The cost of painkillers used by knee surgeons are getting many of their patients bent out of shape!!
Two different studies have been conducted on exparel recently and it was found that this so called analgesic, Exparel was no better or effective than an older form of the treatment and as per studies exparel is said to combine bupivacaine, an injectable drug of standard care with a proprietary technique for administering pain relief.
But what shocks us is the wholesale cost of a single vial of Exparel costs about $285 whereas the normal bupivacaine costs only $3. Because of this, the study authors who published their papers at the annual meeting of American Association of Hip and Knee say that the difference in price can no way be justified. A few practices have even stopped the usage of these drugs.
According to Rajesh Jain, an orthopaedic surgeon at Virtua Health System in Voorhees, New Jersey, who was also a co-author of one paper, “Exparel did help the patient and it indeed is a very safe drug to use but the big question is if it is really worth the cost. The drug was not found to be better effective than the previous, so there is no reason to spend such a whooping amount on it.
Pacira vs FDA
Last year Pacira(Exparel's manufacturer) filed a lawsuit blaming the Food and Drug Administration of misusing its power. This was in response to an FDA warning letter that was issued to the company last year that accused Pacira Pharmaceuticals of promoting the usage of the drug in the surgeries for which it was not even approved in the first place. The FDA also mentioned clearly that the drug should only be used and marketed for a 24 hour pain relief and not for 72 hours.
Pacira Pharmas retaliated to this by saying that the FDA had misinterpreted the product labelling and restricted its free speech as well. A lot of negotiations have been going on for many weeks and the most recent development was that the FDA took an unusual step by taking the warning letter off their website, giving hints to a few legal experts that the agency may allow Pacira to market the drug for longer durations of pain relief eventually. Right now the agency does not wish to discuss its move, indicating allegation.
On the other hand, Exparel has been widely discussed and debated in the entire orthopaedic community and many contrasting papers have been released and published over the last one year discussing the effectiveness and the value of the drug. And such a dispute has come up during one of the most controversial times where there is already an existing issue of price rise of medications and a few surgeons have point out that Exparel is just another example of prescription drug rate going up, burning a hole in the patient’s pockets.
But Pacira still sticks to its statement and says that Exparel is totally worth its price since the drug is much more cost effective compared to other expensive options like pain pumps that the patients rely on on a long term basis. The company also pointed out a few studies to fortify its arguments, including the one in which it was found that 100 patients on who the drug was administered experienced significantly very less pain, needed lesser pain medications and were able to get discharged much before than other patients who had a nerve block.
More controversy
Dr James Jones, senior VP and chief medical officer at Pacira admitted that Exparel is way expensive than old bupivacaine but he added that the older version of the drug does not provide pain relief for a longer duration of time. Moreover it also needs the use of other treatments, at times narcotics and maybe even longer hospital stays. The company states that it also brings added costs.
There was supposedly an independent study conducted by a physician who did consulting work for Pacira but Outpatient Surgery magazine covered a story last year mentioning about the ties between the drug firm and physicians who conducted the research supporting the medication Exparel. It was found that the particular study was initiated by the researchers with the funding given by the drug maker.
Pacira also made a statement that in order for Exparel to be successfully administered and showing optimum results, it should be administered repeatedly. Once the physicians see the results for themselves, they would be better comfortable in prescribing the drug to their patients.
Wall Street analysts got hold of this statement made by Pacira and said that, “The difficulty Pacira will face if that they would have to train physicians thoroughly on how to use the drug properly for better utilization of money and to derive the best results.”
Nevertheless, a few physicians claimed that they already knew how to administer the drug in an appropriate manner during the procedures. Because of the stark difference in the cost of the old and the new drugs, many hospitals have already discontinued its use.