Distributors Inch Towards Opioid Litigation Settlement with $26 Billion Offer

According to several reports and regulatory filings from last week, it appears that four companies tied into the opioid multi-district litigation are close to a settlement agreement with states and local municipalities approaching $26 billion. Following the mid-October announcement from opioid manufacturer Johnson & Johnson that it would contribute upwards of $5 billion as part of the settlement, discussions among the plaintiffs and three major drug distributors indicate a collective $21 billion payment.

The number proposed is $3 billion above a similar offer from the defendants from 2019. The revised offer includes an additional $1 billion from each of the four defendants and greater clarity around distribution $2 billion in legal fees. The funds collected as part of the settlement agreement would be distributed among plaintiffs over the course of 18 years and may be reduced based upon the number of state and local municipalities that opt-out of the settlement.  One finalized, the agreement will then need to be approved by Judge Dan Aaron Polster, who has been overseeing the multidistrict litigation since 2018.

Articles & Resources

New York Times $26 Billion Settlement offer in Opioid Lawsuits Gains Wide Support

Washington Post – Johnson & Johnson, Three Other Companies Close in on $26 Billion Deal on Opioid Litigation

Reuters – McKesson Says States Seek $21 Billion from Drug Distributors in Opioid Settlement

ICER Issues Preliminary Review of Digital Addiction Therapies

The Institute for Clinical and Economic Review (ICER) published an evidence report on Friday looking into the potential benefits of three digital products aimed at addressing opioid use disorder. reSET-O, Connections, and DynamiCare are all digital health technologies for OUD. Overall, the report underscored the need for long-term clinical data to support it’s effectiveness in thwarting illicit drug use/recidivism and/or a patient’s ability to maintain treatment protocol. Other concerns were raised around cost of such products and differences in clinical outcomes as compared to the standard of care. ICER will host a stakeholder session on November 18th aimed at reviewing the evidence and discussing long-term value and comparative clinical effectiveness of these products.

The timing of the ICER report publication coincides with data released by a former CEPOP Focus Topic Speaker, Pear Therapeutics, regarding their product for the treatment of opioid use disorder. In the Journal of Current Medical Research and Opinion, Pear Therapeutics’ CMO Dr. Yuri Maricich and colleagues identify data from a 3,000 patient review that demonstrated product utilization and reduction in illicit opioid use and increased retention in treatment. Looking ahead, the product, reSET-O, may serve as a valuable addition to medication-assisted treatment (i.e. buprenorphine) in the treatment of individuals with opioid use disorder.

Articles & Resources

Institute for Clinical and Economic Review – ICER Publishes Evidence Report on Digital Therapeutics for Opioid Use Disorder

Fierce Biotech – ICER Says More Data is Needed on Digital App Treatments for Opioid Use Disorder

Journal of Current Medical Research and Opinion – Real-World Evidence for a Prescription Digital Therapeutic to Treat Opioid Use Disorder

Pear Therapeutics – Pear Therapeutics Announces Publication of Real-Word Data Demonstrating of Impact of reSET-O For Patients with Opioid Use Disorder

FDA Announces Public Workshop on Opioid REMS

In a Federal Register Notice published on Thursday, the Food and Drug Administration announced a public workshop and comment docket focused on “Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes— Exploring the Path Forward for Assessment.” The workshop, which will be held on December 11, 2020, will aim to solicit feedback from the public about ways to evaluate the effectiveness of the opioid analgesics REMS program with particular focus on measurable outcomes and better understanding of the impact of continuing education programs.

As part of the workshop, the agency has also published a lengthy issues paper that provides an overview of the REMS program and existing challenges with prescriber education and intervention.

The public docket (FDA– 2020–N–1561) will accept comments through February 11, 2021, open for 60 days following the completion of the workshop. For those interested in registering, please email [email protected].

Articles & Resources

Federal Register –  Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes—Exploring the Path Forward for Assessment; Public Workshop; Issues Paper; Request for Comments

LINK to FDA Public Workshop Page

FDA Issues Paper – Methods for Evaluating the Opioid Analgesic Risk Evaluation and Mitigation Strategy

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the issue. Links to relevant articles are provided below.

Articles & Resources

Journal of the American Medical Association – Modeling Mitigation Strategies to Reduce Opioid-Related Morbidity and Mortality in the US

Journal of Surgical Oncology – Opioid Prescribing Exceeds Consumption Following Common Surgical Oncology Procedures

Health Affairs – Confronting an Opioid Crisis and Promoting Health from All Angles

Michigan Medicine – Taking a Scalpel to Opioid Painkiller Risks

The Tennessean – Tennessee Sen. Joey Hensley Put on Medical Probation for Unethical Opioid Prescriptions

Pain Medicine News – Tracking Diversion During COVID-19

MedCity News – Mass General, Fern Health Broaden Digital Collaboration for Pain Management

This Week’s Calendar

We think that there was an election, or something big, that occurred last week. Looking ahead, Congress remains in recess for another week with no hearings or related events on the calendar. We have, however, included several virtual events that may be of interest to Policy Report recipients. In the instance that there are any changes to the schedule for this week, we will make additional information available.

  • Resources for Integrated Care
    Strategies for Non-Opioid Pain Management: A Panel Discussion
    Tuesday, November 10th, 2:30pm – 3:30pm ET; Registration
  • A Discussion Led by Faegre Drinker Colleagues…
    Telemedicine Prescribing of Controlled Substances – Next Steps on DEA’s Long-Awaited Special Registration Regulations
    Tuesday, November 10th, 4:00pm – 5:00pm ET; To Register, please email Jennifer McBride
  • The National Academy of Medicine
    NAM Action Collaborative on Countering the U.S. Opioid Epidemic
    Thursday, November 12th, 9:00am – 2:15pm ET; Registration

Questions about the above content can be directed to [email protected]