CurrentMass General Brigham Health PlanPolicy N/A

New-to-market (NTM) medication prior authorization

Defines prior authorization requirements and limited-duration coverage for new-to-market medications under Mass General Brigham Health Plan (MassHealth UPPL), applying to pharmacy and medical benefits for members covered by the plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyNew-to-market (NTM) medication prior authorization

Policy CodePolicy N/A

Change TypeClarified criteriarevised duration limits

Effective DateFeb 20, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of inadequate response or intolerance to all formulary alternatives or documentation of contraindications.

SourceLink

POLICY UPDATE CHANGES

Clarified that contraindications to formulary alternatives require documentation from the prescriber.

Reviewed and updated for Pharmacy & Therapeutics; updated approval durations to 3 months and added language about exceeding FDA-recommended duration up to a 3-month maximum when deemed medically necessary by the plan.

MassHealth UPPLPlan

Pharmacy & MedicalBenefits

3 monthsInitial duration

Prior AuthorizationProgram

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Coverage Criteria

Initial Approval Criteria

Covered when ALL of the following are met:

NTM Approval Core: (1) The requested drug 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; AND (2) ONE of the following is met:

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

Contraindications require prescriber documentation per policy clarification.

Limitations / Duration

Coverage duration limits

Standard duration: Duration of coverage will be limited to three (3) months unless one of the exceptions below applies.3 months

Exceptions: Exception A: If the FDA-approved package insert recommends a duration less than 3 months for the requested diagnosis, coverage is limited to that FDA-recommended duration. Exception B: If requesting duration longer than the FDA-recommended duration, coverage may exceed the FDA-recommended duration up to a maximum of 3 months if deemed medically necessary by the plan.<=3 months

Uses that are not FDA-approved and that are not recognized off-label uses for the treatment of cancer or HIV/AIDS are not eligible for coverage under this policy. The requested drug must be used for an FDA‑approved indication covered by the member's plan or for a recognized off‑label use specifically for cancer or HIV/AIDS in order to meet the policy's coverage criteria.

Requests that do not include documentation from the prescriber showing an inadequate treatment response or intolerance to ALL formulary alternatives for the diagnosis (or to at least one agent within each class when multiple classes exist), or that fail to document contraindications to all formulary alternatives when asserted, may be considered not medically necessary and are at risk for denial. The prescriber must provide the required clinical documentation described in the policy to support approval.

Initial Therapy Criteria

Initial therapy duration

Initial authorization duration

Initial duration: Initial approvals are limited to three (3) months unless the FDA label specifies a shorter duration or an exception per policy applies.3 months

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for new-to-market medications under the plan; approval is contingent on meeting the coverage guidelines and documentation requirements.

Step Therapy

Step therapy not required

No step therapy program is specified in this policy; the step therapy box is unchecked and no step requirements apply.

Documentation Required

Required clinical documentation

Prescriber must provide documentation of inadequate treatment response or intolerance to all formulary alternatives (or to at least one agent within each class when multiple classes exist), or documentation of contraindications to all formulary alternatives, or that all other available lines of treatment have been exhausted when this is the only FDA‑approved option.

Definitions

New-to-market (NTM) medications

DefinitionNew-to-market (NTM) medications are recently introduced drugs that undergo review prior to formulary placement.

Review processNTM medications are evaluated by the Pharmacy and Therapeutics Committee and the Drug Coverage Committee to analyze current literature and determine benefits and risks before addition to the formulary.

Prior authorization requirementPrior authorization is required for NTM medications; approval is contingent on meeting the policy's coverage criteria and documentation requirements.

Covered indicationsApproval applies when the drug is used for an FDA‑approved indication covered by the member's plan or for a recognized off‑label use in cancer or HIV/AIDS.

Documentation expectationsPrescriber must document inadequate response or intolerance to all formulary alternatives, a contraindication to all formulary alternatives, or that all other guideline‑consistent treatment options have been exhausted when the product is the only FDA‑approved option.

Background

New‑to‑market medications are reviewed by the plan’s Pharmacy & Therapeutics Committee and the Drug Coverage Committee prior to formulary placement. These committees evaluate the available literature and benefit‑risk profile of the medication to determine whether to add the product to the formulary and to define any coverage conditions. Prior authorization determinations for new‑to‑market drugs are contingent on meeting the committee‑defined coverage guidelines and documentation requirements.

Site of Care

Note

Site of care not specified

Site of care is not specified within this policy.