The Scottish Medicines Consortium has endorsed the use of Eisai’s epilepsy drug Zonegran under the National Health Service in adult patients with partial seizures, thereby beating the National Institute of Health and Clinical Excellence in becoming the first UK drugs watchdog to approve use of the new medicine.
Zonegran (zonisamide) is licensed for use as an adjunctive therapy for partial seizures in adults, with or without secondary generalisation (when a seizure spreads to both halves of the brain resulting in stiff muscles and the jerky body movements commonly associated with epileptic ‘fits’), and offers a new hope to patients in which such seizures remain uncontrolled.
Although the drug was launched across the UK in June 2005, it is not due for review by NICE until 2008, adding fuel to the current debate over the time it takes to get new drugs approved for use under the NHS in England. “It will be two years before NICE will assess the role of zonisamide in the treatment of epilepsy. SMC approval means that Scottish patients may have easier access to this newer drug than patients south of the border who may have to await updated NICE guidelines,” remarked Dr John Paul Leach, epilepsy specialist and consultant neurologist at the Western Infirmary in Glasgow.
This is particularly relevant considering that up to a third of the 440,000 people with epilepsy in the UK have seizures which are uncontrolled, and many of these have already tried a variety of therapies. Lack of seizure control inevitably has a significant impact on daily life, so the need for an effective option is great.
Susan Douglas-Scott, Chief Executive of Epilepsy Scotland, commented: “Epilepsy is a highly individual condition and finding a treatment or combination of treatments that achieve adequate seizure control can be difficult. Unfortunately, a significant proportion of people still have seizures that are resistant to all currently available drugs. Epilepsy Scotland is pleased that new treatments are being made available in Scotland at the earliest opportunity.”
Available in South Korea since 1992, Zonegran has now been used in more than one million patients worldwide, according to Eisai, which purchased the US and European rights to the drug from Ireland’s Elan for $130 million in 2004.