New drug could further help people with epilepsy
A recently licensed drug that helps control seizures in adults who have epilepsy could soon be recommended for use in the NHS. This comes as draft guidance from the National Institute for Health and Care Excellence (NICE) out today (17 June) provisionally advises that retigabine (also called Trobalt, manufactured by GlaxoSmithKline) could be prescribed as an add-on treatment option if other medicines have been ineffective or produced unmanageable side effects.
Epilepsy is a common neurological disorder characterised by recurring seizures. It affects between 260,000 and 416,000 people in England and Wales, 55% of whom will experience partial onset seizures, which are caused by too much electrical activity in one part of the brain. When this excessive activity reaches the whole brain, it is called secondary generalisation.
People with epilepsy often need to take a combination of drugs to control their seizures. NICE provisionally recommends retigabine as an add-on (adjunctive) treatment option for adults with partial onset seizures (with or without secondary generalisation) who have not responded well to the following drugs: carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, sodium valproate and topiramate.
The draft decision means that people with epilepsy may soon have another treatment option on the NHS to help control their seizures.
Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE said: "Seizures can be extremely debilitating as they can interfere with a person's social life, employment and other daily activities. While there are a number of effective anti-epileptic drugs already widely available on the NHS, people can have different responses to them. It's therefore very important for doctors to have a broad range of options so that they can find the right combination for their patients.
"Our draft guidance sets out the circumstances where retigabine could be used as an additional option to treat partial onset seizures for adults who have epilepsy and whose previous treatments have not worked. We are very pleased to able to issue these draft recommendations so soon after retigabine's regulatory approval. Once published, we hope that our final guidance will lead to even more people having greater control of the condition."
Retigabine was licensed for use by the European Medicines Agency in March this year, however NHS healthcare settings across England and Wales are not legally obliged to allocate funding for it.
The draft guidance (called a final appraisal determination) is now with interested third parties, who have the opportunity to appeal against the proposed guidance and highlight any factual errors.
If NICE does not receive any appeals then final guidance will be published in July 2011.
Until NICE issues its final guidance, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
About the draft guidance (final appraisal determination)
1. For further information about NICE's final appraisal determination of retigabine as an adjunctive treatment for partial onset seizures in epilepsy, visit: http://guidance.nice.org.uk/TA/Wave23/33. Contact the NICE press office for embargoed copies.
2. The appeal period will run from Friday 17 June until Friday 1 July 2011.
3. Due to the positive provisional recommendation, it was deemed appropriate to proceed straight to the final stage of guidance development, which is to give consultees an opportunity to appeal against the proposed recommendations. This is designed to speed up the process of publishing positive guidance to the NHS so that patients can receive new treatments quicker.
4. Retigabine (Trobalt, GlaxoSmithKline) is a prescription-only oral medicine that can reduce partial onset seizures. While other anti-epileptic drugs work by controlling the calcium or sodium channels found in the nerve cells of the brain, retigabine works by opening the potassium channels. A pack of 84, 50mg-strength tablets costs £19.46, although prices may vary in different settings because of negotiated procurement discounts.
5. NICE previously recommended carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, sodium valproate and topiramate as treatment options for adults with epilepsy in 2004. For further information about NICE Technology Appraisal 74 on “Epilepsy (adults) - newer drugs”, visit: www.nice.org.uk/TA74.
6. NICE is currently updating its clinical guideline on the diagnosis and management of epilepsies in children and adults. For further information visit: http://guidance.nice.org.uk/CG/WaveR/52
1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
2. NICE produces guidance in three areas of health:
- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS
3. NICE produces standards for patient care:
- quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
- Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
This page was last updated: 16 June 2011