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Positive subjective measures in abuse liability studies and real-world nonmedical use: Potential impact of abuse-deterrent opioids on rates of nonmedical use and associated healthcare costs

Alan G. White, PhD, Joseph LeCates, PhD, Howard G. Birnbaum, PhD, Wendy Cheng, MPH, MPhil, Carl L. Roland, PharmD, MS, Jack Mardekian, PhD

Abstract


Objective: To quantify the potential impact of reductions in positive subjective measures from human abuse liability studies on real-world rates of nonmedical use of prescription drugs and associated healthcare resource utilization and costs.

Design: Positive subjective endpoints “overall drug liking,” in-the-moment “drug liking,” and “drug high” Emaxs (peak effects) were recorded from published studies. Nonmedical use data were obtained from the 2010 National Survey on Drug Use and Health (NSDUH) and Drug Abuse Warning Network surveys. Multivariate regressions evaluated the association between the positive subjective endpoints and nonmedical use rates, controlling for prescription volume, whether the drug is an opioid, and controlled substance schedule. A published budget-impact model was used to assess healthcare resource utilization and cost impacts of abuse-deterrent opioid formulations.

Results: A five-point reduction in overall drug liking/drug liking/drug high Emax was associated with a 0.25/0.10/0.05 (standard errors: 0.11/0.12/0.07) percentage point decrease in the NSDUH lifetime nonmedical use rates. Those decreases yielded a 11.3/4.2/2.1 percent reduction compared to the samples’ lifetime nonmedical use rates of 2.21/2.38/2.36 percent. On the basis of a number of assumptions, these reductions were associated with private payer cost reductions for a morphine and oxycodone abuse-deterrent formulation in the ranges of $147.9-324.1 million and $230.7-958.7 million, respectively.

Conclusions: Reductions in overall drug liking were significantly associated with reduced real-world nonmedical use, healthcare utilization, and costs. Associations using drug high and drug liking were directionally consistent with this finding though not statistically significant. A reduction in positive subjective measures associated with an abuse-deterrent formulation has potential to reduce abuse and associated healthcare utilization and costs.


Keywords


opioid, abuse, human abuse liability, costs, abuse-deterrent formulation

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References


US Office of National Drug Control Policy: Epidemic: Responding to America's Prescription Drug Abuse Crisis. Washington, DC: Executive Office of the President of the United States, 2011.

Division of Unintentional Injury Prevention of the National Center for Injury Prevention and Control: Policy Impact: Prescription Painkiller Overdoses. Atlanta, GA: US Department of Health and Human Services, CDC, 2011.

Centers for Disease Control and Prevention: Drug Overdose in the United States: Fact Sheet. Atlanta, GA: Centers for Disease Control and Prevention, 2013.

Jones CM, Mack KA, Paulozzi LJ: Pharmaceutical overdose deaths, United States, 2010. JAMA. 2013; 309(7): 657-659.

Substance Abuse and Mental Health Services Administration: Highlights of the 2011 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013.

Birnbaum HG, White AG, Schiller M, et al.: Societal costs of prescription opioid abuse, dependence, and misuse in the United States. Pain Med. 2011; 12(4): 657-667.

Inocencio TJ, Carroll NV, Read EJ, et al.: The economic burden of opioid-related poisoning in the United States. Pain Med. 2013; 14: 1534-1547.

Sehgal N, Manchikanti L, Smith HS: Prescription opioid abuse in chronic pain: A review of opioid abuse predictors and strategies to curb opioid abuse. Pain Physician. 2012; 15(3 suppl): ES67-ES92.

Center for Drug Evaluation and Research at the US Food and Drug Administration: Guidance for Industry Abuse-Deterrent Opioids—Evaluation and Labeling. Rockville, MD: US Department of Health and Human Services, CDC, 2013.

Center for Drug Evaluation and Research at the US Food and Drug Administration: Guidance for Industry Assessment of Abuse Potential of Drugs Guidance for Industry Assessment of Abuse Potential of Drugs. Rockville, MD: US Department of Health and Human Services, CDC, 2010.

Katz N: Clinical studies of abuse deterrent opioid analgesics: Definitions, current approaches, and critical Issues. Paper presented at IMMPACT X, Arlington, VA, June 3, 2009.

White AG, Birnbaum HG, Schiller M, et al.: The economic impact of opioid abuse, dependence, and misuse. Am J Pharm Benefits. 2011; 3(4): 59-70.

White AG, Birnbaum HG, Mareva MN, et al.: Direct costs of opioid abuse in an insured population in the United States. J Manag Care Pharm. 2005; 11(6): 469-479.

Strassels SA: Economic burden of prescription opioid misuse and abuse. J Manag Care Pharm. 2009; 15(7): 556-562.

White AG, Birnbaum HG, Rothman DB, et al.: Development of a budget-impact model to quantify potential cost savings from prescription opioids designed to deter abuse or ease of extraction. Appl Health Econ Health Policy. 2009; 7(1): 61-70.

Schoedel K, Levy-Cooperman N, Chen N, et al.: Post-Hoc Analysis of Abuse Potential Measures. Ontario, Canada: Kendle Early Stage, 2009.

Schoedel K, Shram M, Levy-Cooperman N, et al.: Defining clinically important differences in subjective abuse potential measures. Paper presented at 74th Annual Meeting of The College on Problems of Drug Dependence, Palm Springs, CA, 2012.

Substance Abuse and Mental Health Services Administration: National Survey on Drug Use and Health, 2010 Codebook. Rockville, MD: US Department of Health and Human Services, CDC, 2014.

Substance Abuse and Mental Health Services Administration: Drug Abuse Warning Network Methodology Report, 2010 Update. Rockville, MD: US Department of Health and Human Services, CDC, 2012.

Butler SF, Cassidy TA, Chilcoat H, et al.: Abuse rates and routes of administration of reformulated extended-release oxycodone: Initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment. J Pain. 2013; 14(4): 351-358.

Endo Health Solutions Inc: Endo Health Solutions Supplements Citizen Petition With Preliminary Data Showing a 59% Drop in Abuse of the Reformulated, Designed to be Crush-Resistant, OPANA® ER. News Release. November 13, 2012.

Eaton TA, Comer SD, Revicki DA, et al.: Determining the clinically important difference in visual analog scale scores in abuse liability studies evaluating novel opioid formulations. Qual Life Res. 2012; 21(6): 975-981.




DOI: https://doi.org/10.5055/jom.2015.0269

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