CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial PlansPolicy 2025 P 1226-10

Nerlynx® (neratinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Defines prior authorization/notification coverage criteria, durations, and reauthorization rules for Nerlynx (neratinib) across indications including extended adjuvant HER2-positive early-stage or node-positive breast cancer, advanced/metastatic breast cancer, breast cancer with brain metastases, recurrent/metastatic cervical cancer, and patients <19 years of age for UnitedHealthcare commercial plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyNerlynx® (neratinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1226-10

Change TypeRevised (7/2025); Formatting (7/2024)

Effective DateOct 1, 2025

Next Review Date

Key ActionCoverage for Nerlynx requires prior authorization/notification and members must meet the specified clinical criteria for the indicated diagnosis and therapy setting; authorizations are typically issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

7/2025 annual review: updated background and references; added criteria for cervical cancer per NCCN Compendium.

7/2024 annual review: formatting changes to criteria without change to clinical intent.

5Covered Indications (major categories)

12 monthsTypical authorization duration

P&T approvals 2017-2025Policy review history

Coverage Summary

Defines prior authorization/notification coverage criteria, durations, and reauthorization rules for Nerlynx (neratinib) across indications including extended adjuvant early-stage or node-positive HER2-positive breast cancer, advanced/metastatic breast cancer, breast cancer with brain metastases (with specified combinations), recurrent/metastatic HER2-positive cervical cancer, and patients <19 years of age for UnitedHealthcare commercial plans. Authorizations are typically issued for 12 months and reauthorization generally requires no evidence of progressive disease while on Nerlynx therapy (per indication-specific rules). Policy number: 2025 P 1226-10; payer: UnitedHealthcare.

Initial Therapy Criteria

Early-Stage or Node-Positive Breast Cancer (Extended adjuvant)

Authorization will be issued for 12 months.

One of

A - Early-stage extended adjuvant
- Diagnosis of early-stage breast cancer
- Disease is human epidermal growth factor receptor 2 (HER2)-positive
- Used as extended adjuvant therapy following adjuvant trastuzumab-containing therapy (e.g., Herceptin, Kanjinti)
B - Node-positive high risk extended adjuvant
- Diagnosis of node positive breast cancer
- Disease is hormone receptor (HR)-positive and HER2-positive
- Used as extended adjuvant therapy following adjuvant trastuzumab-containing therapy (e.g., Herceptin, Kanjinti)
- Patient has a perceived high risk of recurrence

NCCN Recommended Regimens

Authorization will be issued for 12 months when recognized by NCCN with Category of Evidence and Consensus of 1, 2A, or 2B.

The drug has been recognized for treatment of the cancer indication by The NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Patients less than 19 years of age

Authorization will be issued for 12 months.

ALL of the following

Patient is less than 19 years of age

Continuation / Reauthorization Criteria

Reauthorization is typically issued for 12 months and generally requires that the patient does not show evidence of progressive disease while on Nerlynx therapy. This reauthorization rule is specified for advanced/metastatic breast cancer, breast cancer with brain metastases, and recurrent/metastatic cervical cancer; the pediatric (<19 years) and extended adjuvant early-stage/node-positive criteria note standard 12-month authorizations with duration limits but do not add separate progressive-disease reauthorization requirements in their nodes. (See respective reauthorization nodes within each criteria group.)

NCCN / Other Supported Uses

NCCN supports additional uses of Nerlynx beyond the labeled indications, including combinations for brain metastases (e.g., with capecitabine or paclitaxel) and other settings described in the NCCN Drugs and Biologics Compendium. Coverage for NCCN-recognized uses is allowed when the regimen is listed in the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B under the 'NCCN Recommended Regimens' criteria group.

Applicable Codes

ICD-10 Diagnoses referenced (general guidance)ICD-10

No codes listed

Provider Actions

Prior Authorization

Prior authorization required

Coverage for Nerlynx requires prior authorization/notification and members must meet the specified clinical criteria for the indicated diagnosis and therapy setting; authorizations are typically issued for 12 months.

Authorization duration: 12 months

Documentation Required

Documentation of prior therapies and disease status

Document the member's diagnosis and HER2 status. For extended adjuvant use, document prior trastuzumab-containing therapy. For metastatic or brain metastases settings, document prior anti-HER2 regimens (including receipt of two or more prior anti-HER2 regimens when required). For HR-positive/HER2-negative stage IV patients, document prior CDK4/6 inhibitor therapy when applicable. For reauthorization, document lack of evidence of progressive disease while on Nerlynx therapy.

Clinical Evidence & References

Evidence sources referenced in the brief include the NCCN Drugs and Biologics Compendium recommendations (accessed June 3, 2025) and the Nerlynx FDA package insert (March 2022). The brief notes that NCCN recognition underpins certain covered uses and that the background describes indications such as extended adjuvant therapy and combination use with capecitabine for advanced disease.

Background

Nerlynx (neratinib) is a kinase inhibitor indicated as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer to follow adjuvant trastuzumab-based therapy, and is indicated in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. The NCCN additionally supports use as extended adjuvant therapy in HR-positive, HER2-positive node-positive/high-risk patients, fourth-line-and-beyond combination with capecitabine for recurrent or stage IV HER2-positive disease, single-agent or combinations for certain HR-positive/HER2-negative or triple-negative stage IV disease after CDK4/6 inhibitor therapy, combinations for brain metastases, and as second-line or subsequent therapy for HER2-positive cervical cancer.

Quick facts

Effective date2025-10-01

Last review2025-07

Policy number2025 P 1226-10

StatusCURRENT

Revision History

2025-07annual_reviewLatest

updated background and references; added criteria for cervical cancer per NCCN Compendium

2024-07annual_review

formatting changes to criteria without change to clinical intent