Pacira, Trinity Health aim to address opioid use in surgeries

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A partnership between Pacira Pharmaceuticals and Trinity Health, one of the nation's largest health systems, aiming to curb opioid use, follows a settlement with the FDA that allowed the drugmaker to more broadly market its only therapy.

Pacira markets Exparel, a non-opioid painkiller injected during surgical procedures, which was approved by the FDA in 2011.

See also: The FDA settles with Pacira, rescinds warning letter

In 2015 Pacira sued the FDA after receiving a warning letter accusing the company of promoting the drug for uses outside its label, which limited marketing to two indications. Pacira responded, saying it had distributed truthful and non-misleading information about Exparel for a broader range of indications. The FDA eventually settled the case, agreeing to drop the marketing restrictions and revise Exparel's label. The agency said in a statement at the time that the “revised labeling is based on scientific evidence that was previously submitted,” according to Reuters.

In recent months Pacira announced two partnerships, one in January with Johnson & Johnson to co-promote Exparel for use in certain surgeries, such as spine and trauma procedures. DePuy Synthes, J&J's orthopedics business, is the one of the largest orthopedic manufacturers in the world.

See also: Industry watches Pacira's off-label case against the FDA

The second partnership, with Trinity Health, was announced in March to identify alternative ways to control pain without opioids after surgery. Under that agreement, Pacira and Trinity will identify the types of patients who can be most helped by minimizing the use of opioids. Then, the teams will develop formal strategies — as well as training methods for clinicians — aimed at reducing or replacing opioids for pain control.

A study in 2016 in JAMA Internal Medicine found that many surgeries are associated with an increased risk of chronic opioid use.

“This collaboration is not built around our products,” said David Stack, Pacira's CEO. “It's really built around education and collaborating to address the epidemic.”

See also: Pacira gets OPDP opioid promotion Warning Letter

The ambitious scope of the program makes it somewhat unique as partnerships between drugmakers and health systems have historically consisted of one-off programs, according to Pratap Khedkar, ZS Associates' managing principal. Barriers such as a lack of trust between pharma companies and health systems, legal issues like the Anti-Kickback Statute, and agreeing on what is valuable for both organizations have made the success of these agreements elusive at times and also hindered widespread adoption. “These partnerships haven't scaled, to put it bluntly,” Khedkar said.

This is Pacira's first health-system partnership aimed at treating patients affected by this issue, Stack said.

Specifically, the companies will look to tackle the opioid epidemic by working to change the current pain management paradigm from a reliance on opioids. The goal is for prescribers to view narcotic pain relievers as a last-ditch measure, according to Stack and Paul Conlon, SVP of clinical quality and patient safety for Trinity Health, a Catholic not-for-profit health system with 93 hospitals and 120 continuing care programs.

See also: Industry watches Pacira's off-label case against the FDA

To that end, they plan to work together to identify specific instances in which patients are getting opioids that are unnecessary and identify certain procedures after which patients are likely to stay on opioids for a long period of time.

Separately, creating those processes could also stand to benefit Exparel, Pacira's only FDA-approved product. Identifying and developing more effective ways for clinicians to treat subpopulations in a given area, like pain management, can prove fruitful for pharma companies in markets they dominate, even in unbranded efforts, according to ZS Associates' Khedkar.

“Companies will work with a provider system in order to gain data into a particular subpopulation,” he said. “The kicker is, once this process in place, reps may be able to improve the uptake of this process or protocol change.”

Exparel saw sales of $265 million in 2016, an increase of 11% from the year prior. Pacira forecasted sales for the drug to reach up to $310 million this year.

See also: Lobbyists create off-label principles following FDA lawsuits

Conlon noted that this initiative is not about using one drug over another drug. “It's about: what are the strategies we can deploy to reduce the amount of opioids in the community,” he said.

Stack, too, points out that the central focus of the collaboration is not to promote Exparel but to look for ways to address the opioid epidemic in a broader sense. He did note, however, that the company is exploring the use of Exparel as an alternative to opioids in clinical trials but said that's “downstream.”

“We think what we have to do now is get folks together [and] explain where the opioid epidemic came from, so clinicians can understand how patients are exposed to opioids,” Stack added.

See also: In draft guidance, the FDA defines appropriate off-label comms as being 'consistent' with the label

Mobility for patients after surgery is another concern for clinicians, in part because it can keep patients in the hospitals and hinder recovery. Improved mobility has also been touted an outcomes benefit of Exparel. In 2015, research conducted by the University of Illinois College of Medicine found that using Exparel to treat pain after a knee replacement led to “notable improvements in postoperative mobility and length of hospital stay.” An analysis of that data found that using Exparel could lead to cost savings of $366 per patient. The lead researcher for the study, Carl Asche, has served on Pacira's advisory board.

This kind of research is “integral to gaining institute-wide adoption and being accepted as the new standard of care in postsurgical pain management,” Stack said in a release at the time.

Another area ripe for more education about reducing the use of opioids may be for patients with certain cancers that require surgery, like a mastectomy or certain ovarian cancer cases.

See also: Off-label cases against the FDA move forward

“In many cases, the patient doesn't get a dose of their oncology therapeutic immediately following their surgery because the immune system is being downregulated by opioids, and so you can imagine the angst of not starting on your therapeutic because you have to wait several days for your immune system to recover,” Stack explained. “If we can lower the amount of opioid that's required and allow them to get their therapeutic during the same stay as their hospitalization, it's a win-win for everybody.” 

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