Buprenorphine and the elimination of the X-waiver
By Larry Kravitz, MD, Chris Allen, and Matthew Seghers
As primary care physicians, we all want to help end the opioid crisis. But the options for family physicians in this epidemic have been limited. Most of us are not addiction specialists. Most of us do not work in substance abuse rehab clinics. Within the traditional primary care clinic setup is the undercurrent of our daily struggles, as our patients succumb to progressive illness, and with that, often the emergence of chronic pain conditions. Tackling chronic pain can be one of the most vexing issues in medicine, and primary care is at the frontlines of handling these patients.
Statistics from the National Institute on Drug Abuse are staggering: Roughly 21-29% of patients prescribed opioids for chronic pain misuse them, between 8-12% of people using an opioid for chronic pain develop an opioid use disorder, and approximately 80% of people who use heroin first misused prescription opioids. COVID-19 only exacerbated opioid-related consequences, with several publications from prominent organizations such as the Journal of the American Medical Association and the American Medical Association outlining the harrowing spikes in both non-fatal and fatal overdoses. Texas has not been immune to these trends, as highlighted in a KHOU segment from December 2020 that describes a record-breaking number of calls to first responders for overdoses.
When the opioid crisis hit full force, I began to hear more and more about a drug many felt to be highly underutilized for management of chronic pain and opioid addiction: Buprenorphine. You may also know it as Suboxone or Belbucca. According to UpToDate, buprenorphine is “a mu-opioid receptor agonist with high affinity for the receptor but low intrinsic activity and is an antagonist at the kappa-opioid receptor. It produces little physical dependence, is associated with less opioid-induced hyperalgesia than other opioids, and importantly, produces less respiratory depression than other long-acting opioids.” Given this description, buprenorphine seems to be a promising medication that may offer benefits that exceed those of traditional opioids. My interest was piqued in the use of buprenorphine, and I subsequently initiated the process of obtaining my X-waiver.
The X-waiver is a certification required under the Drug Addiction Treatment Act (DATA 2000) before a physician can prescribe or administer buprenorphine. The requirement of an X-waiver has hindered the adoption of buprenorphine by mainstream physicians.
The process wasn’t simple. I had to complete eight hours of training, largely focused around avoiding biases in treating patients addicted to opioids with a small dash of abstract pharmacology mixed in. As a physician who has practiced for three decades, I have repeatedly practiced the art of gathering evidence-based data on new prescription drugs to make informed prescribing decisions. I felt that the training did not provide the information needed for my primary intended use: chronic pain management. After completing the process and receiving my X-waiver, I was no longer surprised that none of my partners used buprenorphine in their practice. Rather than serving a public health purpose, the X-waiver seemed to impede the implementation of a promising opioid alternative.
As the months went by, I identified several of my chronic pain patients who seemed to be ideal candidates to transition to buprenorphine. With patient consent, here is one story. A male in his 40s, married with children, who currently works in construction equipment sales. His wife is a medical professional, so he is no stranger to the issues plaguing our health care system such as the opioid crisis. When he was in his 20s, he suffered a severe ankle injury that healed poorly, and eight operations later, his ankle is a complete bone-on-bone mess. His orthopedist laid out three options, none of which were guaranteed solutions to his pain: Arthrodesis, which could lead to further leg compromise, ankle replacement expected to last only a decade, or a below-the-knee amputation.
His daily routine is plagued by chronic pain and limited ambulation. After nearly half a decade with pain management, he found himself on 320 mg of sustained release oxycodone every day. This dose was adequate to control his pain and allowed him to continue a life with physical exercise modified around his ankle. Two years ago, along with a pain specialist, we made the decision to introduce buprenorphine into his medication regimen, and he has been able to decrease his oxycodone use to 80 mg per day over this timeframe. In the next 12 months, we plan on decreasing the dose to zero. A patient who was on unsettling doses of oxycodone is now on an excellent trajectory toward being maintained on buprenorphine alone. He has become unshackled from a self-image of narcotic dependency and feels more in control of his world.
Like many chronic pain patients, his financial burden was also taxing. Oxycontin cost him well over $1,000 a month, often with his insurance balking at the expense. Buprenorphine 2 mg sublingual tablets are priced in the range of $15-30 for a quantity of 60 on GoodRx. For my patient, buprenorphine is a road to a safe and normative life, a medical life that matches his activity goals.
As previously alluded to, the DEA has recently provided increased flexibility for providing buprenorphine to patients. The X-waiver requirement has been removed as of January 2021 for providers treating under 30 simultaneous buprenorphine patients and those using the medication in a hospital setting. This has opened the door for primary care physicians to add buprenorphine to their toolkit of chronic pain management without the previous regulatory requirements. Buprenorphine is still not the easiest medicine to use. Side effects of dizziness and nausea are more prominent than the familiar hydrocodone. Additionally, transitioning patients from other opioids to buprenorphine is more of an art than my X-waiver training led me to believe. But the pharmacology is reassuring, and as the pandemic only continues to exacerbate opioid use disorders among patients around the country, I would encourage all primary care physicians to examine their practices for any potential patients that may reap an abundance of reward from this oft underutilized medication.