CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lapatinib (Tykerb) — Coverage Criteria

Defines medical necessity and prior authorization criteria for lapatinib (Tykerb) for FDA‑approved and compendial oncology indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLapatinib (Tykerb) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approval may be granted for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

FDA + compendiacovered indication sources

HER2, HR, RAS, BRAF, EGFRbiomarkers referenced

Coverage Criteria

Covered indications and required conditions

Covered when ALL of the following are met for the specified indication groups:

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Breast cancer (HER2+ metastatic/advanced): Member has HER2‑overexpressing metastatic or advanced breast cancer; lapatinib will be used in combination with capecitabine; member has received prior therapy including an anthracycline, a taxane, and trastuzumab; disease progression on trastuzumab prior to initiation is expected per limitations of use.

Authorization of 12 months may be granted.

Breast cancer (HR+, HER2+) with aromatase inhibitor: Used in combination with an aromatase inhibitor (eg, letrozole, anastrozole, or exemestane) for postmenopausal women with hormone receptor‑positive metastatic breast cancer that overexpresses HER2 when hormonal therapy is indicated.

Authorization of 12 months may be granted.

CNS metastases from HER2+ breast cancer: Treatment of brain (central nervous system) metastases from HER2‑positive breast cancer in combination with capecitabine.

Authorization of 12 months may be granted.

EGFR‑positive recurrent chordoma: Treatment of EGFR‑positive recurrent chordoma as a single agent.

Authorization of 12 months may be granted.

Colorectal cancer with HER2 amplification: Treatment of colorectal cancer (including appendiceal and anal adenocarcinoma) with HER2‑amplified and RAS and BRAF wild‑type disease in combination with trastuzumab when the member is not appropriate for intensive therapy; the requested medication will be used as subsequent therapy for progression of advanced or metastatic disease.

Authorization of 12 months may be granted.

Covered Regimens

Regimen	Indication	Coverage status	Notes
Lapatinib + capecitabine	HER2‑overexpressing metastatic or advanced breast cancer in patients who have received prior therapy including an anthracycline, a taxane, and trastuzumab (disease progression on trastuzumab prior to initiation is expected).	Covered	Authorization of up to 12 months may be granted.

Regimen	Indication	Coverage status	Notes
Lapatinib + letrozole (aromatase inhibitor)	Postmenopausal women with hormone receptor (HR)‑positive metastatic breast cancer that overexpresses HER2 when hormonal therapy is indicated.	Covered	Authorization of up to 12 months may be granted.

Regimen	Indication	Coverage status	Notes
Lapatinib (single agent)	EGFR‑positive recurrent chordoma.	Covered	Authorization of up to 12 months may be granted.

Regimen	Indication	Coverage status	Notes
Lapatinib + capecitabine	Treatment of brain (CNS) metastases from HER2‑positive breast cancer in combination with capecitabine.	Covered	Authorization of up to 12 months may be granted.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and may be granted for up to 12 months when approval criteria for FDA‑approved or compendial indications are met. Authorization of 12 months may be granted for treatment of breast cancer with no response to preoperative systemic therapy or recurrent, advanced, or metastatic HER2‑positive breast cancer when criteria are met.

Prior authorization required for FDA‑approved and compendial uses
Authorization may be granted up to 12 months for eligible breast cancer indications

Note

Preceding Therapy Expectations

For metastatic HER2‑positive breast cancer, lapatinib (Tykerb) is indicated in combination with capecitabine for patients who have received prior therapy including an anthracycline, a taxane, and trastuzumab. Lapatinib may also be used in combination with an aromatase inhibitor (e.g., letrozole, anastrozole, or exemestane) with or without trastuzumab for HR‑positive, HER2‑overexpressing metastatic breast cancer where hormonal therapy is indicated.

Lapatinib + capecitabine for progression after anthracycline, taxane, and trastuzumab
Lapatinib + aromatase inhibitor ± trastuzumab for HR‑positive, HER2‑overexpressing disease

Documentation Required

Required Diagnostic Documentation

Provide the following diagnostic documentation to initiate prior authorization review: hormone receptor (HR) status, HER2 status, RAS and BRAF mutation status, and EGFR mutation testing results where applicable.

Hormone receptor (ER/PR) status
HER2 status (IHC and/or FISH results)
RAS (KRAS/NRAS) and BRAF mutation status for applicable tumor types
EGFR mutation testing results when clinically relevant

Denial Risk

Non‑Covered Indications

Requests for indications not listed (outside FDA‑approved indications or recognized compendia) are considered experimental/investigational and are not medically necessary.

Non‑covered: indications not FDA‑approved or compendial

Line of Therapy

subsequent therapy

Subsequent therapy for colorectal cancer: Lapatinib in combination with trastuzumab is used as subsequent therapy for progression of advanced or metastatic HER2‑amplified, RAS and BRAF wild‑type colorectal cancer (including appendiceal and anal adenocarcinoma); member is not appropriate for intensive therapy.

Authorization of 12 months may be granted.

second-line

Second‑line (breast cancer after trastuzumab): For metastatic HER2‑positive breast cancer, lapatinib in combination with capecitabine is indicated for patients who have received prior therapy including an anthracycline, a taxane, and trastuzumab, with disease progression on trastuzumab prior to initiation.

Authorization of 12 months may be granted.

Biomarker Requirements

RAS and BRAF — biomarker requirements

Markers requiredRAS and BRAF must be wild-type for colorectal cancer indications.

Indication contextRequired for treatment of colorectal cancer (including appendiceal and anal adenocarcinoma) with HER2 amplification in combination with trastuzumab.

Line of therapyUsed as subsequent therapy for progression of advanced or metastatic disease when member is not appropriate for intensive therapy.

DocumentationSubmit RAS and BRAF mutation status to initiate prior authorization review.

EGFR — biomarker requirements

Marker requiredEGFR mutation/positivity required for chordoma indication.

Indication contextEGFR-positive recurrent chordoma: lapatinib may be used as a single agent.

Authorization noteAuthorization of 12 months may be granted for treatment of EGFR-positive recurrent chordoma.

DocumentationSubmit EGFR mutation testing results (where applicable) to initiate prior authorization review.

Definitions

HER2‑positive — definition and requirements

DefinitionHER2-overexpressing (HER2-amplified) tumors: tumors with increased expression or amplification of human epidermal growth factor receptor 2.

Required documentationSubmit HER2 status to initiate prior authorization review.

Relevant indicationsRequired for use in advanced/metastatic breast cancer (with capecitabine or letrozole) and for colorectal cancer with HER2 amplification when specified criteria are met.

Testing implicationHER2 positivity must be demonstrated by appropriate testing per clinical standards prior to approval.

Background

Lapatinib (Tykerb) is an oral tyrosine kinase inhibitor primarily used for HER2‑overexpressing breast cancer. Compendial uses include treatment of CNS metastases from breast cancer, HER2‑amplified, RAS and BRAF wild‑type colorectal cancer in combination with trastuzumab, and EGFR‑positive recurrent chordoma. Authorization may be granted for these indications when criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLapatinib (Tykerb) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approval may be granted for up to 12 months when criteria are met.

SourceLink

On This Page

OpenPayer

Lapatinib (Tykerb) — Coverage Criteria

Coverage Criteria

Covered Regimens

Coding

Provider Actions and Requirements

Line of Therapy

Biomarker Requirements

Definitions

Background