CurrentHealth NetPolicy CP PHAR.109

Clinical Policy: Tesamorelin (Egrifta SV, Egrifta WR)

Defines medical necessity criteria, dosing limits, prior authorization/documentation requirements, approval durations, contraindications, and coding implications for tesamorelin (Egrifta SV and Egrifta WR) for treatment of excess abdominal fat in HIV-infected adults with lipodystrophy across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Tesamorelin (Egrifta SV, Egrifta WR)

Policy CodePolicy CP PHAR.109

Change TypeRevised criteria; added formulation; quantity restriction

Effective Date03.01.14

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

POLICY UPDATE CHANGES

3Q 2024 annual review: revised clinical indicators for abdominal lipodystrophy criteria to require waist circumference and waist-hip ratio thresholds that reflect efficacy studies and removed criteria allowing pediatric use.

RTA 04.10.25: added newly approved Egrifta WR formulation.

3Q 2022 annual review: added quantity restriction (1 vial per day) to dosing requirement and updated HCPCS codes.

3Q 2021 annual review: added HCPCS code J3590.

3Q 2025 annual review: no significant changes; references reviewed and updated.

2Formulations covered

4Key approval criteria items

1HCPCS codes referenced

Coverage Summary

Tesamorelin (brand names Egrifta SV and Egrifta WR) is a growth hormone-releasing factor analog indicated to reduce excess abdominal fat in HIV-infected adult patients with lipodystrophy.

Policy stance: covered_with_criteria — medical necessity is defined by the clinical criteria in this policy.

Definitions: Egrifta SV is the smaller-volume single-dose vial formulation of tesamorelin (2 mg powder for reconstitution) dosed as 1.4 mg SC once daily; Egrifta WR is a multiple-dose vial formulation (11.6 mg powder for reconstitution) that provides seven daily doses after reconstitution and is dosed as 1.28 mg/day administered as one vial per week.

Initial Therapy Criteria

Continuation Therapy Criteria

Other Diagnoses / Indications (Not Authorized / Off-Label)

Provider Actions & Operational Rules

Prior Authorization

Prior authorization and dosing limits

Requests are subject to prior authorization. Dosing must not exceed the specified limits: Egrifta SV — 1.4 mg per day (one single‑dose vial per day); Egrifta WR — 1.28 mg per day (one multiple‑dose vial per week, which provides daily doses for 7 consecutive days after reconstitution).

J3590

Documentation Required

Clinical documentation required for prior authorization

Submit clinical documentation to support that the member meets all approval criteria, such as office chart notes, laboratory results, or other relevant clinical information.

Office chart notes
Lab results
Other clinical information

Documentation Required

Adherence to antiretroviral therapy

Document that the member is currently receiving antiretroviral therapy and is adherent to that therapy.

Billing Rule

Quantity restriction

Operational quantity restriction: one vial per day for dosing requirements. Egrifta WR is supplied as a multiple‑dose vial that, after reconstitution, provides daily doses for 7 consecutive days — any unused reconstituted solution should be discarded. Note that the one‑vial‑per‑day operational quantity restriction was added in the 3Q2022 review.

Denial Risk

Non‑FDA or off‑label uses

Coverage is not authorized for non‑FDA approved (off‑label) indications unless there is sufficient documentation of efficacy and safety per the referenced off‑label use policies.

Commercial off‑label policy: CP.CPA.09 / CP.CPA.190 (formulary/no coverage)
Marketplace off‑label policy: HIM.PA.154 / HIM.PA.33 (formulary/no coverage)
Medicaid off‑label policy: CP.PMN.53 / CP.PMN.255 (formulary/no coverage)

Applicable Codes

HCPCS / Billing codes referencedHCPCS

J3590

Unclassified biologics

Clinical Evidence

Primary clinical evidence supporting tesamorelin efficacy includes pooled analyses of phase 3, multicenter, double-blind, placebo-controlled trials and the NEJM 2007 trial demonstrating metabolic effects and reduction in abdominal (visceral) fat.

Efficacy endpoints in these trials focused on reduction in abdominal/visceral adipose tissue (VAT) and related metabolic effects.

The policy’s clinical indicator thresholds for abdominal lipodystrophy (waist circumference and waist-hip ratio) were revised to reflect the thresholds used in efficacy studies and the FDA-labeled indication.

Dosing used in efficacy and product labeling is Egrifta SV 1.4 mg/day (single-dose vial) and Egrifta WR 1.28 mg/day delivered via one reconstituted vial per week (providing seven daily doses).

Background

Tesamorelin acts as a growth hormone-releasing factor analog to stimulate endogenous growth hormone release and is indicated for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy.

Formulation history: On June 15, 2020, Theratechnologies discontinued the original Egrifta and permanently replaced it with Egrifta SV, a smaller-volume injection that can be stored at room temperature. A later approved multiple-dose vial formulation, Egrifta WR, provides seven daily doses after reconstitution.

Product dosing and forms: Egrifta SV is supplied as a single-dose vial with 2 mg powder for reconstitution and is dosed 1.4 mg (0.35 mL) subcutaneously once daily. Egrifta WR is supplied as a multiple-dose vial with 11.6 mg powder for reconstitution; one reconstituted vial yields daily doses for seven consecutive days and is dosed as 1.28 mg/day (administered via one vial per week).

Revision History

05.09.24revised

03.29.22added

3Q 2022 annual review: added quantity restriction (1 vial per day) to dosing requirement and updated HCPCS codes.

04.10.25added

RTA 04.10.25: added newly approved Egrifta WR formulation.