Red tape hinders addiction-curbing drug
A buprenorphine shot is effective against opioid dependency. But it’s not easy to get.
OAKLAND — Dr. Andrew Herring has a clear goal walking into every appointment with patients seeking medication to treat an opioid use disorder: persuade them to get an injection of extended-release buprenorphine.
At his addiction clinic at Highland Hospital, a bustling public facility in Oakland, Herring promotes administering a shot of buprenorphine in the belly to provide a month of addiction treatment rather than prescribing oral versions that must be taken daily. For him, the shots’ longer-acting protection is a “game changer” and may be his only chance to help a vulnerable patient at risk of overdose.
“At any point in time, they’re just a balloon that’s going to go,” Herring said. “You might only have this one interaction. And the question is, how powerful can you make it?”
In California, where overdose deaths have been rising for years, addiction experts say administering a month’s worth of anti-addiction medication holds great potential, particularly for people without housing or who struggle with other forms of instability. Yet despite its promise, the use of injectable buprenorphine remains fairly limited, especially compared with other forms of addiction medication. Researchers have yet to publish studies comparing different ways to administer buprenorphine.
Buprenorphine, one of three medications approved in the U.S. to treat opioid use disorder, works by binding to opioid receptors in the brain and reducing cravings and withdrawal symptoms. And because it occupies those receptor sites, buprenorphine keeps other opioids from binding and ensures that if a patient takes a high dose of a drug like heroin or fentanyl, they are less likely to overdose. Patients often stay on buprenorphine for years.
If Herring prescribes a supply of buprenorphine as a tablet or film that is placed under the tongue, the patient must commit to taking the medication at least once a day, and many fall out of treatment. He said this is especially true for his patients experiencing homelessness and those who also use methamphetamine.
“It’s like a religious thing — you have to wake up every morning and repeat your vows,” Herring said. “In reality, there are a lot of people who deserve treatment who can’t meet that requirement.”
Oral forms of buprenorphine have been available to treat addiction since 2002 and can be purchased as a generic for less than $100 a month. Injectable buprenorphine, sold under the brand name Sublocade, received FDA approval in 2017. It has a hefty list price of $1,829.05 for a monthly injection. The drugmaker Indivior reported $244 million in revenue from Sublocade last year alone, with a company goal to eventually make $1 billion in annual sales. No generic or competing version of the drug is available.
Most patients won’t pay full price, Indivior says, because most health plans cover the drug. Physicians, however, say the high cost can be a barrier for patients with private health plans, which sometimes resist covering the medication. Medi-Cal, California’s health insurance program for low-income people, covers Sublocade without prior authorization, making the treatment accessible to the majority of Herring’s patients.
Still, addiction experts say, Sublocade use remains limited because of the regulatory hurdles required to dispense it.
Providers must register with the U.S. Drug Enforcement Administration and obtain a waiver to prescribe buprenorphine because it’s considered a controlled substance. In addition, clinics must complete an FDA safety certification program to dispense the medication. And Sublocade can be ordered only by a specialty pharmacy, which must also pass the FDA program.
“At many hospitals, that will mean either a delay in getting this medication on our shelves or just opting out,” said Dr. Rais Vohra, regional director for the California Bridge Network, a state-funded program that supports hospitals in offering treatment for substance use disorders, including Herring’s clinic.
Vohra said Community Regional Medical Center in Fresno, where he works as an emergency physician, is still looking through the documentation requirements to see if the hospital’s pharmacy can distribute the medication — which would make it one of the few Central Valley providers to do so.
Oral buprenorphine, by contrast, is a simple prescription that most local drugstores keep in stock.
“All the hoops that clinicians and patients have to jump through to get this medication is crazy. We don’t do that for any other disease,” said Dr. Hannah Snyder, who runs the addiction clinic at Zuckerberg San Francisco General Hospital across the bay.
Several clinicians noted that access remains a problem even with oral forms of buprenorphine. Despite a cascade of studies proving the effectiveness of medication-assisted treatment, many patients across the country struggle to find a provider willing to prescribe buprenorphine in any form — especially in communities of color.
“The most important question isn’t whether longacting injectable bupe is a better solution than sublingual buprenorphine for opioid use disorder,” said Dr. Michael Ostacher, a professor at Stanford University School of Medicine, who is comparing injectable and oral versions of buprenorphine through Veterans Affairs. “The bigger question is how we increase access to treatment for all people who need [the medication].”
Angela Griffiths is among the patients who say Sublocade has changed their lives. Griffiths, 41, of San Francisco, used heroin for 18 years. When she was pregnant with her daughter in 2016, doctors put her on methadone, which made her feel “miserable.” Three years ago, she said, she switched to buprenorphine films, but carrying the strips with her everywhere still made her feel tied to her addiction.
“The ritual of taking something every day plays something in your mind,” Griffiths said.
When doctors at the SF General clinic switched her to monthly Sublocade injections, she described the change as “extraordinary.”
“I’m not reaching for my drawer anymore for a fix,” she said. “I have the freedom to wake up and start my day however I want, whether it’s to go to the patio and drink a cup of coffee or to snuggle with my daughter in bed a little longer. It’s there; I don’t have to take anything.”
In states where Medicaid plans may still require prior authorization, waits for Sublocade can stretch into months. Across the border at the Northern Nevada Hopes clinic in Reno, for example, Dr. Taylor Tomlinson said she tells patients that between battles for coverage and pharmacy delays, they might have to wait two months for an injection.
“I’m always going to offer it to a patient who I think would be a good candidate, but in the time they have to wait, they get interested in other things,” Tomlinson said. “It creates a barrier to care.”
California’s Medicaid program does not require prior authorization, but providing Sublocade is still a challenge. At the Placerville clinic supported by the California Bridge Network, director Dr. Juliet La Mers said a quarter of her buprenorphine patients get injections. Still, they often wait two weeks before Sublocade arrives from the specialty pharmacy.
Herring has been able to cut through some of that red tape at his Oakland clinic by working with the Highland pharmacy to stock and distribute Sublocade. As soon as a patient agrees to an injection, Herring simply calls the pharmacy down the hall and administers it on the spot.
Herring sees urgency to increase the use of injectable buprenorphine as fentanyl use rises across California. For years, the deadly synthetic opioid was concentrated mostly on the East Coast; in 2018, 88% of deaths from synthetic opioids occurred in the 28 states east of the Mississippi River. But more recently, fentanyl has begun to infiltrate Western states. From 2018 to 2020, deaths from fentanyl overdoses in California quintupled, according to state data.
“No one understands what they’re dealing with,” Herring said of fentanyl’s potency. “This is the time where our greatest deaths are going to occur.”