The National Institute for Health and Clinical Excellence has issued final guidance recommending the use of Eli Lilly and Daiichi Sankyo’s clot buster Efient on the National Health Service, but only under certain conditions diminishing the number of patients eligible for treatment.

As expected, the cost regulator has given the all clear for NHS doctors to dish out Efient (prasugrel) in combination with aspirin to prevent atherothrombotic events in patients with acute coronary syndromes undergoing angioplasty, but only when the procedure is necessary due to a certain type of heart attack known as ST-segment-elevation myocardial infarction.

In addition, NICE is allowing use of the drug on the NHS in cases where a blood clot blocks a stent during treatment with Sanofi-aventis’ blood thinner Plavix (clopidogrel), or if patients have diabetes mellitus, as it considers Efient a cost-effective use of resources in these circumstances.

The Institute previously noted that its decision to bar patients with non-ST-segment-elevation MI but without diabetes from access to the drug was fuelled by concerns relating to the available clinical evidence for this setting, in particular that the effectiveness of prasugrel was “highly uncertain for these patients”.

And while the companies have claimed that Efient is more effective than its rival Plavix on the back of data from the TRITON-TIMI 38 trial - which showed a 19% reduction in relative risk for cardiovascular death, non-fatal heart attack or non-fatal stroke when compared with Plavix - the Institute’s Expert Review Group questioned whether these results could be generalised to clinical practice and concluded that the two drugs are “broadly equivalent” in terms of clinical effectiveness at 15 months in the patent group.

In addition, the price of Plavix, a 28-pill strip of which has a price-tag of £36.35 compared to £47.56 for the Efient equivalent, looks set to fall after generic formulations of the drug were given a positive opinion by European regulators earlier this year, further widening the gap in cost and making the therapy a more attractive treatment option for the cost regulator.

Commenting on the new guideline, Dr Carole Longson, Director at NICE said it will “offer an additional treatment option for these specific individuals at risk of blood clots,” and the Institute added that those patients who do not meet the treatment criteria but are already receiving the drug should be able to continue therapy until they and their clinicians consider it appropriate to stop.