“Other developed nations assessed drugs based on value ... but the U.S. remains one of the few developed nations that doesn’t," said Alexander Egilman, a researcher at Yale. "We all say we spend too much on drugs, and this approach seems to be working for other countries, based on outcomes, such as lifespans. So why aren’t we considering this?” In other pharmaceutical news: dark money, former FDA chief Scott Gottlieb's new position, off-label marketing practices, and more.
As the U.S. grapples with rising prices for medicines, a new analysis finds Medicare spent more than $26 billion in recent years on dozens of medicines that were not recommended for coverage in three other wealthy nations because government advisory groups there found the drugs did not have sufficient value to justify the costs. The researchers identified a total of 134 medicines that were approved by the Food and Drug Administration prior to 2016 but were not endorsed by agencies in Australia, Canada, and the U.K. that conduct so-called health technology assessments, according to the study in the Journal of General Internal Medicine. (Silverman, 7/24)
Meetings of the Institute for Clinical and Economic Review don’t usually get one’s heart pumping. But a meeting Thursday at the Massachusetts Institute of Technology may prove to be the exception to that rule. Patients Rising Now, an advocacy group that says it promotes transparency in health care and that is a fierce opponent of ICER’s, is expected to face off with the self-professed “watchdog of drug pricing” as it reviews three drugs for Duchenne muscular dystrophy. (Sheridan, 7/24)
Sen. Elizabeth Warren is not done with Scott Gottlieb. Already peeved that the former Food and Drug Administration Commissioner joined the Pfizer (PFE) board just weeks after leaving the agency, the Massachusetts Democrat and presidential candidate expressed “disappointment” that Gottlieb refused to resign as she requested earlier this month. And so she is now asking the drug maker to disclose its interactions with Gottlieb and whether it examined the ethical ramifications of making him a director. (Silverman, 7/24)
A former Sun Pharmaceuticals sales rep has filed a lawsuit claiming he was fired for balking at alleged off-label marketing practices, the latest in a growing number of incidents concerning business practices at one of the world’s largest generic drug makers. In his lawsuit, Damian Frantz contended that company policy prohibiting illegal marketing was ignored and, instead, that a supervisor “expressly directed” him to “do whatever is needed to get” a clinical team to “talk off label” to physicians and health plans, among others. In general, the company sought to “aggressively solicit opportunities to present off-label information to decision-makers about its drugs.” (Silverman, 7/24)
A young couple in Aventura was running out of time and praying for a miracle. Their daughter, Eliana Cohen, fast approaching her second birthday, was diagnosed with a rare disease that could keep her from walking, eating and breathing on her own.But her best hope also happened to be the world’s most expensive drug — a $2.1 million treatment called Zolgensma. Without support from insurance, her parents Ariel and Shani Cohen turned to their Jewish community through social media in hopes of covering the staggering cost. The outpouring of support, from South Florida and around the world, proved equally staggering. (Rosa, 7/24)
In a former church parsonage in Grundy County, Tenn., Karen Wickham ladled out her lentil stew as people arrived for an evening health education class. Wickham and her husband, Steve, are white-haired, semi-retired nurses who have dedicated the last years of their working lives to helping people with Type 2 diabetes control and even reverse the condition with diet and exercise. Wendy Norris is in the group, and she has brought along her father and daughter. Since her diagnosis several years ago, Norris said, her doctor prescribed insulin shots and told her to watch what she ate. (Farmer, 7/25)
The Pharmaceutical Research and Manufacturers of America, a leading industry trade group, spent $16.1 million on lobbying in the first six months of the year, up 4% from the $15.5 million it spent in the first half of 2018. PhRMA spent $27.5 million over the full year in 2018, also a record. (Rosenberg, 7/24)
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