INTRODUCTION
In 2015, 38% of adults used prescription opioids, with slightly higher rates among older adults.1 Risks of opioids have been well-described and are greater among older adults and when used concurrently with three commonly prescribed “opioid potentiator” drug classes: benzodiazepines, non-benzodiazepine sedative hypnotics, and gabapentinoids.2, 3 These drugs also have risks when used on their own; in particular, there has been an increasing risk of death associated with benzodiazepine use.4
Medicare formulary coverage and utilization management strategies, including quantity limits, prior authorization, and step therapy, offer opportunities to limit potentially unsafe use of opioid potentiators, similar to coverage restrictions of opioids.5 Based on Centers for Disease Control guidelines that propose more limited opioid availability and the fact that formulary restrictions are infrequently used to control opioid prescribing, Medicare recently proposed formulary changes to restrict opioid availability based on maximum daily dosage and initial fill quantity.6 Many states have also legislated quantity limits for opioids.
However, coverage of opioid potentiator medications is unknown. Medicare began covering benzodiazepines in 2013 for select conditions, broadening coverage in 2014 for any medically accepted indication. We characterized Medicare formulary coverage of benzodiazepines, non-benzodiazepine sedative-hypnotics, and gabapentinoids from 2013 to 2017.
METHODS
We used 2013, 2015, and 2017 Medicare Prescription Drug Formulary Files, which include data on all Medicare Advantage and Stand-alone Part D plan formularies. We identified all benzodiazepines, non-benzodiazepine sedative-hypnotics, and gabapentinoids available in oral formulations. We characterized median formulary coverage of the lowest dose of the generic version of each drug, or the brand-name version when generics were unavailable. We focused on generics since they are used more commonly than the bioequivalent brand-name version, and on the lowest dose because higher doses can be created from lower doses. We excluded two brand-name drugs (Rozerem and Lunesta) that became available as a generic between 2013 and 2017, as generic availability impacts brand-name formulary coverage.
For each drug in each year, we determined the proportion of formularies not providing coverage; providing restrictive coverage using one or more utilization management strategy (quantity limit, prior authorization, or step therapy); or providing unrestrictive coverage (no utilization management). We summarized median coverage across all drugs in all three years. Analyses were conducted in R Studio version 3.2.3.
RESULTS
There were 12 benzodiazepines, 3 non-benzodiazepine sedative hypnotics, and 3 gabapentinoids eligible for the study. The median proportion of formularies not providing coverage across all drugs was 21.8% (interquartile range [IQR], 0.3–64.8%) in 2013, 14.4% (IQR, 0.0–66.3%) in 2015, and 17.6% (IQR, 0.0–68.7%) in 2017 (Table 1). The median proportion of formularies providing restrictive coverage was 63.3% (IQR, 49.6–69.4%) in 2013, 70.1% (IQR, 65.8–81.2%) in 2015, and 66.8% (IQR, 54.4–77.9%) in 2017, with the largest growth in use of quantity limits, a smaller increase in prior authorization, and infrequent use of step therapy. The median proportion of formularies providing unrestrictive coverage in the 3 years was 33.3% (IQR, 27.1–43.7%), 27.0% (IQR, 16.3–32.2%), and 27.9% (IQR, 18.0–41.6%), respectively. In 2017, 47.9% of formularies provided unrestrictive coverage of at least 1 benzodiazepine, 39.9% of at least 1 non-benzodiazepine sedative-hypnotic, and 67.2% of at least 1 gabapentinoid.
Medicare coverage in 2017 of each drug varied (Table 2). Quazepam and gabapentin enacarbil were not covered by any plan, whereas lorazepam, diazepam, clonazepam, doxepin, pregabalin, and gabapentin were covered by all. Among benzodiazepines, hypnotics (estazolam, flurazepam, and triazolam) had lower rates of coverage, whereas anxiolytics (alprazolam, diazepam, and lorazepam) had higher rates, albeit usually with restrictions.
DISCUSSION
From 2013 to 2017, Medicare prescription drug plan formularies had relatively unchanged rates of benzodiazepine, non-benzodiazepine sedative hypnotic, and gabapentinoid coverage with small increases in the use of quantity limits. More than a quarter of formularies provided unrestrictive coverage of these potentially unsafe opioid potentiators in 2017, and approximately 20% provided unrestrictive coverage of alprazolam and lorazepam, the two most commonly prescribed benzodiazepines. Furthermore, despite concern about the potential for prescription abuse, gabapentin was covered without restrictions by almost 60% of formularies.
The CMS overutilization monitoring system currently flags co-prescription of benzodiazepines and opioids, and CMS has proposed flagging co-prescription of other potentiator drugs with opioids.6 Although we could not examine co-restriction of opioids and opioid potentiators using Medicare formulary data, our findings suggest opportunity for greater use of utilization management strategies to reduce use of these potentially unsafe medications.
References
Han B, Compton WM, Blanco C, Crane E, Lee J, Jones CM. Prescription opioid use, misuse, and use disorders in US adults: 2015 National Survey on Drug Use and Health. Ann. Intern. Med. 2017;167(5):293–301.
National Institutes of Health. Benzodiazepines and Opioids. https://www.drugabuse.gov/drugs-abuse/opioids/benzodiazepines-opioids. 2018. Accessed: October 26, 2018.
Gomes T, Greaves S, van den Brink W, et al. Pregabalin and the Risk for Opioid-Related Death: A Nested Case–Control Study. Ann. Intern. Med. 2018.
National Institutes of Health. Overdose Death Rates. https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates. 2018. Accessed: October 26, 2018.
Samuels EA, Ross JS, Dhruva SS. Medicare formulary coverage restrictions for prescription opioids, 2006 to 2015. Ann. Intern. Med. 2017;167(12):895–896.
Centers for Medicare and Medicaid Services. 2019 Medicare Advantage and Part D Advance Notice Part II and Draft Call Letter. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-02-01.html. 2018. Accessed: October 26, 2018.
Acknowledgements
During the conduct of this work, Dr. Dhruva was supported by the National Clinician Scholars Program and the Department of Veterans Affairs. Ms. Vijay received a student research grant provided by the Yale School of Medicine Office of Student Research.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of Interest
Over the past 36 months, Dr. Ross received support through Yale University from the Food and Drug Administration as part of the Centers for Excellence in Regulatory Science and Innovation (CERSI) program, from Johnson and Johnson to develop methods of clinical trial data sharing, from Medtronic, Inc. and the Food and Drug Administration (FDA) to develop methods for postmarket surveillance of medical devices, from the Blue Cross Blue Shield Association to better understand medical technology evaluation, from the Centers for Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting, from the Agency for Healthcare Research and Quality (AHRQ) to examine community predictors of healthcare quality, and from the Laura and John Arnold Foundation, which established the Collaboration for Research Integrity and Transparency (CRIT) at Yale University. Dr. Shah received support from the Food and Drug Administration as part of the Centers for Excellence in Regulatory Science and Innovation (CERSI) program, through the Mayo Clinic from the Centers for Medicare and Medicaid Services (CMS), Agency for Healthcare Research and Quality (AHRQ), National Science Foundation, and Patient-centered Outcomes Research Institute (PCORI). All remaining authors declare that they do not have a conflict of interest.
Disclaimer
The authors assume full responsibility for the accuracy and completeness of the ideas presented, which do not represent the views of the Department of Veterans Affairs or any other supporting institutions
Additional information
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Vijay, A., Ross, J.S., Shah, N.D. et al. Medicare Formulary Coverage and Restrictions for Opioid Potentiators from 2013 to 2017. J GEN INTERN MED 34, 518–520 (2019). https://doi.org/10.1007/s11606-018-4752-8
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11606-018-4752-8