Methadone remains vital in buprenorphine era

More than 28,000 people a year die from opioid overdoses in the United States, and never before has the addiction treatment field gotten more visibility. Medication-assisted treatment (MAT) is now embraced even by many formerly “abstinence-only” treatment programs. Meanwhile, the two specialty sectors that provide MAT—opioid treatment programs (OTPs) almost exclusively using methadone, and office-based opioid treatment (OBOT) using only buprenorphine—are positioned to provide the medications more broadly to meet growing demand.

But with the increased attention by stakeholders to expand access to the office-based buprenorphine option, are OTP methadone clinics losing favor? And is there anything of a turf battle between the providers? Ultimately, experts say, there's a valuable role for both.

OTPs have existed for more than 50 years and traditionally dispensed only methadone for the treatment of addiction. Highly regulated by the federal government, OTPs are now allowed to dispense buprenorphine as well as methadone, but few have made the transition. By comparison, OBOTs, which had their start 15 years ago, only offer buprenorphine and have far fewer restrictions: A prescribing physician interested in treating addiction completes an eight-hour training course and registers with the Drug Enforcement Administration (DEA) as a Narcotic Treatment Program.

Thanks to federal rule changes, the number of physicians qualified to prescribe buprenorphine has increased—but not as fast as once predicted and not fast enough to keep pace with demand. Initially, a mandated cap limited OBOT physicians to treat only 30 patients the first year of prescribing and 100 patients after that. Under a new rule finalized in July, however, physicians now can treat up to 275 patients. More than 1,600 physicians have signed on for the increase as of October, according to federal officials. Many observers believe it's still not enough.

Apples and oranges

What is clear is that both modalities have been growing with the opioid epidemic. The number of patients receiving methadone treatment in OTPs has been steadily increasing, according to Substance Abuse and Mental Health Services Administration (SAMHSA) statistics, as have the number of patients in treatment with physicians waivered to provide buprenorphine under the Drug Addiction Treatment Act of 2000 (DATA 2000).

The use of buprenorphine in OBOT was conceptualized and is practiced differently from the treatment offered in an OTP, with very different regulations on a state-to-state basis, says Kelly J. Clark, MD, president-elect of the American Society of Addiction Medicine (ASAM), which represents numerous DATA 2000 providers. “Some states have substantial buprenorphine restrictions in place, with some being counter to what we know is quality and effective care,” she says.

Clark, who is chief medical officer of CleanSlate Centers, a Massachusetts-based buprenorphine clinic chain, also has worked in an OTP. But it’s difficult to compare the two kinds of treatment, she says. “As with most medical care, we have unfortunately little comparative analysis between known effective treatment options,” she says.

Because the vast majority of data on buprenorphine comes from an office-based environment and the only data on methadone comes from clinic settings, any comparisons between the two medications are really just comparing OBOT and OTP. “It’s an apples and oranges situation,” says Clark.

She believes buprenorphine has several clinical advantages over methadone. Methadone is a full agonist with a higher risk of overdose compared to buprenorphine, she says. Buprenorphine also has a longer duration of action than methadone.

While the medications work in similar ways, the differences between treatment in a doctor's office and treatment in an OTP are stark. With buprenorphine, a physician provides the induction (initial dose) while the patient is in some withdrawal. From then on, the physician provides monthly prescriptions, which the patient fills at a pharmacy. Some buprenorphine physicians elect to provide additional services, especially in early treatment—mainly the physicians who are addiction specialists. There is no requirement for counseling or drug testing with buprenorphine provided in an OBOT setting, although these services are recommended.

Patients in OTPs, however, must come in for their methadone dose every day at first. Clinics often are located far from the patient's residence. Dosing hours are usually in the early morning or evening, so that patients can get to work, but it is still an inconvenience for many. However, OTPs also provide comprehensive care, offering wraparound services such as employment counseling, case management and drug testing. As patients stay in treatment longer, they in some cases can earn “take-home” doses of the drug, and in some states, that can be a month’s worth.

Buprenorphine's rapid development

The federal government provided the funds for the development of buprenorphine (as brand drug Suboxone) under the National Institute on Drug Abuse (NIDA) and SAMHSA. The most difficult part of the development involved combining buprenorphine with naloxone, an approach taken to combat diversion. Today, the federal government, in the face of the increasing urgency of an opioid epidemic, has been trying to get OBOT into more widespread use.

H. Westley Clark, MD, professor of public health at Santa Clara University, has studied both medications. He was director of SAMHSA’s Center for Substance Abuse Treatment (CSAT) when buprenorphine was developed and when it went through the growth process to full commercialization. He also has participated in OTPs for the Department of Veterans Affairs and others.

He says some healthcare stakeholders saw buprenorphine as a quick panacea.

As the opioid epidemic was emerging, Congress sought more sites for treatment. There were about 1,000 OTPs then, and the heavily regulated programs would be difficult to expand. The operating premise was that another solution was needed, preferably with a medication that was not Schedule II. Buprenorphine was developed with the hope that physicians would be in a position to meet the demand. It didn’t happen, according to experts.

Stigma of methadone

There also were so many negative associations—albeit undeserved—with methadone along the way, the federal buprenorphine development process dissociated itself from OTPs.

“Methadone was highly stigmatized,” says Westley Clark, recalling his years at SAMHSA. The thought was, “If we could use buprenorphine without that kind of baggage, perhaps we could increase access,” he says.

Initially, the plan resulted in making buprenorphine available to the middle class with OTPs continuing to provide safety-net care. But at the same time, there was nothing in the system to allow SAMHSA or any other entity to track patients in OBOT settings.

“If you’re going to do this quasi-clinical experiment, shouldn’t you know if it’s working?” Westley Clark says.

The Department of Health and Human Services (HHS), SAMHSA’s parent agency, appears to be leaving it up to the providers.

“Now that the floodgates are being opened, the question should be who’s tracking this?” says Westley Clark, who asked that question frequently when he was at SAMHSA. “Treatment is the bridge between active using and no need to use.”

If it’s clear that people are not benefiting from the new wave of physicians signing up to prescribe buprenorphine, Congress might press for additional regulations, he says. But experts believe there is a significant lack of information on this population overall.

Buprenorphine use in OTPs

Buprenorphine use is increasing in historically methadone-focused OTPs as well. Jerry Rhodes, former CEO of CRC Health Group and now chairman of opioid addiction treatment organization BayMark Health Services, estimates that buprenorphine constitutes about 5% to 10% of OTP treatment today. But there are cost problems. The American Association for the Treatment of Opioid Dependence (AATOD), the national group representing OTPs, just completed a survey with 51 OTPs from 30 states participating. It found that the primary impediment to adding more buprenorphine in OTPs is the lack of reimbursement.

“It’s not a reluctance on the part of OTPs,” says AATOD President Mark Parrino.

The federal policy behind buprenorphine was driven by the theory that it’s easier to get a physician to prescribe it than it is to open an OTP, says Parrino. But this policy failed to consider the possibility that physicians in general resist treating patients with addiction in their private-practice settings.

“They know that now,” Parrino says. So in the coming year, it will be important to determine how many more physicians end up treating patients with buprenorphine under the increased cap.

Many patients prefer to go to a physician instead of an OTP. For many, that is the model they know: Go to a doctor, get a prescription, go to the pharmacy and fill it. But just as there are OBOT providers who specialize in treating addiction and could treat many patients, some may be viewed as “pill mills” where physicians see only a business opportunity in dispensing buprenorphine, Parrino notes.

“I’m not saying all OTPs are good, and all DATA 2000 practices are not good,” Parrino says. “I have never said that. But I am saying that OTPs have an oversight mechanism in place. There is no opt-out provision, and in the regulatory guidance for OTPs, it says that they must do drug screening, and they must have diversion control programs. With DATA 2000, they’re encouraged, but not required.” OTPs that are not in compliance with the regulations are shut down.

“The relative lack of regulation for office-based services certainly has appeal to some providers and some patients,” adds Rhodes.

Patient matching

According to CleanSlate’s Kelly Clark, clinicians refer patients to certain modalities based on a number of factors: medical comorbidities; cost and insurance coverage; geographic access; requirements for intensity of care; and patient preference. “OTPs occupy a unique space within the addiction treatment field, and I do not foresee a day when OTPs will cease to be a necessary part of our care system,” she says.

Stuart Gitlow, MD, past president of ASAM and a leading practitioner in buprenorphine treatment, agrees that the main difference between the two medications is most OTPs don’t offer buprenorphine, and federal rules do not allow OBOT practices to offer methadone.

“The evidence suggests that in general, buprenorphine leads to better outcomes, but I think that very much needs to be determined on an individualized basis,” Gitlow says. “In general, a programmatic approach can be useful for the more complicated patient.”

Gitlow frequently compares addiction to diabetes, another chronic disease. He says that a patient with diabetes who has only intermittent compliance would be better off receiving treatment from a multidisciplinary team instead of just taking medication. On the other hand, a patient who is stable and who follows self-care regimens closely might be perfectly fine with fewer office visits under the care of a single clinician.

“Similarly, a patient with opioid use disorder who is stable, having no difficulty with medication compliance, and who is active in 12-Step, can be seen by his physician a few times a year,” he says. “But a patient with the same disease complicated by comorbidities and infrequent treatment compliance would be best served by a much more intensive treatment program.”

Gitlow doesn’t view OTPs as competition to his office-based program. “Rather, we work best for somewhat different patient populations,” he says. “To that end, there have been quite a few patients that I’ve referred to local OTPs, and quite a few patients that have been referred to my office from the OTPs.”

There are plenty of patients to go around. But OTP advocates are correct to be concerned about the increase of the buprenorphine cap to 275, Westley Clark believes. Ultimately, will the community of providers subscribe to the idea that a patient with an opioid use disorder can maintain on buprenorphine alone? With the buprenorphine six-month implant now available, and a one-month injection expected to be available soon, that question is more than philosophical.

The cost factor also will play a role in determining whether someone chooses buprenorphine or methadone treatment. “Those who can afford it will gravitate toward buprenorphine,” says Westley Clark.

And as the opioid epidemic continues, the need for treatment will become more and more pressing with greater attention being paid to overdose prevention, expansion of OTPs and integration of care. “There will be a steady demand for treatment over the next 10 years,” says AATOD's Parrino.

The American Academy of Addiction Psychiatry (AAAP) has a grant to conduct buprenorphine training in the states, and AATOD will partner with the academy to extend the training opportunity to any medical professional working in an OTP, says Parrino. “That would not have happened five years ago,” he says.

In essence, there is no real “competition” between OTPs and OBOT physicians in the way that one treatment program might think that the program across town will get the patients it doesn’t admit. There are plenty of patients to go around, experts agree.

AATOD takes the view that OTPs and OBOT practices provide complementary services. Some patients will be better suited to treatment in one over the other. The future will likely hold an approach where OBOT practices and OTPs can work together through referrals.

Alison Knopf is a freelance writer based in New York.

Scheduling difference

Methadone is a Schedule II drug under the Controlled Substances Act, indicating it is in the most highly regulated category of legal medication. Buprenorphine is on the less regulated Schedule III. Both medications have been proven highly effective in the treatment of opioid use disorders. If the patient fails to follow the regime, the risk of relapse and the likelihood of overdose due to diminished tolerance increases.

Defining terms

In this article, “buprenorphine” is used to mean the combination of buprenorphine with naloxone. Buprenorphine-naloxone, a mixed agonist-antagonist product, is approved for the treatment of opioid addiction. Brand names of the oral version are Suboxone, Bunavail and Zubsolv.