CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tukysa (tucatinib) — coverage criteria

Defines prior authorization, documentation, and coverage criteria for tucatinib (Tukysa) for HER2-positive breast cancer and RAS wild-type HER2-positive colorectal cancer for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTukysa (tucatinib) — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of HER2 (and RAS/BRAF where applicable) and confirm tucatinib is prescribed in the required combination regimen.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

2FDA-approved indications listed

3required biomarker items

Coverage Criteria for Tukysa (tucatinib)

Initial therapy — HER2-positive breast cancer

Covered when ALL of the following are met for the FDA breast indication:

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Initial therapy — HER2-positive colorectal cancer

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

Colorectal cancer (FDA) - combination with trastuzumab: Adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancerDisease progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy

Combination with trastuzumab required; member must be RAS and BRAF wild-type; authorization up to 12 months

Compendial indications

Compendial uses considered covered when criteria met:

Compendial breast/colorectal uses: Breast cancer: recurrent unresectable disease or no response to preoperative systemic therapy; Colorectal cancer: BRAF wild-type diseasemust meet documentation and combination therapy requirements

Other compendial uses listed in the document; all other indications are experimental/investigational and not medically necessary

All indications not explicitly listed as FDA-approved or as recognized compendial uses are considered experimental/investigational and not medically necessary for coverage purposes. This policy limits coverage to the FDA-approved indications and the compendial uses enumerated in the document; requests for Tukysa for any other diagnoses or settings should be denied as not meeting medical necessity criteria.

Covered Drug Regimens and Indication Mapping

Regimen	Indication	Key coverage criteria	Coverage status
Tukysa (tucatinib) in combination with trastuzumab and capecitabine	Advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases	Member has HER2-positive disease; disease progressed after one or more prior anti-HER2–based regimens in the metastatic setting; regimen must be used in combination with trastuzumab and capecitabine; prior authorization may be granted for up to 12 months.	Covered with criteria

Regimen	Indication	Key coverage criteria	Coverage status
Tukysa (tucatinib) in combination with trastuzumab	RAS wild-type HER2-positive unresectable or metastatic colorectal cancer	Member has HER2-positive disease and RAS wild-type (KRAS/NRAS) and BRAF wild-type as applicable; disease progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; regimen must be used in combination with trastuzumab; prior authorization may be granted for up to 12 months.	Covered with criteria

Coding and Billing

Prior chemotherapy — colorectal indication (operational)

RequirementFor the FDA colorectal indication, disease must have progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

ContextApplies to adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer as per FDA indication.

Authorization noteAuthorization may be granted for up to 12 months when clinical criteria are met.

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior authorization required (up to 12 months)

Prior authorization is required. Authorization of up to 12 months may be granted when the specified clinical criteria for the breast or colorectal indications are met; document clinical history, prior therapies, and required biomarker and combination-therapy information as part of the request.

Authorization of 12 months may be granted for treatment of HER2-positive breast cancer in combination with trastuzumab and capecitabine when criteria are met [[see source]].
Authorization of 12 months may be granted for colorectal indication when criteria are met.

Step Therapy

Combination therapy requirement

Tucatinib (Tukysa) must be prescribed in combination with trastuzumab; for the FDA breast indication it must also be given with capecitabine as specified in the coverage criteria.

Requested tucatinib will be used in combination with trastuzumab (required).
For HER2‑positive breast cancer indication, combination with trastuzumab and capecitabine is required.

Documentation Required

Required biomarker documentation (HER2, RAS, BRAF)

Submit documentation of biomarker testing to initiate prior authorization: HER2 status where applicable, RAS mutation status where applicable, and BRAF mutation status where applicable.

Documentation of human epidermal growth factor receptor 2 (HER2) status, where applicable.
Documentation of RAS mutation status (KRAS/NRAS), where applicable.
Documentation of BRAF mutation status, where applicable.

Denial Risk

Experimental/Investigational exclusions — denial risk

Use of tucatinib for indications not listed as FDA-approved or in the compendial uses is considered experimental/investigational and is not medically necessary; such requests may be denied.

All other indications are considered experimental/investigational and not medically necessary.

Line of Therapy Requirements

subsequent — Line of therapy

Prior anti-HER2 therapy: For breast cancer indication: disease progressed after one or more prior anti-HER2-based regimens in the metastatic settingone or more prior anti-HER2 regimens

Used to determine line of therapy/subsequent use

Prior chemotherapy (colorectal): For colorectal cancer indication: disease progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapyprior standard chemotherapy

Used to determine line of therapy/subsequent use

subsequent — Line of therapy

Prior chemotherapy (colorectal): Progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy (including appendiceal or anal adenocarcinoma where applicable)prior standard chemotherapy

Establishes that tucatinib is used after standard cytotoxic regimens; required for FDA colorectal indication

Biomarker and Diagnostic Requirements

HER2 — biomarker testing/documentation

Required testDocumentation of HER2 status must be submitted to initiate prior authorization review.

When requiredRequired for both breast and colorectal indications where applicable to confirm HER2-positive disease.

Accepted evidencePathology or molecular testing reports demonstrating HER2 overexpression or amplification as documented in the medical record.

RAS (KRAS/NRAS) — biomarker requirement

RequirementRAS (KRAS/NRAS) must be wild-type for the FDA colorectal indication.

DocumentationSubmit RAS mutation testing results (absence of activating KRAS and NRAS mutations) with prior authorization request.

ScopeApplies to adult patients with HER2-positive unresectable or metastatic colorectal cancer treated in combination with trastuzumab.

BRAF — biomarker requirement (when specified)

Requirement when specifiedBRAF must be wild-type (absence of activating BRAF mutations) when required for the colorectal cancer indication or compendial listings.

DocumentationSubmit BRAF mutation testing results when applicable to the indication being requested.

Role in coverageBRAF wild-type status is noted as a requirement in colorectal indication and compendial uses where specified.

Definitions

HER2-positive — definition

DefinitionHER2-positive disease: tumor confirmed to overexpress human epidermal growth factor receptor 2 (HER2).

Clinical implicationRequired to identify patients eligible for tucatinib-containing regimens for breast and colorectal indications.

Evidence sourceDetermination based on pathology/molecular testing demonstrating HER2 overexpression or amplification.

RAS wild-type — definition

DefinitionRAS wild-type: absence of activating KRAS and NRAS mutations (no detectable activating mutations in KRAS or NRAS).

Testing requirementRoutinely documented by molecular testing and required for the FDA colorectal indication.

Coverage impactRAS mutation presence excludes patients from the RAS wild-type colorectal indication for tucatinib plus trastuzumab.

BRAF wild-type — definition

DefinitionBRAF wild-type: absence of activating BRAF mutations when required for the colorectal cancer indication.

When requiredBRAF testing is required and must show wild-type status for specified colorectal indications or compendial listings.

DocumentationSubmit BRAF mutation testing results with the prior authorization request when applicable.

Background

Tucatinib (Tukysa) is a HER2-directed tyrosine kinase inhibitor referenced in this policy for specific FDA and compendial uses. The policy identifies compendial contexts—such as recurrent unresectable breast cancer, lack of response to preoperative systemic therapy in breast cancer, and BRAF wild-type colorectal cancer—where tucatinib may be considered per compendia; it also clarifies that all other indications are experimental/investigational and not medically necessary.