Risperidone

PBAC's latest decision on Risperidone: Recommended with restriction (2024). Considered for Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.

Eligible population

Adults with schizophrenia in whom tolerability and effectiveness have been established with oral risperidone.

Therapy area

Mental health

Line of therapy

Any

Evidence base

RCT

Primary endpoint

ORR

Pivotal trial size

438 patients

Key trials

PRISMA-3, Kane 2003, Gopal 2010, Nasrallah 2010, Kramer 2010, Bossie 2011, Takahashi 2013

Comparator

risperidone 2-weekly LAI (Risperdal Consta) and paliperidone 1-monthly LAI (Invega Sustenna)

Economic model

Cost-minimisation

ICER note

Cost-minimisation analysis; no ICER calculated by design.

Submission history

• Jul 2005: Not recommended
• Nov 2005: Recommended · Authority required
• Mar 2006: Not recommended
• Nov 2006: Recommended with restriction · Authority Required
• Mar 2011: Recommended with restriction · Authority Required (STREAMLINED)
• Nov 2015: Recommended with restriction · Restricted
• Aug 2019: Recommended with restriction · Restricted
• Mar 2024: Recommended with restriction · Authority Required

Similar precedents

• Clozapine
  similarity 0.66
• Paliperidone palmitate
  similarity 0.67
• Paliperidone
  similarity 0.66
• Quetiapine
  similarity 0.66
• Brexpiprazole
  similarity 0.63
• Ziprasidone hydrochloride
  similarity 0.63