Nuplazid - NC Standard

Restricted Product(s)

• Nuplazid (pimavanserin)

FDA Approved Use

• For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Criteria for Approval of Restricted Product(s)

1. The patient has a diagnosis of Parkinson’s disease (PD); AND 
2. The patient’s psychotic symptoms (hallucinations and/or delusions) started after the diagnosis of PD; AND 
3. The patient has been inadequately treated with another atypical antipsychotic (such as quetiapine or clozapine); OR 
4. The provider believes that a trial of another atypical antipsychotic (such as quetiapine or clozapine) would be detrimental to the patient OR would likely be ineffective based on documented clinical reasoning; AND 
5. If on pharmacologic therapy for PD, the provider has ruled out a change of PD therapy as an option for minimizing psychotic symptoms; AND 
6. If on pharmacologic therapy for PD, the patient has been stable for 30 days prior to the start of Nuplazid; AND 
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. 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 
4. 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). 

References

All information referenced is from FDA package insert unless otherwise noted below.

Miyasaki JM, Shannon K, Voon V, Ravina B, Kleiner-Fisman G, Anderson K, Shulman LM, Gronseth G, Weiner WJ, Practice Parameter: Evaluation and treatment of depression, psychosis, and dementia in Parkinson disease (an evidence-based review). Neurology April 11, 2006 vol. 66 no. 7 996-1002

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

May 2022: Criteria update: Duration of approval changed to 365 days. Nuplazid 17mg tablets removed from policy (obsolete).

Sept 2020: Annual Criteria Review. Format updates. No changes to policy.

Jul 2018: New to market 10 mg tablets and 34 mg capsule added to policy

May 2016: Original utilization management criteria issued.