The Medicines Company's Angiox (bivalirudin) has received backing from the National Institute for Health and Clinical Excellence (NICE) in the treatment of adults who have suffered a ST-segment-elevation myocardial infection (STEMI).
NICE says the drug should be used in combination with aspirin and clopidogrel in adults who have had a STEMI - which is caused by narrowing and blockage of the coronary artery - or those who are undergoing primary percutaneous coronary intervention.
Around 180,000 people in the UK are admitted to hospital each year with an MI and nearly 30,000 of such patients in England and Wales die, according to NICE. Current standard treatments for STEMI which aim to re-open the blocked artery include primary percutaneous coronary intervention (PCI) - a surgical procedure where fine wires, balloons or stents are inserted into the arteries to disrupt the blood clot and open the coronary artery.
Treatments used in conjunction with primary PCI for people with STEMI are anticoagulants (heparin and low-molecular-weight heparin), which prevent the blood from clotting, and anti-platelet drugs - including the glycoprotein 11b/111a inhibitors as well as aspirin, clopidogrel and prasugrel - to prevent platelet aggregation and formation of blood clots.
Angiox is a type of anticoagulant and is given intravenously at the time of the PCI, together with aspirin and clopidogrel, to prevent blood from clotting during the procedure.
NICE's appraisal committee compared the drug's use with that of the commonly-used anticoagulant heparin in conjunction with glycoprotein 11b/111a inhibitors, and considered that, on the basis of the available evidence, Angiox in combination with clopidogrel and aspirin was both more effective and less expensive. It was also found to be associated with a lower incidence of major bleeding events compared with heparin and glycoprotein inhibitors.
Dr Carole Longson, director of NICE's health technology evaluation centre, pointed out that the number of PCIs being carried out is increasing every year, and she said this new guidance from NICE will provide the NHS in England and Wales with "another important tool to enable it to treat people who have had a heart attack more effectively."
Supporting the positive recommendation, Professor Anthony Gershlick, interventional cardiologist at the University Hospitals of Leicester, commented: "in carrying out primary PCI we not only have the delicate task of clearing the blockage and, hopefully, saving the heart-attack patient, we also have to deal with the concern that the life-saving anti-clotting drugs we are giving these sick patients during the procedure can potentially cause post-operative bleeding which is sometimes fatal. This is a routine concern in this type of patient."
Angiox costs £310 per 250mg vial, excluding value-added tax (VAT), and a median of one vial is expected to be used per patient. It is administered by injection or infusion. The product has a marketing authorisation as an anticoagulant in adult patients undergoing PCI, including those with a STEMI, an indication which is an extension of the original and was approved in November 2009.