CurrentNeighborhood Health Plan of Rhode IslandPolicy 3782-A

Tukysa (tucatinib)

Defines coverage, prior authorization documentation, and duration (authorization/continuation) criteria for tucatinib (Tukysa) for FDA-approved and select compendial indications including HER2-positive breast cancer, HER2-positive RAS wild-type colorectal cancer, and HER2-positive biliary tract cancers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTukysa (tucatinib)

Policy CodePolicy 3782-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit documentation of HER2 status and RAS and/or BRAF mutation status, as applicable, to initiate prior authorization review; authorization is for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

3Covered Indications (major)

12Authorization Duration (months)

>=1Prior anti-HER2 regimens required for breast cancer

Coverage Summary & Scope

This policy defines coverage and prior authorization criteria for tucatinib (Tukysa) as covered with criteria for FDA-approved and selected compendial uses, including HER2-positive breast cancer, HER2-positive RAS wild-type colorectal cancer, and HER2-positive biliary tract cancers. Authorization may be granted when the specific indication criteria and documentation requirements are met.

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Initial Therapy Criteria (Authorization)

Covered Indications / Authorization Criteria

Authorization of 12 months may be granted when the following criteria are met for each indication:

FDA-approved Indication - Breast Cancer

ALL of the following
- Tukysa will be used in combination with trastuzumab and capecitabine
- Patient is an adult with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases
- Patient has received one or more prior anti-HER2-based regimens in the metastatic setting OR criteria below for subsequent/initial therapy are met
Alternate breast cancer use (authorization details)
- Used as subsequent therapy for members with no response to preoperative systemic therapy, recurrent unresectable, advanced unresectable, or metastatic disease including limited or extensive brain metastases
- OR used as initial therapy for members with small asymptomatic brain metastases

FDA-approved Indication - Colorectal Cancer

Patient is an adult with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer
Disease has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Tukysa will be used in combination with trastuzumab

Compendial / Biliary Tract Cancers

Patient has locally advanced, unresectable, resected gross residual (R2) or metastatic HER2-positive biliary tract cancer (including gallbladder cancer, intrahepatic and extrahepatic cholangiocarcinoma)
Tukysa will be used in combination with trastuzumab

Compendial additional uses (listed but lower-tier)

Breast cancer - recurrent unresectable disease
Breast cancer - no response to preoperative systemic therapy
Colorectal cancer - BRAF wild-type disease

Colorectal cancer additional requirements

The disease is negative (wild-type) for RAS (KRAS and NRAS) and BRAF mutations
Requested medication will be used in combination with trastuzumab
Intensive therapy is not appropriate or the member has experienced disease progression

Continuation / Reauthorization Criteria

Continuation of Therapy

Reauthorization criteria

ALL of the following

Patient requests reauthorization for an indication listed in the coverage criteria section
There is no evidence of unacceptable toxicity while on the current regimen
There is no evidence of disease progression while on the current regimen

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required with documentation

Submit documentation of HER2 status and RAS and/or BRAF mutation status, as applicable, to initiate prior authorization review. When the coverage criteria are met for an approved or compendial indication, authorization may be granted for 12 months.

Documentation Required

Molecular testing documentation

Provide documentation of HER2 status for HER2-targeted uses. For colorectal (and anal/appendiceal) cancers, provide RAS (KRAS/NRAS) mutation status demonstrating RAS wild-type; provide BRAF mutation status where required.

Denial Risk

Not medically necessary for unlisted indications

Requests for indications that are not listed among the FDA-approved or specified compendial uses are considered experimental/investigational and not medically necessary and may be denied.

Documentation Requirements for Prior Authorization

Submission of the following information is necessary to initiate the prior authorization review:

ALL of the following

Documentation of HER2 status, where applicable
Documentation of RAS mutation status, where applicable
Documentation of BRAF mutation status, where applicable

Clinical Evidence & References

Primary evidence source: Tukysa [package insert], Seagen, Inc.; January 2023.

Compendia/guidelines: NCCN Drugs & Biologics Compendium 2024 and relevant NCCN Guidelines (Colon Cancer 2024; Anal Carcinoma 2024).

Tucatinib (Tukysa) is a HER2-directed tyrosine kinase inhibitor indicated in combination regimens for HER2-positive cancers. The policy references FDA-approved indications — for use with trastuzumab and capecitabine in advanced unresectable or metastatic HER2-positive breast cancer (including patients with brain metastases) and with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer — and selected compendial uses including HER2-positive biliary tract cancers.