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    Bavencio®

    Drugs - Bavencio® (avelumab) [EMD Serono, Inc.]

    October 2017

    Therapeutic area - Oncology

    Initial approval criteria

    Merkel cell carcinoma (MCC)

    • Patient must be at least 12 years of age AND
    • Patient must have a diagnosis of metastatic MCC AND
    • Patient has tried and failed guideline recommended chemotherapy treatment regimen(s) AND
    • Prescriber must attest that patient will be provided reproductive health instructions during therapy and for at least 1 month after stopping therapy
    • Initial approval is for 3 months

    Urothelial carcinoma (UC)

    • Patient must be at least 18 years of age AND
    • Patient must have a diagnosis of metastatic UC AND
    • Patient has had disease progression during or following platinum-containing chemotherapy OR
    • Patient has had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy AND
    • Prescriber must attest that patient will be provided reproductive health instructions during therapy and for at least 1 month after stopping therapy
    • Initial approval is for 3 months

    Renewal approval criteria

    • Documentation that patient has no disease progression AND
    • Absence of any one of the following unacceptable toxicities from the drug:
      • Grade 3 or 4 pneumonitis or recurrent Grade 2 pneumonitis
      • AST/ALT more than 5 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal
      • Grade 4 diarrhea or colitis or recurrent Grade 3 diarrhea or colitis
      • Serum creatinine more than 1.5 and up to 6 times the upper limit of normal
      • Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks
      • Persistent Grade 2 or 3 immune-mediate adverse reactions lasting more than 12 weeks
    • Renewal approval is for 6 months

    Denial criteria

    Patient is currently participating in clinical trials for MCC or UC

    Quantity limits

    • 10mg/kg every 2 weeks
    • Patient’s weight (in kg) must be submitted at time of request

    Background information

    Bavencio is FDA-approved for MCC and UC indications under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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