CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tukysa (tucatinib) — Coverage Criteria and Prior Authorization

Defines clinical and utilization management criteria for authorization of tucatinib (Tukysa) for metastatic HER2-positive breast cancer and certain HER2-positive, RAS wild-type colorectal cancer, and governs prior authorization and continuation requests for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTukysa (tucatinib) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeAdministrative review — no material clinical changes

Effective DateMar 29, 2024

Next Review DateMar 13, 2024

Key ActionObtain prior authorization; continuation requests require prior year use, no disease progression or intolerance, and no added medications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

300 mgsingle dose maximum

30 / 120monthly tablet limits

2024-03-29effective date

UMfinal approval

Coverage Criteria for Tukysa (tucatinib)

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Covered indications

Covered when ALL of the following are met:

Breast carcinoma indication: Member has metastatic HER2-positive breast cancer and has experienced disease progression on one or more anti‑HER2 regimens in the metastatic setting

based on policy section II.B

Colorectal carcinoma indication: Member has HER2‑positive, RAS wild‑type metastatic or unresectable colorectal cancer that progressed following fluoropyrimidine-, oxaliplatin-, and/or irinotecan‑based chemotherapy AND tucatinib will be used in combination with trastuzumab or a trastuzumab biosimilar

based on policy section II.C

Supportive evidence requirement: Use is supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature

based on policy purpose and evidence requirements in section I

Continuation therapy

Continuation requests are approvable when ALL of the following are met:

Recent prior use: Requested medication was used within the last year

policy section II.A.1

No progression or intolerance: Member has not experienced disease progression and/or has not shown intolerance to the requested medication

policy section II.A.2

No additional medications: No additional medication(s) are being added to the continuation request

policy section II.A.3

Requests will be excluded (denied) when any of the following apply: the member has experienced disease progression on Tukysa (tucatinib); there is lack of documentation of HER2 protein overexpression (and, for the colorectal cancer indication, lack of documented RAS wild-type status in tumor specimens); the requested dosing exceeds the single-dose maximum of 300 mg; or the requested supply would exceed monthly tablet limits (30 tablets/month for 50 mg strength or 120 tablets/month for 150 mg strength).

Requests for investigational or off‑label use without sufficient supporting evidence will also be excluded. The policy defines insufficient evidence as lacking appropriate patient- and regimen-representative published data, clinically meaningful outcomes (for example ASCO-recommended thresholds), or acceptable study design; single case reports and meeting abstracts without full peer-reviewed articles are generally not adequate.

Initial Therapy Criteria

Initial therapy criteria

Initial approvals are for FDA‑ or compendia‑supported indications:

Breast cancer initial use: Metastatic HER2‑positive breast cancer in members who have experienced disease progression on one or more anti‑HER2 regimens

policy section II.B

Colorectal cancer initial use: HER2‑positive, RAS wild‑type metastatic or unresectable colorectal cancer that progressed after fluoropyrimidine-, oxaliplatin-, and/or irinotecan‑based chemotherapy; tucatinib must be used in combination with trastuzumab or a trastuzumab biosimilar

policy section II.C

Evidence support: Indication supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO clinical guidelines, or acceptable peer‑reviewed literature

policy purpose (section I)

Continuation Therapy Criteria

Continuation criteria

Continuation requests may be approved under the following conditions:

Used within last year: Medication was used within the last year

policy section II.A.1

No progression or intolerance: There is no documented disease progression on the medication and no intolerance to the requested medication

policy section II.A.2

No additional medications added: No additional medication(s) are being added to the continuation request

policy section II.A.3

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization and Continuation Rules

Prior authorization is required for Tukysa (tucatinib). Continuation requests may be approved without re-applying this policy when: the medication was used within the last year; the member has not experienced disease progression or intolerance to the requested medication; and no additional medications are being added to the continuation request.

Prior authorization required for initial requests
Continuation requests exempt when all continuation criteria are met

Step Therapy

Combination Requirement for Colorectal Cancer

For the colorectal cancer indication, Tukysa must be used in combination with trastuzumab (Herceptin) or a trastuzumab biosimilar. This combination is specified for members with HER2-positive, RAS wild-type metastatic or unresectable colorectal cancer after progression on fluoropyrimidine-, oxaliplatin-, and/or irinotecan-based chemotherapy. Ensure treatment sequencing follows step-therapy expectations (i.e., prior standard chemotherapies tried and documented) before approval.

Combination required: Tukysa + trastuzumab or trastuzumab biosimilar for CRC
Indication limited to HER2-positive, RAS wild-type metastatic/unresectable CRC after progression on recommended chemotherapies

Documentation Required

Required Supporting Documentation

Required supporting documentation must be submitted with the authorization request. Acceptable sources include FDA approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS standards. For the colorectal cancer indication, documentation of tumor testing confirming HER2 protein overexpression and RAS wild‑type status in tumor specimens is required. Include prior treatment history showing progression on fluoropyrimidine, oxaliplatin, and/or irinotecan‑based regimens when applicable.

Acceptable evidence: FDA labeling, CMS compendia, NCCN/ASCO guidelines, or qualifying peer‑reviewed literature
For CRC: pathology or molecular testing reports confirming HER2 overexpression and RAS wild‑type status
Documentation of prior chemotherapy regimens and disease progression as applicable

Denial Risk

Common Exclusion Triggers

Requests lacking required documentation or meeting exclusion criteria may be denied. Common exclusion triggers include documented disease progression on Tukysa, missing HER2 or RAS wild‑type testing for the colorectal cancer indication, single‑dose or monthly dosing that exceeds policy limits, and investigational/off‑label uses not supported by accepted evidence sources.

Denial risk if disease progression on Tukysa is documented
Denial risk if HER2 or RAS wild‑type documentation is absent for CRC requests
Denial risk if dosing exceeds 300 mg single dose or monthly tablet limits (30 x 50 mg or 120 x 150 mg)
Denial risk for investigational/off‑label uses not supported by CMS compendia or acceptable peer‑reviewed literature

Indication	Step therapy requirement
HER2-positive, RAS wild-type metastatic or unresectable colorectal cancer that progressed after fluoropyrimidine-, oxaliplatin-, and/or irinotecan-based chemotherapy	Tucatinib must be used in combination with trastuzumab or a trastuzumab biosimilar

Key Definitions

inv-11: HER2-positive definition

DefinitionHER2‑positive: tumor overexpressing human epidermal growth factor receptor 2 as documented in pathology

Indication contextRequired for metastatic breast cancer indication in the policy (breast carcinoma section)

Documentation requirementLack of documentation of HER2 overexpression is an exclusion criterion

inv-12: RAS wild-type

Definition for colorectal cancerRAS wild‑type: absence of activating RAS mutations in tumor testing required for the colorectal cancer indication

Indication contextPolicy permits tucatinib for HER2‑positive, RAS wild‑type metastatic or unresectable colorectal cancer in combination with trastuzumab

Documentation requirementLack of documentation of RAS wild‑type status in tumor specimens is an exclusion criterion

Background

Tucatinib (Tukysa) is an oral HER2-directed tyrosine kinase inhibitor indicated for use in metastatic HER2-positive breast cancer after progression on one or more anti‑HER2 regimens and is recognized for use in certain HER2-positive, RAS wild-type metastatic or unresectable colorectal cancers when given in combination with trastuzumab (Herceptin) or trastuzumab biosimilars following progression on standard chemotherapy. Use must align with FDA labeling, CMS‑recognized compendia, NCCN/ASCO guideline recommendations, or acceptable peer‑reviewed literature.

Clinical management and authorization decisions require documentation of tumor HER2 overexpression (and RAS wild‑type status for colorectal cancer) and adherence to dosing limits described in policy and the FDA label; consult the package insert for administration and monitoring details.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTukysa (tucatinib) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeAdministrative review — no material clinical changes

Effective DateMar 29, 2024

Next Review DateMar 13, 2024

Key ActionObtain prior authorization; continuation requests require prior year use, no disease progression or intolerance, and no added medications.

SourceLink

On This Page

OpenPayer

Tukysa (tucatinib) — Coverage Criteria and Prior Authorization

Coverage Criteria for Tukysa (tucatinib)

Initial Therapy Criteria

Continuation Therapy Criteria

Provider Actions and Authorization Requirements

Dose and Coding Limits

Quantity Limits for Tucatinib

Step Therapy / Combination Requirements

Key Definitions

Background

Biosimilar Combination Guidance

Site of Care Guidance