CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tukysa (tucatinib) — Coverage Criteria for Combination Regimens

Covers medical necessity and prior authorization criteria for tucatinib (Tukysa) in combination regimens for HER2-positive breast cancer and RAS wild-type HER2-positive colorectal cancer for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTukysa (tucatinib) — Coverage Criteria for Combination Regimens

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of HER2, RAS, and BRAF status as applicable and request prior authorization for approved indications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

HER2+primary biomarker for breast

RAS wild-typerequired biomarker for colorectal

BRAF wild-typedocumented for colorectal use

Coverage Criteria

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Breast Cancer — Initial/Subsequent Therapy

Covered when ALL of the following are met for HER2-positive breast cancer (Tukysa in combination with trastuzumab and capecitabine):

Breast cancer indication: Patient has advanced unresectable or metastatic HER2-positive breast cancer (including brain metastases) or recurrent unresectable disease

Includes patients who have received one or more prior anti-HER2-based regimens in the metastatic setting, and allows use as initial therapy for small asymptomatic brain metastases

Combination regimen: Tukysa will be used in combination with trastuzumab and capecitabine

Per FDA-approved indication

Documentation of HER2-positive status must be provided

See documentation requirements for acceptable test results

Clinical scenario: Member meets one of the eligible clinical scenarios: prior anti-HER2 therapy in the metastatic setting; recurrent unresectable or advanced disease; no response to preoperative systemic therapy; OR small asymptomatic brain metastases as initial therapy

Multiple clinical entry points allowed per FDA and compendial language

Colorectal Cancer — Therapy

Covered when ALL of the following are met for RAS wild-type HER2-positive colorectal cancer (Tukysa in combination with trastuzumab):

Colorectal cancer indication: Patient has unresectable, advanced, or metastatic HER2-positive colorectal cancer (including appendiceal and anal adenocarcinoma)

Indication reflects disease progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy per FDA language

Molecular requirements: Tumor is RAS (KRAS and NRAS) wild-type and BRAF wild-type

Documentation of RAS and BRAF status required

Combination regimen: Tukysa will be used in combination with trastuzumab

Per FDA-approved indication

Patient fitness: Member is not appropriate for intensive therapy or has experienced disease progression

Clinical judgment regarding suitability for more intensive therapy

Continuation of Therapy / Reauthorization

Continuation of therapy covered when ALL of the following are met:

Ongoing benefit: No evidence of unacceptable toxicity and no disease progression while on the current regimen

Authorization of 12 months may be granted for continued treatment

Covered Regimens

Regimen	Indication	Coverage
Tukysa (tucatinib) in combination with trastuzumab and capecitabine	Advanced unresectable or metastatic HER2-positive breast cancer (including brain metastases); for patients who have received one or more prior anti‑HER2–based regimens in the metastatic setting, recurrent unresectable disease, no response to preoperative systemic therapy, or as initial therapy for small asymptomatic brain metastases	Covered with criteria
Required documentation	Documentation of HER2‑positive status is required for coverage	Covered with criteria (authorization may be granted for 12 months)

Regimen	Indication / Molecular Requirements	Coverage
Tukysa (tucatinib) in combination with trastuzumab	RAS (KRAS and NRAS) wild‑type HER2‑positive unresectable, advanced, or metastatic colorectal cancer (including appendiceal and anal adenocarcinoma) that has progressed following fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy; tumor should be RAS wild‑type and BRAF wild‑type (documentation required)	Covered with criteria
Patient fitness / prior therapy	Member is not appropriate for intensive therapy or has experienced disease progression; prior standard chemotherapy as described above	Covered with criteria (authorization may be granted for 12 months)

Provider Actions & Requirements

Prior Authorization

Prior authorization — 12-month approvals

Prior authorization may be granted for up to 12 months for approved indications when the criteria specific to breast or colorectal cancer are met. For breast cancer this includes HER2-positive disease in combination with trastuzumab and capecitabine for recurrent unresectable disease, no response to preoperative systemic therapy, advanced/metastatic disease (including limited or extensive brain metastases), or as initial therapy for small asymptomatic brain metastases. For colorectal cancer this includes unresectable, advanced, or metastatic colorectal cancer (including appendiceal and anal adenocarcinoma) when all applicable molecular and combination criteria are satisfied.

Breast cancer: up to 12 months when criteria for HER2-positive disease with trastuzumab + capecitabine are met
Colorectal cancer: up to 12 months when criteria for unresectable/advanced/metastatic disease and molecular requirements are met

Documentation Required

Intensity of prior therapy / progression

Provide documentation that the member is not appropriate for intensive therapy or has experienced disease progression when applicable. This clinical context must be documented in the medical record to support the request.

Document reason patient is not appropriate for intensive therapy (e.g., comorbidities, performance status) or evidence of disease progression
Include relevant clinical notes, imaging, or physician assessment supporting progression or intolerance to intensive regimens

Documentation Required

Required biomarker documentation

Provide documentation of biomarker status when applicable to the requested indication. Submission of these results is necessary to initiate the prior authorization review.

HER2 status (when applicable)
RAS mutation status (KRAS and NRAS) (when applicable)
BRAF mutation status (when applicable)

Denial Risk

Non-covered indications

Requests for indications not listed (i.e., outside FDA-approved or compendial uses) are considered experimental/investigational and are not medically necessary. Such requests are likely to be denied unless compelling peer-reviewed evidence supports the use and prior authorization criteria are met.

Non-covered: any indication not listed in approved or compendial uses
All other indications are considered experimental/investigational and not medically necessary

Line of Therapy

second-line | subsequent

Line of therapy: Use consistent with the described line: breast cancer — subsequent therapy after one or more prior anti-HER2 regimens in the metastatic setting (or specific initial therapy scenarios such as small asymptomatic brain metastases); colorectal cancer — after progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy

Reflects FDA-approved line-of-therapy language

Biomarker Requirements

inv-15: HER2 — Positive/overexpression or amplification as documented

RequirementTumor must be documented HER2-positive (overexpression or gene amplification)

Supporting indication (breast)Required for HER2-positive advanced/metastatic breast cancer indication (combination with trastuzumab and capecitabine)

DocumentationProvide documentation of HER2 status as part of prior authorization submission

inv-16: RAS (KRAS, NRAS) — Wild-type (negative for mutations)

RequirementTumor must be RAS wild-type (no activating KRAS or NRAS mutations)

Supporting indication (colorectal)Required for RAS wild-type HER2-positive unresectable/metastatic colorectal cancer indication (combination with trastuzumab)

DocumentationProvide documentation of RAS (KRAS and NRAS) mutation status as part of prior authorization submission

inv-17: BRAF — Wild-type (negative for mutation)

RequirementTumor should be BRAF wild-type (no BRAF mutation) where referenced

Compendial mentionBRAF wild-type disease is listed under compendial uses for colorectal cancer

DocumentationProvide documentation of BRAF mutation status when applicable

Background

Tucatinib (Tukysa) is a HER2‑directed tyrosine kinase inhibitor referenced in this policy for treatment of HER2‑positive malignancies in combination regimens. The policy lists FDA‑approved and compendial uses for breast and colorectal cancer and requires that molecular testing be documented when applicable (for example, HER2 status and, for colorectal disease, RAS and BRAF mutation status). Coverage is limited to the specific indications and regimens described; other uses are treated as experimental/investigational and not medically necessary.

Definitions

inv-11: HER2-positive — Tumors that test positive for human epidermal growth factor receptor 2 overexpression or amplification; required for listed breast cancer indications.

DefinitionTumors that test positive for human epidermal growth factor receptor 2 (HER2) overexpression or amplification

Required useHER2-positive status is required for the listed breast cancer indications

DocumentationHER2 status must be provided with the prior authorization request

inv-12: RAS wild-type — Absence of activating KRAS and NRAS mutations; required for listed colorectal cancer indication.

DefinitionRAS wild-type denotes absence of activating KRAS and NRAS mutations

Required useRAS wild-type status is required for the listed colorectal cancer indication

DocumentationRAS (KRAS and NRAS) mutation status must be provided with the prior authorization request

inv-13: BRAF wild-type — Absence of BRAF mutation; referenced for colorectal disease criteria/compendial uses.

DefinitionBRAF wild-type indicates absence of BRAF mutation

ContextBRAF wild-type is referenced for colorectal disease in compendial uses

DocumentationBRAF mutation status should be provided when applicable for colorectal cancer reviews