Scottish cost regulators have taken a U-turn on the use of Eisai’s epilepsy drug Zebinix, now recommending its use on the National Health Service in Scotland, but only under certain conditions.

Following a resubmission of the drug after it was initially knocked back in January, the Scottish Medicines Consortium is now endorsing the use of Zebinix (eslicarbazepine acetate) as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.

However, the approval is based on the stipulation that doctors should only prescribe the drug for patients with hard-to-treat (highly refractory) forms of the disease, who despite prior heavy treatment with anti-epileptic drugs remain uncontrolled, and is contingent upon the availability of a patient access scheme - under which Zebinix is available at a discount price - in the country.

According to Eisai, epilepsy affects almost 40,000 people in Scotland alone, and up to 40% of those suffering from partial seizures do not achieve adequate seizure control, placing a huge burden on patients and families and highlighting the urgent need for new and effective therapies.

As Martin Brodie, Professor of Medicine and Clinical Pharmacology at the University of Glasgow and Director, Epilepsy Unit, Western Infirmary, Glasgow, further explained, uncontrolled seizures are associated with “poor quality of life, reduced likelihood of employment and an increased risk of psychological co-morbodities such as depression and anxiety”, and so he welcomed the SMC’s decision to recommend the use of Zebinix on the NHS as “it gives physicians another string to their therapeutic bow and people with epilepsy the possibility of improved seizure control”.

Elsewhere, the news was also good for Napp Pharmaceuticals, after the cost watchdog said it accepted OxyNorm (oxycodone hydrochloride 50mg/ml injection) for use within NHS Scotland for the treatment of moderate-to severe pain in patients with cancer, but with restrictions.

The SMC has agreed that the drug is indeed cost effective for the NHS, but only when used in patients who have difficulty tolerating morphine or diamorphine therapy, and who need a high dose of oxycodone delivered via a syringe pump, which normally means the daily preparation of an additional syringe with oxycodone 10mg/mL.

Cancer patients typically require a number of different medications delivered by a syringe pump, and if a high dose of oxycodone is needed for adequate pain control, then volume limitations can prevent the combination of medications within the same syringe.

Less syringes, less cost

However, using the higher strength of oxycodone injection will allow smaller volumes of the medication, thus reducing the need for an additional syringe pump. According to Napp, this can have many advantages such as reduced nursing time, less potential for measurement errors, and cost savings to the health service.

The SMC submission was based on a cost-minimisation analysis comparing oxycodone injection 50mg/ml to oxycodone injection 10mg/ml, which found that using the higher strength in the community/hospice setting could result in a cost-saving of £86.31 per patient for an 11 day treatment periods. Around 174 patients in Scotland would be eligible for the 50mg/ml form, and the firm estimates the budget impact in year one to be a £12,000 net saving based on 80% uptake, it said.

“The development of a more concentrated formulation of oxycodone was prompted by repeated requests from health professionals in Scotland and the rest of the UK and we are delighted that it has been accepted for restricted use in Scotland”, noted Antony Mattessich, Napp’s managing director.

The SMC also turned away several drugs from the NHS, including Yondelis (trabectedin), for the treatment of patients with advanced soft tissue sarcoma, after PharmaMar’s “justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance”, and Renvela (sevelamer carbonate), for the control of hyperphosphataemia in adult patients receiving dialysis, after Genzyme failed to present a sufficiently robust case.