ModifiedMass General Brigham Health PlanPolicy N/A

Egrifta SV (tesamorelin)

Defines prior authorization, clinical criteria, quantity limits, specialty dispensing, and continuation requirements for Egrifta SV (tesamorelin) for treatment of HIV-associated lipodystrophy (reduction of excess abdominal fat). Applies to pharmacy benefit with specialty designation.

Policy Summary

PayerMass General Brigham Health Plan

PolicyEgrifta SV (tesamorelin)

Policy CodePolicy N/A

Change TypeRevised criteria and administrative updates

Effective DateOct 1, 2021

Next Review Date

Key ActionObtain prior authorization and submit documentation including HIV-associated lipodystrophy diagnosis, antiretroviral therapy duration, sex-specific waist circumference, evidence other causes of VAT ruled out, failed lifestyle modification, and decreased waist size for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Switched from CVS SGM to custom criteria; added waist circumference measurements for initial and reauthorization; administrative change of drug name to Egrifta SV due to discontinuation of original product.

2Quantity limit entries

6 monthsMax approval duration

specialtyDispensing requirement

Coverage Summary & Scope

Egrifta SV (tesamorelin) is covered with criteria for reduction of excess abdominal fat in HIV-associated lipodystrophy and is subject to prior authorization. Coverage applies to the pharmacy benefit and this medication has been designated specialty and must be dispensed via a contracted specialty pharmacy. The policy defines clinical eligibility, documentation requirements, quantity limits, and reauthorization rules to align coverage with available evidence and plan specialty-supply controls.

Initial Therapy Criteria

Initial Authorization

Authorization may be granted when ALL the following criteria are met and documentation is provided:

ALL of the following

Member has been using antiretroviral therapy for at least two months within the last 90 daysat least 2 months within the last 90 days
Member is diagnosed with lipodystrophy associated with HIV
Other potential causes of visceral adipose tissue (VAT) accumulation/central obesity have been ruled out
Sex-specific waist circumference
- Female waist circumference: For female members: current waist circumference is > 88 cm> 88 cm
- Male waist circumference: For male members: current waist circumference is > 102 cm> 102 cm
Member has failed lifestyle modification with diet and exercise

Members New to the Plan (Special Allowance)

Members New to the Plan

Special allowance:

Authorization may be granted for members new to the plan who are currently receiving treatment with Egrifta (excluding when the product is obtained as samples or via manufacturer's patient assistance programs)

Continuation / Reauthorization Criteria

Continuation / Reauthorization

Reauthorization may be granted when ALL of the following are met and documentation is provided:

ALL of the following

Clinical documentation is submitted supporting the member has had a decrease in waist size from baseline
Member is currently receiving antiretroviral therapy

Prior Authorization, Documentation & Billing Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Egrifta SV. Authorization may be granted for members new to the plan who are currently receiving treatment (excluding samples and manufacturer patient assistance program supplies) or when initial coverage criteria are met.

Documentation Required

Clinical documentation required

Required documentation: diagnosis of HIV-associated lipodystrophy; evidence member has been on antiretroviral therapy for at least 2 months within the last 90 days; current waist circumference measurement (sex-specific: >88 cm for females, >102 cm for males); documentation that other causes of visceral adipose tissue (VAT) accumulation/central obesity have been ruled out; documentation of failed lifestyle modification with diet and exercise. For reauthorization, clinical documentation must show a decrease in waist size from baseline and that the member is currently receiving antiretroviral therapy.

HIV-associated lipodystrophy diagnosis
Antiretroviral therapy duration (≥2 months within last 90 days)
Waist circumference measurement (female >88 cm; male >102 cm)
Evidence other causes of VAT ruled out
Documented failure of lifestyle modification (diet and exercise)
For reauthorization: decreased waist size from baseline and current antiretroviral therapy

Billing Rule

Specialty pharmacy dispensing

Egrifta SV must be dispensed via a contracted specialty pharmacy as designated by the plan.

Billing Rule

Quantity limits

Quantity limits: Egrifta vial 1 mg — 60 per 30 days; Egrifta SV vial 2 mg — 30 per 30 days.

Egrifta vial 1 mg: 60 per 30 days
Egrifta SV vial 2 mg: 30 per 30 days

Denial Risk

Reauthorization timeframe

Initial approvals and reauthorizations may be granted for up to 6 months. Claims submitted beyond an authorized period may be denied unless a reauthorization is obtained.

Clinical Evidence and Background

Egrifta (tesamorelin) is a growth hormone releasing factor FDA indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. This policy aligns coverage to the prescribing information and evidence and implements plan specialty-supply controls including prior authorization and specialty pharmacy dispensing requirements.

Prescribing information: Egrifta SV (tesamorelin) prescribing information, Theratechnologies; October 2019.

Definitions: VAT = Visceral adipose tissue.

Policy Revision History

07/21/2021reviewLatest

Change reviewed at July P&T: switched from CVS SGM to custom criteria; added sex-specific waist circumference measurements for initial authorization and reauthorization; administrative drug name change to Egrifta SV due to discontinuation of the original product. (Effective 10/01/2021)

10/01/2021effective_dateLatest

Policy changes became effective: implementation of custom criteria including waist circumference thresholds for females (> 88 cm) and males (> 102 cm), continuation/reauthorization requirement for documented decrease in waist size, specialty pharmacy dispensing designation, and quantity limits (Egrifta vial 1 mg — 60 per 30 days; Egrifta SV vial 2 mg — 30 per 30 days).