Results From Head-to-Head Comparison of Exparel and Conventional Bupivacaine New study shows not much separates standard bupivacaine from pricey Exparel. Published: November 12, 2015 Category: Outpatient Surgery > General Surgical News and Reports PAIN RELIEF Exparel works, but costs significantly more than traditional options that are just as effective. In a head-to-head comparison of Exparel and conventional bupivacaine at relieving pain after knee replacement, a new study shows Exparel is no better than the long-available generic — despite costing 25 times as much. To determine if the drug decreased post-op pain scores or reduced opioid consumption during recovery from unilateral knee replacement, researchers at the Virtua Joint Replacement Institute in Voorhees, N.J., randomly assigned 207 patients to receive intra-articular injections of bupivacaine and morphine at the conclusion of the procedure, a periarticular injection of bupivacaine and morphine, or a periarticular injection of Exparel. Patients in each group reported similar pain scores and consumed the same amount of morphine equivalents, according to the findings. The effectiveness of Exparel had previously been compared with placebo, but this was the first head-to-head comparison of identical intra-articular and periarticular injections administered to total knee patients. While both drugs worked well, Exparel costs $402 a dose, compared with approximately $16 for the traditional pain control methods. Reducing and managing pain after knee replacement is possible with a medication that is both affordable and effective, which could lead to significant healthcare savings, researchers say. "In the current era of medicine, value-based care is being sought out as the defining outcome," says Rajesh Jain, MD, orthopedic surgeon at Virtua Health and lead author of the study. "Value is a combination of quality of care, including outcomes and cost." The findings support an Outpatient Surgery Magazine special report that compared the cost-effectiveness of Exparel with straight bupivacaine. The report suggests surgical facilities might be paying too much for pain relief that falls short of the 72 hours of analgesia that Exparel is marketed to provide. Researchers presented their findings at the recent meeting of the American Association of Hip and Knee Surgeons in Dallas, Texas, earlier this month. At the same meeting, Pacira Pharmaceuticals, the maker of Exparel, announced the results of a study that shows the drug decreases opioid use and hospital readmission rates in patients who undergo total knee replacements. The company claims the additional cost of using Exparel is offset by shorter anesthesia induction times, shorter hospital stays and lower rates of 30-day readmissions.
What this poorly-presented article did NOT mention is that the institution improperly used EXPAREL! The total volume used was way too low, and the necessary additional Marcaine (needed to bridge the time gap between EXPAREL administration and onset of efficacy) was not used. These are two major no-no's for anyone in the know. Our data (yes, I'm a rep for Pacira) clearly shows that proper EXPAREL usage and technique produces superior results when compared to EVERYTHING else. "Figures don't lie, but liars sure can figure."
Actually, including the study mentioned above, there are now at least 3 RCTs showing no benefit of the max FDA approved dose of Exparel (266 mg) vs. plain bupivacine in TKR. One of the studies was actually sponsored by Pacira. While the Pacira sponsored study shows some benefit of 532 mg of Exparel compared to 150 mg plain bupiv, this should be interpreted cautiously since 532 mg of Exparel is roughly 600 mg of bupivacaine. The idea that these studies may be negative b/c they didn't mix Exparel with additional plain bupiv is a fallacy. The abstract below is an example of an RCT that did exactly this and still showed no difference. Even if there was a "gap" in Exparel effectiveness, the drug should still show differences on Post op day 1 and 2 due to its purported long duration of effect, but none of the studies show analgesic benefit of Exparel 266 mg vs. plain bupiv on any days. So, in reality, "those in the know" actually know that Exparel is probably no better than plain bupiv. J Arthroplasty. 2015 Sep;30(9 Suppl):64-7. doi: 10.1016/j.arth.2015.01.059. Epub 2015 Jun 3. Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial. Schroer WC1, Diesfeld PG1, LeMarr AR1, Morton DJ1, Reedy ME1. Author information Abstract Liposomal bupivacaine periarticular injection (PAI) offers sustained bupivacaine release after TKA, but few prospective independent studies exist. In this prospective, blinded study, liposomal bupivacaine was randomized against bupivacaine and incorporated into a comprehensive multimodal pain management protocol. 111 primary TKAs were randomized to receive PAI: 58 patients received 266 mg (20cc) liposomal bupivacaine mixed with 75 mg (30cc) 0.25% bupivacaine, and 53 patients received 150 mg (60cc) 0.25% bupivacaine. Visual analog pain scores and narcotic use were determined. No pain score differences occurred between study and control patients: Day 1: 4.5/4.6 (P=0.73); Day 2: 4.4/4.8 (P=0.27); or Day 3: 3.5/3.7 (P=0.58). Narcotic use was similar during hospitalization, 51.8/54.2 (P=0.34). The study medication costs $285, and the control medication costs $2.80. This finding does not justify the routine use of liposomal bupivacaine. Copyright © 2015 Elsevier Inc. All rights reserved.
So given the above, the product should be hard sell to both doctors and insurance. Is it? Then why is Pacira on a hiring spree, LOTS of territory openings. Are you guys making goals? Do docs want to talk to you?
Exparel has to be administered correctly (expanded with NPFS to accommodate surgical site and 40ish needle sticks placed in the right place depending on the procedure, this provides adequate coverage of the nerves needing it). I would question the validity of the studies' design/administration. Why are there so many openings?? Because the company SUCKS! They have little clue on how to run a successful team as they manage by fear. They don't understand the selling cycle involved in hospital sales and think it is like primary care where numbers can increase yesterday. Get sales or lose your job. The drug is not an easy sell, but it is one that makes sense when used appropriately and correctly. You don't sell to insurance. Many insurances are/or were reimbursing for it (at the surgery center level), it is bundled in a hospital setting (DRG) so insurance isn't necessarily a hurdle. The bottom line cost addition to the procedure is the cost issue (~$315/vial). They split territories is one reason for the number of openings. The other is people are finally fed up and realizing that they can't stand it any longer while waiting for their stock options with a much higher strike price to be worth anything. No job security with this company. Caution if considering.
