CurrentUnitedHealthcarePolicy CS2024D0060K

Review at Launch for New to Market Medications

Defines UnitedHealthcare's medical benefit review process for FDA-approved, provider-administered, new-to-market medications that are reimbursable on the medical benefit; applies to providers submitting claims or pre-service determinations for affected drugs.

Policy Summary

PayerUnitedHealthcare

PolicyReview at Launch for New to Market Medications

Policy CodePolicy CS2024D0060K

Change TypeNo material change

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionProviders are strongly encouraged to request a pre-determination for medications on the Review at Launch Medication List prior to providing the service.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≤6 momax auth duration

C9399, J3490, J3590example codes

Review at Launch Listrelated doc

UHC P&TP&T evaluation

Coverage Criteria

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Launch review applicability: Medication is FDA-approved; healthcare provider-administered; and reimbursable on member's medical benefit.

Medications meeting these are placed on the Review at Launch Medication List and reviewed upon FDA approval.

Medical necessity standards: Medical necessity review uses either a UHC P&T-approved medical benefit drug policy or applicable Medicaid state criteria; additionally considers FDA labeling, compendia (if available), and current standard of care.

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

This policy defines UnitedHealthcare's medical benefit review process for FDA-approved, provider-administered medications identified as new-to-market and reimbursable on the member's medical benefit. It applies to providers submitting claims or seeking pre-service determinations for drugs listed on the Review at Launch Medication List. Exception: This Medical Benefit Drug Policy does not apply in states with a specified state-specific policy — Indiana, Louisiana, and Ohio have separate Review at Launch policies; North Carolina has no state-specific policy and the national policy applies.

Services determined to be experimental, investigational, unproven, or not medically necessary by the clinical evidence are excluded from coverage under this policy. Medical necessity reviews use UHC Pharmacy & Therapeutics (P&T) approved medical benefit drug policies or applicable Medicaid state criteria and consider FDA labeling, compendia, and current standard of care. If a pre-determination is not requested, UnitedHealthcare may later deny the service or item as not medically appropriate or not covered.

Provider Actions & Requirements

Prior Authorization

Prior Authorization / Pre-service Review Required

Pre-service review (pre-determination) is required for new-to-market medications listed on the Review at Launch Medication List. Providers are strongly encouraged to request a pre-determination before providing or referring for the service to verify coverage and medical necessity.

Applies to medications placed on the Review at Launch Medication List (new-to-market, FDA-approved, provider-administered, reimbursable on medical benefit).
Authorization reviews will assess health plan benefits and medical necessity and may authorize up to the maximum FDA-approved dose and frequency for up to 6 months.

Note

Possible Future Placement on Prior Authorization List

Medications reviewed through the Review at Launch program may later be placed on the Prior Authorization List following evaluation by the UnitedHealthcare Pharmacy and Therapeutics (P&T) Committee and a final utilization management determination.

Placement on the Prior Authorization List may follow P&T review and utilization management assessment.
Providers should monitor plan communications and the Prior Authorization List for updates after P&T decisions.

Documentation Required

Documentation & Review Standards

Required clinical documentation and review standards will be used to determine medical necessity. Reviews use UHC P&T approved medical benefit drug policies, applicable Medicaid State criteria, FDA labeling, compendia (if available), and current evidence-based literature.

Documentation should support indication, patient age, dosing, contraindications, relevant genetic or diagnostic testing, and clinical trial inclusion/exclusion criteria when applicable.
Authorization will consider FDA-approved labeling and may authorize up to the maximum FDA-approved dose/frequency for no more than 6 months.

Denial Risk

Risk of Denial Without Pre-determination

If a pre-determination is not requested for a medication on the Review at Launch Medication List, UnitedHealthcare may deny the service or item as not medically appropriate or not covered.

Potential denial risk if pre-determination not obtained prior to providing service.
Providers must request a pre-service organization determination when there is reason to believe a service may not be covered.

Background

The Review at Launch program enables UnitedHealthcare to evaluate and implement coverage and utilization management for newly FDA-approved, provider-administered medications reimbursable under the medical benefit. Reviews determine benefit coverage and medical necessity for drugs identified on the Review at Launch Medication List and remain in effect until UnitedHealthcare either removes the requirement for pre-service review or places the drug on the Prior Authorization List.

At launch, medical necessity reviews are conducted using a UHC P&T-approved medical benefit drug policy or applicable Medicaid state criteria and also consider FDA-approved labeling, compendia, and current standard of care. Authorizations follow FDA-approved dosing up to the maximum dose and frequency, with authorization durations limited to no more than 6 months at launch.

Providers are strongly encouraged to request a pre-determination prior to providing treatment for medications on the Review at Launch Medication List to verify coverage and reduce the risk of subsequent denial.

Definitions

New-to-market medication — definition and key attributes

DefinitionAn FDA-approved, healthcare provider-administered medication that is reimbursable on a member's medical benefit and identified for review at launch.

Regulatory statusU.S. Food and Drug Administration (FDA) approved.

Administration settingHealthcare provider–administered (provider-administered).

Benefit/payment pathwayReimbursable on the member's medical benefit (medical benefit coverage).

Identification and trackingMedications meeting these criteria are placed on the Review at Launch Medication List and reviewed upon FDA approval.

Review considerationsReviewed for health plan benefits (covered/reimbursable service) and medical necessity using applicable UHC criteria.

Initial Therapy / Launch Review

Initial Therapy/Launch Review

Initial review at market launch

Applicability: Applies to newly FDA‑approved, provider‑administered, medical‑benefit reimbursable medications identified on the Review at Launch Medication List.

Providers are strongly encouraged to request a pre‑determination prior to providing treatment; claims will be reviewed against plan benefits and medical necessity.

Continuation Criteria / Authorization Duration

Continuation/Authorization Duration

Authorization limits at launch

Duration limit: Authorization will be for no more than 6 months.<= 6 months

Authorization is up to the maximum FDA‑approved dose and frequency within that period.

Step Therapy and Post-Launch Actions

Step	Requirement / Description	Related action
1	Medications identified on the Review at Launch Medication List may be subject to additional utilization management or may be moved to prior authorization requirements after evaluation by the UnitedHealthcare Pharmacy & Therapeutics Committee.	May be added to the Prior Authorization List after P&T evaluation; Review at Launch Medication List is updated over time with additions and removals.