Reuters (12/20/11) Krauskopf, Lewis
GlaxoSmithKline Plc executive German Pasteris is in charge of an Alzheimer's treatment that is years from reaching the market, if it ever does, but he already is making sure the global healthcare system will pay for it. Pasteris is one of 25 executives appointed last year to shepherd the British drugmaker's experimental medicines. His job is to consult insurance companies and former officials from national health agencies about the Alzheimer's drug on the best way to show its value to patients. With governments in the United States and Europe looking to slash spending and avert a debt crisis, Glaxo and its rivals want to make sure their medicines are a must-have for patients. To do so, they are seeking input earlier than ever in the clinical research process, in some cases five years or more before regulators would even look at a product. "The ultimate goal was not optimal reimbursement and access," Pasteris said. "Today it is." These views are shaping more clinical trials, which is having major ramifications for the business of Big Pharma. Angus Russell, CEO of British drugmaker Shire Plc., said companies "all over the industry" are dropping experimental products they fear will not gain strong reimbursement. Pharmaceutical investors also are a huge source of pressure. As drug manufacturers invite marketing input earlier than before, some fear they risk the very innovation that leads to landmark new medicines. Industry experts point to advances that took time to prove their worth, and they worry that drugmakers may abandon categories where "good enough" medicines already exist. In light of soaring healthcare costs, the drug industry has been sharply criticized for launching expensive new medicines that proved only slightly better than their predecessors. Health insurers and government agencies pushed back, and now drug companies are forging closer ties with those "payors". Those relationships allow access to vast databases of medical claims to see how drugs are used once they are approved, so drugmakers can learn which medicines they should be comparing their own products to and what goals they should seek in clinical trials.