ModifiedColorado Rocky Mountain Health PlansPolicy N/A

Tukysa (tucatinib) — Prior Authorization and Coverage Criteria

Defines prior authorization, coverage criteria, and reauthorization rules for tucatinib (Tukysa) for indicated cancers and NCCN-recommended uses for members of Colorado Rocky Mountain Health Plans under UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTukysa (tucatinib) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded biliary tract cancer criteriaclarification of 12-month authorization

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization supporting documentation demonstrating diagnosis, biomarker status, and prior therapies to request coverage.

SourceLink

POLICY UPDATE CHANGES

Added criteria for NCCN recommended use of Tukysa in biliary tract cancers.

Annual review with no changes to clinical criteria noted in 3/2024; subsequent 3/2025 update added biliary tract criteria.

Authorization duration specified as 12 months.

2025-06-01policy effective date

12 monthsauthorization duration

auto processage <19

NCCN 1/2A/2BNCCN accepted

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possibleautomated approvals

Coverage Criteria for Tukysa (tucatinib)

inv-01: Initial Authorization — HER2-positive advanced/metastatic breast cancer

Covered when ALL of the following are met:

Breast cancer (advanced/unresectable or metastatic): (1) Diagnosis of breast cancer; (2) Disease is advanced unresectable or metastatic; (3) Disease is human epidermal growth factor receptor 2 (HER2)-positive; (4) Patient has been previously treated with an anti-HER2–based regimen in the metastatic setting (e.g., trastuzumab, pertuzumab, ado-trastuzumab emtansine); (5) Treatment is used in combination with trastuzumab and capecitabine.

Authorization will be issued for 12 months.

inv-03: Initial Authorization — Brain metastases

Covered when ALL of the following are met:

Brain metastases (HER2-positive breast cancer): (1) Diagnosis of brain metastases in a patient with HER2-positive breast cancer; (2) Patient has been previously treated with an anti-HER2–based regimen in the metastatic setting (e.g., trastuzumab, pertuzumab, ado-trastuzumab emtansine); (3) Treatment is used in combination with trastuzumab and capecitabine.

Authorization will be issued for 12 months.

inv-04: Initial Authorization — Colorectal cancer

Covered when ALL of the following are met:

Colorectal cancer (HER2-amplified, RAS/BRAF wild-type): (1) Diagnosis of unresectable, advanced, or metastatic colorectal cancer that is HER2-amplified and RAS and BRAF wild-type; (2) Disease is HER2-positive; (3) One of the following: (a) patient has previously been treated with fluoropyrimidine-, oxaliplatin-, and/or irinotecan-based chemotherapy; OR (b) patient is not appropriate for intensive therapy; (4) Treatment is used in combination with trastuzumab.

Authorization will be issued for 12 months.

inv-05: Initial Authorization — Biliary tract cancers

Covered when ALL of the following are met:

Biliary tract cancers (HER2-positive): (1) Diagnosis of one of the following: gallbladder cancer, intrahepatic cholangiocarcinoma, or extrahepatic cholangiocarcinoma; (2) Disease is HER2-positive; (3) Disease status is unresectable, resected with gross residual (R2), or metastatic; (4) Patient has received at least one prior systemic therapy; (5) Treatment is used in combination with trastuzumab.

Authorization will be issued for 12 months.

inv-06: NCCN Recommended Regimens

NCCN Recommended Regimens: Recognition of the requested tucatinib regimen in the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B may support coverage per applicable criteria.

inv-07: General coverage conditions

Covered when regimens are recognized by NCCN and other payer and state requirements are met

Coverage conditions: (1) The requested tucatinib regimen is recognized by the NCCN Drugs and Biologics Compendium with Category 1, 2A, or 2B; AND (2) Member-specific benefit plan coverage and any applicable state mandates allow coverage; AND (3) Any other applicable utilization management programs, automated approval rules, or supply limits are satisfied.

Specific clinical diagnosis, prior therapies, and dosing criteria are specified in the indication-specific criteria.

Coverage review and prior authorization requirements apply to adult members. For members 19 years of age and older, the member must meet the clinical criteria listed in this policy for the specific indication to be eligible for coverage of Tukysa (tucatinib). State mandates and the member-specific benefit plan may supersede or modify coverage; where a state law requires coverage that differs from this policy, the state requirement will take precedence.

Coverage may be limited or excluded when other legal or plan-level constraints apply. Authorization will be issued for 12 months when criteria are met; however, state mandates, federal regulatory requirements, or the member-specific benefit plan may restrict or prohibit coverage. Other payer policies and utilization management programs may also affect authorization decisions.

Initial Therapy Authorization Criteria

inv-22: Initial therapy requirements

Initial authorization criteria by indication

Breast cancer initial: See criteria set: diagnosis of HER2-positive advanced/unresectable or metastatic breast cancer; prior anti-HER2–based regimen in the metastatic setting; used in combination with trastuzumab and capecitabine.

Authorization will be issued for 12 months.

Brain metastases initial: See criteria set: brain metastases in HER2-positive breast cancer; prior anti-HER2–based regimen in the metastatic setting; used in combination with trastuzumab and capecitabine.

Authorization will be issued for 12 months.

Colorectal cancer initial: See criteria set: unresectable/advanced/metastatic HER2-amplified, RAS and BRAF wild-type colorectal cancer; prior fluoropyrimidine-, oxaliplatin-, and/or irinotecan-based chemotherapy OR patient not appropriate for intensive therapy; used in combination with trastuzumab.

Reauthorization and Continuation Criteria

inv-02: Reauthorization

Reauthorization covered when the following is met:

Reauthorization: Patient does not show evidence of progressive disease while on Tukysa therapy.

Authorization will be issued for 12 months upon reauthorization.

inv-24: Reauthorization / Continuation Therapy

Continuation / reauthorization requirement

Continuation: Approval on reauthorization requires that the patient does not show evidence of progressive disease while receiving Tukysa.

Reauthorizations are issued for 12 months.

inv-25: Re-authorization

Provider Actions, Documentation, and Operational Rules

Prior Authorization

Prior Authorization Required / Operational Rules

Prior authorization is required for members age 19 and older. Members under 19 automatically process without coverage review. Authorization, when approved, will be issued for 12 months. Automated approval/re-approval may be used based on prior claim/medication history, diagnosis codes (ICD-10), and claim logic. Supply limits may apply. State mandates, federal regulatory requirements, and the member-specific benefit plan may impact coverage and result in denial.

Prior authorization required for members ≥19; members <19 auto-process
Authorization duration: 12 months
Automated approvals/re-approvals may be used based on claims/diagnosis history
Supply limits may apply
State mandates and benefit plan limits may affect coverage

Denial Risk

Step Therapy and Prior Treatment Tables

Indication	Prior therapy requirement
{"text":"Breast cancer (advanced unresectable or metastatic)","status":""}\|{"text":"Prior exposure to an anti-HER2–based regimen in the metastatic setting (e.g., trastuzumab, pertuzumab, ado‑trastuzumab emtansine)","status":""}
{"text":"Brain metastases from HER2‑positive breast cancer","status":""}\|{"text":"Prior exposure to an anti-HER2–based regimen in the metastatic setting","status":""}
{"text":"Colorectal cancer (HER2‑amplified; RAS/BRAF wild‑type)","status":""}\|{"text":"Prior fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy — OR patient not appropriate for intensive therapy","status":""}
{"text":"Biliary tract cancers (HER2‑positive gallbladder or intra/extrahepatic cholangiocarcinoma)","status":""}\|{"text":"At least one prior systemic therapy","status":""}

Step therapy requirements	Management note
{"text":"Step therapy rules not specified in this policy excerpt","status":""}\|{"text":"Any step therapy requirements (if applicable) are managed via other utilization management programs; automated approval/re‑approval processes may be used based on claim/medication history and ICD‑10 diagnosis codes","status":""}

Quantity Limits and Supply Constraints

Quantity limits — Tukysa (tucatinib)

Quantity limit statusTukysa (tucatinib) may be subject to supply limits (supply limits may be in place).

Unitper month (tablet or course) as managed by payer supply-limit rules.

Exceptions/AutomationApprovals or re-approvals may be granted based on prior claim/medication history and diagnosis codes; supply limits still apply.

Site-of-Care Considerations

Note

Site‑of‑care rules not specified in this excerpt

Site‑of‑care rules for Tukysa are not specified in this excerpt; other utilization management programs may dictate whether an infusion center or other setting is required.

Background

Tucatinib (Tukysa) is a small-molecule tyrosine kinase inhibitor that selectively targets HER2. It is indicated in combination with trastuzumab and capecitabine for adult patients with HER2-positive advanced or metastatic breast cancer, including patients with brain metastases, following one or more prior anti-HER2 regimens. Tucatinib is also indicated in combination with trastuzumab for RAS wild-type, HER2-amplified unresectable or metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, and NCCN-recognized regimens support its use in additional HER2-positive malignancies such as biliary tract cancers per the policy update.

Definitions and Key Terms

HER2-positive

DefinitionTumors that overexpress or have amplification of the human epidermal growth factor receptor 2 (HER2).

Clinical relevanceRequired biomarker status for Tukysa use in breast cancer, brain metastases, biliary tract cancers, and colorectal cancer indications where HER2-amplified is specified.

DocumentationClinical documentation must support HER2-positive status for coverage determinations.

RAS wild-type

DefinitionAbsence of activating RAS mutations (RAS wild-type).

Indication-specific roleRequired for the colorectal cancer tucatinib indication (HER2-amplified, RAS and BRAF wild-type).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTukysa (tucatinib) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded biliary tract cancer criteriaclarification of 12-month authorization

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization supporting documentation demonstrating diagnosis, biomarker status, and prior therapies to request coverage.

SourceLink

On This Page

Authorization will be issued for 12 months.

Biliary tract cancer initial: See criteria set: HER2-positive gallbladder or cholangiocarcinoma (unresectable, R2 residual, or metastatic); at least one prior systemic therapy; used in combination with trastuzumab.

Authorization will be issued for 12 months.

inv-23: Initial therapy authorization

Initial coverage considerations

Accepted evidence sources: Regimens recognized by the NCCN Drugs and Biologics Compendium with Category 1, 2A, or 2B, or FDA‑labeled indications per the Tukysa package insert, may form the basis for initial authorization.

Specific prior therapies or biomarker requirements are documented in indication-specific criteria.

Re-authorization: Authorization may be re-issued for up to 12 months; re-authorization decisions may be based on prior claims/medication history, diagnosis codes, and/or claim logic per program settings.

Supply limits may apply.

Coverage will be denied if the member does not meet the specific clinical criteria for the requested indication, or if the member-specific benefit plan, state mandates, federal requirements, or other utilization management programs do not support coverage. For members 19 and older, failure to provide documentation demonstrating required prior therapies, molecular markers, or treatment intent may trigger denial.

Denial possible if listed clinical criteria for the indication are not met
Denial possible if member benefit, state/federal mandates, or other utilization programs do not support coverage
Missing required documentation for members ≥19 may trigger denial

Documentation Required

Required Clinical Documentation

Submit clinical documentation that supports the requested indication and demonstrates that all coverage criteria are met. Documentation should include: diagnosis and site (e.g., breast cancer with brain metastases; colorectal cancer), HER2 status for applicable indications, and where specified RAS and BRAF status for colorectal cancer. Include prior treatment history (dates and regimens) to show required prior anti-HER2 exposure for breast cancer indications and prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy for colorectal cancer. Also provide the planned regimen showing combination use with trastuzumab and capecitabine when applicable.

Diagnosis and disease site (e.g., breast cancer, colorectal cancer, brain metastases)
HER2 status (required)
For colorectal cancer: RAS and BRAF status (when specified)
Detailed prior treatment history with dates and regimens (e.g., prior anti‑HER2 agents for breast cancer; fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy for colorectal cancer)
Planned concurrent regimen (e.g., tucatinib + trastuzumab ± capecitabine)

Step Therapy

Step / Prior Therapy Requirements

Prior exposure to specified therapies is required before approval for the listed indications. For HER2‑positive advanced/metastatic breast cancer (including brain metastases), patient must have received one or more prior anti‑HER2 based regimens in the metastatic setting (examples: trastuzumab, pertuzumab, ado‑trastuzumab emtansine). For RAS wild‑type HER2‑positive unresectable or metastatic colorectal cancer, disease must have progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy. Ensure documentation shows these prior therapy requirements are met.

Breast cancer (including brain metastases): prior anti‑HER2 therapy in the metastatic setting (e.g., trastuzumab, pertuzumab, ado‑trastuzumab emtansine)
Colorectal cancer: progression after fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy
Planned use must be in combination with trastuzumab and, for breast cancer brain metastases indication, capecitabine as specified

DocumentationPrior authorization requires documentation of RAS (and BRAF where specified) wild-type status for colorectal cancer coverage determinations.

NCCN Recommended Regimens

DefinitionRegimens recognized by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B.

Coverage impactRecognition by NCCN with Category 1/2A/2B may support coverage per the policy's general coverage conditions.

ScopeIncludes NCCN-recognized regimens for breast cancer, colorectal cancer, brain metastases, and biliary tract cancers as applicable.

Indication	Prior therapy requirement
{"text":"Breast cancer (advanced unresectable or metastatic)","status":""}\|{"text":"Prior exposure to an anti-HER2–based regimen in the metastatic setting (e.g., trastuzumab, pertuzumab, ado‑trastuzumab emtansine)","status":""}
{"text":"Brain metastases from HER2‑positive breast cancer","status":""}\|{"text":"Prior exposure to an anti-HER2–based regimen in the metastatic setting","status":""}
{"text":"Colorectal cancer (HER2‑amplified; RAS/BRAF wild‑type)","status":""}\|{"text":"Prior fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy — OR patient not appropriate for intensive therapy","status":""}
{"text":"Biliary tract cancers (HER2‑positive gallbladder or intra/extrahepatic cholangiocarcinoma)","status":""}\|{"text":"At least one prior systemic therapy","status":""}