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Abilify MyCite®

Drug - Abilify MyCite® (aripiprazole tablets with sensor) [Otsuka America Pharmaceuticals Inc.]

April 2020

Therapeutic area - Antipsychotics

Approval criteria

  • Patient must be ≥ 18 years of age AND
  • Patient must have at least one of the following:
    • Diagnosis of schizophrenia OR
    • Diagnosis of bipolar I disorder OR
    • Diagnosis of major depressive disorder and aripiprazole will be used as adjunctive therapy AND
  • Patient has tolerability to oral aripiprazole with suboptimal effects (as assessed by prescriber) that may be due to adherence problems OR
  • There is a documented intervention by prescriber if nonadherence is detected AND
  • Patient has a smart phone compatible with the device AND
  • Patient or guardian gives consent to a healthcare provider and caregiver (if applicable) to monitor the portal AND
  • Patient has not received Abilify MyCite for ≥ 90 days/calendar year AND
  • Prescriber provides a clinical reason the patient is not a candidate for long acting injectable atypical antipsychotic
  • Initial approval is for 30 days

Renewal criteria

Patient must:

  • Continue to meet initial criteria AND
  • Have prescriber attestation that patient benefited from therapy AND
  • Have prescriber attestation that there is a continued need for device (e.g., continued suboptimal effects) AND
  • Have a healthcare provider and caregiver (if applicable) agree to continue to monitor device AND
  • Not have worsened target symptoms AND
  • Not have had any treatment-limited adverse effects (e.g., hypersensitivity, suicidality, neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, pathological gambling and other compulsive behaviors, orthostatic hypotension, falls, seizures, cognitive and motor impairment, dysphagia, disruption in body temperature regulation, and leukopenia, neutropenia, and agranulocytosis) AND
  • Have a healthcare provider state reason why the patient cannot use long acting injectable atypical antipsychotic if there is continued nonadherence
  • Renewal approval is for 30 days

Quantity limits

  • 1 kit per 30 days
  • Maximum duration of treatment with Abilify Mycite is 90 days per calendar year

Background information

  • Abilify MyCite is a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion
  • The ability of Abilify MyCite to improve patient compliance or modify aripiprazole dosage has not been established
  • The use of Abilify MyCite to track drug ingestion in “real-time” or during an emergency is not recommended because detection may be delayed or not occur


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

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