UnitedHealthcare Review at Launch Coverage

Coverage Criteria — Review at Launch

Review at Launch coverage logic

Covered status determined after review; initial handling at launch:

Launch handling: When a medication is listed on the Review at Launch Medication List, it 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 sources: Medical necessity will be reviewed based on either a UnitedHealthcare Pharmacy and Therapeutics (UHC P&T) approved medical benefit drug policy OR all of the following: FDA‑approved labeling (including indication, patient age requirements, dosing recommendations, contraindications, and clinical trial inclusion criteria), compendia (if available), and current standard of care as per evidence‑based literature (if available).

Biosimilar handling: For an FDA‑approved and launched biosimilar not listed in a Medical Benefit Drug Policy, the product may be excluded until reviewed; alternatively, authorize if the provider attests the biosimilar would be clinically superior. Authorizations are limited to the maximum FDA‑approved dose and frequency and a duration of no more than 6 months.6 months

Medications that appear on the Review at Launch Medication 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. Providers are therefore strongly encouraged to request a pre-determination to confirm coverage and any temporary authorization parameters while the review is pending.

Applicable Codes and HCPCS Updates

Applicable Codes (reference list)HCPCS

C9399	Unclassified drugs or biologicals (Hospital Outpatient Use Only).
J3490	Unclassified drugs.
J3590	Unclassified biologics.

Policy history HCPCS updatesHCPCS

Q5161	HCPCS code replacement example for Bosaya (denosumab-kyqq) as noted in history.
Q5162	HCPCS code replacement example for Bildyos (denosumab-nxxp) as noted in history.
J9256	HCPCS code added for Imaavy (nipocalimab-aahu) as noted in history.

Provider Responsibilities and Authorization Notes

Prior Authorization

Pre-determination and temporary authorization limits

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 earliest. Providers are strongly encouraged to obtain a pre-determination or temporary authorization for new-to-market medications to confirm coverage and, for approved biosimilars, initial authorization may be limited to the maximum FDA‑approved dose, frequency, and duration for no more than 6 months.

Excluded until reviewed or December 31 of the following calendar year (whichever is earliest).
Providers encouraged to seek pre-determination to ensure coverage.
Initial authorization for approved biosimilars limited to FDA maximum dose/frequency and up to 6 months.

Documentation Required

Background — Review at Launch Program

The Review at Launch program evaluates newly FDA-approved, provider-administered medications reimbursable under the medical benefit. When a product is listed on the Review at Launch Medication List, UnitedHealthcare will assess medical necessity using either a UHC P&T–approved medical benefit drug policy or a combination of FDA-approved labeling, compendia (if available), and current evidence-based standard of care. Following review, UnitedHealthcare will communicate any utilization management strategy and the medication’s coverage status.

Key Definitions

Review at Launch Medication List

DefinitionAn external list maintained by UnitedHealthcare identifying new-to-market medications subject to review at launch.

PurposeIdentifies products that 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.

Where to findReview at Launch Medication List (linked in policy): https://www.uhcprovider.com/content/dam/provider/docs/public/policies/attachments/exchange/review-at-launch-medication-list-iex.pdf

Applies toFDA-approved, provider-administered medications reimbursable under the medical benefit for Individual Exchange plans.

Quantity Limits for New-to-Market Medications

New-to-market medications / biosimilars — Initial authorization limits

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

ScopeApplies to new‑to‑market medications and FDA‑approved biosimilars that are provider‑administered and reimbursable under the medical benefit.

Biosimilar handling optionsFor an FDA‑approved and launched biosimilar not listed in a Medical Benefit Drug Policy: either exclude until reviewed or authorize if provider attests the biosimilar would be clinically superior (authorization limited to FDA maximum and up to 6 months).

Provider recommendationProviders are strongly encouraged to seek a pre‑determination for new‑to‑market medications subject to review at launch to ensure coverage and avoid potential later denials.

Site of Care Applicability

Note

Applicability to infusion center/site of care

This policy applies to medications that are provider‑administered and reimbursable under the medical benefit; whether a particular infusion center or other site of care is covered is determined by the member's benefit plan.

Policy governs provider‑administered, medical‑benefit reimbursable medications.
Site‑of‑care specifics (e.g., infusion center) are subject to the applicable benefit plan.

Biosimilar Handling at Launch

Billing Rule

Handling of FDA‑approved launched biosimilars

For an FDA‑approved and launched biosimilar that is not listed in a Medical Benefit Drug Policy, UnitedHealthcare will either exclude the biosimilar from coverage until it is reviewed and a utilization management strategy is communicated, or may authorize it if the provider attests the biosimilar would be expected to produce a superior clinical response; any authorization is limited to the maximum FDA‑approved dose/frequency and duration for no more than 6 months.

Option 1: Exclude until reviewed or until December 31 of the following calendar year, whichever is earliest.
Option 2: Authorize if provider attests superiority; authorization limited to FDA maximum dose/frequency and up to 6 months.

OpenPayer

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