CurrentUnitedHealthcarePolicy 2024 P 1262-7

Vizimpro (dacomitinib) prior authorization/notification

UnitedHealthcare prior authorization/notification policy for Vizimpro (dacomitinib) for treatment of non-small cell lung cancer (NSCLC), specifying initial and reauthorization clinical criteria, age-based auto-approval, authorization duration, and references. State mandates and plan benefits may supersede criteria.

Policy Summary

PayerUnitedHealthcare

PolicyVizimpro (dacomitinib) prior authorization/notification

Policy CodePolicy 2024 P 1262-7

Change TypeAnnual reviewprior material expansion in 11/2022

Effective DateFeb 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Vizimpro for members age 19 and older; authorization issued for 12 months when criteria met.

SourceLink

POLICY UPDATE CHANGES

11/2024 annual review: No changes to coverage criteria

11/2022 added coverage for EGFR S768I, L861Q, and G719X mutation positive tumors

5EGFR mutations listed for coverage

12 moAuthorization duration

<19Automatic processing threshold

NCCNCompendium recognition

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Coverage Summary

Initial Authorization

Vizimpro will be approved based on all of the following criteria:

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC).
Disease is recurrent, advanced, or metastatic.
ONE of the following EGFR mutations:
- Exon 19 deletion.
- Exon 21 L858R substitution.
- S768I.
- L861Q.
- G719X.

Reauthorization

Vizimpro will be approved for reauthorization when the following criterion is met: Authorization will be issued for 12 months.

ALL of the following

Patient does not show evidence of progressive disease while on Vizimpro therapy.

Age-based automatic approval

For members under age 19, prescriptions will automatically process without a coverage review. Authorization will be issued for 12 months.

ALL of the following

Patient is less than 19 years of age.

Applicable Codes

No codes specified in documentmixed

No codes listed

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required for Vizimpro for Adults

Prior authorization is required for Vizimpro (dacomitinib) for adult members. Authorization duration: 12 months. This prior authorization requirement applies to members age 19 and older.

Documentation Required

Documentation of Mutation Status Required

Required documentation to support a request for Vizimpro includes all of the following:

Diagnosis of non-small cell lung cancer (NSCLC)
Disease stage documented as recurrent, advanced, or metastatic
Tumor EGFR mutation status confirming one of: exon 19 deletion; exon 21 L858R substitution; S768I; L861Q; or G719X

Documentation Required

Clinical Evidence & References

Evidence sources include the Vizimpro package insert (Pfizer, December 2020) and the NCCN Drugs and Biologics Compendium (accessed September 25, 2024). The policy notes that NCCN recommendations influenced expansion of coverage to additional EGFR mutations per the changes log.

Background

Vizimpro (dacomitinib) is a kinase inhibitor indicated for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletion or EGFR exon 21 L858R substitution mutations. The NCCN also recommends Vizimpro as first-line or continuation therapy for recurrent, advanced, or metastatic NSCLC with EGFR S768I, L861Q, and/or G719X mutation–positive tumors.

Key coverage facts

EGFR mutations listed for coverage5

Authorization duration12 months

Automatic processing thresholdage <19

Recognition of compendium guidanceNCCN

Revision History

11/2024annual review

No changes to coverage criteria

11/2022material change

Added coverage for EGFR S768I, L861Q, and G719X mutation positive tumors