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

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

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

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