) AND generic octreotide acetate LAR (generic Sandostatin LAR Depot).
If generic octreotide acetate LAR is unavailable due to shortage, failure of brand Sandostatin LAR Depot is required.
IL HIM (Illinois Health Insurance Marketplace) requests: step therapy bypass effective 01/01/2026.

Certain statutory changes (e.g., IL HB 5395) create bypasses for HIM for step therapy requirements noted in this policy.

Approval duration noteFor HIM (and Medicaid) initial therapy approval duration was extended to 12 months per 4Q 2025 review.