CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Tukysa (tucatinib)

Defines clinical indications, inclusion and exclusion criteria, continuation rules, medication management and approval authority for tucatinib (Tukysa) coverage and reimbursement for Neighborhood Health Plan of Rhode Island (via Evolent utilization management). Applies to FDA-approved and certain off-label uses supported by recognized compendia or peer-reviewed literature.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Tukysa (tucatinib)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 29, 2024

Next Review Date

Key ActionAll medication requests for Tukysa must be processed by Evolent and supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes (has_material_change = false).

2Covered Indications (breast, colorectal)

4Explicit Exclusion Reasons

11Committee Review Dates Listed

Coverage Summary

Policy defines accepted indications for tucatinib (Tukysa) including FDA-approved uses and certain off-label uses supported by recognized compendia or peer-reviewed literature. Evolent is responsible for processing all medication requests from network ordering providers and will determine authorization; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

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Initial Therapy Criteria

Breast Carcinoma (metastatic HER2+)

Tukysa (tucatinib) may be used when ALL of the following are met:

Member has metastatic HER2-positive breast cancer
Member has experienced disease progression on one or more anti-HER2 regimens in the metastatic setting

Colorectal Cancer (HER2+, RAS wild-type)

Tukysa (tucatinib) may be used in combination with trastuzumab when ALL of the following are met:

Member has HER2-positive and RAS wild-type metastatic or unresectable colorectal cancer
Disease has progressed following treatment with fluoropyrimidine, oxaliplatin, and/or irinotecan-based chemotherapy
Tucatinib is used in combination with Herceptin (trastuzumab) or trastuzumab biosimilars

Exclusions / Not Medically Necessary

Exclusion Criteria / Not Medically Necessary

Tukysa is not approvable when ANY of the following exclusion criteria are present:

Disease progression on Tukysa (tucatinib)
Lack of documentation for HER2 protein overexpression (and for colorectal cancer indication, lack of documentation of RAS wild-type) in tumor specimens
applies specifically to colorectal cancer indication requirement for HER2 and RAS status
Dosing exceeds single dose limit of Tukysa (tucatinib) 300 mg300 mg
Treatment exceeds the maximum limit of 30 (50 mg) or 120 (150 mg) tablets/month30 x 50 mg or 120 x 150 mg per month
Investigational use for off-label indication that lacks sufficient evidence or is not generally accepted by the medical community
Sufficient evidence defined by CMS compendia, NCCN/ASCO, peer-reviewed literature and multiple evidentiary criteria

Sufficient evidence: evidence supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 criteria, including consideration of patient and regimen representation, clinically meaningful outcomes, study design, and the relative strength of randomized versus non-randomized data.

Provider Actions

Prior Authorization

Prior authorization required

All medication requests for Tukysa must be processed by Evolent. Requests must be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature per CMS requirements.

Documentation Required

Tumor biomarker documentation for colorectal cancer

Provide documentation of HER2 protein overexpression and RAS wild‑type status in tumor specimens for the colorectal cancer indication. Lack of this documentation is an exclusion to coverage.

Denial Risk

Denial for investigational/off-label without sufficient evidence

Requests for off‑label indications that lack supporting evidence in CMS compendia, NCCN, ASCO, or acceptable peer‑reviewed literature may be denied as investigational/not medically necessary.

Billing Rule

Dose and quantity limits enforcement

Claims may be denied if dosing limits are exceeded: single dose must not exceed 300 mg, and monthly tablet quantities must not exceed the stated maxima (30 tablets of 50 mg or 120 tablets of 150 mg per month).

Clinical Evidence

Murthy RK et al., NEJM 2020: tucatinib in combination with trastuzumab and capecitabine evaluated for HER2-positive metastatic breast cancer and cited as a key trial supporting the breast carcinoma indication.

Tukysa prescribing information (Seattle Genetics, Inc. 2023): the product prescribing information is referenced as supporting labeling and dosing guidance for Tukysa across approved indications.

These evidence sources are linked to the covered indications as follows: the Murthy NEJM trial supports Tukysa use for metastatic HER2-positive breast cancer in combination with trastuzumab and capecitabine; the prescribing information provides the FDA-labeled use, dosing limits, and safety information referenced for both breast and colorectal indications.

Background

Background: This policy defines accepted indications for Tukysa (tucatinib), including FDA-approved and certain off-label uses supported by recognized compendia or acceptable peer-reviewed literature per CMS criteria. Evolent processes all medication requests and enforces documentation, clinical criteria, dosing, and quantity limits.

Intent and accepted indications: Tukysa may be used for metastatic HER2-positive breast cancer after progression on one or more anti-HER2 regimens in the metastatic setting, and in combination with trastuzumab for HER2-positive, RAS wild-type metastatic or unresectable colorectal cancer after progression on fluoropyrimidine-, oxaliplatin-, and/or irinotecan-based chemotherapy.

Evolent processing and reimbursement: All medication requests for Tukysa must be submitted to and processed by Evolent; unauthorized medications may be non-reimbursable. Requests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature meeting CMS requirements, and required tumor biomarker documentation (e.g., HER2 and RAS status) must be provided for colorectal cancer indications.

Additional notes: The policy enforces dosing and quantity limits (single dose limit of 300 mg and monthly tablet maxima of 30 tablets (50 mg) or 120 tablets (150 mg)); investigational/off-label uses lacking sufficient evidence may be denied.