Abilify MyCite - NC Standard
Restricted Product(s):
- Abilify MyCite® (aripiprazole tablets with sensor)
- Abilify MyCite® Kit (aripiprazole tablets with sensor, pod, and strips
FDA Approved Use:
- For the treatment of adults with schizophrenia
- For the acute treatment of bipolar I disorder in adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate
- For the maintenance treatment of bipolar I disorder in adults as monotherapy and as adjunct to lithium or valproate
- For the adjunctive treatment of adults with major depressive disorder (MDD)
Criteria for Approval of Restricted Product(s):
Initial Coverage
- The patient is currently taking generic aripiprazole and tolerates the medication [medical record documentation required]; AND
- The patient has experienced adherence issues with generic aripiprazole tablets with no sensor; AND
- The prescriber has documented all of the following strategies to try to improve patient adherence;
- Utilization of a pill box.
- Utilization of a reminder (e.g. alarm, application, or text reminder).
- Involving family members or friends to assist.
- Coordinating timing of dose to coincide with dosing of another daily medication; AND
- The patient has tried and failed or has a clinical contraindication/intolerance to a long acting injectable antipsychotic (e.g., Abilify Maintena, Risperdal Consta, etc); AND
- Prescriber attests that Abilify MyCite is medically necessary for the patient to maintain compliance, avoid life-threatening worsening of symptoms, and reduce healthcare resources utilized due to lack of adherence; AND
- Prescriber agrees to track and document adherence of Abilify MyCite through software provided by the manufacturer; AND
- For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
Duration of Approval: 180 days (6 months)
Continuation Coverage
- The patient has a prior approval for this medication from Blue Cross NC; AND
- The patient is clinically stable on Abilify MyCite; AND
- Patient adherence to aripiprazole therapy has increased since the initiation of Abilify MyCite; AND
- The patient requires the continued use of Abilify MyCite to remain adherent to aripiprazole therapy.
Duration of Approval: 365 days (1 year)
Quantity Limitations:
Quantity limitations apply to brain and associated generic products.
Medication | Quantity per Day (unless specified) |
---|---|
Abilify MyCite® (aripiprazole) 2mg | 1 tablet with sensor |
Abilify MyCite® (aripiprazole) 2mg starter pack | 1 tablet with sensor, 1 pod and 7 strips |
Abilify MyCite® (aripiprazole) 2 mg maintenance pack | 1 tablet with sensor and 7 strips |
Abilify MyCite® (aripiprazole) 5mg | 1 tablet with sensor |
Abilify MyCite® (aripiprazole) 5mg starter pack | 1 tablet with sensor, 1 pod and 7 strips |
Abilify MyCite® (aripiprazole) 5mg maintenance pack | 1 tablet with sensor and 7 strips |
Abilify MyCite® (aripiprazole) 10mg | 1 tablet with sensor |
Abilify MyCite® (aripiprazole) 10mg starter pack | 1 tablet with sensor, 1 pod and 7 strips |
Abilify MyCite® (aripiprazole) 10mg maintenance pack | 1 tablet with sensor and 7 strips |
Abilify MyCite® (aripiprazole) 15mg | 1 tablet with sensor |
Abilify MyCite® (aripiprazole) 15mg starter pack | 1 tablet with sensor, 1 pod and 7 strips |
Abilify MyCite® (aripiprazole) 15mg maintenance pack | 1 tablet with sensor and 7 strips |
Abilify MyCite® (aripiprazole) 20mg | 1 tablet with sensor |
Abilify MyCite® (aripiprazole) 20mg starter pack | 1 tablet with sensor, 1 pod and 7 strips |
Abilify MyCite® (aripiprazole) 20mg maintenance pack | 1 tablet with sensor and 7 strips |
Abilify MyCite® (aripiprazole) 30mg | 1 tablet with sensor |
Abilify MyCite® (aripiprazole) 30 mg starter pack | 1 tablet with sensor, 1 pod and 7 strips |
Abilify MyCite® (aripiprazole) 30mg maintenance pack | 1 tablet with sensor and 7 strips |
Quantity Limit Exception Criteria:
- The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
- The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
- The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
- If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
Duration of Approval: 365 days
References:
All information referenced is from FDA packaged insert unless otherwise noted below.
Policy Implementation / Update Information:
April 2021: Criteria update: Added new to market starter and maintenance packs to the policy.
April 2021: Criteria change: Annual criteria review. Format updates. Changed criteria points regarding adherence & added continuation coverage.
January 2021: Criteria change. Require a trial and failure of Abilify Maintena.
November 2018: Original utilization management criteria issued.
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