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DrugAdakveo® (crizanlizumab-tmca) [Novartis Pharmaceuticals Corporation]

April 2020

Therapeutic area - Sickle Cell Disease

Initial approval criteria

  • Patient must be ≥ 16 years AND
  • Patient has a confirmed diagnosis of sickle-cell disease, of any genotype (e.g., HbSS, HbSC, HbS/beta0-thalassemia, HbS/beta+-thalassemia, and others) as determined by one of the following:
    • Identification of significant quantities of HbS with or without an additional abnormal β-globin chain variant by hemoglobin assay OR
    • Identification of biallelic HBB pathogenic variants where at least one allele is the p.Glu6Val pathogenic variant on molecular genetic testing AND
  • Patient had an insufficient response to a minimum 3-month trial of hydroxyurea (unless contraindicated or intolerant) AND
  • Patient experienced 1 or more vaso-occlusive crises (VOC)* in the previous year despite adherence to hydroxyurea therapy
  • Therapy will not be used in conjunction with voxelotor (Oxbryta) or L-glutamine (Endari) AND
  • Initial approval is for 6 months

*VOC is defined as an event prompting either a visit or outreach to the provider which results in a diagnosis of VOC being made necessitating subsequent interventions such as narcotic pain management, non-steroidal anti-inflammatory therapy, hydration, etc.

Renewal criteria

  • Patient must continue to meet the above criteria AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: severe infusion related reactions (e.g., fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, shortness of breath or wheezing), etc. AND
  • Disease response as evidenced by a decrease in the frequency of vaso-occlusive crises (VOC) necessitating treatment, reduction in number or duration of hospitalizations, and/or reduction in severity of VOC
  • Renewal approval is for 12 months

Quantity limits

  • 12 vials during the first 28 days
  • 6 vials per 28 days, thereafter

Billing for Adakveo

  • Adakveo must be billed as a medical claim


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

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