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Canadian Drug Review Reimbursement Decision

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  Invega Sustenna
Generic Paliperidone palmitate
Company Janssen-Ortho Inc.
Indication schizophrenia
Condition Mental and behavioural disorders
Submission Type
Patient Population Paliperidone palmitate is the palmitate ester prodrug of paliperidone, a selective, monoaminergic antagonist that exhibits dopamine (D2) and serotonin type 2A (5-HT2A) antagonism; paliperidone is the active metabolite of risperidone. Paliperidone palmitate is approved by Health Canada for the treatment of schizophrenia. After two initial intramuscular (deltoid) injections (150 mg on day one and 100 mg on day eight), paliperidone (as palmitate) is administered through either deltoid or gluteal intramuscular injection monthly, at a recommended maintenance dose of 75 mg (range: 25 mg to 150 mg). Paliperidone palmitate is available in single-use prefilled syringes in dose strengths of paliperidone base of 50 mg per 0.5 mL, 75 mg per 0.75 mL, 100 mg per 1 mL, or 150 mg per 1.5 mL (as 78 mg, 117 mg, 156 mg, or 234 mg of paliperidone palmitate, respectively). Where doses of paliperidone palmitate are specified below, they refer to the dose of the paliperidone base.
Status Complete
Date of Recommendation 2011-04-25
Recommendation Summary Do not list
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that paliperidone palmitate not be listed at the resubmitted price.
Reason for Recommendation In one double-blind randomized controlled trial (RCT) employing Health Canada-approved doses, paliperidone palmitate was reported to be non-inferior to risperidone long-acting injection (LAI) based on similar reductions in the Positive and Negative Syndrome Scale (PANSS). However, non-inferiority of paliperidone palmitate compared with risperidone LAI was demonstrated at an approximately xREDACTEDx dose equivalency ratio, and therefore, at this dose equivalency, paliperidone palmitate would be more costly. This confidential information was used to make the CEDAC recommendation and the manufacturer requested that this information be kept confidential pursuant to the CDR Confidentiality Guidelines.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.

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