Currentsierra health and lifePolicy 2025D0060K

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

Defines UnitedHealthcare's process for reviewing newly FDA-approved, provider-administered medications reimbursable under the medical benefit, including initial exclusion and subsequent medical necessity review; affects providers submitting claims for new-to-market medical benefit drugs.

Policy Summary

Payersierra health and life

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

Policy CodePolicy 2025D0060K

Change TypeMultiple list updates (adds/removals) and HCPCS updates

Effective DateDec 1, 2025

Next Review Date

Key ActionRequest a pre-service organization determination (prior authorization) for new-to-market provider-administered medications listed on the Review at Launch Medication List to avoid denial.

SourceLink

POLICY UPDATE CHANGES

Added Boncresa (denosumab-mobz) to the Review at Launch Medication List.

Added Exdensur (depemokimab-ulaa) and Nufymco (ranibizumab-leyk) to the Review at Launch Medication List.

Updated Review at Launch Medication List with multiple adds/removals and HCPCS code updates for specific products (e.g., Imaavy, Yimmugo).

6 monthsMax biosimilar auth

1Policy number

3Example HCPCS codes

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Review and Medical Necessity Determination

Covered status determined after review when ALL of the following are considered

Review criteria: Medication reviewed for medical necessity based on: (1) a UnitedHealthcare Pharmacy and Therapeutics (UHC P&T) approved medical benefit drug policy; and (2) FDA-approved labeling (including indication, patient age requirements, dosing recommendations, contraindications, and clinical trial inclusion criteria), compendia if available, and current standard of care per evidence-based literature.

Medication initially may be excluded until review is complete or until December 31 of the following calendar year.

Biosimilar Authorization Conditions

Authorization conditions for biosimilars when considered for coverage

Biosimilar exceptions/authorization: For an FDA-approved and launched biosimilar not listed in a Medical Benefit Drug Policy: either the product is excluded from coverage until UnitedHealthcare reviews the biosimilar and communicates a utilization management strategy (or until December 31 of the following calendar year, whichever is earliest); OR all of the following conditions are met: provider attests that in their clinical opinion the clinical response would be expected to be superior with the biosimilar product; and authorization is limited to the maximum FDA-approved dose and frequency, and duration for no more than 6 months.6 months

Authorization contingent on provider attestation and UHC review; initial authorization duration typically limited to no more than 6 months.

Medications that appear on the Review at Launch Medication List are excluded from coverage until UnitedHealthcare has reviewed the product and communicated a utilization management strategy, or until December 31 of the following calendar year, whichever is earliest. When a listed medication is reviewed, coverage is determined based on a UnitedHealthcare P&T–approved medical benefit drug policy and on FDA‑approved labeling, compendia (if available), and current evidence‑based standards of care.

Providers are strongly encouraged to request a pre‑service organization determination for new‑to‑market medications subject to Review at Launch. If a pre‑determination is not requested and coverage is uncertain, UnitedHealthcare may later deny the service or item as not medically appropriate or not covered. If a provider reasonably believes a service may not be covered, the provider must obtain a pre‑service determination before providing or referring for the service; providers may not collect payment from commercial members for non‑covered services without prior written member consent.

Coding and Billing

Applicable Codes (examples provided)HCPCS

C9399	Unclassified drugs or biologicals (hospital outpatient use only).
J3490	Unclassified drugs.
J3590	Unclassified biologics

HCPCS updates in policy historyHCPCS

J9256

Applicable HCPCS code added for Imaavy (nipocalimab-aahu) per policy history.

inv-07: Authorization duration for biosimilar

Maximum initial authorization durationAuthorization for a biosimilar (when authorized) will be for no more than 6 months.

Dose and frequency limitsAuthorization limited to the maximum FDA‑approved dose and frequency.

Provider attestation requirementProvider must attest that, in their clinical opinion, the clinical response would be expected to be superior with the biosimilar product when seeking authorization.

Post‑authorization reviewAdditional utilization management may be applied after initial authorization following UnitedHealthcare review.

Provider Actions and Requirements

Prior Authorization

Prior authorization / Review at launch — New-to-market, provider-administered medications

New-to-market, provider-administered, medical-benefit medications listed on the Review at Launch Medication List require prior review. These medications will either be excluded from coverage until reviewed and a utilization management strategy is communicated, or reviewed for medical necessity per UnitedHealthcare criteria.

Medications listed on the Review at Launch Medication List are subject to review at launch.
If not reviewed, medications may be excluded from coverage until reviewed or until December 31 of the following calendar year, whichever is earlier.
When reviewed, medical necessity is based on UHC P&T-approved medical benefit drug policies or FDA labeling, compendia (if available), and current evidence-based standard of care.

Billing Rule

Background

The Review at Launch program enables UnitedHealthcare to evaluate newly FDA‑approved, provider‑administered medications reimbursable under the medical benefit and determine coverage status and subsequent utilization management. Medications listed for review are either temporarily excluded until review is complete or are reviewed for medical necessity using a UHC P&T‑approved medical benefit policy together with FDA labeling, compendia, and current evidence. For biosimilars where authorization is allowed, initial authorization will be limited to FDA‑approved dose and frequency and typically for no more than 6 months, and providers may be asked to attest that the biosimilar is expected to provide superior clinical response when relevant.

Definitions

inv-14: New-to-market, FDA-approved, provider-administered medical benefit medication listed on Review at Launch Medication List

DefinitionA new-to-market, FDA‑approved, provider‑administered medical benefit medication listed on the Review at Launch Medication List is a medication that is FDA approved, administered by a healthcare provider, reimbursable on the member's medical benefit, and subject to Review at Launch when listed.

Initial coverage statusMedication listed on the Review at Launch Medication List is excluded from coverage until it is reviewed by UnitedHealthcare and a utilization management strategy is communicated, or until December 31 of the following calendar year, whichever is earliest.

Medical necessity review basisIf reviewed, medical necessity is determined using a UHC P&T approved medical benefit drug policy, FDA‑approved labeling (indication, age, dosing, contraindications, trial criteria), compendia (if available), and current standard of care per evidence‑based literature.

Provider action recommendedProviders are strongly encouraged to request a pre‑determination to ensure coverage for medications subject to Review at Launch.

Initial Therapy Criteria

Initial Authorization

Initial authorization approach for new-to-market medical benefit drugs

Initial authorization rules: A medication subject to review at launch may be excluded from coverage until UnitedHealthcare completes its review; if the medication is authorized, dosing, frequency, and duration will be limited to FDA-approved parameters. For biosimilars, initial authorization (where allowed) is typically limited to no more than 6 months.6 months

Further utilization management may be applied after review; providers are strongly encouraged to request a pre-determination to avoid potential denials.

Step Therapy

Step	Requirement / Review Consideration
1	Medications will be reviewed for medical necessity based on: (a) a UnitedHealthcare Pharmacy and Therapeutics (UHC P&T) approved medical benefit drug policy; and (b) FDA‑approved labeling (including indication, patient age, dosing, contraindications, clinical trial inclusion criteria), compendia if available, and current standard of care per evidence‑based literature. A medication listed on the Review at Launch Medication List is excluded from coverage until reviewed and a utilization management strategy is communicated, or until December 31 of the following calendar year, whichever is earliest.

Step

Requirement / Review Consideration

Medications will be reviewed for medical necessity based on: (a) a UnitedHealthcare Pharmacy and Therapeutics (UHC P&T) approved medical benefit drug policy; and (b) FDA‑approved labeling (including indication, patient age, dosing, contraindications, clinical trial inclusion criteria), compendia if available, and current standard of care per evidence‑based literature. A medication listed on the Review at Launch Medication List is excluded from coverage until reviewed and a utilization management strategy is communicated, or until December 31 of the following calendar year, whichever is earliest.

Site of Care

Note

Infusion center (site of care applies)

Applies to healthcare provider‑administered medications reimbursable on the member's medical benefit; site of care is determined per the claim/benefit (e.g., infusion center).

Confirm reimbursement and site‑of‑care rules per the member's medical benefit when scheduling infusion or clinic administration.

Biosimilar Guidance

Step Therapy

Biosimilar authorization — up to 6 months

Authorization for a biosimilar (when permitted) may be provided up to the maximum FDA‑approved dose, frequency, and duration for no more than 6 months; provider attestation regarding expected superior clinical response may be required.

Initial authorization typical limit: 6 months; additional utilization management may follow after review.