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.

• For diagnosis of HER2-positive Breast Cancer [4-6]
  Used for the first-line treatment of HER2-positive locally-advanced or metastatic breast cancer.

Criteria

Brand Tykerb, generic lapatinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of HER2-positive metastatic or recurrent breast cancer [2-6]
AND
• Used in combination with one of the following: [3]
• Trastuzumab
• Xeloda (capecitabine)
• Aromatase inhibitors [e.g., Aromasin (exemestane), Femara (letrozole), Arimidex (anastrozole)]

Brand Tykerb, generic lapatinib

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease

P & T Revisions

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. 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.
3. National Comprehensive Cancer (NCCN) Drugs & Biologics Compendium. National Comprehensive Cancer Network, Inc. 2020. Accessed August 26, 2022.
4. DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically. Accessed August 12, 2020.
5. Moy B, Goss PE. Lapatinib: current status and future directions in breast cancer. Oncologist. 2006;11:1047-57.
6. Gomez H, Doval D, Chavez M, et al. Efficacy and safety of lapatinib as first-line therapy for ErbB2-amplified locally advanced or metastatic breast cancer. J Clin Oncol. 2008 May 5 [Epub ahead of print].
7. Lapatinib Prescribing Information. Lupin Pharmaceuticals, Inc. Baltimore, MD. November 2023.

---

Revision History

• 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.

---