This guidance updates and replaces NICE clinical guideline 20. This guidance also updates and replaces NICE technology appraisal 76 (2004) and NICE technology appraisal 79 (2004).
Epilepsy is a common neurological disorder characterised by recurring seizures. Different types of epilepsy have different causes. Accurate estimates of incidence and prevalence are difficult to achieve because identifying people who may have epilepsy is difficult. Epilepsy has been estimated to affect between 362,000 and 415,000 people in England. In addition, there will be further individuals, estimated to be 5–30%, so amounting to up to another 124,500 people, who have been diagnosed with epilepsy, but in whom the diagnosis is incorrect. Incidence is estimated to be 50 per 100,000 per year and the prevalence of active epilepsy in the UK is estimated to be 5–10 cases per 1000. Two-thirds of people with active epilepsy have their epilepsy controlled satisfactorily with anti-epileptic drugs (AEDs). Other approaches may include surgery. Optimal management improves health outcomes and can also help to minimise other, often detrimental, impacts on social, educational and employment activity. The previous NICE guideline on epilepsy stated that the annual estimated cost of established epilepsies was £2 billion (direct and indirect costs).
Newer and more expensive AEDs are now being prescribed, and with an increase in treatment costs likely in coming years it is essential to ensure that AEDs with proven clinical and cost effectiveness are identified. The evidence used to develop the previous NICE guideline for epilepsy and related technology appraisals showed no difference in effectiveness between newer and older AEDs, or between the newer drugs (as monotherapy) for seizure control. However, a recent large multicentre trial (the SANAD trial) evaluating newer drugs in newly diagnosed epilepsy (accepting some limitations) suggested that sodium valproate should be the drug of choice in generalised and unclassifiable epilepsies, and lamotrigine in focal epilepsies. It was therefore considered necessary to review new evidence regarding AEDs within an update of NICE clinical guideline 20 (which was published in 2004).
The guideline will assume that prescribers will use a drug's summary of product characteristics to inform decisions made with individual patients.
This guideline recommends some drugs for indications for which they do not have a UK marketing authorisation at the date of publication, if there is good evidence to support that use. Where recommendations have been made for the use of drugs outside their licensed indications ('off-label use'), these drugs are marked with a footnote in the recommendations.