Primary navigation

    Scemblix™

    Drug - Scemblix™ (asciminib) [Novartis Pharmaceuticals Corporation]

    April 2022

    Therapeutic Area - Oncology, Oral - Hematologic

    Initial approval criteria

    • Patient is ≥ 18 years of age AND
    • Patient has a diagnosis of chronic myeloid leukemia (CML) AND
    • Patient’s disease is Philadelphia chromosome-positive (Ph+) AND
    • Patient has chronic phase disease AND
      • Patient is resistant, or intolerant, or had an inadequate response to prior therapy consisting of a 3 month trial or longer, with ≥ 2 tyrosine kinase inhibitor (e.g., imatinib, bosutinib, dasatinib, nilotinib, ponatinib) OR
      • Patient has the T315I mutation AND
    • Patient does NOT have uncontrolled hypertension AND
    • Patient will avoid concomitant therapy with all of the following:
      • Coadministration of asciminib 200 mg twice daily with strong CYP3A4 inhibitors (e.g., fluconazole, itraconazole, clarithromycin); if concomitant use is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications will be implemented AND
      • Coadministration of asciminib 200 mg twice daily with certain CYP3A4 substrates (e.g., midazolam), where minimal drug level changes may result in serious adverse reactions AND
      • Coadministration of all doses of asciminib with select CYP2C9 substrates (e.g., warfarin) if minimal concentration changes has the potential to cause serious adverse reactions; if concurrent therapy is unavoidable, reduce the dosage of the CYP2C9 substrate AND
      • Coadministration of all doses of asciminib with itraconazole oral solution containing hydroxypropyl-β-cyclodextrin AND
    • Patient’s serum lipase and amylase levels will be measured periodically during treatment AND
    • Patient will be monitored and managed according to the prescribing information for myelosuppression, cardiovascular toxicities, and hypersensitivity AND
    • Patients of reproductive potential will have a negative pregnancy confirmed prior to starting asciminib therapy and have been counselled to use effective contraception during therapy and for 1 week after the last dose
    • Initial approval is for 6 months

    Renewal criteria

    • Patient continues to meet initial approval criteria AND
    • Patient has NOT experienced unacceptable toxicity from the drug. Examples of unacceptable toxicity include myelosuppression, pancreatic toxicity, hypertension, hypersensitivity, cardiovascular toxicity, etc. AND
    • Patient has been adherent to therapy AND
    • Treatment response as indicated by 1 of the following BCR-ABL1 (IS) transcript levels:
      • > 0.1% to 10% at 3 months or 6 months OR
      • > 0.1% to 1% at 12 months and beyond (if treatment goal is long-term survival) OR
      • ≤ 0.1% at 12 months and beyond (if treatment goal is treatment-free remission)
    • *NOTE: cytogenetic assessment of response may be used if quantitative RT-PCR (QPCR) using International Scale (IS) for BCR-ABL1 is not available
    • Renewal approval is for 6 months

    Quantity limits

    • Maximum dose is 400 mg/day
    • 20 mg (2 tablets/day): 60 tablets/30 days
    • 40 mg (10 tablets/day): 300 tablets/30 days

    Background 

    Scemblix is a kinase inhibitor indicated for the treatment of adult patients with:

    • Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). This indication is approved under accelerated approval based on major molecular response (MMR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
    • Ph+ CML in CP with the T315I mutation

    Questions?

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

    back to top