Tukysa (tucatinib)

Indications for Prior Authorization

Tukysa (tucatinib)
  • For diagnosis of Breast Cancer
    Indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

  • For diagnosis of Colorectal cancer
    Indicated in combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

    This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Criteria

Tukysa

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Breast Cancer

  • Diagnosis of breast cancer
  • AND
  • Disease is one of the following:
    • Advanced unresectable
    • Metastatic
    AND
  • Disease is human epidermal growth factor receptor 2 (HER2)-positive
  • AND
  • Used in combination with trastuzumab and capecitabine
  • AND
  • Patient has received one or more prior anti-HER2 based regimens (e.g., trastuzumab, pertuzumab, ado-trastuzumab emtansine)
Tukysa

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Colorectal Cancer

  • Diagnosis of colorectal cancer
  • AND
  • Disease is one of the following:
    • Unresectable
    • Metastatic
    AND
  • Disease is human epidermal growth factor receptor 2 (HER2)-positive
  • AND
  • Patient has RAS wild-type tumors
  • AND
  • Used in combination with trastuzumab
  • AND
  • Patient has progressed following treatment with ONE of the following:
    • Fluoropyrimidine-based chemotherapy
    • Oxaliplatin-based chemotherapy
    • Irinotecan-based chemotherapy
Tukysa

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

  • Patient does not show evidence of progressive disease while on therapy
P & T Revisions

2024-06-05, 2023-07-05, 2023-05-25, 2023-03-01, 2022-06-16, 2021-09-27, 2021-06-03, 2021-04-09, 2020-06-04

  1. Tukysa Prescribing Information. Seattle Genetics, Inc. Bothell, WA. January 2023.

  • 2024-06-05: 2024 Annual Review - no changes
  • 2023-07-05: Removed specialist requirement
  • 2023-05-25: 2023 Annual Review - no changes
  • 2023-03-01: Addition of new indication for colorectal cancer
  • 2022-06-16: 2022 Annual Review - no changes
  • 2021-09-27: Annual review: Updated background and added EHB formulary to the guideline.
  • 2021-06-03: Annual review: Updated background and added EHB formulary to the guideline.
  • 2021-04-09: Updated GPIs
  • 2020-06-04: New program

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