UnitedHealthcare Tukysa Prior Auth Coverage

Coverage Criteria for Tucatinib (Tukysa)

Initial Therapy - Breast cancer

Covered when ALL of the following are met

Breast cancer advanced/metastatic: (1) Diagnosis of breast cancer AND (2) disease is advanced unresectable or metastatic AND (3) disease is HER2-positive AND (4) patient has been previously treated with an anti-HER2-based regimen in the metastatic setting (e.g., trastuzumab, pertuzumab, ado-trastuzumab emtansine) AND (5) used in combination with trastuzumab and capecitabine

Authorization will be issued for 12 months

Initial Therapy - Brain metastases

Covered when ALL of the following are met

Breast cancer with brain metastases: (1) Diagnosis of brain metastases with HER2-positive breast cancer AND (2) patient has been previously treated with an anti-HER2-based regimen AND (3) used in combination with trastuzumab and capecitabine

Authorization will be issued for 12 months

Initial Therapy - Colorectal cancer

Covered when ALL of the following are met

Colorectal cancer: (1) Diagnosis of unresectable, advanced or metastatic colorectal cancer that is HER2-amplified and RAS and BRAF wild-type AND (2) one of the following: patient has previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy OR patient is not appropriate for intensive therapy AND (3) used in combination with trastuzumab

Authorization will be issued for 12 months

Initial Therapy - Biliary tract cancers

Covered when ALL of the following are met

Biliary tract cancers: (1) Diagnosis of gallbladder cancer, intrahepatic cholangiocarcinoma, or extrahepatic cholangiocarcinoma AND (2) disease is HER2-positive AND (3) disease is unresectable, resected gross residual (R2), or metastatic AND (4) patient has received at least one prior systemic therapy AND (5) used in combination with trastuzumab

Authorization will be issued for 12 months

Reauthorization

Reauthorization: Patient does not show evidence of progressive disease while on Tukysa (tucatinib) therapy

Authorization will be issued for 12 months

General coverage and authorization conditions

Covered when documentation and program rules are met; authorization details:

Authorization conditions: Approval is contingent on (1) alignment with NCCN/Biologics Compendium recognized regimens (Category 1, 2A, or 2B) or prior clinical/claim history supporting use, (2) applicable state/federal mandates and the member’s benefit plan, and (3) any supply limits or utilization management rules.

Authorization issued for 12 months; automated processes may be used.

For members under 19 years, prescriptions for Tukysa will automatically process without a coverage review. Prior authorization criteria described in this policy do not apply to these members and no additional documentation or review steps are required for coverage determination.

This document segment does not list any explicit exclusion conditions. Coverage decisions may still be subject to program rules, state or federal mandates, and any applicable utilization management controls (for example, supply limits).

UnitedHealthcare may approve initial requests and reauthorizations based solely on prior claims/medication history, diagnosis codes (ICD-10), and automated claim logic where permitted by program rules. Use of these automated approval and re-approval processes varies by program and therapeutic class and may be applied instead of a full clinical review.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for tucatinib (Tukysa). Requests must demonstrate indication-specific criteria (diagnosis, disease stage, HER2 status, prior therapies, and concomitant use with required agents) as described in the coverage criteria.

Prior authorization required for Tukysa (tucatinib) for all indications covered by this policy
Demonstrate indication-specific criteria at time of request

Prior Authorization

Authorization Duration

Authorizations (initial and re-authorization) will be issued for up to 12 months when criteria are met. Approvals may follow NCCN-recognized regimens where applicable.

Standard authorization duration: 12 months
NCCN-recommended regimens may be used to support regimen selection

Initial Therapy Authorization Requirements

Initial Therapy

Initial authorization requires meeting indication-specific criteria including diagnosis, HER2 status, prior therapies, and use with specified combination agents.

Initial authorization: See coverage criteria per indication: breast cancer (with/without brain metastases), colorectal cancer, biliary tract cancers; required combinations include trastuzumab +/- capecitabine depending on indication; prior anti-HER2 therapy required for breast indications; prior systemic therapy or chemotherapy requirements as specified for colorectal and biliary tract cancers

Authorization will be issued for 12 months

Initial therapy considerations

Initial authorization considerations

Initial approval basis: Initial approval may be issued when use aligns with NCCN/Compendia recognized regimens (Category 1, 2A, or 2B) or may be granted based on prior claim/medication history and diagnosis coding per program rules.

State mandates and member benefit plan coverage may also impact approval.

Continuation / Reauthorization Criteria

Continuation Therapy / Reauthorization

Reauthorization conditioned on lack of disease progression

Continuation therapy: Patient does not show evidence of progressive disease while on Tukysa (tucatinib) therapy

Authorization will be issued for 12 months

Re-authorization may be granted and will be issued for 12 months; approval may be based on prior claim/medication history, diagnosis codes, and automated re-approval processes where applicable.

Supply limits may apply.

Re-authorization

Re-authorization may be granted and will be issued for 12 months; approval may be based on prior claim/medication history, diagnosis codes, and automated re-approval processes where applicable.

Step Therapy Considerations

Step	Requirement
1	Patient must have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy before approval for tucatinib in combination with trastuzumab for the colorectal cancer indication
1	OR documentation that the patient is not appropriate for intensive therapy (alternative to prior multi‑agent chemotherapy)

Step	Note
1	Use of automated approval and re‑approval processes varies by program and therapeutic class; specific step therapy requirements are not detailed in this document segment and approvals may be based on prior claim/medication history and diagnosis codes

Quantity Limits and Coding Notes

inv-27: Tukysa (tucatinib) — supply limits note

Quantity/supply limitsSupply limits may be in place for Tukysa (tucatinib).

Prior authorization requiredPrior authorization is required and approvals may follow program rules or automated processes (see authorization criteria).

Authorization durationAuthorizations are issued for 12 months when criteria are met.

Use with combination agentsCovered uses specify combination with trastuzumab ± capecitabine depending on indication (breast, brain metastases, colorectal, biliary).

Automated approvalsUnitedHealthcare may approve initial and re-authorization based on prior claim/medication history and diagnosis codes where applicable.

Background on Tucatinib (Tukysa)

Tucatinib (Tukysa) is an oral kinase inhibitor used as a targeted oncologic therapy. It is indicated in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, after prior anti-HER2 therapy. Tucatinib is also indicated in combination with trastuzumab for certain HER2-amplified colorectal cancers (RAS and BRAF wild-type) after progression on standard chemotherapy regimens, and has recognized use in HER2-positive biliary tract cancers per compendia. References supporting these indications include the Tukysa package insert and recognized compendia such as the NCCN and Biologics Compendium.

Definitions and Reference Terms

inv-19: HER2-positive definition

DefinitionHER2-positive: disease demonstrating human epidermal growth factor receptor 2 (HER2) overexpression or amplification determined by standard testing methods.

Testing contextHER2 status is required to establish eligibility for Tukysa across covered indications (breast cancer, brain metastases, colorectal, biliary tract cancers).

Clinical confirmationDocumented HER2-positivity should be supported by clinical/pathology records consistent with standard HER2 testing prior to authorization.

Implication for treatmentHER2-positive status indicates the patient may be eligible for Tucatinib in combination with trastuzumab (and capecitabine when specified).

inv-20: NCCN recommended regimens — Category definitions

NCCN Category meaning

Policy Revision History

2025-06-01Effective dateLatest

Policy effective date set to 2025-06-01; program P&T approvals documented through 3/2025.

2025-03Annual review / content update

Annual review with addition of criteria for NCCN‑recommended use of Tukysa in biliary tract cancers and updated background and references.

2024-03Update—FDA-driven criteria added

OpenPayer

Prior authorization and coverage criteria for tucatinib (Tukysa)

Coverage Criteria for Tucatinib (Tukysa)

Provider Actions, Authorization & Documentation

Initial Therapy Authorization Requirements

Continuation / Reauthorization Criteria

Step Therapy Considerations

Quantity Limits and Coding Notes

Background on Tucatinib (Tukysa)

Definitions and Reference Terms

Policy Revision History