CurrentMass General Brigham Health PlanPolicy N/A

New-to-market (NTM) medications — pharmacy prior authorization

Defines prior authorization criteria and coverage limits for new-to-market pharmacy medications (commercial/exchange members) and describes review process and limitations, including GLP-1 stipulations for diabetes vs weight management.

Policy Summary

PayerMass General Brigham Health Plan

PolicyNew-to-market (NTM) medications — pharmacy prior authorization

Policy CodePolicy N/A

Change TypeClarified

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization showing the requested new-to-market medication is for an FDA‑approved indication covered by the member's plan or a recognized off‑label oncology/HIV/AIDS use, plus required documentation of prior treatment failure, contraindication, or exhaustion of other guideline-consistent therapies.

SourceLink

POLICY UPDATE CHANGES

Limitations section was updated to specify that GLP-1s indicated for the treatment of type 2 diabetes will not be approved for non-FDA approved indications (e.g., weight management, prediabetes, type 1 diabetes).

6max duration (months)

Commercial/Exchangeplan

Pharmacybenefit

Prior Authprogram

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Coverage Criteria

Initial Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

NTM Approval Core Criteria: Requested medication is being used for an FDA-approved indication that is covered under the member's plan documents OR for a recognized off-label use of an FDA-approved drug used in the treatment of cancer or HIV/AIDS.

From Coverage Guidelines

Failure/Contraindication/Exhaustion: ONE of the following is met: - a) Documentation from the prescriber that the member had an inadequate treatment response or intolerance to ALL formulary alternatives for the given diagnosis (or to at least one agent within each of a given class of agents when more than one class is available for the diagnosis); OR - b) Member has a contraindication to all formulary alternatives; OR - c) Requested agent is the only FDA-approved product for the member's diagnosis and documentation from the prescriber shows that all other available lines of treatment consistent with generally accepted practice and/or guidelines from a nationally recognized entity have been exhausted.

From Coverage Guidelines

The policy explicitly restricts use of GLP-1 receptor agonists approved for the treatment of type 2 diabetes from being authorized for non‑FDA‑approved indications. Examples of disallowed uses include weight management, prediabetes, and type 1 diabetes. Requests for these non‑FDA indications will not meet the plan's coverage criteria and may be denied.

Coverage for GLP-1 agents that are indicated for weight management or obesity is not determined by this policy alone and may vary by member. Providers and billing staff must refer to the individual member's plan documents for specific coverage rules, exclusions, and any plan‑level benefits that apply.

Coding & Limits

Maximum coverage duration

Standard maximum duration6 months (or up to a complete course of therapy if therapy is less than 6 months, per FDA label or as deemed medically necessary)

Policy effective limitationDuration limited to 6 months unless FDA package insert indicates shorter course

Plan discretionPlan may deem longer or shorter duration medically necessary on a case-by-case basis

Provider Actions & Requirements

Prior Authorization

Prior authorization required for NTM pharmacy drugs

Prior authorization is required for new-to-market medications on the pharmacy benefit; approval requires that the requested medication is being used for an FDA‑approved indication covered under the member's plan documents or for a recognized off‑label oncology or HIV/AIDS use, plus meeting one of the medication-failure/contraindication/exhaustion conditions described in the Coverage Guidelines.

Step Therapy

No step therapy specified

No step therapy program is specified for new‑to‑market medications in this policy.

Documentation Required

Document prior treatment failures or contraindications

Definitions

New-to-market (NTM) medication

DefinitionA new-to-market (NTM) medication is a medication newly introduced to the market that is subject to evaluation by the Pharmacy and Therapeutics Committee and Drug Coverage Committee before formulary placement.

Committee reviewMedications are evaluated by the Pharmacy and Therapeutics Committee and Drug Coverage Committee to analyze current literature, benefits, and risks prior to formulary addition.

Coverage gatingPrior authorization requires that the medication meet approval criteria (FDA‑approved indication covered by the member's plan or recognized off‑label oncology/HIV/AIDS use) and meet failure/contraindication/exhaustion conditions as documented by the prescriber.

Initial Therapy Criteria

Initial Therapy — Initial authorization requirements for NTM drugs on pharmacy benefit.

Initial authorization requirements for NTM drugs on pharmacy benefit

Indication requirement: Requested medication must be for an FDA-approved indication covered under the member's plan or for a recognized off-label use of an FDA-approved drug for cancer or HIV/AIDS.

From Coverage Guidelines

Prior therapy/contraindication/exhaustion: Documentation must show one of the following: inadequate response or intolerance to ALL formulary alternatives for the diagnosis (or at least one agent within each class when multiple classes exist); OR contraindication to all formulary alternatives; OR that the requested agent is the only FDA-approved product for the diagnosis with documentation that all other guideline-consistent lines of treatment have been exhausted.

From Coverage Guidelines

Continuation Therapy Criteria

Continuation Therapy — Duration and continuation rules for ongoing therapy.

Duration/Continuation rules

Continuation/Duration: The duration of coverage will be limited to 6 months or up to a complete course of therapy if therapy is less than 6 months, as noted in the FDA-approved package insert or as deemed medically necessary by the Plan.6 months

From Limitations

Background

New‑to‑market medications undergo formal review by the health plan's Pharmacy & Therapeutics and Drug Coverage Committees prior to formulary placement. These reviews evaluate the available literature on clinical benefit and risks to determine whether the medication and its indications will be added to the pharmacy benefit and, if so, under what prior authorization criteria and limitations.