From the September 3, 2007, issue of "The Gray Sheet"
A committee meets this week to consider whether to move forward with preliminary recommendations for the Nation Health Service of England and Wales to stop paying for drug-eluting stents.
Public comments on the recommendations were due Aug. 29 in the lead up to a National Institute of Health and Clinical Excellence (NICE) appraisal committee meeting on Sept. 4. This will be the fourth meeting by the committee on this topic in two years, but it is expected to submit its final appraisal to NICE in time for the institute to release final recommendations by January.
The $80-$100 million UK drug-eluting stent market is only a small piece of the $5.5-$6 billion worldwide market, but to the extent that an NHS decision could set a precedent for other European countries to follow, NICE's deliberations may have a larger impact on an already struggling sector.
The downturn in the drug-eluting stent space during the past year has been dramatic in the wake of new data about the risks of late stent thrombosis and high-profile results questioning the clinical value of intervention versus medical therapy in certain cardiac patients.
However, the medical community in Britain is strongly opposing NICE's preliminary appraisal, making it more likely that the final policy will be toned down.
Drug-Eluting Stents Not Cost-Effective - Committee
Specifically, the committee is recommending that NHS no longer pay for drug-eluting stents because it has concluded the devices are not cost-effective compared to bare-metal stents, according to the Appraisal Consultation Document on ischemic heart disease and coronary stents released Aug. 1.
The committee acknowledged that clinical trials show drug-eluting stents reduce the rate of revascularization in target lesions and target vessels for up to three years, compared with bare-metal stents.
However, it concludes that the risk of death or acute myocardial infarction is about the same with either type of stent.
To determine if the extra cost of a drug-eluting stent versus a bare-metal stent is justified by the reduction in revascularization, the committee conducted a cost-effectiveness analysis based on an audit of two observational studies at the Cardiothoracic Center in Liverpool.
According to the Liverpool audit, a drug-eluting stent costs about £600 (about $1,210) more than a comparable bare-metal stent, but implanting a drug-eluting stent instead of a bare-metal stent reduces the risk of needing a revascularization by 65%. The overall mean number of stents implanted per patient is about 1.6, according to the audit.
Based on these figures, the committee concludes that the incremental cost per quality-adjusted life year (QALY) added by using a drug-eluting stent instead of a bare-metal stent is £174,000 (about $351,000) for all patients, £148,000 (about $299,000) for long lesions, £146,000 (about $295,000) for diabetes, and £116,000 (about $234,000) for small vessels.
The appraisal document notes that some medical centers have managed to negotiate the price down so that the premium for drug-eluting stents over bare-metal stents is only £300 (about $605). At that price, drug eluting stents would still be too expensive for the general population - £101,000 (about $204,000) per QALY - but would be cost-effective in patients with long lesions and patients with narrow vessels - £65,000 (about $131,000) and £41,000 ($83,000) per QALY, respectively, according to the committee.
"However, the Committee understood that there is no national procurement of [drug-eluting stents] at a price premium that would fall below £300. Thus, the Committee was unable to alter its conclusion that [drug-eluting stents] could not be considered a cost-effective use of NHS resources."
The NICE group observes that further collection of long-term data may reveal subgroups for which drug-eluting stents are cost-effective.
They also hope to see long-term randomized controlled trials comparing newer drug-eluting stents to established drug-eluting stents as well as newer bare-metal stents.
British Cardiologists Rally Against NICE Proposal
UK doctors, represented by the British Cardiovascular Intervention Society and British Cardiac Society, are pleading with the committee to reconsider and are recruiting their members to lobby NICE to soften its stance before making a final recommendation.
BCIS sent a letter to its members asking them to register their comments on the proposed recommendation on the NICE Web site. "If there was ever a moment when we need the combined efforts of interventionists in the UK then this is it. Please do not feel complacent and let us all down."
"We are deeply disappointed by this draft guidance and will make every effort to ensure this conclusion is reversed before the final guidance is produced," BCIS President Martyn Thomas and BCS President Nick Boon write in an Aug. 6 joint statement.
"Thus far our presentation of scientific data showing the amount of benefit from drug-eluting stents has been inconceivably ignored," they write.
The cardiology professional groups say they are especially puzzled by the appraisal committee's emphasis on the Liverpool audit and apparent disregard for many randomized controlled trials and registries of drug-eluting stents.
"This advice is at variance with established clinical practice and international guidelines, ignores the results of well-conducted international randomized controlled trials and has been heavily influenced by the findings of a deeply flawed audit from a single UK centre," Boon and Thomas explain.
The groups also claim that "the costs of drug-eluting stents used to calculate cost effectiveness in the current guidance are grossly inflated compared to the true costs that hospitals pay today in the UK."
The physicians want NICE to recommend that NHS pay for drug-eluting stents at least for patients with small vessels, long lesions and/or diabetes - about 40%-55% of coronary intervention patients, according to the societies.
"We have demonstrated to the NICE committee that if DES are limited to these patient groups (and based on the randomized world literature) then they are cost-effective within the recognized parameters of the NHS using contemporary costs of DES."
If the committee's preliminary recommendations are adopted, it will increase the number of repeat revascularizations in the UK, the doctors predict, causing waiting lists to grow and the overall cost of treating coronary disease to increase.
Patients who are ineligible for coronary bypass surgery may find they have no treatment option at all and must accept a lower quality of life with angina, they say.
Boston Sci Is Most Exposed To "Spill-Over"
Given the relatively small size of the UK drug-eluting stent market, the immediate impact on drug-eluting stent makers would be minimal and partially offset by an increase in sales of bare-metal stents.
Further, Morgan Stanley analyst Glenn Reicin, who covers the stent market, says he expects NICE will back off denying all coverage of drug-eluting stents. But "one cannot rule out something more dramatic," he notes.
Boston Scientific, with a leading 28% drug-eluting-stent market share in the United Kingdom (including Taxus and Promus), stands to lose the most if drug-eluting stent reimbursement disappears in England and Wales, but Reicin predicts the end of the that market would only cost the company 1% of its 2008 earnings per share.
However, "there is bigger risk that this action sets a precedent that could potentially spill-over into other European countries," he says.
If the idea of denying coverage of drug-eluting stents catches on in Europe, the impact to the manufacturers, especially Boston Scientific, could be severe, according to Reicin.
Even with the off-set from increased sales of bare- metal stents, Boston Scientific's "total net stent exposure" in Europe accounts for about 26% of its 2008 earnings.
The other manufacturers are much less exposed, with Abbott, Johnson & Johnson and Medtronic only risking 3%, 1% and 3%, respectively, of their 2008 earnings in the European stent market.
- Reed Miller
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