CurrentBlue Cross Blue Shield - IowaPolicy 05.02.43

Interim Policy On New Fda Approvals

Defines interim prior authorization criteria and documentation requirements to approve newly FDA‑approved drugs or existing drugs with newly FDA‑approved indications until drug‑specific or indication‑specific criteria are developed. Applies where no existing prior authorization criteria are available and benefits are subject to contract terms.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyInterim Policy On New Fda Approvals

Policy CodePolicy 05.02.43

Change TypeRevised July 2022; reviewed Oct 2023

Effective DateOct 20, 2020

Next Review Date

Key ActionSubmit prior authorization request with required documentation when no drug-specific or indication-specific prior authorization criteria exist; approval under this interim policy is for up to 6 months (or less if FDA labeling indicates shorter duration).

SourceLink

POLICY UPDATE CHANGES

Policy revised in July 2022 and reviewed in October 2023; no specific clinical policy statement changes documented in the header.

InterimApproval Duration Category

No drug-specific PAApplicability

CoveredCoverage Stance

Coverage Summary

This interim prior authorization policy applies to newly FDA‑approved drugs or existing drugs with newly FDA‑approved indications when no drug‑specific or indication‑specific prior authorization criteria yet exist. It ensures appropriate selection of patients for therapy based on product labeling, clinical guidelines, and clinical studies until drug‑ or indication‑specific criteria can be developed and implemented.

When the interim authorization is used, approval decisions follow the interim criteria and documentation requirements; once drug‑specific or indication‑specific criteria are available and the interim authorization expires, subsequent prior authorization reviews will use the new drug‑specific or indication‑specific criteria.

This policy applies where no existing prior authorization criteria are available and benefits are subject to applicable contract terms. (Policy effective October 20, 2020; revised July 2022; reviewed October 2023.)

Policy metadata and approval threshold

Policy Number05.02.43

SubjectInterim policy for prior authorization of newly FDA-approved drugs or new indications

StatusCURRENT

Effective Date2020-10-20

Last ReviewOctober 2023

Approval duration threshold6 months unless the FDA-approved treatment duration is less than 6 months

Criteria for Approval

Initial Criteria for Approval

The requested newly FDA-approved drug or existing drug with a newly FDA-approved indication may be considered medically necessary when ALL of the following are met:

ALL of the following

There is no prior authorization criteria available for the new drug or for the drug's new indication to review the request.
The requested drug has NOT been excluded from coverage by Wellmark due to plan exclusions (lack of exclusion at launch while awaiting P&T review).
The diagnosis is consistent with an indication listed in the product's FDA-approved prescribing information/package insert.
If applicable
- First line therapies have been tried and failed.
ALL of the following
- Testing requirements have been met if applicable.
- Patient age requirement is met.
- The requested use does not conflict with labeled Limitations of Use if applicable.
ALL of the following
- Clinical trial inclusion criteria (e.g., genetic testing, comorbid conditions, prerequisite therapies) have been met.
- Patient does NOT meet any of the exclusion criteria in the clinical trial(s).
The prescribed dosing will not exceed the maximum FDA-approved dose.

Approval will be for 6 months unless the FDA-approved treatment duration is less than 6 months.6 months unless FDA-approved treatment duration is less than 6 months

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required under interim policy

Submit prior authorization request with required documentation when no drug-specific or indication-specific prior authorization criteria exist. Approval under this interim policy will be for up to 6 months (or for a shorter duration if the FDA-approved treatment duration or labeling indicates a shorter period).

Documentation Required

Required documentation to initiate review

Submit required clinical information to initiate prior authorization review. Include documentation demonstrating the use is consistent with FDA-approved labeling and evidence that applicable clinical trial inclusion/exclusion criteria, testing requirements, and patient age requirements have been met.

Evidence that the request matches the product's FDA-approved labeling/indication
Information showing applicable clinical trial inclusion and exclusion criteria are met
Documentation of required testing (if applicable) and patient age requirements

Billing Rule

Follow FDA labeling for dosing limits

Follow FDA-approved labeling for dosing limits; approvals may be subject to dosing limits consistent with FDA labeling, accepted compendia, and evidence-based practice guidelines. Bill using the appropriate CPT, HCPCS (alpha-numeric), Revenue, and/or ICD diagnostic codes when reporting provider services.

Definitions & Background

The purpose of the interim policy is to ensure appropriate selection of patients for therapy for newly FDA‑approved drugs or new indications by using FDA product labeling, clinical guidelines, and clinical study criteria to guide prior authorization decisions until formal drug‑ or indication‑specific criteria are developed and implemented.

Interim Policy: temporary prior authorization criteria applied to newly FDA‑approved drugs or new indications until drug‑specific or indication‑specific prior authorization criteria can be developed, reviewed, and implemented.

Revision History

2020-10-20original_effective

Original effective date of the interim policy for newly FDA‑approved drugs or new indications.

2022-07revised

Policy revised in July 2022; no specific clinical policy statement changes documented in the header.

2023-10reviewedLatest

Policy reviewed in October 2023; no specific clinical policy statement changes documented in the header.