CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tukysa (tucatinib) coverage — criteria for FDA‑approved and compendial oncology indications

Coverage criteria for tucatinib (Tukysa) for FDA-approved and compendial oncology indications, including HER2-positive breast, colorectal, and biliary tract cancers; governs prior authorization and documentation requirements for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTukysa (tucatinib) coverage — FDA-approved and compendial oncology indications

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of HER2 status and, where applicable, RAS (KRAS/NRAS) and BRAF mutation status.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

FDA + compendialcovered indications

RequiredRAS/BRAF testing

RequiredHER2 documentation

NCCNcompendia cited

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Coverage Criteria for Tucatinib (Tukysa)

inv-01: Breast Cancer (FDA-approved / compendial uses)

Covered when ALL of the following are met for FDA‑approved breast cancer indication

Breast cancer (with trastuzumab and capecitabine): Member has HER2-positive advanced unresectable or metastatic breast cancer, including patients with brain metastases, and has received one or more prior anti-HER2-based regimens in the metastatic setting (or is being treated as subsequent therapy for recurrent/unresectable disease or had no response to preoperative systemic therapy).

Authorization of 12 months may be granted; initial therapy may include small asymptomatic brain metastases.

inv-02: Colorectal Cancer (FDA-approved)

Covered when ALL of the following are met for FDA‑approved colorectal cancer indication

Colorectal cancer (with trastuzumab): Member has unresectable or metastatic HER2-positive colorectal cancer (including appendiceal and anal adenocarcinoma); disease is RAS (KRAS and NRAS) and BRAF wild-type; disease has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy or the member is not appropriate for intensive therapy; and the requested medication will be used in combination with trastuzumab.

Authorization of 12 months may be granted; documentation of prior therapies and mutation status is expected.

inv-03: Biliary Tract Cancers (Compendial/NCCN)

Covered when ALL of the following are met for biliary tract cancers (compendial)

Biliary tract cancers: Member has unresectable, resected gross residual (R2), or metastatic HER2-positive biliary tract cancer (including gallbladder, intrahepatic, or extrahepatic cholangiocarcinoma) and tucatinib will be used in combination with trastuzumab.

Authorization of 12 months may be granted for subsequent treatment.

inv-04: Continuation / Reauthorization

Continuation of therapy

Reauthorization: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

All indications for tucatinib (Tukysa) that are not explicitly listed as FDA‑approved or specified compendial uses in this policy are considered experimental/investigational and not medically necessary.

Indications other than the FDA‑approved indications and the compendial uses enumerated in this policy are considered not medically necessary and are not covered.

Regimens and Combinations

Regimen	Indication / Required disease features	Required combination	Authorization duration	Coverage stance
Tucatinib (Tukysa) + trastuzumab + capecitabine	Advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases; patients who have received one or more prior anti‑HER2–based regimens in the metastatic setting, or as subsequent therapy for no response to preoperative systemic therapy or recurrent/unresectable disease; may be used as initial therapy for small asymptomatic brain metastases.	Trastuzumab; capecitabine required for the breast cancer indication	Authorization of 12 months may be granted	Covered when all criteria are met (FDA‑approved)
Tucatinib (Tukysa) + trastuzumab	Unresectable or metastatic HER2-positive colorectal cancer (including appendiceal and anal adenocarcinoma); disease must be RAS (KRAS/NRAS) and BRAF wild‑type; disease progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy or patient not appropriate for intensive therapy.	Trastuzumab	Authorization of 12 months may be granted	Covered when all criteria are met (FDA‑approved)
Tucatinib (Tukysa) + trastuzumab	Unresectable, resected gross residual (R2), or metastatic HER2‑positive biliary tract cancers (gallbladder, intrahepatic or extrahepatic cholangiocarcinoma).	Trastuzumab	Authorization of 12 months may be granted for subsequent treatment	Covered when all criteria are met (Compendial/NCCN)

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for tucatinib (Tukysa). Requests will be reviewed for FDA‑approved indications and specified compendial uses; approval is contingent on meeting the policy clinical criteria and member eligibility.

Prior authorization required for tucatinib (Tukysa) for all indications listed in this policy.

Denial Risk

Non‑covered Indications

Uses not listed as FDA‑approved indications or specified compendial uses are considered experimental/investigational and are not medically necessary.

Non‑covered: Any use of tucatinib that is not an FDA‑approved indication or an included compendial use.
Non‑covered uses will be denied as not medically necessary.

Authorization Duration and Coding Notes

inv-07: Authorization duration — 12 months

Authorization duration12 months may be granted for initial authorizations and reauthorizations when coverage criteria are met

Applies toAll covered indications (breast, colorectal, biliary tract) when criteria satisfied

Reauthorization conditionNo evidence of unacceptable toxicity or disease progression while on current regimen

Line and Sequence of Therapy

inv-15: second-line and beyond / subsequent therapy

Line of therapy notes: Breast cancer: for patients who have received one or more prior anti‑HER2 regimens in the metastatic setting or as subsequent therapy for recurrent/unresectable disease; Colorectal cancer: after progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy or when the patient is not appropriate for intensive therapy.

Biomarker and Molecular Testing Requirements

inv-16: HER2 — HER2

BiomarkerHER2

RequirementDocumented HER2-positive disease by appropriate testing is required for covered indications

Use withTucatinib is used in combination with trastuzumab (and capecitabine for breast cancer) for HER2-positive disease

inv-17: RAS (KRAS/NRAS) — wild-type

MarkerRAS (KRAS/NRAS)

Required status for colorectal cancerNegative (wild-type) for KRAS and NRAS mutations

Documentation

Definitions

inv-13: RAS wild-type

DefinitionRAS wild-type means the disease is negative for KRAS and NRAS mutations

RelevanceRequired for coverage of tucatinib in unresectable or metastatic colorectal cancer

DocumentationProvider must submit RAS (KRAS/NRAS) mutation testing results as part of prior authorization

inv-14: HER2-positive — HER2-positive disease as documented by appropriate testing

DefinitionHER2-positive disease: disease confirmed as HER2-positive by appropriate testing

RequirementHER2-positive status must be documented for all covered indications of tucatinib

Background

Tucatinib (Tukysa) is a HER2‑directed tyrosine kinase inhibitor used in combination with trastuzumab (and capecitabine for the breast cancer indication) for treatment of HER2‑positive advanced or metastatic cancers. Compendial uses cited in this policy include HER2‑positive biliary tract cancers (gallbladder, intrahepatic and extrahepatic cholangiocarcinoma), as well as HER2‑positive colorectal cancer with appropriate molecular features. Uses not listed in the FDA‑approved or specified compendial indications are considered experimental/investigational and not medically necessary.