A new study led by researchers at the University of Florida College of Pharmacy and the University of North Carolina has determined that prior authorization requirements stand in the way of opioid use disorder patients receiving lifesaving medications. The study published in JAMA Health Forum examined buprenorphine use among more than one million Medicaid patients in California and Illinois from 2013-2020.
Shailina Keshwani, a graduate student in the UF College of Pharmacy and the first author of the study, offered this insight into the research and its findings:
- Can you shed some light on why you decided to study this topic?
Prior authorization is an important tool for the Medicaid programs to control cost and to prove that the prescription is medically necessary, however, prior authorizations for lifesaving drugs like buprenorphine for the treatment of opioid use disorder introduce an additional barrier for the patients. This is an important concern because it delays or interrupts their treatment leading to serious consequences such as not initiating the treatment, illicit drug use or relapse.
- What role does the drug buprenorphine play in treating opioid use disorder?
The Food and Drug Administration, or FDA, has approved three drugs for the treatment of opioid use disorder, which are buprenorphine, methadone and naltrexone. All three medications are equally effective at reducing opioid use, but methadone is required to be administered through opioid treatment programs and naltrexone requires complete detoxification for the patients initiating the treatment, which may be difficult for the active opioid users. On the bright side, buprenorphine can be prescribed by the waivered prescriber in the office-based setting and does not require detoxification.
- What kind of obstacles do prior authorizations present for patients?
Buprenorphine prior authorization requirements include but are not limited to, step-therapy requirements, quantity limits on daily dose and lifetime treatment limits.
- How many patients were involved in your study and where did the data originate?
This study was conducted using publicly available Medicaid drug Utilization data. We analyzed pharmacy prescription claims from California and Illinois. There was a total of 702,643 and 415,115 eligible buprenorphine prescription claims from California and Illinois respectively. After comprehensive policy surveillance and assessment, Medicaid prescription data from California and Illinois were included in the analyses because these states had completely removed buprenorphine prior authorizations during the study period from 2013-2020.
- What method did you use for this study?
The main analysis was performed using the Controlled Interrupted Time Series model. We also assessed the robustness of our findings using a synthetic control method that gives different weights to control states and variables. This unique method added more confidence to our findings.
- What did you find when the prior authorizations were removed from Illinois and California data?
After the removal of prior authorizations in these two states, we found the prescriptions for buprenorphine increased immediately in Illinois, but a similar increase was not observed in California. This heterogeneity in findings may be due to the more administrative burden for prior authorization processing that existed in Illinois than in California, before the policy change.
- What else could be contributing toward buprenorphine prescribing trends, if not prior authorizations?
Previous studies have shown that buprenorphine prescribing trends may depend on the number of prescriber waiver status in a state, prescriber specialty, a clinician’s willingness and treatment preferences and some other factors.
- What is your recommendation or takeaway from this study?
Our study adds to evidence that prior authorizations, especially for lifesaving drugs like buprenorphine for the treatment of opioid use disorder, are unnecessary barriers. Removal of such barriers will help to increase its accessibility. Further research must investigate disparities in access to buprenorphine and other medications for the treatment of opioid use disorder that exists among different populations in our society.
An invited commentary in JAMA Health Forum titled, “The Consequences of Removing Prior Authorization for Buprenorphine in Medicaid — Building an Evidence Base,” adds an additional perspective on this policy health research.