BrivaracetamBriviact
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.
Decisions on record
- Meeting Nov 2019 Recommended Epilepsy
- Meeting Nov 2017 Recommended Epilepsy
- Meeting Mar 2017 Not recommended Brivaracetam is indicated as add-on therapy in the treatment of partial- onset seizures with or without secondary generalisation in patients from 16 years of age with epilepsy.
- Meeting Jul 2016 Not recommended Epilepsy
Access path
- TGA registered · Briviact
TGA label narrower than the PBS population
- Jul 2016Not recommended
vs lacosamide
- Mar 2017Not recommended
lack of robust clinical data for the proposed indication, inadequate transitivity between brivaracetam and lacosamide…
- ↻ resubmittedNov 2017Recommended · restricted
Evidence: Indirect comparison via meta-analysis → Meta-analysis
- Nov 2019Recommended · restricted
Evidence: Meta-analysis → Single-arm
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended changing the Authority Required (STREAMLINED) listing for brivaracetam for treatment of intractable partial onset epileptic seizures, to include patients aged 4 to 15 years. Its recommendation was based on, among other matters, its assessment that the cost-effectiveness of brivaracetam would remain acceptable with the extended listing implemented at the current price, where the listing results in an overall saving to Government.PSD · Nov 2019
7.2 In making its recommendation, the PBAC acknowledged the clinical need for drugs that are effective in reducing seizure frequency for paediatric patients who have failed other lines of AED treatment.PSD · Nov 2019
6.24 The submission requested the current brivaracetam prices be maintained for the proposed extension to the PBS-listing. This implicitly assumed that the equi-effective doses for the population aged 16 years and older would apply to the paediatric population. The current equi-effective doses in adults are 117.6 mg brivaracetam and 316.2 mg lacosamide (paragraph 6.16, brivaracetam PSD, November 2017 PBAC Meeting).PSD · Nov 2019
6.25 A cost comparison of brivaracetam and lacosamide doses was performed during the evaluation to assess whether brivaracetam and lacosamide treatment at equivalent doses would result in similar costs at the AEMP price. For the purposes of the analysis equivalent doses were 4 mg/kg/day of brivaracetam and 8 mg/kg/day of lacosamide.PSD · Nov 2019
as in patients aged 16 years and above and is non-inferior to lacosamide in paediatric patients aged 4 - 15 years in this setting.PSD · Nov 2019
Source: Table 1.1, p14 of the submission AED = antiepileptic drugPSD · Nov 2019
6.2 The PBAC noted and welcomed the input from the National Paediatric Medicines Forum (NPMF) via the Consumer Comments facility on the PBS website. The comments highlighted the benefits that further treatment options would bring to paediatric patients with epilepsy, including improved seizure control and compliance leading to improved school and social activities, reduced burden on carers, and reduced presentations to hospital and GPs.PSD · Nov 2019
6.34 The minor resubmission stated that a Risk Share Arrangement contains the cost to the Government of lacosamide and perampanel. The resubmission acknowledged brivaracetam would be added to the lacosamide/perampanel Risk Share Arrangement and if this is exceeded, the sponsor would bear the financial risk.PSD · Nov 2017
Cost-effectiveness
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.
The PBAC recommended listing brivaracetam considering, among other matters, that the cost-effectiveness of brivaracetam would be acceptable if it were cost-minimised against lacosamide (paragraph 7.1, brivaracetam Public Summary Document (PSD), November 2017 PBAC Meeting). PBAC · 2019
Decision context
PopulationChildren 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.
Risk sharingRisk-share arrangement maintained from previous lacosamide consideration (November 2012 PBAC Meeting).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2019 | Recommended · restricted | lacosamide | — | Single-arm · Surrogate |
| Nov 2017 | Recommended · restricted | lacosamide | — | Meta-analysis · 50% responder rate |
| Mar 2017 | Not recommended | lacosamide | — | Indirect comparison via meta-analysis · Seizure reduction |
| Jul 2016 | Not recommended | lacosamide | — | RCT · 50% responder rate |
Consumer voice
The National Paediatric Medicines Forum highlighted that additional treatment options for paediatric epilepsy would improve seizure control and compliance, leading to better school and social activities, reduced carer burden, and fewer hospital and GP presentations.
The comments highlighted the benefits that further treatment options would bring to paediatric patients with epilepsy, including improved seizure control and compliance leading to improved school and social activities, reduced burden on carers, and reduced presentations to hospital and GPs. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to intractable seizures uncontrolled by specific prior AED trials; TGA label does not require prior treatment failure.