Nerlynx (neratinib) — CareFirst (Caremark)
early-stage HER2-positive breast cancer
Initial criteria
- Member has documentation of human epidermal growth factor receptor 2 (HER2) status or HER2 activating mutation status
- For early stage HER2-positive breast cancer: requested medication will be initiated after completing adjuvant trastuzumab-based therapy and will be used as a single agent
- For breast cancer (recurrent or metastatic, including brain metastases) HER2-positive: will be used in combination with capecitabine and member had no response to preoperative systemic therapy or has recurrent/metastatic disease
- For metastatic breast cancer with HER2 activating mutations: medication will be used in combination with fulvestrant and trastuzumab for third-line or later therapy AND either (a) disease is hormone receptor positive and HER2-negative and member previously received a cyclin-dependent kinase 4 and 6 inhibitor (e.g., Ibrance [palbociclib], Kisqali [ribociclib], Verzenio [abemaciclib]) OR (b) disease is triple negative
- For recurrent or metastatic HER2-mutant cervical cancer: medication will be used as a single agent for subsequent treatment
Reauthorization criteria
- Member is requesting reauthorization for an indication listed in the coverage criteria
- No evidence of unacceptable toxicity or disease progression while on current regimen
- Adjuvant treatment of early-stage breast cancer will be approved for a total of 12 months of therapy
Approval duration
12 months