Pharmacy Prior Authorization Criteria

Nerlynx (neratinib)

Indications for Prior Authorization

Nerlynx (neratinib)

• For diagnosis of Early Stage Breast Cancer
  Indicated as a single agent for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant trastuzumab based therapy

• For diagnosis of Advanced or Metastatic Breast Cancer
  Indicated for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting in combination with capecitabine.

Criteria

Nerlynx

Prior Authorization

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

• Diagnosis of early stage breast cancer
AND
• Treatment duration of Nerlynx has not exceeded a total of 12 months [1, 2, 3, A]

Nerlynx

Prior Authorization (Initial Authorization)

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

• Diagnosis of advanced or metastatic breast cancer

Nerlynx

Prior Authorization (Reauthorization)

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

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-10-02, 2024-02-07, 2023-07-06, 2023-05-04, 2023-03-20, 2022-09-27, 2022-09-07, 2021-09-07, 2021-04-08, 2021-02-11, 2020-10-08, 2020-03-26, 2019-09-16

References

1. Nerlynx Prescribing Information. Puma Biotechnology, Inc. Los Angeles, CA. March 2022.
2. Chan A, Delaloge S, Holmes FA, et al. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2016; 17: 367-77.
3. Per Clinical Consultation with an Oncologist, August 24th, 2017.
4. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Breast Cancer v.7.2021. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed September 20, 2024.
5. Saura C, Garcia-Saenz JA, Xu B,et al. Safety and efficacy of neratinib in combination with capecitabine in patients with metastatic human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2014 Nov 10;32(32):3626-33. doi: 10.1200/JCO.2014.56.3809.
6. The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed on September 20, 2024.

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End Notes

1. Per the ExteNET Lancet study, Nerlynx was administered for no more than 12 months and showed improvement in disease-free survival in trastuzumab (Herceptin)-treated patients with early breast cancer. [2]

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Revision History

• 2024-10-02: 2024 Annual Review - background/references updated
• 2024-02-07: Background update
• 2023-07-06: Updated criteria and removed specialist requirement
• 2023-05-04: Updated criteria.
• 2023-03-20: Updated criteria to remove previous direction given to incorporate NCCN supported regimens.
• 2022-09-27: 2022 Annual Review
• 2022-09-07: Updated criteria to include NCCN supported regimens.
• 2021-09-07: 2021 Annual Review
• 2021-04-08: Updated GPI
• 2021-02-11: updated guideline to remove therapy stage of "initial auth for indication of early stage breast cancer
• 2020-10-08: 2020 Annual review: updated references
• 2020-03-26: Revised guideline to add new indication
• 2019-09-16: 2019 Annual Review. No clinical criteria changes.

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