Title: Clinical and cost effectiveness of interventions for epilepsy in the NHS
Funder: Department of Health (England)

Abstract: 6. Details of proposed programme Background (1000 characters max):Epilepsy is the most common serious neurological condition with a lifetime cumulative incidence of 3-5%. Around a third of people diagnosed with of epilepsy continue to have seizures despite optimal medical treatment while around two thirds enter remission from seizures often at the cost of side effects of treatment. Also one third are women of childbearing potential who require reliable evidence about the effects of treatments on the unborn child. Epilepsy is also associated with a number of co-morbidities including anxiety depression and memory problems UK cost-of-illness studies mostly dating from the 1990s estimate the direct costs (to the NHS) and indirect costs (e.g. productivity losses through unemployment) of epilepsy to be in the order of £1500 and £2800 per patient per annum respectively [1]. A more recent analysis of the costs of epilepsy across Europe for 2004 estimated the total UK annual healthcare costs at €178m direct non-medical costs (€455m) and indirect costs (€876m) [2]. Thus the economic burden of epilepsy on patients the NHS and society is significant.[1] Pharmacoeconomics. 2008;26(6):463-76. [2] Epilepsia. 2007; 48(12):2224-2233.Theme and scope of proposed programme (1000 characters max):The theme is the clinical and cost effectiveness of interventions for epilepsy in the NHS.The scope of work includes:1.Reviews addressing interventions and treatment policies that are a priority for the NHS assessing outcomes that are important to the NHS patients and clinicians.2.New important complex reviews undertaken by grant staff including:a.Reviews using individual patient data already accessible to the group and collaborators.b.Reviews of observational studies (e.g. for teratogenic effects)c.Systematic reviews of reviews with network meta-analysis where appropriate3.Reviews assessing co-morbidities that are relevant across primary and secondary care4.Facilitation of review and update completion through workshops mentoring direct contact with authors and target setting5.Targeting new reviews identified as important by patients6.Developing capacity within the Cochrane Epilepsy Group and building collaboration with the Liverpool Reviews and Implementation Group (LRiG) and the Bangor Health Economics Group7.Scoping reviewing and conducting economic evaluations of selected topics areas thereby developing health economics as a core competency of the Cochrane Epilepsy GroupProposed reviews to be undertaken and/or updated and how the choice is justified in terms of NHS priorities (2000 characters max):The prioritisation of topics has been informed by consultation with the Mersey Region Epilepsy Association and PatientView that undertook an epilepsy patient survey on behalf of DUETs the James Lind Alliance Swansea University and the University Hospital of Wales. Prioritisation will also be informed by results from an RfPB grant – see below.In the following text (N) = new review (P) = current protocol where review will be facilitated (U) = review update. Reviews will be undertaken by those employed on the grant or will be facilitated by employed reviewers and through support of volunteer reviewers facilitated by the review staff within LRiG. Where possible all reviews will include outcome measures that will be used in the new quality standards for the NHS providing users with up-to-date evidence on the effects of the assessed interventions on the likely impact on the quality and effects of health care in items of greatest relevance to the NHS.1.We are of the view that evidence syntheses and economic evaluations of the following strategies and interventions are NHS priorities:a.Antiepileptic drug treatment following a first seizure (P)b.Antiepileptic drug withdrawal for patients in remission (N)c.Generic substitution for patients taking branded antiepileptic drug treatment (P)2.We have chosen 3 co-morbidities that are common of concern to patients have a significant impact on quality of life and that are often ineffectively managed:a.Depression (N)b.Anxiety (N)c.Memory problems (N)3.Evidence on the teratogenic effects of antiepileptic drugs comes largely from observational studies and is currently absent from the Cochrane Library. We propose a single review that will provide an overview of the effects of currently available antiepileptic drugs in pregnancy. While we could produce numerous reviews of single drugs (there are currently 20) we propose one single large over-arching review which will include over 60 studies and will be equivalent to around 10 reviews in workload (N). 4.Surgical treatment:a.Temporal lobe resection (P)5.Efficacy updates:a.10 Review updates will be prioritised for updating during the time of the award.6.In relation to health economics we will:a.Define criteria and scope existing (and proposed) reviews for relevance of economic evidence synthesis and modellingb.Conduct systematic review of health economic evidence in 5 prioritised topicsc.Develop cost-effectiveness models for up to 4 reviews7.Two systematic reviews of reviews with network meta-analysis where appropriate will be undertaken to pull together information from Cochrane reviews and other non-Cochrane high quality reviews.a.Antiepileptic drug monotherapyb.Add –on treatment for refractory focal epilepsyOutline plan and timetable for undertaking reviews including how award would be used (eg. employment of new researchers) (2000 characters max):TimetableRecruit systematic reviewer and statistician Months 0-3Individual patient data reviewsAntiepileptic drug treatment following a first seizureMonth 0-12Antiepileptic drug withdrawal for patients in remissionMonth 0-12Studies utilising observational studiesAntiepileptic drugs in pregnancy Month 0-24Treatments for depression in people with epilepsyMonth 18-36Interventions for co-morbidities (see depression above)Interventions for anxiety in people with epilepsy Month 19 to 24Interventions for memory problems in people with epilepsy Month 19 to 24Non-drug interventionsTemporal lobe resection Months 1-12Drug reviews – effectiveness updatesUpdates prioritised by review group (10) Months 12-36Health economic updates and modellingUpdates with systematic review of health economic studies (5) Months 6-24Updates with health economic modelling (4) Months 13-36Systematic reviews of reviews – to provide overviews of Cochrane and other high quality systematic reviewsAdd-on therapy for refractory focal epilepsyMonths 13-36Antiepileptic drug monotherapyMonths 13-36Three staff will be employed: a full time statistician yrs 1-3 a full time systematic reviewer yrs 1-3 (both grade 6) and a half time health economist yrs 2-3 (grade 7). LRiG will provide a wide range of review expertise to support employed and volunteer reviewers and to assist in reviewer recruitment. LRiG has also agreed to fund a health economics MPhil studentship for years 1 and 2 (£15k per year). This MPhil student will undertake the ground work to build health economics capacity within the Cochrane Epilepsy Group. Scoping will identify reviews to be prioritised for systematic review of health economic studies and for health economic modelling.The health economist (yrs 2-3) will participate in the prioritisation of health economic reviews and will undertake health economic modelling of 4 interventions prioritised.


Research activity codes: 6.4 SURGERY;6.1 PHARMACEUTICALS
Health categories: NEUROLOGICAL