ModifiedCentenePolicy CP.PHAR.109

Clinical Policy: Tesamorelin (Egrifta SV, Egrifta WR)

Policy governing medical necessity criteria, dosing, and coverage for tesamorelin (Egrifta SV and Egrifta WR) for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy for Centene lines of business.

Policy Summary

PayerCentene

PolicyClinical Policy: Tesamorelin (Egrifta SV, Egrifta WR)

Policy CodePolicy CP.PHAR.109

Change TypeMaterial updates: criteria thresholds and new formulation added

Effective DateMar 1, 2014

Next Review Date

Key ActionSubmit prior authorization with documentation verifying HIV with lipodystrophy, age ≥18, required waist circumference and waist-hip ratio thresholds, antiretroviral adherence, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

Revised clinical indicators for abdominal lipodystrophy to require waist circumference and waist-hip ratio thresholds that reflect efficacy studies.

Added newly approved Egrifta WR formulation to the policy.

Added HCPCS J3590 (unclassified biologics) to coding implications.

≥18minimum patient age for coverage

F ≥94 / M ≥95 cmwaist circumference thresholds required

F ≥0.88 / M ≥0.94waist-hip ratio thresholds required

6 months

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initial approval duration

SV 1.4 mg / WR 1.28 mgmaximum dosing per policy

Coverage Criteria for Tesamorelin (Egrifta)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Approval - HIV with Lipodystrophy: 1) Diagnosis of HIV infection with lipodystrophy; 2) Age ≥ 18 years; 3) Member meets clinical indicators for abdominal lipodystrophy (see child node); 4) Member is currently receiving and adherent to antiretroviral therapy; 5) Dose does not exceed policy limits (a or b): a. Egrifta SV 1.4 mg (1 vial) per day; b. Egrifta WR 1.28 mg per day (1 vial per week).

Approval duration: 6 months (Medicaid/HIM); Commercial 6 months or to member's renewal date, whichever is longer.

Clinical Indicators (waist metrics) — ONE/ANY of specified waist circumference or waist-hip ratio thresholds

Clinical indicators for abdominal lipodystrophy (must meet a OR b):

Clinical indicators: a) If female: waist circumference ≥ 94 cm AND waist-hip ratio ≥ 0.88; OR b) If male: waist circumference ≥ 95 cm AND waist-hip ratio ≥ 0.94.

These thresholds were revised to reflect efficacy studies.

Continuation Therapy — Covered for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met:

Continued Therapy - HIV with Lipodystrophy: 1) Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy; 3) If request is for a dose increase, new dose does not exceed policy limits (a or b): a. Egrifta SV 1.4 mg (1 vial) per day; b. Egrifta WR 1.28 mg per day (1 vial per week).

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to member's renewal date.

Other Indications / Off-label pathway — Requests for other diagnoses/indications and off-label handling

Requests for other diagnoses/indications:

Other Indications: 1) If the drug has had a label change within the last 6 months that is not reflected in this policy, follow formulary/no-coverage or non-formulary policies for the applicable line of business (see referenced policies); OR 2) If the requested use is not listed in section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.

Refer to policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable.

Non‑FDA approved or off‑label indications for tesamorelin that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy or evidence of coverage documents. Refer to the off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) when submitting requests for non‑label indications.

Tesamorelin (Egrifta SV and Egrifta WR) is contraindicated in patients with disruption of the hypothalamic‑pituitary axis (for example due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma). It is contraindicated in patients with active malignancy—preexisting malignancies should be inactive and treatment complete before initiating therapy. Pregnancy is a contraindication, and therapy should not be used in pregnant patients. Do not use in patients with a known hypersensitivity to tesamorelin or any excipients of Egrifta SV or Egrifta WR.

When coverage provisions in this clinical policy conflict with state Medicaid coverage rules, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage requirements or limitations relevant to tesamorelin.

Tesamorelin (Egrifta SV and Egrifta WR) is not indicated for weight loss management. The agents are weight neutral and should not be used with the expectation of promoting weight loss.

Coding and Quantity Limits

HCPCS Codes referencedHCPCS

J3590

Unclassified biologics

Referenced HCPCS CodesHCPCS

J3590

Unclassified biologics

inv-11: Waist circumference — female/male thresholds

Female waist circumference threshold≥ 94 cm

Male waist circumference threshold≥ 95 cm

inv-12: Waist-hip ratio — female/male thresholds

Female waist‑hip ratio threshold≥ 0.88

Male waist‑hip ratio threshold≥ 0.94

inv-13: Quantity restriction — 1 vial per day

Quantity restriction

Provider Requirements, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Requests for Egrifta (tesamorelin) require prior authorization. Provider must document that the member meets the clinical criteria for approval (see Policy/Criteria).

Prior authorization must include clear evidence of HIV with lipodystrophy and that the member meets the abdominal lipodystrophy waist circumference and waist‑hip ratio thresholds.
Age and dosing limits must be documented (age ≥ 18 years; dosing not to exceed 1.4 mg/day for Egrifta SV or 1.28 mg/week for Egrifta WR).

Documentation Required

Supporting Documentation Required

Supporting documentation is required to demonstrate that the member meets all approval criteria. Submit office chart notes, baseline and follow‑up laboratory results, documentation of adherence to antiretroviral therapy, and objective measurements (waist circumference and waist‑hip ratio) as applicable.

Background

Tesamorelin (marketed as Egrifta SV and Egrifta WR) is a synthetic growth hormone‑releasing factor (GHRF) analog formulated to reduce excess abdominal (visceral) fat in adults with HIV‑associated lipodystrophy. The indication is specific to reduction of excess abdominal fat in HIV‑infected adults with lipodystrophy; long‑term cardiovascular safety has not been established and the product is not indicated for weight loss or to improve antiretroviral adherence.

Definitions

inv-23: Tesamorelin / Egrifta — drug definition and formulations (Egrifta SV, Egrifta WR)

Drug class/definitionTesamorelin (Egrifta SV, Egrifta WR) — a growth hormone releasing factor analog indicated to reduce excess abdominal fat in HIV‑infected adults with lipodystrophy.

Formulation - Egrifta SVEgrifta SV: tesamorelin formulation with dosing limit listed as 1.4 mg (1 vial) per day.

Formulation - Egrifta WREgrifta WR: extended-release formulation referenced with a policy maximum dose of 1.28 mg per day.

inv-24: Health Plan — definition/reference to Health Plan

Health Plan definitionHealth Plan: a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates.

Policy role

Policy Summary

PayerCentene

PolicyClinical Policy: Tesamorelin (Egrifta SV, Egrifta WR)

Policy CodePolicy CP.PHAR.109

Change TypeMaterial updates: criteria thresholds and new formulation added

Effective DateMar 1, 2014

Next Review Date

SourceLink

On This Page

Egrifta SV dosing limit1.4 mg (1 vial) per day

Egrifta WR dosing notePolicy notes Egrifta WR maximum 1.28 mg per day (formulation details in policy)

Examples of acceptable documentation: office chart notes, lab results, measurement records, and medication adherence documentation.

If the request is for continued therapy, include evidence of positive clinical response and prior authorization history or continuity‑of‑care enrollment details.

Denial Risk

Insufficient Documentation / Non‑approved Indication

Insufficient documentation or requests for non‑FDA approved (off‑label) indications that are not supported by the applicable off‑label use policy may be denied. If the requested use is not listed in the policy and does not meet exception criteria, follow the referenced off‑label or formulary/non‑formulary policies.

Off‑label requests require sufficient evidence of efficacy and safety per CP.CPA.09 (commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid) as applicable.
Requests lacking required measurement data, adherence evidence, or clinical response documentation are at high risk for denial.

Billing Rule

Coding Inclusion Not a Guarantee of Coverage

Coding inclusion is informational only. Presence of HCPCS or other codes in this policy does not guarantee coverage or payment. Confirm coding and billing requirements with the Health Plan prior to claim submission.

HCPCS codes (e.g., J3590 Unclassified biologics) are listed for reference and are periodically updated.
Inclusion of a code in this policy is not an authorization — submit prior authorization and supporting clinical documentation for coverage determination.

Billing Rule

Documentation and Coding Guidance

Providers should reference the most up‑to‑date coding guidance and Health Plan billing terms when submitting claims. Codes and coding guidance are updated periodically; verify the correct HCPCS/CPT, modifiers, and reimbursement rules before claim submission.

Verify current HCPCS codes and descriptions (policy has noted updates to HCPCS including J3590).
Follow Health Plan‑specific billing guidance and any applicable quantity limits (e.g., quantity restriction of 1 vial per day noted in reviews).

Step Therapy

Step Therapy / Alternatives

Step Therapy: There are no step‑therapy requirements specified in this policy. Alternative coverage pathways are governed by formulary, non‑formulary, and off‑label use policies referenced in this document.

If a newly approved indication or change is not yet reflected in this policy, follow the applicable formulary or non‑formulary policy for the line of business (references provided).
Use off‑label policy references when the requested use is not explicitly covered by this policy.

This clinical policy provides guidance on medical necessity to assist coverage decisions but does not constitute a contract or guarantee of payment.

Provider responsibilityProviders should follow applicable Health Plan terms, conditions, exclusions, and limitations when submitting claims and seek prior authorization per plan procedures.