February 2009 Issues

Eye Care Update

Summary: The economy is causing patients to skip appointments, reducing patient flow in optometric offices. Refractive surgery referrals, contact lens fittings, and even glaucoma medication use are all off. Optometrists don’t expect the economy to stabilize before spring 2010 and not improve before early 2011. ♦ Cost – and the perception of cost – continues to explain why <10% of contact lens patients wear disposable daily wear soft contact lenses. ♦ Alcon’s Opti-Free is the No. 1 contact lens solution recommended, but patients are often buying cheaper solutions or switching to store brands because of cost. ♦ LASIK volume has bottomed or may go down a little more during 2009. Multifocal IOLs are off less, and their outlook is for stability or a slight uptick. ♦ Patients are interested in Allergan’s eyelash extender, Latisse, which some doctors expect to be popular with women. ♦ “Huge” numbers of patients are expected to switch to a generic prostaglandin for glaucoma when one is available. Meanwhile, Pfizer’s Xalatan is losing a little share to Alcon’s Travatan, and Allergan’s Combigan is expected to gain a little. ♦ Cost, lack of insurance coverage, and slow onset of action continue to limit use of Allergan’s Restasis for dry eye.

Conference on Retroviruses and Opportunistic Infections (CROI)

Summary: 21% of HIV+ people are unidentified – more commonly African Americans and Latinos – and testing designed to help identify them is picking up, but slowly. ♦ Evidence is building that treating HIV patients earlier, when their CD4 count is ~500, is beneficial, but experts do not expect guidelines to change until there are more definitive data. ♦ Data continue to suggest that there is an increased risk of heart attack with GSK’s Ziagen (abacavir). ♦ Neurocognitive impairment has reared its head again in HIV, and experts are urging that the choice of antiretroviral therapy be based, at least in part, on a new standard –a drug’s ability to penetrate the blood brain barrier. ♦ Doctors are very enthusiastic about integrase inhibitors, but a trial of switching patients stable on Abbott’s Kaletra to Merck’s Isentress failed to show noninferiority. ♦ Data show definitively that IL-2 is not beneficial in HIV. ♦ Doctors are excited about a potential replacement for new PK boosters such as Gilead’s GS-9350 and Sequoia Pharmaceuticals’ SPI-452 to replace Abbott’s Norvir.

FDA Imposing New Risk Management Program on Many Opioids

Summary: Citing an increase in the misuse, abuse, and unintentional deaths from some extended-release pain medications, the FDA said that it is taking sweeping steps to force 16 manufacturers of two dozen drugs to comply with a new risk evaluation and mitigation strategy (REMS). Opioid drugs formulated in extended-release versions of OxyContin, morphine, and fentanyl patches will be affected.

Society of Thoracic Surgeons

Summary: Cardiothoracic surgeons believe that the SYNTAX trial comparing PCI and CABG will boost CABG volume. ♦ In the current economic environment, hospitals – and surgeons – have pretty much lost interest in expensive technology such as Intuitive Surgical’s da Vinci robot. ♦ Surgeons are worried about reimbursement cuts and too few new surgeons getting trained, but they are upbeat and optimistic about percutaneous valves, viewing them as an opportunity, not a threat. ♦ Within 5 years percutaneous valves are expected to account for 22% of aortic valves, mostly through market expansion, even if the price is $20,000+ each. ♦ Earlier concerns about transapical valve performance have been resolved. ♦ Enthusiasm has waned for Abiomed’s Impella, and surgeons were negative about Evalve’s MitraClip. ♦ Atrial fibrillation ablation is growing, despite the Justice Department investigation of AtriCure.

FDA Cardiovascular and Renal Drugs Advisory Committee Recommends Approval of Lilly/Daiichi Sankyo’s Effient (Prasugrel) --Quick Pulse

Summary: With a 9 to 0 vote in favor of approval, the CardioRenal panel sent a strong message to the FDA that Lilly/Daiichi Sankyo’s Effient (prasugrel) – a new antiplatelet agent – should be approved to treat acute coronary syndrome (ACS) patients. Panel members described prasugrel as a “scientific advance” and a “major advance” and superior to clopidogrel (Sanofi-Aventis’s Plavix).