CurrentColorado Rocky Mountain Health PlansPolicy IEXD0060.09

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

Applies to new FDA-approved, provider-administered medications reimbursable on the medical benefit for Individual Exchange plans (all states except MA, NV, NY). Establishes that medications on the Review at Launch Medication List are excluded until reviewed and sets the medical necessity review criteria and authorization limits (including for biosimilars).

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy IEXD0060.09

Change TypeRoutine reviewsubsequent list updates (2025-2026)

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 to ensure coverage.

SourceLink

POLICY UPDATE CHANGES

12/01/2025: Routine review; no change to coverage guidelines; archived previous policy version IEXD0060.08.

12/05/2025 and subsequent 2026 dates: Multiple updates to the Review at Launch Medication List including additions and removals of specific products and updates to applicable HCPCS codes for certain products.

2025-05/2026Policy activity

Excl. MA/NV/NYGeographic scope

6 monthsBiosimilar authorization

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Coverage Summary

The Review at Launch program allows UnitedHealthcare to review new-to-market, FDA-approved, provider-administered medications reimbursable on the medical benefit. Medications listed on the Review at Launch Medication List are initially excluded from coverage until UnitedHealthcare reviews them and communicates a utilization management strategy; following evaluation a medication may be moved to a covered status once a utilization management strategy has been communicated. This policy applies to Individual Exchange benefit plans in all states except Massachusetts, Nevada, and New York. The policy effective date is December 1, 2025.

Medications Subject to Review at Launch - Coverage and Review Criteria

A medication listed on the Review at Launch Medication List will be subject to the following rules and review for medical necessity:

ALL of the following

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 listed on the Review at Launch Medication List
- Coverage status until review
  - Medication is excluded from coverage until the date UnitedHealthcare reviews it and communicates a utilization management strategy as may be required by law or by December 31 of the following calendar year, whichever is earliest
Either
- A UnitedHealthcare Pharmacy and Therapeutics (UHC P&T) approved medical benefit drug policy
- All of the items in the alternate evidence set
  - 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)
  - Current standard of care, as per evidence-based literature (if available)

Biosimilar-specific Conditions

For an FDA-approved and launched biosimilar product not listed in a Medical Benefit Drug Policy:

ANY of the following

ALL of the following
- Excluded from coverage until the date the biosimilar product is reviewed by UnitedHealthcare and a utilization management strategy has been communicated as may be required by law or by December 31 of the following calendar year, whichever is earliest
ALL of the following
- Provider attests that in their clinical opinion, the clinical response would be expected to be superior with the biosimilar product
- Authorization will be up to the maximum FDA approved dose and frequency
  Authorization duration limited to 6 months

Provider Actions & Billing

Prior Authorization

Pre-determination recommended for new to market medications

Providers are strongly encouraged to seek a pre-determination on any new-to-market medications subject to Review at Launch to ensure coverage; failure to request pre-determination may result in later denial as not medically appropriate or not covered.

Documentation Required

Provider attestation for biosimilars

For biosimilars not listed in a medical benefit drug policy, the provider must attest that, in their clinical opinion, the clinical response would be expected to be superior with the biosimilar product to obtain authorization. Note: this attestation is required when the biosimilar is not listed in a Medical Benefit Drug Policy.

Prior Authorization

Authorization limits for biosimilars

Applicable Codes

Applicable HCPCS/Codes provided for referencemixed

C9399	Unclassified drugs or biologicals (Hospital Outpatient Use Only)
J3490	Unclassified drugs
J3590	Unclassified biologics
Q5162	HCPCS listed in policy history as applicable for Bildyos (denosumab-nxxp)
Q5161	HCPCS listed in policy history as applicable for Bosaya (denosumab-kyqq)
J9256	HCPCS added for Imaavy (nipocalimab-aahu) in policy history
C9305	HCPCS removed for Imaavy (nipocalimab-aahu) in policy history

Clinical Evidence & References

Sources referenced: AHFS Drug Information, Clinical Pharmacology, Micromedex, UpToDate, InterQual.

Background

The Review at Launch program provides UnitedHealthcare the ability to review, evaluate, and implement utilization management strategies for new-to-market medications. While a medication is listed on the Review at Launch Medication List it will be excluded from coverage until UnitedHealthcare completes its review and communicates a utilization management strategy as may be required by law or by December 31 of the following calendar year, whichever is earliest. After review UnitedHealthcare may implement utilization management controls or move the medication to covered status; the program also defines medical necessity review criteria and authorization limits (for example, authorization limits for biosimilars when approved).

Quick facts

Geographic scopeApplicable states: All Individual Exchange states except MA, NV, NY

Biosimilar authorizationAuthorization limit for biosimilars: 6 months

Biosimilar authorization duration threshold<= 6 months

Revision History

2025-12-01routine review

Routine review; no change to coverage guidelines; archived previous policy version IEXD0060.08.

2025-12-05material revision

Updated Review at Launch Medication List: added Itvisma (onasemnogene abeparvovec-brve); updated HCPCS for Imaavy (nipocalimab-aahu) to add J3490 and J3590; updated HCPCS for Yimmugo (immune globulin intravenous, human-dira) to add J3490 and J3590.

2026-04-01material revision