A Medical Device Daily

A panel of the UK's National Institute for Health and Clinical Excellence (NICE) last week denied an appeal filed by Cordis (Miami Lakes, Florida), a unit of Johnson & Johnson (J&J, New Brunswick, New Jersey), regarding reimbursement for drug-eluting stent (DES) devices used to treat coronary artery disease.

NICE issued a guidance in February recommending DES use as a "possible treatment" for coronary artery disease patients – but only if two conditions are met:

The artery to be treated is less than 3 mm in diameter or the affected section of the artery is longer than 15 mm – conditions that indicate a patient is at high risk of requiring further interventions if a conventional bare-metal stent (BMS) is used; and

The additional cost of a DES over a BMS device is no more than $600.

Cordis appealed the guidance, saying it was too restrictive and arguing that NICE was seeking to fix or control the price of the stents or to establish procurement policy for the UK's National Health Service. It cited evidence that DES devices are cost-effective at price premiums up to $800 to $900 over the cost of BMS devices, saying this should be reflected in the guidance.

The appeals panel released its decision late last month.

At about the same time, NICE re-released its final guidance, confirming the criteria it set forth in the February guidance.

"We're disappointed that NICE's appeal panel did not uphold our appeal, and we're in the process of evaluating our options regarding the appeal panel's ruling," said Christopher Allman, a J&J spokesman.

Andrew Dillon, CEO of NICE, said, "The guidance is the result of careful consideration of the evidence, as well as comments received during consultation and further economic modeling. The independent Appraisal Committee took into account the risks and benefits of the different types of stents, and the significant additional costs involved in the use of drug-eluting stents compared to bare-metal stents."

Dillon said that this decision, guiding the recommendation for use of DES, will ensure that, despite their higher cost, they still 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."

According to NICE, J&J could challenge the decision by applying to the High Court for permission to apply for judicial review.

Cervical cancer guidelines issued by DGGG

New cervical cancer prevention guidelines issued by the German Association for Gynecology and Obstetrics (DGGG) recommend testing women 30 and over for (human papillomavirus (HPF), the primary cause of cervical cancer. The guidelines recommend that HPV testing be performed along with a Pap smear for women 30 and older.

The digene HPV Test, developed by Qiagen (Venlo, the Netherlands), is currently the only HPV test approved by regulatory authorities in both Europe and the U.S., the company said.

"Our recommendations recognize the large number of scientific studies that demonstrate greater accuracy in identifying women at risk of having or developing cervical cancer, when a Pap is combined with the HPV test, rather than relying on a Pap smear alone," said Professor Klaus Friese, lead author of the new guidelines and professor of gynecology at the Ludwig-Maximilians-University (Munich). "By using both tests for women 30 and over, when cervical cancer is most common, we hope to greatly reduce the number of women suffering and dying from this disease."

The DGGG guidelines conclude that the sensitivity of the Hybrid Capture II (HC2) technology used by the digene HPV Test is comparable to PCR, the standard technology used in molecular testing. However, according to the guidelines, the specificity (association with actual disease) of HC2 is greater than that for PCR.

Every year, cervical cancer affects nearly 500,000 women worldwide and, after breast cancer, is the second most common malignancy in women. In Germany, 6,200 women are diagnosed with the disease and 1,800 die from it each year.

In most cases, the infection is cleared by the immune system or is suppressed without causing problems. However, in others, the infection persists, leading to abnormal cell changes and disease.

In Germany, the digene HPV Test is reimbursed by most private health insurers for routine screening. Many experts hope that public health insurance will cover HPV testing in the future for primary screening in conjunction with a Pap.

One pilot screening program already initiated is a partnership between public health insurer Deutsche BKK, the Wolfsburg clinical centre and gynecologists in private practice in the city. In the program, Deutsche BKK covers the cost of the digene HPV Test as screening for participants 30 years and older, in conjunction with a Pap.

Tomotherapy to install Hi Art in Sweden

Tomotherapy (Madison, Wisconsin) said it has extended its reach in Europe with the first TomoTherapy Hi Art treatment system set to be installed in Scandinavia, at Lund University Hospital (Lund, Sweden).

Jef Van Dam, general manager of TomoTherapy EMEA, said, "This marks our entry into the Swedish market with a prestigious institution that pioneered the use of many technological advances in Scandinavia and Europe."

Lund University Hospital said that it conducted an investigation of all commercially available intensity-modulated radiation therapy (IMRT) systems, including arc-based options on conventional platforms, to determine what system to purchase.

Jacob Engellau, MD, PhD, head of radiation oncology at Lund University Hospital, said, "As a large center treating 2,500 new patients yearly, we are dependent on high up-time and clinical reliability. The established and clinically well-implemented TomoTherapy Hi Art was the only system that could meet the demands of our clinic."

While the system will be used to treat any array of cancers, the clinical experts at Lund plan to focus on anal, rectal, cervical, stomach and esophageal cancers. They will also be using the system for stereotactic radiosurgery treatments and see greater possibilities for clinical trials involving simultaneously integrated boost (SIB) with or without dose escalation.