Pharmacy Prior Authorization Criteria

Tykerb (lapatinib)

Indications for Prior Authorization

Tykerb (lapatinib)

• For diagnosis of Metastatic Breast Cancer
  (1) In combination with Xeloda (capecitabine), indicated for the treatment of patients with advanced or metastatic breast cancer whose tumors over-express HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. Limitations of use: Patients should have disease progression on trastuzumab prior to initiation of treatment with Tykerb in combination with capecitabine.;

  (2) In combination with Femara (letrozole), indicated for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.

  Tykerb in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.

Criteria

Brand Tykerb, generic lapatinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of HER2-positive breast cancer [3-6]
AND
• One of the following:
• All of the following:
• Disease is one of the following:
• Advanced
• Metastatic
AND
• All of the following:
• Patient has received prior therapy with an anthracycline
• Patient has received prior therapy with a taxane
• Patient has experienced disease progression while on trastuzumab therapy
AND
• Used in combination with Xeloda (capecitabine)
OR
• Both of the following:
• Disease is both of the following:
• Metastatic
• Hormone receptor positive (HR+)
AND
• Used in combination with Femara (letrozole)

Brand Tykerb, generic lapatinib

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease

P & T Revisions

2025-09-02, 2024-08-13, 2023-08-30, 2023-06-26, 2022-10-18, 2022-09-07, 2021-08-31, 2021-05-26, 2021-05-25, 2021-04-09, 2020-10-29, 2020-09-02, 2019-08-16

References

1. Tykerb Prescribing Information. Novartis Pharmaceuticals. East Hanover, NJ. March 2022.
2. Lapatinib Prescribing Information. Lupin Pharmaceuticals, Inc. Baltimore, MD. November 2023.
3. Geyer CE, Forster J, Lindquist D, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006;355(26):2733-2743.
4. National Comprehensive Cancer (NCCN) Drugs & Biologics Compendium. National Comprehensive Cancer Network, Inc. 2020. Accessed August 27, 2025.
5. DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically. Accessed August 27, 2025.
6. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Breast Cancer: Version 4.2025. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed August 27, 2025.

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Revision History

• 2025-09-02: Annual Review 2025 - Guideline updated to align with FDA approved indications only. Note that use in other compendia-supported indications are reviewed via off-label administration guideline.
• 2024-08-13: 2024 Annual Review. Background updates only
• 2023-08-30: 2023 UM Annual review. No criteria changes. Updated references
• 2023-06-26: Removed specialist requirement
• 2022-10-18: Minor grammatical updates
• 2022-09-07: 2022 Annual Review- updated references
• 2021-08-31: annual review: updated indications to match PI, no change in criteria, updated references
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-09: Updated GPIs
• 2020-10-29: Added generic lapatinib. Updated references.
• 2020-09-02: Annual review - updated references.
• 2019-08-16: Annual review: changed Herceptin to trastuzumab given Herceptin hylecta/biosimilar now available.

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