CurrentUnitedHealthcarePolicy CS2025D0060L

Review at Launch for New to Market Medications

Policy governing UnitedHealthcare's process to review new-to-market, FDA-approved, provider-administered medications reimbursable on the medical benefit; places such medications on a Review at Launch Medication List and subjects them to medical necessity review and temporary authorization (up to FDA max dose/frequency for up to 6 months) until further utilization management decisions are made.

Policy Summary

PayerUnitedHealthcare

PolicyReview at Launch for New to Market Medications

Policy CodePolicy CS2025D0060L

Change TypeReview at Launch Medication List updates

Effective DateDec 1, 2025

Next Review Date

Key ActionProviders are strongly encouraged to seek a pre-determination for any new-to-market medication on the Review at Launch Medication List prior to providing the service to ensure coverage.

POLICY UPDATE CHANGES

02/01/2026 - Related Document updated Review at Launch Medication List; added Boncresa (denosumab-mobz), Exdensur (depemokimab-ulaa), Nufymco (ranibizumab-leyk), Yartemlea (narsoplimab-wuug).

01/01/2026 - Related Document updated Review at Launch Medication List; added Itvisma (onasemnogene abeparvovec-brve) and Osvyrti (denosumab-desu); removed prior authorization effective Jan. 1, 2026 for Avtozma (tocilizumab-anoh), Conexxence (denosumab-bnht), Starjemza (ustekinumab-hmny), Stoboclo (denosumab-bmwo).

12/01/2025 - Related Document updated Review at Launch Medication List; added Qivigy (immune globulin intravenous, human-kthm). Archived previous policy version CS2024D0060K.

multipleMedications on Review at Launch List (examples added in 2025-2026)

6 monthsMax temporary authorization duration

Coverage Summary & Scope

This policy governs UnitedHealthcare's process to review new-to-market, FDA-approved, provider-administered medications reimbursable on the medical benefit. Medications identified as subject to this policy are placed on the Review at Launch Medication List and are subject to medical necessity review and temporary authorization while under evaluation.

When authorized under this program, authorization will be up to the maximum FDA approved dose and frequency for a duration of no more than 6 months. The policy takes a mixed coverage stance, as medications are temporarily authorized during review but remain subject to plan benefits and medical necessity determinations and may later be added to the Prior Authorization List or otherwise managed.

Applicability Criteria

This drug policy applies when ALL of the following are met:

ALL of the following

Medication is U.S. Food and Drug Administration (FDA) approved
Medication is healthcare provider administered
Medication is reimbursable on a member's medical benefit
Medication is identified on the Review at Launch Medication List (new-to-market medications placed on this list upon FDA approval)

Applicability

Medical Necessity Review Standards

Medications on the Review at Launch Medication List will be reviewed for medical necessity using ONE of the following OR, when applicable, the listed combination:

ANY of the following

A UnitedHealthcare Pharmacy and Therapeutics (UHC P&T) approved medical benefit drug policy
Medicaid State criteria as required
Or when using clinical evidence sources, ALL of the following
- FDA approved labeling, including but not limited to indication, patient age requirements, dosing recommendations, contraindications, and clinical trial inclusion criteria (e.g., genetic testing, comorbid conditions)
- Compendia (if available)

Authorization Duration and Limits

When authorized under this policy:

ALL of the following

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

Authorization Limits

Provider Requirements & Actions

Prior Authorization

Pre-determination strongly encouraged for Review at Launch medications

Providers are strongly encouraged to seek a pre-determination (pre-service organization determination) for any new-to-market medication on the Review at Launch Medication List prior to providing the service to ensure coverage; failure to request pre-determination may result in later denial as not medically appropriate or not covered.

Documentation Required

Medical necessity documentation standards

Medical necessity reviews will use UHC P&T policies, applicable Medicaid state criteria, and when applicable FDA labeling, compendia, and evidence-based literature. Providers should supply documentation addressing: indication, patient age requirements, dosing recommendations, contraindications, relevant genetic testing and comorbid conditions, and supporting literature to facilitate review.

Billing Rule

Temporary authorization limits

If authorization is granted under Review at Launch, it will be limited to the FDA maximum approved dose and frequency, and the authorization duration will be for no more than 6 months while the medication is under review or until it is added to the Prior Authorization List.

Background & Definitions

The Review at Launch program enables UnitedHealthcare to review and evaluate new-to-market medications upon FDA approval to assess coverage status and to implement appropriate utilization management. The program also provides a mechanism to redirect providers to State Medicaid Fee-For-Service programs when appropriate.

Medications placed on the Review at Launch Medication List are reviewed upon FDA approval and may be added to the Prior Authorization List after evaluation by the UnitedHealthcare Pharmacy and Therapeutics (UHC P&T) Committee and a final utilization management strategy is determined.

Medical benefit medications identified on the Review at Launch Medication List will be reviewed against health plan benefits and for medical necessity while under this policy; claims for these medications will be subject to review to determine whether the service is a covered/reimbursable benefit and meets medical necessity criteria.

Review at Launch Medication List: A list of new-to-market medications identified by UnitedHealthcare to be reviewed upon FDA approval and subject to temporary review and authorization under this policy.

Clinical Evidence & Considerations

Medical necessity reviews for medications on the Review at Launch Medication List will use UnitedHealthcare Pharmacy and Therapeutics (UHC P&T) approved medical benefit drug policies or applicable Medicaid state criteria. When clinical evidence sources are used, reviews will consider FDA approved labeling (including indication, patient age, dosing, contraindications, and trial criteria), compendia (if available), and the current standard of care per evidence-based literature (if available).

No discrete trials or individual evidence items were provided in the brief; evidence[] is empty for this policy.

Revision History & Related Document Changes

12/01/2025revised

Related Document updated Review at Launch Medication List; added Qivigy (immune globulin intravenous, human-kthm). Archived previous policy version CS2024D0060K.

01/01/2026revised

Related Document updated Review at Launch Medication List; added Itvisma (onasemnogene abeparvovec-brve) and Osvyrti (denosumab-desu); removed prior authorization effective Jan. 1, 2026 for Avtozma (tocilizumab-anoh), Conexxence (denosumab-bnht), Starjemza (ustekinumab-hmny), Stoboclo (denosumab-bmwo).

02/01/2026revisedLatest

Related Document updated Review at Launch Medication List; added Boncresa (denosumab-mobz), Exdensur (depemokimab-ulaa), Nufymco (ranibizumab-leyk), Yartemlea (narsoplimab-wuug).