The National Institute for Health and Clinical Excellence (NICE) has recommended that drug-eluting stents can continue to be used in patients who have a higher risk of needing further stents if a conventional bare-metal stent were used instead. It has set a limit for the price differential between drug-eluting and bare-metal stents of £300.
Likely candidates for drug-eluting stents are those in whom the coronary artery is less than 3 mm in diameter, or the segment of the artery to be treated is longer than 15mm.
The new draft guidance on drug-eluting stents, which was issued by NICE on 1st February 2008, is very different from the draft proposals that the agency had put out for comment last year. Those proposals stated that drug-eluting stents “do not represent a cost-effective use of National Health Service resources,” after taking into account the risks and benefits of drug-eluting stents as compared with bare-metal stents. The British Cardiovascular Society, the British Cardiovascular Intervention Society (BCIS), and the British Heart Foundation, had all voiced strong objections to the proposals which now seem to have been reversed in the draft guidance.
Andrew Dillon, NICE Chief Executive, said: “This decision to recommend the use of drug-eluting stents for patients was reached by a careful consideration of the evidence, comments received during consultation and further economic modelling. The independent Appraisal Committee took into account the risks and benefits of the different types of stents, and the significant additional costs involved in the use of drug-eluting stents compared to bare-metal stents.“
In a statement, BCIS President, Dr Mark de Belder said that several members of his organisation and of the British Cardiovascular Society had worked hard with NICE to achieve the current reversal of the original proposals. He said they had had a “long hard battle” and there was “a fundamental disagreement between the economists and the clinical experts, based mainly on the methodology used in the economic modelling exercise used”, but, in the end, the NICE Advisory Committee had paid heed to the clinical experts’ advice and alternative economic models to the one they had commissioned.
Dr De Belder noted, however, that the Advisory Committee had rejected the BCIS request that diabetes was added as an independent factor in choosing a drug-eluting stent, which he claims was not based on scientific principles. He also expressed concern about the methodology by which a price differential between bare-metal stents and drug-eluting stents has been reached. But he added that: “The current guidance, in effect, encourages the status quo. Clinicians will, in the vast majority of cases, be able to provide what they believe to be optimal therapy to their patients”.