CurrentNeighborhood Health Plan of Rhode IslandPolicy 1902-A

Lapatinib (Tykerb) coverage criteria

Defines covered indications, documentation, and authorization criteria for lapatinib (Tykerb) for Neighborhood Health Plan of Rhode Island members, including FDA-approved and compendial uses across breast, CNS metastases, chordoma, and select colorectal cancers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLapatinib (Tykerb) coverage criteria

Policy CodePolicy 1902-A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit hormone receptor status, HER2 status, RAS and BRAF mutation status, and EGFR mutation testing results where applicable to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

FDA + compendialcoverage sources

HER2/EGFR/RAS/BRAFrequired biomarker tests

Coverage Criteria for Lapatinib (Tykerb)

FDA-Approved Indications (Breast cancer)

Covered when ALL of the following are met for FDA-approved breast cancer indications:

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FDA-approved HER2+ breast cancer with capecitabine: Lapatinib in combination with capecitabine for advanced or metastatic breast cancer with tumor overexpression of HER2

Patient should have received prior therapy including an anthracycline, a taxane, and trastuzumab; disease progression on trastuzumab is required prior to initiation of lapatinib with capecitabine

Lapatinib with letrozole: Lapatinib in combination with letrozole for postmenopausal women with hormone receptor–positive metastatic breast cancer that overexpresses HER2 when hormonal therapy is indicated

Breast cancer — compendial combination therapy

Covered breast cancer compendial combinations when ANY of the following apply:

Lapatinib combination options: Requested medication used in combination with an aromatase inhibitor (with or without trastuzumab) for HR-positive disease; or in combination with capecitabine or trastuzumab

Authorization of up to 12 months may be granted when criteria are met

Central Nervous System metastases

Covered compendial indication for CNS metastases from breast cancer:

CNS metastases from HER2+ breast cancer: Lapatinib in combination with capecitabine for brain metastases from HER2-positive breast cancer

Authorization of up to 12 months may be granted

Colorectal cancer

Covered compendial indication for colorectal cancer when ALL of the following are met:

HER2-amplified, RAS and BRAF wild-type colorectal cancer: Lapatinib in combination with trastuzumab for HER2-amplified and RAS and BRAF wild-type colorectal cancer (including appendiceal and anal adenocarcinoma)

Member is not appropriate for intensive therapy OR the medication will be used as subsequent therapy for progression of advanced/metastatic disease; authorization of up to 12 months may be granted

Indication	Regimen / Combination	Key requirements / notes	Coverage status
Advanced or metastatic HER2-positive breast cancer (FDA-approved)
Lapatinib in combination with capecitabine
Tumors must overexpress HER2; patient should have received prior therapy including an anthracycline, a taxane, and trastuzumab; disease progression on trastuzumab is required prior to initiation of lapatinib with capecitabine.
covered

second-line | subsequent

Prior therapy context: Used after prior therapies as specified (e.g., prior anthracycline, taxane, and trastuzumab for breast cancer; or as subsequent therapy for progression of advanced/metastatic colorectal disease)

For lapatinib with capecitabine, disease progression on trastuzumab is required before initiation

Provider Authorization and Documentation Requirements

Prior Authorization

Authorization length and reauthorization

Prior authorization may be granted for up to 12 months for specified indications when criteria are met. Reauthorization may be granted for up to 12 months when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Authorization length: up to 12 months for initial approval when criteria are met
Reauthorization: up to 12 months if no unacceptable toxicity or disease progression

Prior Authorization

Requirement for prior trastuzumab

For use of lapatinib (Tykerb) in combination with capecitabine, patients should have disease progression on trastuzumab prior to initiation of treatment with the combination (limitation of use).

Applies to Tykerb + capecitabine combination
Limitation: prior progression on trastuzumab required

Documentation Required

Required diagnostic documentation

Submit diagnostic documentation to initiate prior authorization review.

Hormone receptor (HR) status
HER2 status
RAS and BRAF mutation status (where applicable)
EGFR mutation testing results (where applicable)

Denial Risk

Experimental/Investigational exclusions

All indications for lapatinib not listed in the FDA-approved indications or compendial uses (including those in Sections A–D) are considered experimental/investigational and are not medically necessary.

All other indications not specified as covered/compendial = experimental/investigational and not medically necessary

Biomarker and Diagnostic Test Requirements

inv-16: HER2 — HER2 testing requirement (document HER2 status)

RequirementDocument HER2 status (tumor overexpression of HER2) to establish eligibility for HER2-targeted indications, including breast and colorectal cancer.

Acceptable evidenceHER2 testing as reported by appropriate testing methods described in the medical record or pathology report.

Context — FDA breast indicationsFor FDA-approved breast cancer uses, tumors must overexpress HER2 (see Tykerb combination indications).

inv-17: RAS and BRAF — RAS and BRAF wild-type requirement where applicable.

RequirementDocument RAS and BRAF mutation status as wild-type for eligibility for HER2-amplified colorectal cancer when used with trastuzumab.

ScopeApplies to colorectal cancer (including appendiceal and anal adenocarcinoma) compendial indication for lapatinib plus trastuzumab.

Documentation sourceSubmit RAS and BRAF mutation status in prior authorization documentation.

inv-18: EGFR — EGFR mutation testing requirement for applicable indications.

RequirementDocument EGFR mutation testing results where applicable; EGFR-positivity is required for the chordoma single-agent indication.

ScopeApplies to recurrent EGFR-positive chordoma (lapatinib single agent) and to any other compendial uses requiring EGFR status.

Documentation sourceSubmit EGFR mutation testing results in the prior authorization request when applicable.

Indication	Regimen / Combination	Key requirements / notes	Coverage status
EGFR-positive recurrent chordoma (compendial)
Lapatinib as a single agent
Tumor must be EGFR-positive; authorization may be granted for up to 12 months.
covered

Definitions and Key Terms

inv-13: HER2-positive — Tumors that overexpress HER2 as reported by appropriate testing.

DefinitionTumors that overexpress the human epidermal growth factor receptor 2 (HER2) as reported by appropriate testing.

Clinical relevanceHER2-positive status is required for Tykerb indications in breast cancer and HER2-amplified colorectal cancer.

DocumentationHER2 status must be submitted with prior authorization; tumor overexpression is the eligibility driver.

inv-14: Compendial use — Uses supported by accepted drug compendia such as NCCN and considered covered when approval criteria are met.

DefinitionUses supported by accepted drug compendia such as NCCN and considered covered when approval criteria are met.

Included compendial indicationsBreast cancer compendial combinations; CNS metastases from breast cancer; recurrent EGFR-positive chordoma; HER2-amplified and RAS/BRAF wild-type colorectal cancer.

Coverage implicationCompendial uses are covered when the specific approval criteria (including biomarker and prior-therapy requirements) are satisfied.

Background

Lapatinib (Tykerb) is a small-molecule tyrosine kinase inhibitor that targets the human epidermal growth factor receptors HER2 and EGFR. It is used in combination with other agents for HER2-overexpressing breast cancer and in select compendial indications such as treatment of brain metastases from HER2-positive breast cancer, as single-agent therapy for EGFR-positive recurrent chordoma, and in combination with trastuzumab for HER2-amplified, RAS and BRAF wild-type colorectal cancer. Coverage is contingent on meeting the specific indication criteria, including required biomarker status and prior therapies where specified.