According to an article by Reuters, “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 wants to make sure the global healthcare system will pay for it.”
In the past, an executive like Pasteris would consult insurance companies and former officials from national health agencies about a drug on the best way to show its value to patients, which would prove that a drug worked, and did so safely, so that health regulators would approve it. But as governments in the United States and Europe look to slash spending and avert a debt crisis, Glaxo and its rivals want to make sure their medicines are a must-have for patients.
So, Pasteris is looking to secure the funds way in advance. Possibly, even up to five years in advance according to what the executives told Reuters. To do it, they are seeking input from the people who write the checks earlier than ever in the clinical research process.
“The ultimate goal was not optimal reimbursement and access,” Pasteris said. “Today it is.”
These views are shaping more clinical trials, such as which products to test against and study goals to pursue. And that’s having major ramifications for the business of Big Pharma.
“If you’re going to go out there with a drug that you don’t know whether it’s better than what’s out there, what are you trying to do? Who are we all trying to kid?” said Angus Russell, CEO of British drugmaker Shire Plc. His company has more than doubled its “pharmaco-economic” staff focusing on the value of medicine in the past few years.
Russell said companies “all over the industry” are dropping experimental products they fear will not gain strong reimbursement. For example, Glaxo abandoned a diabetes treatment in mid-stage development in 2009.
They believe this is the answer to the problem of a medication that would cost hundreds of millions of dollars to develop, but does not get widely used once they reach the market.
One could think of it as basically an insurance policy for the drug maker.
Pasteris and GlaxoSmithKline are not the only ones attempting to secure money in advance. Even smaller players are also changing their ways. Ron Cohen, CEO of Acorda Therapeutics, regrets not consulting insurers early about its Ampyra, the first drug to help multiple sclerosis patients walk better.
Now, Acorda plans to hold discussions with health insurers once products reach mid-stage development and is getting informal input earlier — including for a potential multiple sclerosis treatment yet to enter human testing.
“I have no question that the entire industry is moving toward this sort of model,” Cohen said.
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 or worry that drugmakers may abandon categories where “good enough” medicines already exist, like depression, partly because it’s not worth the economic risk.