CurrentUnitedHealthcarePolicy IEXD0060.08

Review at Launch for New-to-Market Medications (Medical Benefit)

Defines UnitedHealthcare's process for reviewing new-to-market, FDA-approved, provider-administered medications billed to the medical benefit and the coverage/authorization approach at product launch. Affects providers seeking coverage for such medications on UnitedHealthcare member medical benefits.

Policy Summary

PayerUnitedHealthcare

PolicyReview at Launch for New-to-Market Medications (Medical Benefit)

Policy CodePolicy IEXD0060.08

Change TypeAdded authorization limits

Effective DateDec 1, 2024

Next Review Date

Key ActionRequest a prior authorization/pre-determination for medications on the Review at Launch Medication List before providing the service to ensure coverage.

SourceLink

POLICY UPDATE CHANGES

Added language that authorization will be up to the maximum FDA‑approved dose and frequency, and duration for no more than 6 months.

6 monthsmaximum initial authorization duration at launch

3 codesexample procedure codes referenced

1+ statespolicy lists state applicability

Coverage Criteria — Review at Launch

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Launch handling: Medication listed on the Review at Launch Medication List will be excluded from coverage until UnitedHealthcare reviews the medication and communicates a utilization management strategy, or until December 31 of the following calendar year, whichever is earliest.

Medical necessity review options: Medical necessity will be reviewed using either: (1) a UnitedHealthcare Pharmacy & Therapeutics (UHC P&T) approved medical benefit drug policy; OR (2) all of FDA approved labeling (including indication, patient age requirements, dosing recommendations, contraindications, and clinical trial inclusion criteria), compendia (if available), and current standard of care evidence.

Biosimilar specific requirement: For an FDA‑approved and launched biosimilar product not listed in a Medical Benefit Drug Policy, the provider must attest that, in their clinical opinion, the clinical response would be expected to be superior with the biosimilar; authorization will be up to the maximum FDA‑approved dose and frequency, and duration for no more than 6 months.6 months

Medications listed on the Review at Launch Medication List are excluded from coverage until UnitedHealthcare completes its review and communicates a utilization management strategy, or until December 31 of the following calendar year, whichever is earlier. During the launch review, medical necessity will be evaluated using either a UnitedHealthcare Pharmacy & Therapeutics (UHC P&T) approved medical benefit drug policy or a review of FDA‑approved labeling, available compendia, and current standard‑of‑care evidence.

Services or items determined by clinical evidence to be experimental, investigational, unproven, or not medically necessary are typically not covered. Providers are strongly encouraged to request a pre‑determination for new‑to‑market medications subject to review at launch because failure to request pre‑determination may result in UnitedHealthcare later denying the service or item as not medically appropriate or not covered.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization / Pre-determination Required

Providers are strongly encouraged to request a pre-determination (prior authorization) for any new-to-market medication listed on the Review at Launch Medication List. Review at Launch requires pre-determination: medications subject to review at launch are excluded from coverage until UnitedHealthcare reviews the medication and communicates a utilization management strategy, as may be required by law or by December 31 of the following calendar year, whichever is earliest. If a pre-determination is not requested, UnitedHealthcare may later deny the service or item as not medically appropriate or not covered. A provider who knows or has reason to believe a service or item may not be covered must request a pre-service organization determination prior to providing or referring for the service or item. Providers may not collect payment from commercial members for services not covered under the applicable benefit plan unless the member provided written consent before the service was rendered.

Affected items: New-to-market, healthcare provider administered medications on the Review at Launch Medication List
Consequence: Excluded from coverage until review completed and UM strategy communicated
Operational note: Pre-determination recommended to avoid later denial

Note

Utilization Management May Be Applied Post-Review

Utilization management strategies (for example, prior authorization, quantity limits, step therapy) may be applied after the initial Review at Launch determination. Even after a medication is reviewed and a UM strategy communicated, UnitedHealthcare may assign or modify utilization management requirements based on the UHC P&T approved medical benefit drug policy, FDA labeling, compendia, and current standard of care evidence. Authorization durations for newly launched products may be limited (for example, up to the maximum FDA-approved dose and frequency and for no more than 6 months in certain circumstances).

UM sources used in post-review decisions: UHC P&T medical benefit drug policies, FDA approved labeling, compendia, and evidence-based literature
Example authorization limit: up to maximum FDA-approved dose/frequency and duration ≤ 6 months (where specified)

Documentation Required

Medical Necessity Documentation and Sources

Medical necessity determinations for Review at Launch medications will reference a UnitedHealthcare Pharmacy and Therapeutics (UHC P&T) approved medical benefit drug policy when available. If no UHC P&T policy exists, review will consider FDA labeling (indication, age, dosing, contraindications, clinical trial criteria), compendia (if available), and current standard of care per evidence-based literature.

Use UHC P&T approved medical benefit drug policies when available
When policy absent, consider FDA labeling, compendia, and evidence-based standard of care

Denial Risk

Pre-determination Advisement to Avoid Denial

Failure to obtain a pre-determination for a medication subject to Review at Launch may result in denial of coverage. To avoid denial, request pre-determination before providing or referring for the service. See the UnitedHealthcare Care Provider Administrative Guide for more detail on pre-service organization determinations and member billing consent requirements.

Risk: Later denial of services or items deemed not medically appropriate or not covered
Action: Request pre-determination prior to service to protect member and provider

Key Definitions

Review at Launch Medication List

DefinitionA list of new-to-market, FDA-approved, provider-administered medications subject to launch review and utilization management prior to routine coverage determination.

Coverage status at launchMedications on this list are excluded from coverage until UnitedHealthcare reviews the medication and communicates a utilization management strategy, or until December 31 of the following calendar year, whichever is earliest.

Medical necessity review sourcesReview is based on either a UnitedHealthcare Pharmacy & Therapeutics approved medical benefit drug policy OR FDA-approved labeling, compendia (if available), and current standard of care evidence.

Biosimilar attestation requirementIf a biosimilar is involved, the provider must attest that the clinical response would be expected to be superior with the biosimilar product.

Initial authorization limitsAuthorization at launch will be up to the maximum FDA‑approved dose and frequency, and duration for no more than 6 months.

Background — Review at Launch Program

The Review at Launch program enables UnitedHealthcare to review, evaluate, and implement programs for new‑to‑market, FDA‑approved, provider‑administered medications billed to the medical benefit. A medication on the Review at Launch Medication List will remain excluded from coverage until it has been evaluated and a utilization management approach communicated, after which the medication may move to covered status under the communicated strategy.

Biosimilar Coverage Note

Billing Rule

Provider attestation required for biosimilars not in a Drug Policy

When a biosimilar is FDA approved and launched but not yet listed in a Medical Benefit Drug Policy, coverage requires the provider to attest that, in their clinical opinion, the clinical response would be expected to be superior with the biosimilar; authorization will be limited to the maximum FDA‑approved dose and frequency for up to 6 months.

If not reviewed, the biosimilar may be excluded from coverage until UnitedHealthcare reviews it or by December 31 of the following calendar year, whichever is earliest.