CurrentUnitedHealthcarePolicy 2024 P 1049-12

Pa Notification Interim New Product Criteria

Policy governs interim authorization criteria for newly FDA-approved drug products that require notification to UnitedHealthcare Pharmacy when drug-specific criteria are not yet available. It outlines approval conditions, authorization duration, quantity ceilings, and special handling for oral oncology products until product-specific criteria are implemented.

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Interim New Product Criteria

Policy CodePolicy 2024 P 1049-12

Change TypeRevised (no material change)

Effective DateMar 1, 2025

Next Review Date

Key ActionProviders must request authorization under this interim criterion for newly FDA-approved drugs designated by UHCP until drug-specific criteria are implemented; approvals issued under this criterion are for the specified duration and quantity limits.

SourceLink

POLICY UPDATE CHANGES

Effective date set to 3/1/2025; P&T approval dates include 12/2024.

Increased default authorization period to 6 months (prior history of 3 months in earlier versions).

1Program Type (Prior Authorization/Notification)

6 monthsDefault Authorization Period

Up to FDA maxQuantity Ceiling

Coverage Summary & Scope

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Policy Number: 2024 P 1049-12. Subject: Interim new FDA-approved drug product notification coverage. Scope: This policy governs interim authorization criteria for newly FDA-approved drug products that require notification to UnitedHealthcare Pharmacy when drug-specific criteria are not yet available. It outlines approval conditions, authorization duration, quantity ceilings, and special handling for oral oncology products until product-specific criteria are implemented.

Overview: This is an interim coverage criterion (Program = Prior Authorization/Notification) that approves recent FDA-approved drugs when all required conditions from the product labeling are met. Authorization under this criterion is issued for a default period of 6 months (or the FDA-approved treatment duration when that is less than 6 months) and allows a quantity ceiling up to the maximum FDA-approved dose. Oral oncology is routed to the Oral Chemotherapeutic Agent Prior Authorization Program. Effective date: 3/1/2025.

Surface thresholds and program-level quick facts

Authorization duration (default)6 months

Quantity ceilingUp to maximum FDA-approved dose

If FDA-approved treatment duration < 6 monthsUse the FDA-approved treatment duration for authorization

Program typePrior Authorization/Notification (Interim New Product Coverage Criteria)

Effective date / most recent reviewEffective 3/1/2025; P&T review most recent 12/2024

Coverage Criteria (Interim Authorization Rules)

Initial Approval for Recent FDA-Approved Drugs Without Drug-Specific Criteria

Covered when ALL of the following are met:

Diagnosis and labeling requirements: Diagnosis is consistent with an indication listed in the product's FDA-approved prescribing information (or package insert).
Additional prescribing information requirements: Additional requirements listed in the 'Indications and Usage' and 'Dosage and Administration' sections of the prescribing information (or package insert) have been met (e.g. first line therapies have been tried and failed; any testing requirements have been met, etc.).

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Initial Approval for Recent FDA-Approved Drugs Without Drug-Specific Criteria

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Authorization Duration and Quantity Limits

Authorization terms applied to approvals under this interim criterion:

Default authorization period and quantity ceiling: Authorization will be issued for 6 months and should allow a quantity ceiling limit up to the maximum FDA approved dose unless otherwise noted on tracking grid or unless the FDA approved treatment duration is less than 6 months.6 months; up to maximum FDA approved dose
Shorter FDA-approved treatment duration: If FDA approved treatment duration is less than 6 months, utilize the approved duration for authorization period.Use FDA-approved treatment duration
Quantity requests above FDA maximum: Requests for higher quantity beyond the FDA approved maximum dosing are not separately reviewable by the PA department.

Oral Oncology Products

Special handling:

Oral Oncology Products: Oral oncology products will use the Oral Chemotherapeutic Agent Prior Authorization Program criteria for review.

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Oral Oncology Products

What Providers Must Do

Prior Authorization

Prior authorization / notification required for interim new products

Providers must request authorization under this interim criterion for newly FDA-approved drugs designated by UnitedHealthcare Pharmacy until drug-specific criteria are implemented. Approvals issued under this criterion will be for the specified duration and quantity limits (authorization issued for 6 months and quantity ceiling up to the maximum FDA-approved dose unless noted otherwise or the FDA-approved treatment duration is less than 6 months).

Documentation Required

Clinical documentation must match FDA labeling

Providers must document that the diagnosis matches an FDA-approved indication and that additional requirements in the 'Indications and Usage' and 'Dosage and Administration' sections of the prescribing information (for example, prior therapy trials or required testing) have been met.

Billing Rule

Quantity requests above FDA maximum not reviewable

Requests for quantities beyond the FDA-approved maximum dosing will not be separately reviewed by the prior authorization department; authorization should allow a quantity ceiling up to the maximum FDA-approved dose unless otherwise noted or the FDA-approved treatment duration is less than 6 months.

Denial Risk

Potential automated denial or approval

UnitedHealthcare may approve initial or re-authorization solely based on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic without additional clinical review. Use of automated approval and re-approval processes varies by program and therapeutic class.

Background and Definitions

This interim guideline establishes the procedure to review requests for newly FDA-approved drug products that require notification and applies only until drug-specific criteria are developed and implemented. UnitedHealthcare Pharmacy will designate medications subject to this criterion and inform the Pharmacy Benefits Administrator. Oral oncology products will be reviewed using the Oral Chemotherapeutic Agent Prior Authorization Program criteria.

For recent FDA-approved drugs without drug-specific criteria, approvals require: (1) a diagnosis consistent with an indication listed in the product's FDA-approved prescribing information (or package insert), and (2) that additional requirements in the 'Indications and Usage' and 'Dosage and Administration' sections of the prescribing information have been met (for example, prior therapies tried and failed or required testing). Authorization will be issued for 6 months and should allow a quantity ceiling limit up to the maximum FDA-approved dose, unless a tracking grid notes otherwise or the FDA-approved treatment duration is less than 6 months. If the FDA-approved treatment duration is less than 6 months, the approved duration should be used. Requests for quantities beyond the FDA-approved maximum dosing are not separately reviewable by the prior authorization department.

Additional rules: UnitedHealthcare may approve initial or re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic. Use of automated approval and re-approval processes varies by program and therapeutic class.

Term	Definition
UHCP	UnitedHealthcare Pharmacy
PBA	Pharmacy Benefits Administrator

Revision History

2025-03-01effective_dateLatest

Effective date set to 3/1/2025; Interim criterion governs review/authorization of newly FDA-approved drugs until drug-specific criteria are implemented. Authorizations issued under this criterion are for 6 months with quantity ceilings up to the maximum FDA-approved dose unless the FDA-approved treatment duration is less than 6 months.

2024-12-01review

P&T annual review completed 12/2024; no changes to coverage criteria (non-material).

10/2023review

P&T review completed 10/2023; no changes to coverage criteria.

8/2021review

Annual review completed 8/2021; no changes to coverage criteria.

8/2020review

Annual review completed 8/2020; no changes to coverage criteria.

8/2019review

Annual review completed 8/2019; updated background to indicate oral oncology drugs utilize the Oral Chemotherapeutic Agent Prior Authorization Program and removed oral chemotherapy from authorization duration instructions.

8/2018review

Annual review completed 8/2018; revised authorization language for oncology.

8/2017review

Review completed 8/2017; updated authorization period to clarify quantity limit.

8/2016review

Review completed 8/2016; updated background to remove reference to general oral oncology criteria.

3/2016review

Review completed 3/2016; increased authorization period for oral oncology drugs to 12 months.

5/2015review

Annual review completed 5/2015; no changes to coverage criteria.

7/2014change

Change implemented 7/2014: Added criteria requiring additional requirements listed in prescribing information and added supply limit ceiling up to FDA-approved maximum dosing.

5/2014change

Change control entry 5/2014 noted; interim new product coverage criteria recorded in program history.

2013-05initial_approval

Program P&T approvals begin in 2013 with ongoing annual reviews recorded thereafter.

unspecifiedpolicy_change

Increased default authorization period historically from 3 months to 6 months (documented in change history).