CurrentCignaPolicy N/A

Oncology - Tukysa (tucatinib) Prior Authorization Policy

Defines Cigna's prior authorization criteria for coverage of Tukysa (tucatinib) tablets for specified oncology indications (breast, colorectal/rectal, and biliary tract cancers) and who is affected (adult patients under Cigna-administered plans).

Policy Summary

PayerCigna

PolicyOncology - Tukysa (tucatinib) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeWording revision (colon/rectal indication)

Effective Date

Next Review DateMay 7, 2025

Key ActionSubmit prior authorization with documentation of patient age, diagnosis (including HER2 and RAS status where applicable), prior anti‑HER2 or systemic therapies, and planned use of Tukysa in combination with trastuzumab (plus capecitabine for breast).

SourceLink

POLICY UPDATE CHANGES

Colon and Rectal Cancer requirement wording changed from 'HER2-positive' to 'HER2-amplified disease' and prior requirements for prior fluoropyrimidine, oxaliplatin, and irinotecan were removed.

3distinct covered tumor types listed

1 yearapproval duration (covered indications)

≥18minimum patient age

trastuzumabcombination therapy required

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Coverage Criteria for Tukysa (tucatinib)

inv-01: Breast Cancer (FDA-approved)

Covered when ALL of the following are met:

Breast Cancer approval criteria: A) Patient is ≥ 18 years of age; AND B) Patient has recurrent or metastatic breast cancer; AND C) Patient has human epidermal growth factor receptor 2 (HER2)-positive disease; AND D) Patient has received at least one prior anti-HER2-based regimen in the metastatic setting; AND E) The medication is used in combination with trastuzumab and capecitabine.

Approve for 1 year

inv-02: Colon or Rectal Cancer (FDA-approved)

Covered when ALL of the following are met:

Colon/Rectal Cancer approval criteria: A) Patient is ≥ 18 years of age; AND B) Patient has unresectable or metastatic disease; AND C) Patient has human epidermal growth factor receptor 2 (HER2)-amplified disease; AND D) Patient's tumor or metastases are wild-type RAS (KRAS wild-type and NRAS wild-type); AND E) The medication is used in combination with trastuzumab.

Approve for 1 year

inv-03: Biliary Tract Cancer (supportive evidence)

Covered when ALL of the following are met:

Biliary Tract Cancer supportive-evidence criteria: A) Patient is ≥ 18 years of age; AND B) Patient has unresectable or metastatic disease; AND C) Patient has human epidermal growth factor receptor 2 (HER2)-positive disease; AND D) Patient has tried at least one systemic regimen; AND E) The medication is used in combination with trastuzumab.

Approve for 1 year

The policy includes a Conditions not covered section listing Tukysa (tucatinib tablets - Seagen). The document does not enumerate specific excluded diagnoses beyond naming the product; providers should refer to the applicable benefit plan and coding rules to determine whether a particular diagnosis or service is excluded under their member’s plan.

Claims for services billed for conditions or diagnoses that are not covered under this Tukysa coverage policy will be denied as not covered. Providers must submit claims with the most appropriate covered diagnosis and procedure codes; submissions lacking covered code(s) under the applicable coverage policy will be denied.

Regimens and Combination Requirements

Regimen	Indication	Coverage status	Key coverage criteria / notes
Tukysa (tucatinib) in combination with trastuzumab and capecitabine
HER2-positive advanced unresectable or metastatic breast cancer (including patients with brain metastases)
Covered
Approve for 1 year when all criteria are met: patient ≥18 years; recurrent or metastatic breast cancer; HER2-positive disease; has received ≥1 prior anti‑HER2–based regimen in the metastatic setting; medication used in combination with trastuzumab and capecitabine.

Regimen	Indication	Coverage status	Key coverage criteria / notes
Tukysa (tucatinib) in combination with trastuzumab
HER2‑amplified unresectable or metastatic colorectal or rectal cancer (tumor or metastases RAS wild‑type [KRAS and NRAS])
Covered
Approve for 1 year when all criteria are met: patient ≥18 years; unresectable or metastatic disease; HER2‑amplified disease; tumor or metastases are RAS wild‑type (KRAS and NRAS wild‑type); medication used in combination with trastuzumab.

Regimen	Indication	Coverage status	Key coverage criteria / notes
Tukysa (tucatinib) in combination with trastuzumab
HER2‑positive unresectable or metastatic biliary tract cancer (supportive evidence)
Covered
Approve for 1 year when all criteria are met: patient ≥18 years; unresectable or metastatic disease; HER2‑positive disease; patient has tried at least one prior systemic regimen; medication used in combination with trastuzumab. NCCN lists Tukysa + trastuzumab as 'useful in certain circumstances' as subsequent line therapy.

Coding, Duration, and Identifiers

Drug identifiersNDC

NDC not listed

Tukysa (tucatinib tablets - Seagen) - no NDC provided in document

inv-07: approval duration — 1 year

Approval durationApprovals are provided for 1 year when specified clinical criteria are met.

Applies to indicationsBreast cancer (FDA-approved), Colon or Rectal cancer (FDA-approved), Biliary tract cancer (supportive evidence).

Action required at renewalPrior authorization must be renewed at 1-year intervals per policy when clinical criteria continue to be met.

Provider Actions, Prior Auth, and Documentation

Prior Authorization

Prior authorization required; approvals for 1 year

Prior authorization is recommended for prescription benefit coverage of Tukysa; when the specified clinical criteria are met for an indication, approvals are provided for 1 year.

Step Therapy

Prior therapy required by indication

Prior therapy requirements differ by indication: for metastatic HER2-positive breast cancer the patient must have received at least one prior anti‑HER2–based regimen in the metastatic setting; for unresectable/metastatic biliary tract cancer the patient must have tried at least one prior systemic regimen.

Breast: "Patient has received at least one prior anti-HER2-based regimen in the metastatic setting." (examples of anti‑HER2 regimens are listed in the policy).
Biliary tract: "Patient has tried at least one systemic regimen;" examples include durvalumab, gemcitabine, cisplatin, pembrolizumab, capecitabine, oxaliplatin, albumin-bound paclitaxel.

Line of Therapy Requirements

inv-15: second-line_or_later

breast line: Patient has received one or more prior anti-HER2-based regimens in the metastatic setting (used in third-line and beyond per NCCN; may be second-line in some cases).

inv-16: subsequent

biliary prior therapy: Patient has tried at least one systemic regimen prior to Tukysa initiation.

Biomarker and Diagnostic Requirements

inv-17: HER2 — HER2 status requirement (amplified/positive) for applicable indications

Required HER2 statusHER2-positive or HER2-amplified disease is required depending on the indication (breast and biliary: HER2-positive; colon/rectal: HER2-amplified).

Evidence basisHER2 requirement aligns with FDA‑approved and supportive‑evidence indications for use of Tukysa in combination regimens.

Documentation to submitPrior authorization requests must document HER2 status (amplified/positive) from tumor or metastasis testing.

inv-18: RAS (KRAS and NRAS) — RAS wild-type requirement for colorectal/rectal indication

Required RAS statusTumor or metastases must be wild‑type RAS (KRAS wild‑type and NRAS wild‑type) for the colon or rectal cancer indication.

Applies to

Background on Tukysa (tucatinib)

Tucatinib (Tukysa) is an oral kinase inhibitor indicated for use in combination regimens for HER2-driven malignancies. The policy supports its use in adults for FDA‑approved indications (notably HER2‑positive advanced or metastatic breast cancer in combination with trastuzumab and capecitabine, and HER2‑amplified unresectable or metastatic colon/rectal cancer in combination with trastuzumab) as well as for select uses with supportive evidence (for example, HER2‑positive unresectable/metastatic biliary tract cancer in combination with trastuzumab). Prior authorization is recommended for prescription benefit coverage and approvals are provided for 1 year when the specified clinical criteria are met.