Secuado

Drug - Secuado® (asenapine film, extended release) [Noven Therapeutics, Inc.]

July 2020

Therapeutic Area - Antipsychotics

Initial approval criteria:

Patient is ≥ 18 years of age; AND
Patient has a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia; AND
Patient does not have severe hepatic impairment (Child-Pugh Class C); AND
Patient has a documented history of receiving oral asenapine without experiencing any treatment-limiting adverse effects; AND
Patient has a documented history of nonadherence to an oral antipsychotic that is unrelated to adverse effects (e.g., based on fill history, prescriber attestation); AND
If patient is taking paroxetine, prescriber has adjusted/will adjust paroxetine dose upon asenapine treatment initiation; AND
Patient has had an adequate trial and failure of ≥ 2 preferred second-generation antipsychotics (one of which is oral asenapine), each at optimal dosages and used for ≥ 4 weeks, unless treatment-limiting adverse effects were experienced; AND
Patient has a history of failure, contraindication, or intolerance to ≥ 1 long-acting injectable antipsychotic.
Initial approval is for 6 months

Patient continues to meet above criteria; AND
Patient’s adherence is documented as ≥ 80% of doses based on prescription fill history; AND
Patient does not have a treatment-limiting adverse effect (e.g., significant application site reactions; tardive dyskinesia; significant weight gain; blood dyscrasias; neuroleptic malignant syndrome); AND
Prescriber has documented clinical improvement or stabilization (e.g., decrease hospitalization versus baseline, decrease in symptoms, maintenance of benefit/lack of or delayed number of psychotic episodes).
Renewal approval is for 12 months

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