The Scottish Medicines Consortium has approved the use of AstraZeneca’s top-selling drug Nexium on the National Health Service for patients with Zollinger-Ellison syndrome.

Nexium (esomeprazole), which was first licensed for the treatment and long-term management of patients aged 12 and above with reflux oesophagitis, is a proton pump inhibitor that was given an additional green light for the treatment of patients with ZES in Europe in November 2006.

ZES is a rare but serious chronic illness characterised by development of tumours that secrete excessive levels of gastrin, a hormone that stimulates the stomach to produce acid, and effective control of gastric acid is crucial in the management of patients with condition, the firm explained.

The treatment group for ZES is fairly small; the estimated prevalence is around 0.1-3 cases per million of the population per year, with 1 to 20 patients in Scotland, so the endorsement by the SMC is unlikely to have a major impact on sales of the drug, which hit 1.29 billion in the third quarter of this year.

In fact, a spokesperson for AstraZeneca told PharmaTimes UK News: “Depending on the actual number of ZES patients in Scotland, the treatment chosen by their physician and the dosages prescribed, the cost to the NHS in Scotland is estimated to be approximately £3000 per year.”

She went on to say that as ZES is such a rare disease, and the budget impact for the NHS is very minimal indeed, “NICE has not, to the best of our knowledge, assessed the use of any PPIs for [the condition]”.

Commenting on the approval, Philip Oldham, Head of Nexium at AstraZeneca said it is a “typical example of AstraZeneca putting the patient first and means that those patients in Scotland who suffer from this condition and are in need of treatment will now have access to this medicine.”

No heart risk
Meanwhile, AstraZeneca received another boost on news that US regulators have found no association between Nexium and an increased risk of heart attacks.

The US Food and Drug Administration has now completed a six-month review which began when AstraZeneca sent the agency a preliminary review of new data from two small long-term clinical studies of Nexium and Prilosec (omeprazole) in patients with severe gastroesophageal reflux disease.

The FDA said back in August that the two studies showed no increased risk of heart problems with long-term use of the drugs, and after reviewing a further batch of studies has now reached the same conclusion.

“Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect,” it stated.