England's influential National Institute for Health and Clinical Excellence (NICE) has reversed its earlier position opposing use of drug-eluting stents (DES), clearing the way for reimbursement of such interventions in what is estimated to be a $100 million market.

If there are no appeals against the draft decision, the final guidance on DES will go into effect in March.

The $750 price difference between bare-metal stents (BMS) and DES in England and Wales are at the heart of the institute's concerns.

NICE unleashed a storm of controversy in August 2007 when it published draft guidance saying DES does not "represent a cost-effective use of National Health Service resources" when compared to BMS devices.

With its new draft guidelines, the institute removed the cloud that was hanging over DES use in the UK with a flat endorsement for patients who are deemed at risk of undergoing follow-on surgeries if a conventional BMS were implanted.

NICE defines these patients as having a coronary artery less than 3 mm in diameter, where the segment of the artery to be treated is longer than 15 mm.

Offering a comprehensive review of 17 studies and 11 different DES devices, the NICE appraisal committee concludes that "revascularization rates were reduced by approximately three-quarters compared with BMS, consistent across most studies."

NICE recommends reimbursement for DES devices that do not cost £300 ($597) more than a BMS device.

The price premium for a DES can range from £233 ($463) to £1,225 ($2,437), according to nine economic evaluations included in the assessment. And a report from the Dow Jones wire service cites a recent survey placing the current premium at around £380 ($756).

The NICE recommendation for reimbursement is expected to exert a downward price pressure on DES manufacturers.

Dr. Anthony Gershlick of Nuffield Leicester Hospital (Surrey), a clinical specialist who served with the Appraisal Committee on behalf of the British Heart Foundation (London) and the British Cardiac Society (London), told the online publication HeartWire the decision was "good news for patients and physicians long convinced that DES are the better choice."

He emphasized that DES came out to be cost effective when the price difference was about $600, saying, "If the price difference is much higher than that, you lose the cost efficacy."

He said the £300 limit set by NICE is not "set in stone" and may well be the only area of the report to be appealed by manufacturers by the Feb. 15 deadline.

A Morgan Stanley analyst told Dow Jones it was possible that the NICE recommendation could lead to a 15% European price cut, reducing the size of the market by $102 million, or 5% in 2008. By 2010, that contraction could accelerate to $251 million.

No other agency is as influential as NICE, which holds a government charter for independent review that is directly linked to the national healthcare plan for clinical practice, public policy and reimbursement.

While the UK is a smaller market for DES, other governments and insurers, such as Germany's 300-plus health funds, closely follow the publicly available guidance and best-practice recommendations.

"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 modeling," said Andrew Dillon, chief executive of NICE.

Forty professors, physicians and cardiology interventionalists make up the standing Appraisal Committee that meets three times each month.

Manufacturers were invited to comment on the draft scope, assessment report and the appraisal, and written submissions were received from Abbott Vascular Devices (Redwood City, California), Biotronik (Lake Oswego, Oregon), Boston Scientific (Natick, Massachusetts), Cordis (Miami Lakes, Florida), Guidant (Indianapolis), Medtronic (Minneapolis) and Sorin Biomedica (Saluggia, Italy).

The committee considered randomized controlled trials submitted by manufacturers comparing DES with BMS.

Significantly, the technology review updated the previous review, published in 2003, that considered only the three devices granted a CE mark at that time — Taxus, from Boston Scientific, Cypher from the Cordis unit of Johnson & Johnson (New Brunswick, New Jersey), and Dexamet from Abbott, which was the second DES on the European market but no longer available in EU markets.

In addition to the Taxus, Dexamet and Cypher stents, DES devices in the new appraisal include the Axxion from Biosensors International (Singapore/Newport Beach, California), the CoStar from Biotronik, the Taxus Libert from Boston Scientific, the Endeavor from Medtronic, the Janus from Sorin, the Xience V from Guidant, and the Yukon from Kiwimed (London/Bangkok).

The DES from each manufacturer was measured against trial results from the company's BMS equivalent.

The NICE Appraisal Committee concluded: "The benefits of DES over BMS for target lesion revascularization (TLR) were seen at 1 year, and this significant difference was maintained for up to three years."

"For the target vessel revascularization [TVR] outcome, there were statistically significant differences in favor of any-type DES over BMS for most of the time points assessed," it said.

TLR at one year for procedures carried out with a DES within individual trials were less than 5%, and typically in the 10% to 25% range for procedures that used a BMS, according to the report's findings.

For TVR, individual studies for Cypher and Endeavor showed statistical significance over BMS up to three years, the report says, adding that not all studies of Taxus showed statistical significance compared with BMS for periods up to three years.

According to data from the British Cardiovascular Intervention Society (BCIS) cited in the report, percutaneous coronary interventions using stents rose to 80% of all procedures in the UK by 1999.

DES first appeared in 2003, immediately claiming 17% of procedures. By 1995 DES took 62% of the market; NICE said that "it may be that utilization rates are now much higher than this."

According to BCIS data, about 70,000 PCI procedures were performed in the UK in 2005.