Join the May All-Participants Meeting at 3PM Eastern with Presentations from the Center for Drug Evaluation and Research (CDER) at FDA and Rubicon Global Enterprises

CEPOP will be hosting its May All-Participants Teleconference today at 3:00 pm EST. Today’s meeting will include presentations from Dr. Marta Sokolowska of CDER, FDA, and Thom Browne of Rubicon Global Enterprises. Dr. Sokolowska will present FDA safety label changes for opioid pain medicines, and Mr. Browne will present on the changing patterns of street drugs. Please contact Sanjyot Sangodkar for meeting details.

HHS-OIG Report Shows Little Diversion and Misuse of Buprenorphine in Medicare Part D Recipients

This week the Department of Health and Human Services Office of Inspector General (HHS-OIG) released a report outlining the low risk of diversion or misuse of buprenorphine for treating Opioid Use Disorder (OUD) in Medicare Part D recipients. The report reviewed 40,000+ Medicare Part D claims from 2021 for buprenorphine indicated for treating OUD. The majority of patients received buprenorphine-naloxone products, and only 16% received buprenorphine monoproducts. Most prescriptions fell within recommended prescribing amounts, primarily 16mg daily. Of the 40,000+ claims, only 35 indicated risky provider behavior, such as prescribing high dosages of buprenorphine. Given that the study took place in 2021, appointments would take place in an office setting, followed by a visit to a retail pharmacy. At the end of 2022, Congress passed the Mainstreaming Addiction Treatment Act (MAT) Act which removed the Drug Addiction Treatment Act (DATA) Waiver requirements allowing more providers to prescribe buprenorphine products for OUD. The investigation supports the removal of the waiver and the expansion of access to buprenorphine. Only 18% of Medicare Part D recipients receive buprenorphine treatment, and black, Asian/Pacific American, Hispanic and Indigenous communities are less likely to receive this treatment. Investigators recommended the following to the Center for Medicare and Medicaid Services (CMS):

  1. Continue monitoring the use of buprenorphine and share data with partners when appropriate;
  2. Inform providers about the low risk of diversion and encourage buprenorphine treatment for OUD;
  3. Educate providers about the availability of buprenorphine under Part D and the availability of combinational products; and
  4. Follow up with providers exhibiting concerning patterns.

Articles & Resources

HHS-OIG—The Risk of Misuse and Diversion of Buprenorphine for Opioid Use Disorder Appears to Be Low in Medicare Part D

HHS-OIG—Complete Report

White House to Meet with Naloxone Makers to Discuss Pricing

In an interview with STAT, Rahul Gupta, Director of the White House Office of National Drug Control Policy (ONDCP), announced a roundtable meeting with naloxone manufacturers to discuss the medication’s pricing. Since the over-the-counter (OTC) approval of naloxone, the cost has been front of mind. The manufacturer of the OTC option previously announced that a Narcan two-pack would be $50; however, stakeholders have expressed that, for many in need, this price may be out of reach. The goal of the meeting is to discuss pricing concerns and the expansion of OTC options for naloxone. While access continues to be a problem, Dr. Gupta noted the expansion in the last decade and the opportunity to routinize naloxone, similar to the external defibrillator kits found in public spaces across the country, saying “This gives an opportunity for businesses, restaurants, law offices, schools, to be able to invest in saving a life…So when that event unfortunately does happen, that’s the best return on investment they can have. At some point, it will come to a place where it’s not only the right thing to do, but the public expects you to do it.” The full article is attached to this email.

Articles & Resources

STAT—Biden Drug Czar to Summon Naloxone Makers to White House to Discuss Pricing

What We Read Last Week

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

Associated Press—Drug Overdoses in the US Slightly Increased Last Year. But Experts See Hopeful Signs

Axios—Candy-Colored Fentanyl Seized in Ohio

The Guardian—The China-Mexico Fentanyl Pipeline: Increasingly Sophisticated and Deadly

Governor Newsom—California Awards $23.3 Million for Students to Become Substance Use Disorder Counselors

The New England Journal of Medicine—Racial Inequality in Receipt of Medications for Opioid Use Disorder

Pharmacy Times—Taking Gabapentin with Opioids for Acute Conditions Increases Risk of Opioid-Use Disorder

SAMHSA—SAMHSA Distributes Additional Grant Funding for Programs That Combat Overdose and Substance Use on Multiple Fronts

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

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