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Opioid Dependence Treatment: Lessons for Reducing Diversion and Cost
The opioid epidemic is spurring searches for more effective care. Despite the commercial availability of abuse-deterrent formulations of medications for the treatment of opioid dependence—such as combinations of buprenorphine and naloxone—research indicates that use of some medications is linked to risks for misuse, abuse, and diversion, with substantial costs for health care providers and society at large. More research is needed directly comparing diversion rates among various abuse-deterrent formulations. However, a recent study on the impact of a state formulary conversion from one abuse-deterrent form of buprenorphine to another offers insights into reducing diversion and cost.
THE BURDEN OF DIVERSION
The financial impact on payers from prescription opioid abuse is sizeable. Established research published in the Journal of Managed Care Pharmacy (2005; 11: 469-479) found that, compared with nonabusers receiving prescription opioids, prescription opioid abusers had significantly more physician visits, mental health inpatient and outpatient services, hospital admissions, emergency department visits, motor vehicle accidents, cases of trauma, and substance abuse treatment. Health care costs for opioid abusers were found to be 8 times higher than for nonabusers with hospital inpatient visits as the largest contributor to increased cost.
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One source of abuse is from diversion—the intentional transfer of a controlled drug from legitimate distribution and dispensing into illegal channels—and the resulting consequences can be significant. Medication diversion negatively impacts the benefit that patients experience from treatment in multiple ways, such as limiting adherence through illicit dispensing, prolonging contact with illicit use, and maintaining participation in maladaptive and illegal behaviors. Diversion creates high risk for criminal behavior and poor treatment outcomes.
Diversion medication can be done by a legitimate patient with good intentions, ie, to help someone who has pain, albeit still illegal activity. According to a 2014 report from the Tennessee Department of Mental Health and Substance Abuse Services, more than half (55%) of Tennessee residents who abuse opioid medications obtain them from a friend or relative who has a prescription.
CURRENT STRATEGIES
There exist multiple approaches for minimizing diversion of opioid medications. National Institute on Drug Abuse director Nora D Volkow, MD, writing with A Thomas McLellan, PhD, MS, in The New England Journal of Medicine in 2016, noted that physicians have attempted to identify dissembling or addicted patients through screening instruments or through detection of “aberrant behaviors” that are thought to be indicative of addiction. However, according to Drs Volkow and McLellan, a recent review of patient screening efforts, by the Agency for Healthcare Research and Quality, showed no evidence that this approach was effective. Additionally, the use of electronic databases by health care providers, designed to monitor information pertaining to suspected abuse or diversion, has been inconsistent.
A potentially more promising approach to minimizing diversion relates specifically to the use of drugs such as buprenorphine. As a mainstay in opioid dependence treatment, this semisynthetic opioid itself provides a low-level high but with reduced risk of overdose. Buprenorphine sublingual and buccal formulations are approved in the United States, both in single-ingredient and naloxone combination formulations.
A 2014 study in the Journal of Substance Abuse Treatment noted that the introduction of office-based treatment with buprenorphine has greatly expanded access to treatment for opioid dependence in the United States. Yet, the study concluded that all three sublingual formulations reviewed, had been diverted. The buccal formulation of buprenorphine, marketed as Bunavail (BioDelivery Sciences), was not a subject of that study. This suggests the question: Do diversion rates differ between the sublingual formulations of buprenorphine—such as Suboxone (buprenorphine; Invidior)—and the buccal formulation, and if so, what conclusions can be drawn?
OPIOID DEPENDENCE TREATMENT
An opportunity to address our question arose October 1, 2015, following a formulary switch of preferred medication by Tenncare (Medicaid) in Tennessee from Suboxone sublingual film to Bunavail buccal film. This conversion made Bunavail the preferred buprenorphine/naloxone treatment for opioid dependence in this major fee-for-service state Medicaid (Tenncare) plan. According to the CDC, approximately one in six Tennessee residents misuse or abuse opioids or are in treatment.
Results showed prescriptions of Suboxone decreased from a consistent peak per week of more than 1600 prescriptions to less than 100 within 30 days of the conversion, while Bunavail weekly prescriptions increased from 19 to approximately 600/week. This approximately 63% reduction in overall buprenorphine prescriptions in the plan remained throughout the measurement period, which resulted in a $14 million decrease in Tenncare medication expenditures. This 63% reduction in overall buprenorphine prescriptions in the state suggests several considerations, one being that a significant amount of previously prescribed buprenorphine/naloxone (Suboxone) use may not have been for its intended purpose as opposed to misuse, abuse, or diversion of the medication.
Medication-assisted therapy is an important part of helping patients manage and overcome opioid addiction. There are still challenges to delivery of care and patient compliance with opioid use and dependence. The data from this study suggest that the buccal formulation of buprenorphine and naloxone, when made available, could have a meaningful impact on overall usage and may serve as an impediment to misuse, abuse, and diversion.
Further studies and analysis of the Tennessee program are ongoing. Providers and payers across the country may find it valuable to study the results in Tennessee and determine if they represent a model that can be applied in other states, amid one of the most urgent health care crises in modern US history—the opioid misuse epidemic.