As you know, the initial draft guidance sent by NICE to all those who submitted evidence to the NICE Advisory Committee suggested that drug-eluting stents were effective but not cost-effective and should not be used in the UK. This draft decision was open for further consultation. The NICE process allows for professional and patient responses to this draft guidance.
This initial assessment was met with disbelief by virtually the entire cardiology community. Many BCIS members made direct submissions to NICE outlining why they believed the guidance to be wrong (see ‘Response to public comments on the ACD’ section on the NICE website). Martyn Thomas (outgoing BCIS President) and Tony Gershlick (Scientific Officer) had worked extremely hard over several years to present the evidence base to NICE and to give the Society’s view on the current role of drug-eluting stents. They had to comment on initial reports from the economic group commissioned by NICE to review the cost-effectiveness of drug-eluting stents. It became clear early on that there was, for the first time, a fundamental disagreement between the economists and the clinical experts, based mainly on the methodology used in the economic modelling exercise used. After the initial guidance Martyn Thomas and Tony Gershlick presented additional data to NICE demonstrating the areas where BCIS took issue with the clinical and economic analysis. Both the former and current President of the British Cardiovascular Society (Drs Nick Brooks and Nick Boon) and its Council offered strong support.
On Friday 25th January 2008, BCIS and the British Cardiovascular Society received the draft of the NICE Final Appraisal Determination (FAD). This demonstrated that the Advisory Committee had paid heed to the clinical experts’ advice and alternative economic models to the one they had commissioned. Their recommendation is that drug-eluting stents can be used for lesions >15mm or in vessels <3mm (i.e. the same as the previous guidance) but only as long as the average price difference between drug-eluting stents and bare metal stents is less than £300.
The Advisory Committee rejected the BCIS request that diabetes was added to the above two criteria as an independent factor in choosing a DES. BCIS believes that the Committee’s reason for doing this was not based on scientific principles. BCIS also believes that the scientific basis for the latter part of the guidance is fundamentally flawed, and although this is more of an issue for industry, it will clearly affect local tendering exercises. Moreover, it may have consequences for future NICE evaluations for the technologies we use in our patients. We now have to decide whether to make an appeal against the FAD. The deadline for this to be submitted is February 15th 2008.
Manufacturers of drug-eluting stents are also considering the appeals process but it is not yet clear whether they will proceed. Should the appeals process be activated, then there will be an additional 3 months delay before the final guidance is available.
This has been a long hard battle, the nature of which has led some to call into question the processes by which NICE makes decisions. Some members of BCIS feel that the Society should appeal as we have so much additional evidence compared to 2003 to support the use of drug-eluting stents. We also have to weigh up whether an appeal is likely to be heard, not least because there are only limited grounds on which to base an appeal, and these are somewhat stacked in favour of NICE (this part of the process has been criticised by the review of NICE undertaken by Parliaments’ Health Select Committee.
The fact is though that the original NICE decision to deny this technology to English patients has been overturned. 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.
The issue that is most under debate relates to the methodology by which a price differential between bare metal stents and drug-eluting stents has been reached, and whether by mentioning this NICE has overstepped its powers. The decision, if it stands, will clearly affect local pricing arrangements. We understand that these will not need to be changed immediately but will be introduced at a time consistent with local tendering exercises. We will keep BCIS members informed regarding the appeals process.
In conclusion, BCIS is currently weighing up the pros and cons of whether to submit an appeal. If we do not, we are considering alternative forms of registering our dissatisfaction with this process, mainly to ease the way with future technology assessments. I would welcome any views relating to the current appeals process – email me at mark.debelder@stees.nhs.uk.

Mark de Belder
BCIS President