Analysis: Payers take early role in determining the fate of new drugs

Reuters has picked up on a key trend among drug developers these days: Going to payers early in the development process to gauge the commercial viability of the treatments they're working on. The payer challenge is being added to the regulatory review that once dominated discussions about which drugs would be pushed in the pipeline. And some patient advocates are not in the least bit pleased to see the results.

"I have no question that the entire industry is moving toward this sort of model," Acorda CEO Ron Cohen tells Reuters scribe Lewis Krauskopf. Acorda, which developed the multiple sclerosis treatment Ampyra, is now going to insurers at the mid-stage point to assess the marketing challenges it faces for a new drug. Some pharma companies are starting these discussions a good five years ahead of any potential approval.

"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 Shire CEO Angus Russell.

The problem, as Krauskopf notes, is that patient advocates are seeing the early focus on payer issues and commercial potential as a major threat to the development of new drugs that may be viewed as marginal performers, but could offer a valuable new addition to the global pharmacy for depression and other diseases.

"There is a concern that in five, 10 years we won't have anything really new for patients with major mental illnesses, and that would be absolutely a tragedy," said Dr. Alan Schatzberg, former president of the American Psychiatric Association. "It's an unfortunate outcome that we are slowing drug development."

- here's the article from Reuters