March 2011 Issues

18th Conference on Retroviruses and Opportunistic Infections (CROI)
Summary: Doctors were very interested in Bristol-Myers Squibb’s attachment inhibitor BMS-663068 and GSK’s oncedaily integrase inhibitor dolutegravir (GSK-1349572). ♦ Yet, the real excitement at CROI was over zinc finger technology developed by Sangamo Biosciences that can be used in several different ways to disable the CCR5 and CXCR4 cells that HIV depends on to survive. ♦ Once-daily oral regimens are extremely important in HIV, but doctors are not ready to jump quickly to new QD regimens like Gilead’s Btripla or Quad, which are likely to be reserved for patients who cannot/will not take Gilead’s Atripla. ♦ Gilead’s Viread (tenofovir) has an important role in both HIV and hepatitis B, but a new low-dose, high potency prodrug, GS-7340, could replace it for many uses, except perhaps prevention. ♦ Merck’s Isentress (raltegravir) continues to have a loyal following despite its BID dosing because of good tolerability. ♦ Both Merck’s Victrelis (boceprevir) and Vertex’s telaprevir appear to be effective in HIV/HCV co-infected patients.

Cardiovascular Research Technologies (CRT) Conference
Summary: Edwards Lifesciences’ Sapien transcatheter aortic valve is expected to beat surgery in the PARTNER Cohort A and to get accelerated approval from the FDA. ♦ U.S. reimbursement for TAVI is still uncertain, and cardiologists are more worried about escalating healthcare costs. CMS does not appear to have a reimbursement plan in mind yet. ♦ The idea of limiting TAVI to “centers of excellence” appears to have been abandoned, but experts agree that not every hospital should be doing the procedure, emphasizing the need for training and a team approach. ♦ Many cardiologists want to use TAVI offlabel in lower-risk patients, and the FDA seems to accept that this will happen, but doctors are approaching this cautiously. ♦ Interest is growing in embolic protection with TAVI to lower the stroke rate. ♦ Second-generation TAVI devices may offer repositioning and retrievability, which are viewed as important features. ♦ Although FDA requirements for TAVI device approval continue to be criticized as hindering innovation, the Agency is not lowering the bar. ♦ FDA is expected to mandate TAVI training but leave the details to industry.

American Academy of Orthopaedic Surgeons (AAOS)
Summary: Hip and knee implant procedure volume appears to have bottomed and is holding relatively steady. ♦ Hospitals are trying to get more aggressive on pricing, but so far the efforts have met with limited success. Physician alignment with hospitals may be the most important factor in controlling costs, and physicians are increasingly being employed by hospitals, so pricing pressure is likely to increase. ♦ Insurers have not gotten very aggressive with joint replacements, but surgeons believe that is starting to change. ♦ There is little interest in custom knees, which many surgeons consider a gimmick. ♦ Use of metal-on-metal hips has been falling and will continue until the implants are <1% of procedures, but use is unlikely to go to zero because there are niche patients who benefit and because it is the only option for hip resurfacing. ♦ Synthes remains the leader in trauma equipment, but the other major orthopedic companies are nibbling away at its position, particularly with bundling and good service.