CurrentUnitedHealthcarePolicy 2025D0113D

Medical Benefit Therapeutic Equivalent Medications Excluded Drugs

Defines UnitedHealthcare's policy for excluding medical benefit medications deemed therapeutically equivalent to covered alternatives and describes when clinical review may allow coverage; applies to provider-administered medical benefit medications under UnitedHealthcare plans.

Policy Summary

PayerUnitedHealthcare

PolicyMedical Benefit Therapeutic Equivalent Medications Excluded Drugs

Policy CodePolicy 2025D0113D

Change TypeRoutine reviewno change to coverage guidelines

Effective DateOctober 1, 2025

Next Review Date

Key ActionSubmit medical records documenting trial and failure, intolerance, or contraindication to preferred therapies when requesting approval for an excluded medication.

SourceLink

POLICY UPDATE CHANGES

Routine review; no change to coverage guidelines

up to sixtherapeutic equivalence determinations per calendar year

1policy (Medical Benefit Drug Policy)

Oct 1, 2025effective date

Coverage Criteria

Approval for Excluded Therapeutically Equivalent Medications

Policy Summary

PayerUnitedHealthcare

PolicyMedical Benefit Therapeutic Equivalent Medications Excluded Drugs

Policy CodePolicy 2025D0113D

Change TypeRoutine reviewno change to coverage guidelines

Effective DateOctober 1, 2025

Next Review Date

Key ActionSubmit medical records documenting trial and failure, intolerance, or contraindication to preferred therapies when requesting approval for an excluded medication.

SourceLink

On This Page

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Approval conditions: 1) Reviewed against available clinical evidence, which includes applicable Medical Benefit Drug Policies; 2) Submission of medical records documenting history of trial and failure, inadequate response, or intolerance to the therapeutically equivalent covered medications as listed in the Medical Benefit Therapeutic Equivalent Medications - Excluded Drug List with Preferred Alternatives; 3) One of the following: a) Provider explanation of potential rationale for how the excluded medication will work if stating the patient failed on the covered therapeutically equivalent product (including where the alternative has the same active ingredient or is a biosimilar/highly similar product); or b) Documentation that the member had an adverse reaction to an inactive ingredient in the alternative product.

From Coverage Rationale

Medications listed on the Medical Benefit Therapeutic Equivalent Medications - Excluded Drug List with Preferred Alternatives are subject to exclusion from coverage unless otherwise required by law or the member's benefit plan design. This policy applies to certain medical benefit medications that are healthcare provider administered and that have been deemed therapeutically equivalent by the UnitedHealthcare Pharmacy & Therapeutics Committee. When a medication is listed on the excluded drug list, it will be excluded from coverage unless an exception is allowed by the member's benefit documents or applicable law.

When the member's benefit plan design allows clinical review, an excluded medication may be approved only if all approval conditions are met: the request is reviewed against available clinical evidence (including applicable Medical Benefit Drug Policies); medical records document a history of trial and failure, inadequate response, or intolerance to the therapeutically equivalent covered medications; and either the provider explains why the excluded medication is expected to work despite failure on the covered equivalent or there is documentation of an adverse reaction to an inactive ingredient in the alternative product.

UnitedHealthcare Medical Benefit Drug Policies represent determinations about whether a health service is proven effective based on published clinical evidence and whether it is medically necessary under the member's benefit plan. Services or treatments that are determined by the clinical evidence to be experimental, investigational, unproven, or not medically necessary are typically not covered.

Excluded therapeutically equivalent medications are not covered except when an approved exception is granted in accordance with the approval criteria described in this policy and as allowed by the member's benefit plan design or legal requirements.

Provider Actions and Requirements

Prior Authorization

Clinical review required for excluded medications

Certain medications listed on the Medical Benefit Therapeutic Equivalent Medications - Excluded Drug List with Preferred Alternatives may be excluded from coverage. When the member's benefit plan design allows, prior clinical review may be requested to consider approval of an excluded medication.

Excluded medications identified on the excluded drug list
Approvals only when allowed by the member's benefit plan design

Step Therapy

Step / Failure requirement

Before approval of an excluded medication, documentation must show a history of trial and failure, contraindication, or intolerance to the therapeutically equivalent covered medications listed as preferred alternatives. Coverage decisions require review of available clinical evidence and applicable Medical Benefit Drug Policies.

History of failure, contraindication, or intolerance to preferred products required
Clinical evidence reviewed against applicable Medical Benefit Drug Policies

Documentation Required

Required documentation for clinical review

Providers must submit medical records documenting prior trials, inadequate response, or intolerance to the therapeutically equivalent covered medications. Medical records should include dates of treatment, dose and duration, reason for discontinuation, and any adverse reactions. Provider rationale explaining why the excluded medication is expected to work when the covered alternative failed (or documentation of adverse reaction to an inactive ingredient) should be included when applicable.

Medical records with trial dates, dose, duration, and reason for failure/intolerance
Provider explanation of rationale for excluded medication when claiming failure on equivalent product
Documentation of adverse reaction to an inactive ingredient in the alternative product (if applicable)

Denial Risk

Exclusion triggers

Medications appearing on the Medical Benefit Therapeutic Equivalent Medications - Excluded Drug List with Preferred Alternatives trigger exclusion review. When a drug is designated as therapeutically equivalent to a covered product and listed as excluded, the exclusion applies unless the member's plan permits exception based on documented clinical criteria.

Drugs listed on the Medical Benefit Therapeutic Equivalent Medications - Excluded Drug List with Preferred Alternatives
Therapeutically equivalent products and approved biosimilars designated by UnitedHealthcare
Exclusions applied except where plan design or law requires coverage

Definitions

Therapeutically equivalent — definition and determination criteria

DefinitionMedications/products having essentially the same efficacy and adverse effect profile as another covered medication/product, as determined by the UnitedHealthcare P&T Committee (distinct from FDA Orange Book equivalence).

Determination sourcesIncludes drugs approved via 505(b)(2) without clinical efficacy trials, branded drugs approved via ANDA (listed as single‑source brand), product extensions (new strengths/manufacturers/generics), and multi‑product packaging.

Frequency of determinationsTherapeutic equivalence determinations may be made up to six times during a calendar year.

Coverage implicationTherapeutically equivalent medications are generally excluded from coverage unless state law, benefit design, or an approved exception allows otherwise.

Biosimilar — definition noting similarity to a reference product

DefinitionA biological pharmaceutical product approved based on showing it is highly similar to a reference product and has no clinically meaningful differences in safety and effectiveness from the reference product.

Role in exclusionsA product with an approved biosimilar that is therapeutically equivalent to another covered product may be subject to exclusion under the policy.

Determination frequencyDeterminations involving biosimilars and therapeutic equivalence may be made up to six times per calendar year.

Background

UnitedHealthcare defines therapeutically equivalent as medications or products having essentially the same efficacy and adverse effect profile as another covered medication/product, as determined by the UnitedHealthcare P&T Committee. Determinations about therapeutic equivalence may consider conventional generics, 505(b)(2) products, product extensions, multiple-packaging products, and biosimilars.

Such therapeutic equivalence determinations may be made up to six times per calendar year. For biosimilars, UnitedHealthcare considers a biosimilar to be a biological product approved based on showing it is highly similar to a reference product with no clinically meaningful differences in safety and effectiveness; a product with an approved biosimilar that is therapeutically equivalent to another covered product may be subject to exclusion under this policy.

OpenPayer

Medical Benefit Therapeutic Equivalent Medications Excluded Drugs

Coverage Criteria

Provider Actions and Requirements

Definitions

Background

Step Therapy Requirements

Site of Care

Biosimilar Guidance