RETIGABINE FOR EPILEPSY

Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation: an assessment based on the manufacturer’s submission to NICE

Background

The aim of this NICE STA was to appraise the clinical and cost-effectiveness of retigabine within its licensed indication for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation. CRD researchers comprised the Evidence Review Group for this STA. The work involved a detailed assessment of the manufacturer’s submission to NICE on the clinical and cost-effectiveness of retigabine.

Findings

The manufacturer’s review of clinical effectiveness and the evaluation of cost effectiveness had, without clear clinical justification, excluded some comparators included in the NICE scope, and this has implications for the cost-effectiveness evaluation of retigabine. Clinical effectiveness: Evidence from good quality RCTs demonstrates that retigabine is more effective than placebo for the adjunctive treatment of partial epilepsy. Treatment effect does not appear to be affected by number of baseline concomitant AEDs, although the majority of patients were on 2 AEDs.

The results of the systematic review and network meta-analysis demonstrate that the comparator AEDs, eslicarbazepine, lacosamide, pregabalin, tiagabine and zonisamide are also more effective than placebo and no significant difference was found between any of these comparators and retigabine. The efficacy of retigabine in comparison with the other relevant AEDs had not been explored.

Cost effectiveness :the manufacturer’s de novo decision analytic model evaluated the cost-effectiveness of retigabine compared with eslicarbazepine acetate, lacosamide, pregabalin, tiagabine, zonisamide and no treatment. It, and the ERG’s assessment of it, demonstrated that retigabine is not a cost-effective option at any place in a treatment sequence at a £30,000 threshold under any of the scenarios evaluated by the ERG or the manufacturer. However, it was not less cost-effective than comparators already in use in the NHS.

 

Conducted by: Dawn Craig1, Stephen Rice1, Fiona Paton1, Dave Fox1, Nerys Woolacott1

1. Centre for Reviews and Dissemination

Further details

Project page on NIHR HTA Programme website

Related guidance

Commissioned to inform NICE Technology Appraisal Guidance: Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation. London: National Institute for Clinical Excellence; 2011

Publications

Craig D, Rice S, Paton F, Fox, D, Woolacott, N. Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation: a Single Technology Appraisal. Centre for Reviews / Dissemination and Centre for Health Economics, 2011

Craig D, Rice S, Paton F, Fox D, Woolacott N. Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation: A NICE Single Technology Appraisal. Pharmacoeconomics 2013;31(2):101-10

Funding

Commissioned by the NIHR HTA Programme in support of NICE's Single Technology Appraisal process.

NICE’s single technology appraisal (STA) process is specifically designed for the appraisal of a single product, device or other technology, with a single indication. The STA process normally covers new technologies and is designed to provide recommendations in the form of NICE guidance soon after the technology is introduced into the UK market. The principal evidence in the STA process is submitted by the manufacturer or sponsor of the technology.