Under 2% of Medicaid‐covered youths get MAT after OD: Study

Fewer than one‐third of youths receive addiction treatment after an opioid overdose, and only one in 54 receive pharmacotherapy (methadone, buprenorphine or naltrexone), a study published in JAMA Pediatrics reports. The researchers urge interventions to link these youths to treatment after an overdose, and call for improving access to medications: methadone, buprenorphine, and naltrexone.     

From starter OTP to acquisition by BayMark: A 3‐year journey

BayMark Health Services has acquired Counseling Solutions, a treatment provider focusing on methadone and buprenorphine treatment with locations in Chatsworth, Georgia, and Brasstown, North Carolina. When Zachary Talbott first started working to open his opioid treatment program (OTP) in Chatsworth more than three years ago, he had no plans to sell it (see ADAW, Aug. 17, 2015).     

‘Cash‐only’ buprenorphine a threat to opioid crisis

In an editorial written by the principal researcher on the clinical trials that led to the approval of buprenorphine‐naloxone to treat opioid use disorder, the increase in cash‐only buprenorphine clinics is called a threat to the opioid treatment system. “Proliferation of Cash‐Only Buprenorphine Treatment Clinics: A Threat to the Nation's Response to the Opioid Crisis,” by Art Van Zee, M.D., of the St. Charles Clinic, Stone Mountain Health Services, and David Fiellin, M.D., of the Yale University School of Medicine, was published in the March issue of the American Journal of Public Health.     

Sublocade: Why a placebo arm?

In a time when people are dying from illicit fentanyl overdoses, why would a trial for a new medication to treat opioid use disorder — a formulation of buprenorphine, already proven to be safe and effective in oral form — include a placebo arm? This was the question asked by many when the results of Indivior's trial for Sublocade, a buprenorphine injection that lasts a month, were published last month in The Lancet (see ADAW, Feb. 25). The trial results were what led to Sublocade's approval by the Food and Drug Administration (FDA) for the treatment of opioid use disorder more than a year ago (see ADAW, Dec. 11, 2017).     

Sublocade trial data published: Better than placebo

Sublocade, a buprenorphine injection that lasts a month, was approved by the Food and Drug Administration (FDA) for the treatment of opioid use disorder more than a year ago (see ADAW, Dec. 11, 2017), but the data that led to the approval was not public. It was made public in an article by Sublocade manufacturer Indivior published Feb. 18 in The Lancet.     

Mallinckrodt donates hand sanitizers to all OTPs

Mallinckrodt, a pharmaceutical company that makes methadone and buprenorphine for opioid treatment programs (OTPs) as well as many other medications, started out making hand sanitizer for its own plant employees when the pandemic began this winter. It wasn't long, however, before the company recognized that OTPs needed hand sanitizer — like everyone else, they were unable to get it. So last month, the St. Louis–based company started distributing it — for free — to all OTPs, not only its customers.     

Many buprenorphine prescribers don't take Medicaid or uninsured patients

In a survey in which callers seeking buprenorphine treatment for opioid use disorder (OUD) posed as patients with either Medicaid or no insurance, researchers found that few were offered an appointment with the possibility of buprenorphine induction at the first visit. The calls were conducted in Massachusetts, Maryland, New Hampshire, West Virginia, Ohio and the District of Columbia, all of which have a high burden of OUD. The callers found that out of 546 clinicians on the buprenorphine prescriber database maintained by the Substance Abuse and Mental Health Services Administration (SAMHSA), new appointments were offered to 54% of Medicaid callers and 62% of uninsured (meaning cash‐paying) patients, but that only 27% of Medicaid and 41% of uninsured callers had a possibility of buprenorphine treatment, and not all would get it right away. In fact, the median wait time for the first appointment was six days.     

Bill to deregulate buprenorphine raises concerns among OTPs

The Mainstreaming Addiction Treatment Act (H.R. 2482) would deregulate buprenorphine. Adminstration of the medication is held to high standards when used in the treatment of opioid use disorder, like methadone. Also like methadone, those standards don't apply when the medication is used to treat pain. The bill only applies to buprenorphine.     

Veto of New York buprenorphine PA bill angers advocates

New York Governor Andrew Cuomo's veto on Jan. 1 of a bill that would have removed prior‐authorization barriers for all formulations of buprenorphine in the Medicaid program was greeted with dismay by the Legal Action Center and others who had fought hard for it. He did, however, sign a similar bill that removed prior‐authorization buprenorphine barriers for commercial insurance. So, it is only the poor who will be adversely affected.     

Barriers to treating youth with medications for OUDs

Strategies to get medications to treat opioid use disorder (OUD) to young people immediately after diagnosis are urgently needed, a study published in the September issue of JAMA Pediatrics concluded. Young people with OUDs who receive naltrexone, methadone or buprenorphine are more likely to stay in treatment, yet these medications are underused. Only one in four youths receive medications for OUD shortly after diagnosis. For youths under 18, it's one in 21.     

Stop Stigma Now plans for future

Stop Stigma Now is planning to combine the names of NDRI‐USA and Stop Stigma Now, in a move that the organization hopes will give it more gravitas. Stop Stigma Now is a growing force in the methadone treatment patient community, which has been eclipsed by the general move to buprenorphine and naltrexone in media coverage.     

‘Secret shopper’ study finds many barriers to OUD treatment

Treatment programs that don't accept insurance, but only cash, create a barrier for opioid use disorder (OUD) treatment, according to a study by Stephen Patrick, M.D., and colleagues, many of whom are from the Vanderbilt Center for Child Health Policy at Vanderbilt University Medical Center in Nashville. And despite the fact that pregnant women with OUD are a priority population for treatment due to the risks to the fetus of continued opioid abuse, nonpregnant women are more likely than pregnant women to be given an appointment for treatment with a buprenorphine‐waivered clinician.     

DEA allows buprenorphine inductions based on telephone only

Last week, the Drug Enforcement Administration (DEA) said opioid treatment programs (OTPs) and Drug Addiction Treatment Act (DATA)–waived prescribers can treat new patients with buprenorphine based on a telephone call only. The Controlled Substances Act (CSA), enforced by the DEA, requires all new patients being treated with controlled substances to have an in‐person — or, for now, telemedicine — physical exam. Now, however, because of the coexisting COVID‐19 pandemic and opioid overdose crisis, the DEA has dropped this requirement. This follows the decision of the Substance Abuse and Mental Health Services Administration (SAMHSA) to allow exemptions from the OTP take‐home regulations allowing stable patients to be given 14 or 28 days of methadone doses, instead of coming in more frequently (see DEA, SAMHSA relax OTP/OBOT regulations due to COVID‐19, ADAW March 23, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32664 ).     

Correction

In “Is naloxone really needed in buprenorphine product?” (ADAW, June 10), there is an error. The sentence reading “But it is known that naloxone, an opioid antagonist (it is the active ingredient of Vivitrol)…” should have read “But it is known that naloxone, an opioid antagonist (it is the active ingredient of Narcan).…” We regret the error.     

Clarification on Braeburn's CAM2038/Brixadi/Buvidal

In our recent article “Sublocade: Why a placebo arm?” (see ADAW, March 11), we referred to the investigational medication CAM2038, an injectable (weekly subcutaneous depot) form of buprenorphine that is competing with Sublocade in the buprenorphine market. To make the terminology clear, the name of the investigational medication, developed by Braeburn in partnership with Camurus (Braeburn's European partner), is Brixadi. In Europe and Australia, however, the product is approved and marketed by Camurus under the trade name Buvidal. The Food and Drug Administration (FDA) granted tentative approval to Brixadi in December 2018, but Sublocade has exclusivity. “Brixadi's clinical development program was designed with input from the FDA,” said Sonnie Kim, Pharm.D., Braeburn vice president and head of medical affairs, in an email to ADAW. CAM2038 was found effective in Phase 2 research (see ADAW, June 26, 2017). The most recent results were published in JAMA Internal Medicine ( https://jamanetwork.com/journals/jamainternalmedicine/article‐abstract/2681061 ). We regret any confusion. For more information, go to www.braeburnrx.com .     

SAMHSA guidelines for recovery housing emphasize MAT

If there's any question about the appropriateness of medication‐assisted treatment (MAT) using methadone and buprenorphine for recovery housing residents, it has been settled by the most recent report from the federal government: Don't ban it, and, furthermore, do it.     

LAC and RTI: Eliminate Medicaid prior auth for bupe

Since April 2018, Medicare limited utilization management — most often done via prior authorization requirements — for buprenorphine to treat opioid use disorder (OUD). In response, virtually all plans that covered this treatment removed prior authorization requirements. Medicaid plans should do the same, according to RTI, writing in the July 9 issue of the Journal of the American Medical Association (JAMA).     

Fiellin: Keep the prescriber training for buprenorphine

It seems that almost everyone wants to deregulate buprenorphine for opioid use disorder (OUD) — with proposed legislation focused on getting rid of the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver altogether (see ADAW, Oct. 11, “Bill to deregulate buprenorphine raises concerns among OTPs,” https://onlinelibrary.wiley.com/doi/10.1002/adaw.32510 ).     

States call on HHS to immediately change year‐1 bupe cap

A coalition of 22 states and territories is requesting that the federal Department of Health and Human Services (HHS) lift restrictions on providing buprenorphine, one of the only three federally approved medications to treat opioid use disorder (OUD). “Buprenorphine is an essential tool in the fight to end the opioid epidemic,” said Howard Zucker, M.D., commissioner of health for New York state, which is leading the initiative. “Removing federal restrictions on prescribing buprenorphine will ultimately save lives and eliminate unnecessary barriers that prevent people with opioid use disorder from having access to treatment,” he said.