Medical Device Dailys
An appeal by Cordis (Miami Lakes, Florida) regarding the methodology used in setting guidelines for the use of drug-eluting stents (DES) for the treatment of coronary artery disease in the UK has been turned down and the final guidance, which fixes reimbursement for stents from the National Health Service (NHS), now goes into effect.
In February, England's National Institute for Health and Clinical Excellence (NICE) issued draft guidelines that cleared the way for the reimbursement of DES in what is estimated to be a $100 million market (Medical Device Daily, Feb. 4, 2008).
That decision reversed an earlier position taken by NICE in August 2007, when it published draft guidance saying DES does not "represent a cost-effective use of National Health Service resources" when compared to bare-metal stents (BMS).
According to Andrew Dillon, chief executive at NICE, "The guidance is the result of careful consideration of the evidence, as well as comments received during consultation and further economic modeling."
He added, "This decision to recommend the use of drug-eluting stents will ensure that, despite their higher cost, they will continue to be an important treatment option for patients who would be at high risk of requiring further interventions if a bare-metal stent was used instead."
The guidance recommends the use of drug-eluting stents for patients who are at high risk of requiring further interventions if a conventional bare-metal stent were used instead.
NICE clinical practice guidelines define such patients as having a coronary artery less than 3 mm in diameter, or where the segment of the artery to be treated is longer than 15 mm.
The guidance also states that drug-eluting stents should be used only if the price difference between it and a bare-metal stent is no more than 300 ($595).
Cordis' appeal of the Final Appraisal Determination (FAD) centers on this price difference, and the modeling used to determine the economic benefits for DES vs. BMS.
The objections from Cordis were that NICE failed to act fairly in accordance with its published procedures, that the institute exceeded its powers, and that the guidance is "perverse in the light of the evidence submitted."
In its appeal, Cordis argued DES cost-effectiveness "is largely insensitive to BMS price," saying DES in the price premium range of 400 to 450 ($795 to $894) are cost-effective regardless of a BMS price.
"It is perverse for the Appraisal Committee to recommend a price premium of no more than 300, equivalent to less than 5,000 quality-adjusted life-year (QALY), when premiums of 400- 450 result in incremental cost-effectiveness ratios (ICERs) within the institute's cost effectiveness range of 20,000- 30,000/QALY," said the Johnson & Johnson (New Brunswick, New Jersey) unit.
Saying there "is no legitimate reason for NICE to impose a maximum price premium of 300," which is "an unprecedented step," Cordis insisted that if the institute persists in this approach, the premium should be expressed as a price range and not a fixed target.
Cordis' recommendation to replace the 300 point with the statement "in the range of 400 to 450" was not adopted by NICE.
NICE holds a government charter for independent review of clinical practices, which in turn becomes directly linked to NHS reimbursement.
Other European governments and insurers, such as Germany's 300-plus health funds, closely follow the NICE guidance and best-practice recommendations.
Sapphire NC joins OrbusNeich lineup
OrbusNeich (Hong Kong) said its Sapphire NC coronary dilatation catheter has joined the company's product lineup with the receipt of CE-mark approval.
A non-compliant balloon, Sapphire NC has controlled growth of only 0.6% per atmosphere of pressure over the working pressure range for controlled dilatations. Furthermore, it has a high 22 atmospheres-rated burst pressure, allowing what the company termed "confident treatment of tough, calcified lesions and for post-stent dilatation."
Huay-Cheem Tan, MD, of National University Hospital (Singapore), called Sapphire NC "a reliable, easily deliverable, high-performance balloon with assured results when used during percutaneous coronary intervention."
OrbusNeich said Sapphire NC combines "advanced precision and material engineering technologies to provide optimum reliability and deliverability."
The company said the balloon catheter's HIST (HIgh Speed Tracking) tip "enables flexible tracking along the guidewire, while TIFO (Tight Fold) processing results in a slender profile for enhanced crossability through tight lesions."
Sapphire NC is available in a wide range of sizes for precise dilatation to match popular stent lengths.
OrbusNeich supplies products to interventional cardiologists in more than 60 countries.
Surgical disposables market grows
New analysis from Frost & Sullivan (F&S; London), Central and Eastern European Surgical Disposables Markets, finds that the market totaled revenues of $35.1 million in 2007 and estimates this to nearly triple to $101.5 million by 2014.
F&S said there has been a "significant uptake" of surgical disposables such as drapes, gowns, gloves and masks in central and Eastern Europe. The trend has been supported by ongoing education drives to spread awareness about hospital-related diseases.
"It is vital that every healthcare worker plays a part in minimizing the risks of cross-infection," said analyst Radha Sawhny "Accordingly, the surgical disposables market in central and Eastern Europe is poised for strong growth, as uptake levels will increase significantly over the next five years."
The report noted that the market does face the challenge of adhering to, and maintaining, EU standards of healthcare. "As new eastern European member states join the EU, they are compelled to raise their healthcare standards to meet EU-mandated standards," Sawhny said.
F&S said CE-marked devices such as disposable drapes, gowns and masks "have to be produced to a high quality, and this increases the manufacturing costs. This is posing a challenge to companies operating in this region, as they face the added challenge of the strong and entrenched market presence of Asian manufacturers."