he price of a painkiller used in knee surgery is getting some doctors bent out of shape.
In recent weeks, two different studies have concluded that the medicine, an analgesic called Exparel, is no more effective than an older form of the treatment. Exparel combines bupivacaine, an injectable drug that has been a standard of care, with a proprietary technique for administering pain relief.
However, the wholesale price for a vial of Exparel costs about $285 versus about $3 for bupivacaine. As a result, the study authors — whose papers were released last month at the annual meeting of the American Association of Hip and Knee Surgeons — maintain the difference in price can’t be justified. Some practices have discontinued using the drug.
“We’re not saying Exparel didn’t help the patient, and it appears to be a safe drug to use,” said Dr. Rajesh Jain, an orthopedic surgeon at Virtua Health System in Voorhees, N.J., who was a coauthor of one paper. “The big issue is if it’s worth the cost. We didn’t find it to be any more effective, so there’s no reason to spend more on an expensive drug.” (Here is the other paper).
This is not the only controversy surrounding Exparel and its manufacturer, Pacira Pharmaceuticals.
Read more: FDA yanks Pacira letter
Last fall, Pacira filed a lawsuit accusing the Food and Drug Administration of overstepping its authority to thwart inappropriate marketing. The lawsuit was a response to an FDA warning letter issued last year that alleged the company promoted Exparel for use in surgeries for which the drug was not approved. The FDA also argued Exparel should only be marketed for 24-hour pain relief, not 72 hours.
The drug maker countered that the FDA incorrectly interpreted the product labeling, and restricted its free speech. Negotiations have been under way for several weeks and, recently, the FDA took the unusual step of removing the warning letter from its web site, suggesting to some legal experts that the agency may eventually allow Pacira to market the drug for longer pain relief. The agency would not discuss its move, citing litigation. A resolution to the closely watched skirmish may come before the end of the month.
Meanwhile, Exparel has been widely debated in the orthopedic community, where dueling papers have been released over the past year discussing its effectiveness and value. The dispute has emerged amid an escalating national controversy over the rising cost of medicines and some surgeons point to Exparel as yet another example of prescription drug pricing run amok.
Pacira maintains Exparel is worth the price, because the drug is more cost-effective than such expensive options as pain pumps that some surgeons increasingly rely on. And the company cited several studies to bolster its argument, including one that found that 100 patients given the drug had significantly less pain, required fewer narcotics, and were discharged sooner than patients who received a nerve block.
Dr. James Jones, senior vice president and chief medical officer at Pacira, acknowledged that Exparel is more expensive than standard bupivacaine, but he said that the older drug does not provide pain relief for as long. It also requires the use of still other treatments, sometimes narcotics, and often longer hospital stays. And these bring added costs, the company maintains.
We should note that one study, which Pacira described as independent, was conducted by a physician who has done consulting work for Pacira, according to a government database, while Outpatient Surgery magazine in a story last summer noted ties between the drug firm and physicians who conducted research supporting Exparel.
Jones wrote us that this particular study and two others sent us were initiated by the researchers and were funded by the drug maker.
Meanwhile, Pacira also explained that successfully administering Exparel requires repeated use, and as physicians eventually become more comfortable with using the treatment, they will achieve better patient outcomes.
This line of argument is echoed by Wall Street analysts. “The difficulty Pacira has is that they have to train physicians on how to use it properly to be able to save money,” said Shibani Malhotra, who tracks Pacira and other drug makers for Nomura Securities.
Nonetheless, some physicians said they are familiar with how to administer medications during procedures. Given the difference in cost, Dr. Matthew Austin, a coauthor of one recent prospective study comparing Exparel with the older treatment, said his institution, the Rothman Specialty Orthopaedic Hospital in Philadelphia, discontinued use. We should note that Austin also does consulting work for other device makers, according to the OpenPayments federal database.