CurrentMass General Brigham Health PlanPolicy N/A

GamaSTAN (Immune Globulin [Human]) prior authorization and coverage

This policy governs prior authorization, coverage criteria, and use limitations for GamaSTAN (immune globulin) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members; affects specialty pharmacy dispensing and prescribers requesting authorization.

Policy Summary

PayerMass General Brigham Health Plan

PolicyGamaSTAN (Immune Globulin [Human]) prior authorization and coverage

Policy CodePolicy N/A

Change TypeFormulary/system operational change

Effective Date01/01/2024

Next Review DateN/A

Key ActionSubmit prior authorization requests under the pharmacy benefit and ensure documentation supports the specific prophylaxis indication and timeframe.

SourceLink

POLICY UPDATE CHANGES

Reviewed at Dec P&T, switched from SGM to Custom; effective 1/1/2024.

4FDA-approved indications listed

Prior AuthorizationProgram type required

Pharmacy BenefitBenefit applied

1 monthInitial approval duration

Coverage Criteria for GamaSTAN (Immune Globulin)

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Hepatitis A prophylaxis

Authorization may be granted when ONE of the following is met:

Hepatitis A prophylaxis: Member was exposed to hepatitis A virus within the past 2 weeks (eg, household contact, sexual contact, and child care center or classroom contact with an infected person)exposure within past 2 weeks

supports postexposure use

Hepatitis A prophylaxis: Member is at high risk for hepatitis A exposure (examples of populations at high risk for hepatitis A are travelers to and workers in countries of high endemicity of infection and illicit drug users)high risk status

supports preexposure/high-risk use

Measles (rubeola) prophylaxis

Authorization may be granted when ALL of the following are met:

Measles prophylaxis: Member is unvaccinated and has not had measles previously and was exposed to measles within the past 6 daysexposure within past 6 days

single combined requirement

Varicella prophylaxis

Authorization may be granted when ALL of the following are met:

Varicella prophylaxis - exposure: Member was exposed to varicella within the past 10 daysexposure within past 10 days

time window requirement

Varicella prophylaxis - risk: Member is at high risk for severe varicella (eg, immunocompromised persons, newborns/infants, pregnant women)high risk status

patient risk requirement

Varicella prophylaxis - VZIG: Varicella zoster immune globulin (eg, Varizig) is not availableVZIG unavailable

requires VZIG unavailability

Rubella prophylaxis in pregnancy

Authorization may be granted when ALL of the following are met:

Rubella prophylaxis: Member was recently exposed to rubellarecent exposure

timeframe not numerically specified

Rubella prophylaxis: Member is currently pregnantpregnancy

pregnancy required

Continuation criteria

Continuation of therapy

Continuation: All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteriameet initial criteria

applies to continuations and transfers

Requests for GamaSTAN for indications other than the four FDA‑approved prophylactic uses listed in the policy are considered experimental/investigational and not medically necessary. The FDA‑approved indications are: pre‑ or post‑exposure prophylaxis of hepatitis A; postexposure prophylaxis/modification of measles (rubeola) in susceptible persons; postexposure prophylaxis of varicella in immunosuppressed patients when varicella‑zoster immune globulin is not available; and postexposure prophylaxis of rubella during pregnancy.

Use of GamaSTAN for any indication beyond the four FDA‑approved prophylactic indications listed in this policy is not medically necessary and may be denied. Providers should document that the requested use aligns with one of the specified FDA‑approved prophylactic scenarios before submitting an authorization request.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for GamaSTAN under the pharmacy benefit; continuation requests (including new members) must meet initial authorization criteria. This medication is specialty and must be filled at a contracted specialty pharmacy.

Benefit: Pharmacy Benefit (specialty pharmacy required)
Program type: Prior Authorization
Contact (Pharmacy Benefit): Phone: 800-711-4555; Fax: 844-403-1029

Step Therapy

No step therapy requirement documented for GamaSTAN.

Documentation Required

Required Clinical Documentation

Documentation must support the specific prophylaxis indication and timeframe. For continuation or new-member continuation requests, documentation must demonstrate the member meets the initial authorization criteria for the requested FDA‑approved indication.

Hepatitis A: evidence of exposure within the past 2 weeks or documentation of high‑risk travel/occupation/behavior.
Measles (rubeola): evidence the member is unvaccinated, lacks prior measles infection, and was exposed within the past 6 days.
Varicella: evidence of exposure within the past 10 days, documentation the member is high risk for severe varicella (eg, immunocompromised, newborn/infant, pregnant), and confirmation that varicella‑zoster immune globulin is not available.
Rubella: evidence of recent exposure and that the member is currently pregnant.

Denial Risk

Non‑FDA Indications

Requests for indications other than the four FDA‑approved uses (hepatitis A prophylaxis, measles postexposure prophylaxis/modification, varicella postexposure in specified high‑risk patients when VZIG is unavailable, and rubella postexposure in pregnancy) are considered experimental/investigational and not medically necessary.

OpenPayer

GamaSTAN (Immune Globulin [Human]) prior authorization and coverage

Coverage Criteria for GamaSTAN (Immune Globulin)

Provider Actions and Authorization Requirements

Definitions and Related Products

Background