US FDA Approval Versus Patient Access: A Real-World Anecdote
Executive Summary
During meeting on real-world evidence, FDA’s Bob Temple describes real-world problem of patient access: his struggles to convince his insurer to cover Lilly/BI's diabetes drug Jardiance – which he helped review.
Sometimes, US FDA officials have to fight with insurers for their medicines just like everybody else.
Center for Drug Evaluation & Research Deputy Director for Clinical Science Bob Temple offered a personal example of that reality during a National Academy of Sciences, Engineering & Medicine workshop on Real World Evidence March 6-7.
In the context of discussions about the way payors uses evidence to supplement – or contravene – regulatory decisions, Temple reported his own challenge in convincing his insurer to cover Eli Lilly & Co./Boehringer Ingelheim GMBH's Jardiance (empagliflozin) – even though the drug has an FDA approved cardiovascular outcomes claim.
Temple, of course, knows all about that claim since he played a key role in shepherding the application through an at times skeptical FDA advisory committee review and on to approval. (Also see "Can A Safety Study Support A Superiority Claim? Barely, US FDA Advisors Say" - Pink Sheet, 4 Jul, 2016.)
“The empaglifozin study, which showed pretty impressive results, was in a pretty typical diabetic population,” Temple said. “If I were a payor, I am not sure I would apply it to non-diabetics – although you can make an argument that it might.”
“But the people who were in it were on other drugs, and they added this. It is $10k a year or something and my health care plan makes it very hard to get it. I finally managed by yelling at them a lot. They didn’t make it easy.”
Former FDA Commissioner Robert Califf was struck by Temple’s anecdote and returned to it later in the meeting: “I am still reeling from the thought of Dr. Temple talking to his pharmaceutical benefits manager about access to the drug that he approved.”
Temple, by the way, said the story had a happy ending. The drug “had a pretty good effect.”
Maybe next up will be a celebrity endorsement deal?
From the editors of the RPM Report