RetiredUnitedHealthcarePolicy CSLA2025D0060L

Review At Launch New To Market Medications La Cs

Policy governs UnitedHealthcare Louisiana medical benefit handling of new-to-market, FDA-approved, provider-administered, reimbursable medications placed on a Review at Launch Medication List; outlines review criteria, review sources, authorization limits and operational instructions until a final PA decision is made or the program is retired.

Policy Summary

PayerUnitedHealthcare

PolicyReview At Launch New To Market Medications La Cs

Policy CodePolicy CSLA2025D0060L

Change TypeRetired

Effective DateDec 1, 2025

Next Review Date

Key ActionProviders are strongly encouraged to seek a pre-determination on any new to market medications subject to review at launch; if pre-determination is not requested UnitedHealthcare may later deny the service as not medically appropriate or not covered.

SourceLink

POLICY UPDATE CHANGES

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

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

01/01/2026: Review at Launch Medication List updated; added Itvisma (onasemnogene abeparvovec-brve), Osvyrti (denosumab-desu); removed Avtozma, Conexxence, Starjemza, Stoboclo (prior authorization effective Jan. 1, 2026).

12/01/2025: Review at Launch Medication List updated; added Qivigy (immune globulin intravenous, human-kthm).

Retired 2026-04-01Policy status

Louisiana-onlyGeographic scope

Coverage Summary & Scope

This policy governs UnitedHealthcare Louisiana medical benefit handling of new-to-market, FDA-approved, provider-administered, reimbursable medications placed on a Review at Launch Medication List. It outlines inclusion and review criteria, evidentiary sources and authorization limits, and operational instructions used while a final prior authorization decision is pending or until the program is retired. The policy was effective December 1, 2025 and was retired with Louisiana plan membership disenrolled on April 1, 2026.

Key policy facts

Policy statusRetired 2026-04-01

Geographic scopeLouisiana-only

Max initial authorization duration6 months

Policy numberCSLA2025D0060L

Effective date2025-12-01

Last review2026-04-01

Applicability / Inclusion Criteria

This drug policy applies to new medications that meet ALL of the following:

Food and Drug Administration (FDA) approved
Healthcare provider administered
Reimbursable on a member's medical benefit

Medical Necessity Review Sources & Authorization Limits

Medical Necessity Review Sources

Medical necessity reviews will be conducted using BOTH of the following:

One of the following
- A UnitedHealthcare Pharmacy and Therapeutics (UnitedHealthcare P&T) approved medical benefit drug policy
- Medicaid State criteria as required
- Or all of the following evidentiary sources
  - FDA approved labeling, including but not limited to indication, patient age requirements, dosing recommendations, contraindications, and clinical trial inclusion criteria (ex. genetic testing, comorbid conditions)

Pediatric / EPSDT Consideration

EPSDT Consideration

Pediatric coverage note

In accordance with EPSDT, children less than 21 years of age are entitled to receive all Medicaid coverable and medically necessary services

Provider Actions & Operational Guidance

Prior Authorization

Pre-determination recommended for Review at Launch medications

Providers are strongly encouraged to seek a pre-determination on any new to market medications that are subject to Review at Launch; if pre-determination is not requested UnitedHealthcare may later deny the service as not medically appropriate or not covered.

Documentation Required

Medical necessity documentation sources

When requesting authorization, provide documentation consistent with UnitedHealthcare P&T policy or Medicaid State criteria or FDA labeling, compendia and evidence-based literature as applicable.

Applicable Codes

Reference HCPCS/Unclassified drug codesHCPCS

C9399	Unclassified drugs or biologicals.
J3490	Unclassified drugs.
J3590	Unclassified biologics.

Background

The Review at Launch program allows UnitedHealthcare to review, evaluate, and implement programs for new-to-market medications, assess their coverage status, and redirect providers to State Medicaid Fee-For-Service when appropriate. Medications placed on the Review at Launch Medication List are evaluated and may be added to the Prior Authorization List after review by the UnitedHealthcare Pharmacy & Therapeutics Committee. During the review period, claims for these medications are assessed against health plan benefits and medical necessity per the policy.

Clinical Evidence & Evidence Sources

Medical necessity determinations rely on FDA-approved labeling, compendia (if available), and current evidence-based standard of care literature, in combination with a UnitedHealthcare P&T–approved medical benefit drug policy or applicable Medicaid State criteria. No individual trials or specific evidence items were provided in the brief.

Revision History

2025-12-01update

Review at Launch Medication List updated; added Qivigy (immune globulin intravenous, human-kthm).

2026-01-01update

Review at Launch Medication List updated; added Itvisma (onasemnogene abeparvovec-brve), Osvyrti (denosumab-desu); removed Avtozma, Conexxence, Starjemza, Stoboclo (prior authorization effective Jan. 1, 2026).

2026-02-01update

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