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    Copiktra™

    Drug - Copiktra™ (duvelisib) [Verastem, Inc.]

    June 2019

    Therapeutic area - Oncology, Oral - Hematologic

    Initial approval criteria

    • Patient has a diagnosis that is listed on the FDA-approved label

    OR

    • Patient is at least 18 years old AND
    • Patient does not have an active infection, including clinically important localized infections AND
    • Patient has not received previous therapy with a small-molecule inhibitor (phosphtidylinositol-3 kinase inhibitor [PI3-K]) therapy (e.g., idelalisib, etc.) AND
    • Patient has not received previous therapy with a Bruton’s tyrosine kinase (BTK) inhibitor (e.g., ibrutinib, acalabrutinib, etc.) AND
    • Patient does not have CNS lymphoma or leukemia AND
    • Patient has chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) AND
      • Patient has relapsed or refractory disease AND
      • Copiktra will be used as a single agent AND
      • Patient has received ≥ 2 prior therapies, which include treatment with ofatumumab AND
      • Patient is not eligible for purine analog therapy (e.g., fludarabine, cytarabine) AND
      • Patient must not have undergone prior autologous hematopoietic stem cell transplant (HSCT) within 180 days of the first dose OR prior allogeneic transplant AND
      • Patient does not have Richter’s transformation or prolymphocytic leukemia OR
    • Patient has follicular lymphoma AND
      • Copiktra will be used as a single agent AND
      • Patient has a diagnosis of low-grade follicular lymphoma (i.e., excludes large cell, grade 3b disease) AND
      • Patient must not have undergone prior allogeneic hematopoietic stem cell transplant (HSCT) AND
      • Used as subsequent therapy for relapsed or refractory disease, after ≥ 2 prior therapies including both rituximab AND chemotherapy (i.e. alkylator or purine analog) OR radioimmunotherapy
    • Initial approval is for 6 months

    Renewal criteria

    • Patient continues to meet criteria identified in initial criteria AND
    • Disease response as defined by lack of disease progression, improvement in tumor size and/or improvement in patient symptoms AND
    • Absence of unacceptable toxicity from the drug (e.g., active/severe infections, hematologic toxicity [neutropenia], severe diarrhea or colitis, hepatotoxicity, pneumonitis, severe cutaneous reactions [Stevens-Johnson syndrome and toxic epidermal necrolysis], anaphylaxis)
    • Renewal approval is for 6 months

    Quantity limits

    • 25 mg capsules: 2 capsules per day
    • 15 mg capsules: 2 capsules per day

    Questions?

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

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