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Large Joints Feature

Courtesy of Pacira Pharmaceuticals

New Study Supports Exparel Cost Effectiveness

Biloine W. Young • Wed, January 24th, 2018

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In an article by Allison Inserro, published on AJMC.com, “Patients having total knee arthroplasty (TKA) who were treated with liposomal bupivacaine were discharged to their homes sooner and had a significantly shorter hospital stay compared with patients who did not receive that drug during surgery, according to a recently published study looking at the value and cost effectiveness of the drug.”

The study, “Cost-effective peri-operative pain management: assuring a happy patient after total knee arthroplasty,” was published in the January 2018 issue of The Bone and Joint Journal. One of study authors was Richard Iorio, M.D., chief of adult reconstruction at NYU Lagrone Medical Center, Hospital for Joint Diseases.

“Liposomal bupivacaine is sold under the name Exparel. Exparel is delivered through a proprietary foam-based delivery system and costs about $300 per dose. The price of generic bupivacaine is about $3 a dose. The FDA approved Exparel in 2011 for a single-dose infiltration into the surgical site to produce postsurgical analgesia.”

The FDA is presently “reviewing a supplemental new drug application to include administration of Exparel via a nerve block for prolonged regional analgesia.”

“Currently, there are no well-defined guidelines for the best pain management protocol in patients undergoing TKA”, the authors wrote. Traditional methods of management include the use of opioids, patient-controlled analgesia (PCA) and peripheral nerve blocks.”

“The authors hypothesized that a decrease in complications with at least equivalent pain control would lead to improved cost-effectiveness.”

“The study cited some of the side effects of other methods of pain control.

  • Peripheral nerve blocks have been associated with an increased risk of falls, nerve injury, and temporary loss of motor function, which can delay rehabilitation.
  • Side effects of opioids include respiratory, hemodynamic, urinary, and gastrointestinal disturbances”

“He also explained that decisions about cost-effectiveness need to be based on the entire cost of an episode.”

“If you have a fall in the hospital because of a femoral nerve block, or you give a patient a narcotic and they get dizzy or nauseous and vomit and their length of stay is extended, or they get too sick from the narcotics and they don’t get good pain relief … and can’t participate in their rehabilitation, they stay in the hospital longer and they even have to go to a rehab.”

Iorio said, “While $300 for 1 drug may seem expensive, an extra day in the hospital might cost close to $6,000, a stay in a rehab center might cost $5,000 to $10,000, and a fall with a fracture after a joint replacement might cost $50,000 to $100,000.”

During the study, between September 2013 and September 2015, the institution where the study was conducted, NYU Langone, began changing how they manage pain after TKA to increase patient satisfaction and also to reduce the amount of narcotics. In May 2014, there was a department-wide transition from protocols focused on femoral nerve blocks (FNB) to Exparel.”

“In February 2015, PCA was removed from the protocol while continuing Exparel.”

The study enrolled 1,808 patients who were divided into the following study groups:

  • Cohort 1: 583 patients, who received FNB intra-operatively and PCA for the first 24 hours post-operatively.
  • Cohort 2: 527 patients, who received liposomal bupivacaine injections instead of FNB.
  • Cohort 3: 698 patients, who consisted of all patients who underwent TKA after February 2015, when PCA was removed from the protocol while continuing liposomal bupivacaine injections.

“The protocol for the management of pre-operative pain for each period of time was identical and consisted of 1 administration of oral analgesics (10 mg oxycodone, 200 mg celecoxib, 1000 mg acetaminophen, 50 mg of pregnable).”

“During the operation, a short-acting anesthetic was administered using either 3 ml 3% chloroprocaine or 3 ml 0.5% ropivacaine.  A tourniquet was used and all patients received a periarticular injection (40 cc 0.25% marcaine, 5 cc 5 mg duramorph, and 1 cc 30 mg Toradol).”

In cohort 1, an ultrasound-guided injection of 20 ml of 0.25% bupivacaine was administered. The liposomal bupivacaine periarticular injection, or Exparel, was used in cohorts 2 and 3 consisting of 20 cc of liposomal bupivacaine (13 mg/cc) in 40 cc to 100 cc 0.9% normal saline and was dispersed equally throughout the posterior capsule and the overlying periosteum and soft tissue.”

“All patients underwent the same standardized postoperative clinical pathway and rehabilitation. But Iorio said the group getting Exparel without PCA met their physical therapy milestones more quickly, got out of the hospital faster, and had their pain more controlled.”

“The study recorded the length of stay, whether the patients went home or to a rehabilitation center at discharge, the 30-day readmission rates, and the Hospital Consumer Assessment of Healthcare Providersw and Systems (HCAHPS) scores from the Centre for Quality and Patient Safety database.”

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