Decline in Buprenorphine/Naloxone Prescriptions in a State Medicaid Population Following Formulary Conversion from Suboxone to Bunavail
A large, statewide, fee-for-service Medicaid plan recently (October 2015) executed a complete switch from sublingual buprenorphine–naloxone [(SLBN), Suboxone®] to buccal buprenorphine–naloxone [(BBN), Bunavail®] on its preferred drug formulary. This complete formulary switch provided an opportunity to assess dynamic changes in prescribing patterns, patient/physician acceptance, and indices of potential misuse/diversion.
For the period January 1, 2015 through December 31, 2016, two datasets were analyzed: prescriptions and associated costs for buprenorphine–naloxone (BN) products and urine toxicology test results for patients in the Medicaid plan. The dataset comprised 1370 unique providers ordering 643,225 prescriptions for opioid addiction therapy. Patient and order volumes, and the rate of monthly positive laboratory values for opioid molecules and cocaine were reviewed. A targeted survey of physicians treating opioid-dependent patients with state Medicaid plan coverage was also conducted.
Upon plan conversion to BBN, there was a rapid increase in monthly BBN prescriptions mirrored by a rapid decrease in SLBN prescriptions. Peak in BBN prescriptions (2633 in November 2015) was approximately 60% lower than peak in SLBN prescriptions (6531 in July 2015). An unexpected finding was a 68% reduction of the overall BN market, indicating that many BN prescriptions were abandoned. The reduction was associated with quarterly cost savings to the Medicaid plan of approximately $3.5 million. Toxicology results indicated a reduction in drug positivity (defined as positivity for cocaine and/or any opioids except buprenorphine and methadone) from 13–16% in 2015 to less than 10% in 2016. Heroin positivity decreased from approximately 9% in December 2015 to an average of less than 1% during the last quarter of 2016, while positivity for norbuprenorphine, the major metabolite of buprenorphine, showed a marked increase in 2016 vs 2015. Among physicians who responded to the targeted survey most rated BBN as more difficult to abuse or misuse than SLBN.
The rapid reduction in the overall BN market following a complete formulary switch from SLBN to BBN was associated with quarterly savings of $3.5 million for the state Medicaid plan. Toxicology data suggest that this cost saving was realized in the context of improved physician and patient adherence to treatment protocols. The changing market dynamics can potentially be explained by a number of contributory factors, including a reduction of diversion and illicit distribution of BN following formulary conversion. These results are considered hypothesis-generating and future research should systematically compare the propensity for diversion and abuse of BN products using various epidemiological tracking tools.
BioDelivery Sciences International, Inc.
KeywordsBuccal Buprenorphine Diversion Naloxone Opioid dependence Pain Sublingual
Funding for this study and article processing charges were provided by BioDelivery Sciences International, Inc.
Toxicology datasets and longitudinal data analysis were provided by hc1 Insight LLC.
All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. All named authors met the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Richard Soper has been a consultant to BioDelivery Sciences, Inc. Sireesh Appajosyula has been a consultant to BioDelivery Sciences, Inc. Christina Deximo is an employee of hc1.com Inc.
Compliance with Ethical Guidelines
This article does not contain any studies with human participants or animals performed by any of the authors. On the basis of 45 Code of Federal Regulations of the HHS Protection of human subjects (Section 46.101(b)2), an IRB registration is exempt for research involving survey procedures, as long as it was obtained in a manner in which subjects can not be identified and any disclosure of the human subjects’ responses outside the research could not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. This study met all of those criteria and therefore is exempt from such registration.
The datasets generated and analyzed for this study are not publicly available, as they were obtained from a proprietary database via a licensing agreement.
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