June 2009 Issues

Sleep 2009

Summary: The sleep market is strong, prices are stable, and the outlook for near-term growth appears to be good. ♦ Competitive bidding is currently on hold, but it is likely to be implemented in some form in 2011, and device manufacturers are concerned it could lead to a significant decrease in pricing, stifle innovation, and lead to a monopoly dominated by a few large companies. ♦ At-home diagnosis of OSA will not emerge as a significant market segment until reimbursement improves, but CMS is very interested in this, and DMEs are positioning it as a way for sleep labs to capture additional revenue. ♦ CPAP manufacturers are taking different approaches to compliance monitoring. More sophisticated flow generators are being developed, and wireless monitoring is emerging, but at significant added cost. ♦ Restless legs syndrome and fibromyalgia received some, but not very much, exposure at the meeting.

Transcatheter Valve Therapies (TVT)

Summary: Percutaneous valve use is continuing to ramp up in Europe, but governments/insurers are starting to balk at the cost, and more countries are expected to follow France’s example and cap the number of procedures, perhaps as early as later this year. ♦ Percutaneous aortic valves are being used mostly on-label in highrisk patients, not migrating downward to healthier patients. ♦ European doctors are splitting their use almost equally between Medtronic/CoreValve and Edwards, and that is likely to continue for the near future. ♦ Edwards 18 Fr should be available in late 2009 or early 2010. ♦ Subclavian access won’t eliminate use of the transapical approach, but it may decrease TA volume as a percent of total procedures. ♦ Medtronic/ CoreValve is expected to start its pivotal U.S. trial in June 2010; details on trial design and the nitinol fracture risk continue to delay the start of that trial. ♦ The need for a permanent pacemaker continues to be more of a problem with CoreValve than Edwards, but cardiologists stressed that there are inexpensive pacemakers and length-of-stay is reduced, so the pacemaker cost is not a big issue. ♦ Mitral repair is still considered too difficult and too expensive, with not as much value as hoped.

Fda Advisory Committee Recommends Approval of New Gout Drug – But with Restricted Access -- Quick Pulse

Digestive Disease Week (DDW)

Summary: Diet is effective in eosinophilic esophagitis, but almost impossibly difficult for patients to maintain. Biologics may offer the best hope, but experts weren’t particularly enthusiastic about any of them yet. ♦ Both XenoPort’s arbaclofen placarbil and AstraZeneca’s AZD-3355 look promising as add-on therapy to a PPI for GERD. ♦ Salix’s Xifaxin (rifaximin) is already being used off-label for hepatic encephalopathy, but cost – not insurance reimbursement – is a major issue, and general gastroenterologists do not believe that FDA approval will significantly increase their use of it. ♦ Data showed that Forest Labs/ Ironwood’s linaclotide is effective in IBS, but the clinical significance of the effect is still somewhat uncertain. ♦ Several less invasive or non-invasive approaches to bariatric surgery are being tested, and this has been accompanied by a flattening to slight decrease in use of banding procedures.

FDA Restrictions on Opioids

Summary: Progress on a REMS for long-acting opioids is moving slowly, and implementation is not likely until 2010 or even 2011. ♦ An FDA advisory committee meeting on the REMS is expected in the future. ♦ The FDA is not ruling out the possibility of pulling long-acting opioids from the market, but the Agency really considers that a last resort and does not expect that to happen. ♦ A consortium of 25 pharmas is working on a medication guide, a communication plan, and other elements to assure safe use of opioids, including a patient-physician agreement form, an implementation system, a timetable for submission of assessments, and cooperation with the DEA and state licensing bodies. ♦ Among the suggestions given to the FDA were: a pilot program, tracking systems, multidisciplinary approach, education, and patient contracts. ♦ Two generic manufacturers asked for a separate REMS for methadone products, but that appears unlikely. ♦ Patients are worried the REMS will restrict their access to opioids, and families who have lost loved ones charged that the FDA is not acting fast enough to restrict dangerous drugs. ♦ FDA officials insisted that the REMS is not holding up decisions on pending abuse-resistant opioids. ♦ Unapproved narcotics are being removed from the market, but the companies can submit ANDAs to get them approved. The question is: Will they?

EuroPCR

Summary: Percutaneous aortic valves was the hot topic at PCR. Experts predicted the European explosion in these procedures will continue. The concern is minimizing off-label use. ♦ A SYNTAVI trial is being discussed to compare percutaneous aortic valves with surgery. ♦ A 51% 1-year mortality rate with transapical implantation of Edwards Lifesciences’ Sapien is concerning, but most doctors blamed that on patient selection. However, new data on CoreValve’s subclavian approach led some doctors to suggest tiering valve procedures in this order: transfemoral, subclavian, transapical, surgical. ♦ There was little excitement among European cardiologists about Evalve’s MitraClip mitral repair, though the data looked good, because the technology is not considered mature yet, the cost is high, and reimbursement remains a problem. ♦ The first data on J&J’s new drug-eluting stent, Nevo, looked good – beating Boston Scientific’s Taxus on late loss – but experts insisted this was not a surprise, the data are very preliminary, and deliverability could not be determined from the RES-I trial.