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• National Institute of Clinical Excellence
  J Gunn
  Published on: 6 October 2003
• Drug-eluting stents: maximising benefit and minimising cost
  Julian Gunn
  Published on: 17 February 2003
• Brutal analysis suggests that current drug-elution costs are never financially justifiable
  Darrel P Francis
  Published on: 5 February 2003

• Published on: 6 October 2003

  National Institute of Clinical Excellence

  • J Gunn
  • Other Contributors:
    • AC Morton, C Wales, C Newman, DC Crossman, and DC Cumberland

  Dear Editor

  On 24 June the National Institute of Clinical Excellence (NICE) issued their Appraisal consultation document: coronary artery stents.[1] With the proviso that ‘the decision to use a bare metal stent or drug-eluting stent (DES) will depend on the anatomy of the target vessel for stenting and the severity of the disease’ (presumably reflecting issues of deliverability of the stent platforms on offer), t...

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  Dear Editor

  On 24 June the National Institute of Clinical Excellence (NICE) issued their Appraisal consultation document: coronary artery stents.[1] With the proviso that ‘the decision to use a bare metal stent or drug-eluting stent (DES) will depend on the anatomy of the target vessel for stenting and the severity of the disease’ (presumably reflecting issues of deliverability of the stent platforms on offer), the key point was that a ‘DES is recommended .. [when] .. the target artery is less than 3mm in diameter or the lesion to be stented is longer than 20mm.’

  We applaud the NICE philosophy of selective DES implantation in a resource-hungry health service. It must be appreciated by interventional cardiologists, however, that this guideline will reduce, but not abolish, restenosis. As we recently argued,[2] there is a law of diminishing returns with DESs; escalating numbers (and, therefore, costs) would be required to squeeze the last few % points of restenosis out of the system. Clearly, NICE have grasped this reality and are endorsing a policy of scientific rationing, the science providing some targeting of the few DESs permitted to the lesions most likely to restenose.

  What are the implications of the NICE guidelines? Applying them to our institution reveals that a DES would be used in about 34% of lesions. This would reduce our clinical recurrence (re- PCI) rate - the only restenosis parameter a centre not performing routine follow-up angiography can count – from 9% to 5.1%. A considerable disadvantage of the NICE system would be that no stents of certain important and commonly used sizes would be permitted, such as 3 x16mm, 3 x 18mm or any stent of 3.5mm calibre, even if the target lesion is a long stenosis in the proximal left anterior descending artery of a diabetic patient. If, instead, we allotted DES according to our recommended system, based upon a matrix of restenosis risk,[2] we find that a 34% DES rate would yield an almost identical overall institutional recurrence risk (5.2%), with the advantage that we would have DES available for the sizes and indications mentioned above. Stock control would also be simpler (important if the DES in question has a limited shelf life) because rarely used sizes would not be stocked.

  References

  (1) NICE Appraisal consultation document: coronary artery stents

  (2) Gunn J, Morton A, Wales C, Newman C, Crossman D, Cumberland D. Drug-eluting stents: maximising benefit and minimising cost. Heart 2003;89:127-31.

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  Conflict of Interest:
  None declared.

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• Published on: 17 February 2003

  Drug-eluting stents: maximising benefit and minimising cost

  • Julian Gunn, Senior Lecturer/Hon. Consultant Cardiologist
  • Other Contributors:
    • Allison C. Morton, Clare Wales, Chris M.H. Newman, David C. Crossman, David C. Cumberland

  Dear Editor

  We are grateful to Dr Francis for his response to our analysis [1] of the real implications, both clinical and financial, of implementing a policy of implanting drug-eluting stents. He has stated the case rather more starkly than we did, but we would agree that the main problem is pricing. If these new stents were only slightly more expensive than the current (rather satisfactory) generation of con...

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  Dear Editor

  We are grateful to Dr Francis for his response to our analysis [1] of the real implications, both clinical and financial, of implementing a policy of implanting drug-eluting stents. He has stated the case rather more starkly than we did, but we would agree that the main problem is pricing. If these new stents were only slightly more expensive than the current (rather satisfactory) generation of conventional stents, they would be implanted universally. At the price at which they have been pitched, the manufacturers are forcing us to analyse which patients and lesions we should target with a policy of limited implantation. This requires a detailed knowledge of the risks and benefits inherent in tackling the problem of restenosis – a problem which we demonstrated, in our analysis, to be one which obeys a law of diminishing returns. For sure, limited extra expenditure will reduce the restenosis rate, but only marginally; stent expenditure would have to triple or quadruple to eliminate the last few patients with restenosis. Is this justified, when many more cases could be treated with conventional technology with the same budget?

  We would not want to give the impression that current drug-elution costs are ‘never financially justifiable’; rather, they make us sit up and think about what we are actually achieving with this huge increase in expenditure. We are not sure NICE will help selectivity. NICE may well endorse the use of this product in the lesion types included in RAVEL [2] and SIRIUS [3] trials. We will then have a clinical mandate to use them in a large proportion of our patients, but this will not solve the financial dilemma. Competition with other devices is the most likely long-term solution to this conundrum.

  References

  (1) Gunn J, Morton A, Wales C, Newman C, Crossman D, Cumberland D. Drug-eluting stents: maximising benefit and minimising cost. Heart 2003;89:127-31.

  (2) Morice MC, Serruys PW, Sousa JE,et al. A randomised comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773-80.

  (3) Moses J, Leon M, et al. The SIRIUS trial. Results presented at Transcatheter Cardiovascular Therapeutics meeting, Washington DC, September 24, 2002.

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  Conflict of Interest:
  None declared.

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• Published on: 5 February 2003

  Brutal analysis suggests that current drug-elution costs are never financially justifiable

  • Darrel P Francis, Specialist Registrar in Cardiology

  Dear Editor

  The authors superbly and convincingly demonstrate the difference between clear advantage for the patient (reduced risk of restenosis) and unclear benefit to the healthcare system (increased cost per lesion managed, or reduced number of patients manageable per year). Ultimately, mathematical analysis is likely to reveal that the breakeven point is when the scale factor of the price of the drug eluting stent e...

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  Dear Editor

  The authors superbly and convincingly demonstrate the difference between clear advantage for the patient (reduced risk of restenosis) and unclear benefit to the healthcare system (increased cost per lesion managed, or reduced number of patients manageable per year). Ultimately, mathematical analysis is likely to reveal that the breakeven point is when the scale factor of the price of the drug eluting stent equals the reciprocal of the scale factor of the total number of procedures required per lesion (assuming all procedures will be stents, and the drug-eluting strategy uses exclusively drug-eluting stents).

  Thus, in a lesion and patient with a restenosis risk of 10% for bare stenting (expected number of procedures = 1.1111...) and 5% for drug-eluting stenting (expected number of procedures = 1.0525...), the ratio is 1.06. The drug-eluting strategy is therefore more cost-effective only if the drug-eluting stent is priced at less than a 6% premium above bare metal. Not likely!

  Considering drug elution to roughly halve restenosis, we can make the following table of the premium that can justified for a bare-metal stent for any particular baseline estimate of restenosis rate.

  Baseline restenosis rate (%)	Price premium justifiable for drug coating (%)
  0	0
  5	3
  10	6
  20	12
  30	21
  40	33
  50	50
  60	75
  70	117
  80	200
  90	450

  Therefore, I would go beyond the conclusions of the paper to say that in a cash-limited health care system, only when the baseline risk of restenosis is around 90% is it possibly cost-effective to reach for a drug-eluting stent. Such lesions are unusual...

  Perhaps the government will come to our rescue with funding? Or NICE give us backing to spend the money despite these cost-effectiveness facts-of-life? Or maybe price competition will resolve the problem.

  In the meantime, irrespective of all the above, if I should come in with an acute coronary syndrome, and any of you should be intervening, please can I have a drug-eluting stent. Thanks

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  Conflict of Interest:
  None declared.

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