Brivaracetam

PBAC's latest decision on Brivaracetam: Recommended with restriction (2019). Considered for Extension of existing listing for treatment of intractable partial onset epileptic seizures in combination with anti-epileptic drugs to include patients aged 4-15 years whose condition has not been satisfactorily controlled by other AEDs, and removal of the requirement to maintain patients on two or more other AEDs during continuation therapy.

Eligible population

Children aged 4-15 years with intractable partial onset epileptic seizures whose condition has not been satisfactorily controlled by other anti-epileptic drugs (at least one first-line AED and at least two second-line adjunctive AEDs), treated as add-on therapy.

Therapy area

Neurology

Line of therapy

Later-line

Evidence base

Single-arm

Primary endpoint

Surrogate

Key trials

N01266, N01263, Schubert-Bast (2018), CL0187, CL0258, 1252, 1253, 1258 (brivaracetam RCTs), SP667, SP754, SP755 (lacosamide RCTs)

Comparator

lacosamide

Economic model

Cost-minimisation

ICER note

Cost-minimisation analysis; no ICER calculated. PBAC previously recommended listing for patients aged 16+ years on the basis that cost-effectiveness would be acceptable if cost-minimised against lacosamide.

Risk sharing

Risk-sharing arrangement in place — Risk-share arrangement maintained from previous lacosamide consideration (November 2012 PBAC Meeting).

Submission history

• Jul 2016: Recommended with restriction · Restricted
• Mar 2017: Not recommended · Restricted
• Nov 2017: Noted · Authority Required
• Nov 2019: Recommended with restriction · Restricted

Similar precedents

• Lacosamide
  similarity 0.79
• Eslicarbazepine acetate
  similarity 0.74
• Perampanel
  similarity 0.70
• Levetiracetam
  similarity 0.71
• Fenfluramine
  similarity 0.69
• Pregabalin
  similarity 0.66