Scotland's medicines watchdog, the Scottish Medicines Consortium, has given the go-ahead for lixisenatide, brand name Lyxumia, to be prescribed on the health service to people suffering from Type II diabetes.
The condition, which affects around 220,000 Scots with almost 17,000 new diagnoses made each year, places a huge burden on the NHS and is predicted to increase sharply over the next decade.
Type II diabetes occurs when the pancreas fails to produce enough insulin to maintain a normal blood glucose level, or when a patient is unable to use the insulin their body is producing. This causes a build-up of sugar in the patient's bloodstream.
Although certain ethnic groups, such as people with a South-East Asian or Middle Eastern heritage, are more prone to the disease, the most common cause is obesity, with cases occurring in younger age groups as obesity among Scots becomes more prevalent.
Studies show that adding lixisenatide to insulin or taking it with other oral glucose-lowering medicines improved how well a patient's diabetes is controlled, and also caused a reduction in body weight.
A series of clinical trials with 5000 participants began in May 2008. Results showed that lixisenatide was well-tolerated, with mild nausea and vomiting being the most common side effects.
It is recommended for patients whose existing treatments, combined with a calorie-controlled diet and exercise, do not provide adequate glycaemic control.
Keeping blood sugar levels as near to normal as possible is vital to reduce the risk of long-term complications, such as heart disease, blindness, stroke and kidney failure.
As lixisenatide is less expensive than alternative medicines, it was partly pitched by manufacturer Sanofi to reduce the cost of diabetes care. If NHS patients in Scotland were treated with lixisenatide in preference to similar drugs it is estimated up to 35% more patients could be treated with the same budget. The advice document estimates that, in terms of acquisition costs, switching to lixisenatide would offer a saving of around £197,300 in the first year, rising to £757,700 in five years.
Dr Karen Adamson, consultant diabetologist, St John's Hospital, Livingston, said: "As a clinician I am encouraged by this advice in Scotland. The clinical data has shown Lyxumia is a well-tolerated and effective treatment option. The advice from the SMC indicates Lyxumia also represents value for money to the NHS."
Caroline Horwood, Sanofi diabetes division director, added: "Lyxumia is another step forward in our efforts to develop therapeutic solutions that improve outcomes for people with Type 2 diabetes, an area of significant un-met medical need."
In its guidance, the SMC said it accepted the evidence from clinical trials although it added "evidence to support the effectiveness of lixisenatide compared with the other medicines is uncertain". However, on the economic test, it "provides an additional treatment option for patients at no additional cost" and was therefore recommended for use.
Watchdogs in England, Wales and Northern Ireland have yet to issue their guidance on the drug.