Updates on spring boosters and buprenorphine (Suboxone) prescribing barriers
There’s a lot going on in the world of medicine and I’m deeply engaged in clinical work and ongoing research with my colleagues in Qatar, Israel, and that other far flung foreign land of which I have little cultural understanding: Connecticut.
Meanwhile, here are two big stories I’ve been watching this week.
Spring boosters for the highest risk look promising in the US.
The FDA is moving towards allowing a spring bivalent booster for high risk people. Reports are that people over age 65 and others who are immunocompromised may soon be allowed to get a second dose of the bivalent booster. As I wrote with Dr. Katelyn Jetelina, this is good news. If this goes through, the US will be joining the UK and Canada who have enacted similar policies.
What I’ll add is that data I’ve seen (but cannot yet share) indicates that re-boosting all people ages starting at age 60 and up might be warranted and cost-effective right now.
Has a barrier to prescribe buprenorphine (Suboxone) been replaced by another?
For people with serious opioid use disorders (OUD), abstinence does not work as well as replacing dangerous drugs with safer ones. Medications like methadone and buprenorphine (“Suboxone”) allow patients with OUD to live normal lives.
Until recently, Suboxone could only be prescribed by people who had gone through extra training (which cost hours and dollars). (Methadone still must be obtained by patients from dispensaries on a daily basis. It’s a terrible system that needs to go.) Cass Sunstein and I wrote about how deadly this red tape (“sludge”) was, back in 2019.
Suboxone has become the linchpin of medication for opioid use disorder (MOUD) and is now considered the gold standard for that disorder. Suboxone is a medication that combines buprenorphine and naloxone. It reduces cravings and makes overdoses, even fatal ones, far less likely….This life-saving approach should be the standard of care, but it has not yet become so. Why is this?
The answer is sludge. By federal law, physicians in the United States must obtain a special X Waiver in order to prescribe buprenorphine, one of the active ingredients in Suboxone. The required time and administrative burdens around obtaining the X Waiver are preventing many otherwise willing physicians from prescribing it.
—me and Cass Sunstein, Boston Globe, October, 2019.
Fast forward to 2023. The X Waiver has finally been abolished. This is great news. However, in its place, the DEA announced that a one-time training (8 hours) will be required of all opioid prescribers. The training will cover many drugs, not just buprenorphine. The deadline, announced this week, is whenever a person is up for renewing their DEA license (or upon their first application), starting June 27, 2023.
Sludge bait-and-switch? Yes and no.
Some clinicians won’t have to do the training (including people who did the right thing by overcoming the sludge and got X Waivers anyway—I’m one of those. Others who will be exempt include those board-certified in addiction medicine).
While it’s annoying to have this new requirement, there are a few positive things about it. First, the training does not single out buprenorphine. A legitimate complaint about the X Waiver training was that it treated buprenorphine as special. It didn’t make sense that anyone with a DEA license could prescribe oxycodone, hydromorphone, hydrocodone, or any number of opioids that treat pain and have abuse potential, but in order to prescribe buprenorphine (which is meant to treat OUD), one had to get trained. The new policy at least levels the playing field on controlled substances. Second, in the future, these trainings will be worked in to residency training programs (i.e., just part of the curriculum)—a frictionless process that will be the default. (Sludge, by definition, is all about the friction created by unnecessary barriers.)
Another current I’m watching is related to telehealth and buprenorphine prescribing. I plan to write more about that soon if there’s interest…
Thank you so much for your question on Spring Boosters to Dr. Califf concerning immune compromised and older folks. Sadly, his answers were evasive and generalized, a politician’s response. But YOU did press for specifics and many appreciate that. But for people like myself, severely immune compromised, the problem is specific, immediate, and complex. In 3 weeks, I’m due my disease modifying drug for Progressive MS, Ocrevus. Since it suppresses my immune system (B cells) I must get the COVID booster 2-4 weeks BEFORE the Ocrevus, otherwise I have to wait 12 weeks AFTER the Ocrevus infusion (Brigham MS Center recommendation). That could mean 11 months with no booster since it’s already been over 7 months since my last booster. And “Nearly one month out from the end of the public health emergency in the U.S., hospitalizations are on the rise in 16 different states, and a new omicron subvariant (Omicron XBB.1.16) has been spotted in 18 states. https://www.beckershospitalreview.com/public-health/covid-19-hospitalizations-up-in-16-states-1-month-out-from-end-of-phe.html. I use myself as an example, but this is typical of many people like myself. We are already overwhelmed with catching up on healthcare visits and procedures delayed by COVID. My only other option is to delay my MS treatment as the neuro problems flare. My breathing muscles are impacted and I’m in a wheelchair. I still have a job (part time), I work for my city Commission on Disability (volunteer) and state orgs to help those disabled folks who are not fortunate enough to be white middle class and have med insurance as I do. It is not only a matter of our short life expectancy, but also quality of life. I wish I was 71 and in good enough health to have such a demanding job as FDA Commissioner. Thanks again for your part.
Any idea what’s happening with novavax vaccine? Will it be available in the US as an alternative to the RNA vaccines? Could there be added benefit to mixing and matching?