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DrugSecuado® (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

Renewal criteria:

  • 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

Quantity limits:

  • 30 transdermal systems/30 days


MHCP Provider Call Center 651-431-2700 or 1-800-366-5411

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