Dataset Information

Healthcare Resource Use and Cost: The Impact of Adopting an Abuse-Deterrent Formulation of Extended Release Morphine.

ABSTRACT: Background:Development of abuse-deterrent formulations (ADFs) of prescription opioids (RxO) is an important step toward reducing misuse and abuse. Morphine-ARER (MorphaBond™ ER) is an extended-release (ER) morphine sulfate tablet formulated to deter misuse/abuse via intravenous (IV) and intranasal (IN) routes of administration. Objective:A model was developed to estimate the budget impact to a hypothetical commercial health plan of 10 million members 2 years after adding morphine-ARER to drug formulary. Methods:We analyzed incremental health care resource use (HCRU) associated with RxO misuse/abuse based on a health plan's RxO formulary coverage and patterns of misuse/abuse. Misuse/abuse rates, incremental HCRU and associated costs were based on the 2015 National Survey on Drug Use and Health, an analysis of claims from OptumHealth Care Solutions, Inc. (2013-2015) and published literature. RxO formulary shares were based on 2016-2017 Symphony Retail Prescription data. Morphine-ARER was assumed to capture 20 and 30 percent from branded and 0.3 and 0.6 percent from generic non-ADF ER morphine, in the first and second years, respectively. Proportions of misuse/abuse deterred by physical/chemical properties of morphine-ARER were assumed to be 90 percent via IV and 60 percent via IN administration, with further IN deterrence based on results from morphine-ARER's human abuse liability study. Results:Adding morphine-ARER to formulary resulted in a potential decrease in abuse-related healthcare costs by $557,321 (-$0.00232 per-member per-month [PMPM]), offsetting a pharmacy cost increase of $217,045 (+$0.00090 PMPM), resulting in net cost-savings of $0.00142 PMPM over 2 years, based on certain model assumptions. Conclusion:Placing morphine-ARER on a health plan's drug formulary may result in reduced misuse/abuse and overall cost savings.

SUBMITTER: Rossiter LF

PROVIDER: S-EPMC6974417 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Healthcare Resource Use and Cost: The Impact of Adopting an Abuse-Deterrent Formulation of Extended Release Morphine.

Rossiter Louis F LF Kwong Winghan Jacqueline WJ Marrett Elizabeth E

ClinicoEconomics and outcomes research : CEOR 20200115

<h4>Background</h4>Development of abuse-deterrent formulations (ADFs) of prescription opioids (RxO) is an important step toward reducing misuse and abuse. Morphine-ARER (MorphaBond™ ER) is an extended-release (ER) morphine sulfate tablet formulated to deter misuse/abuse via intravenous (IV) and intranasal (IN) routes of administration.<h4>Objective</h4>A model was developed to estimate the budget impact to a hypothetical commercial health plan of 10 million members 2 years after adding morphine- ...[more]

PMID: 32021338

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Project description:BackgroundSignificant public health concerns exist regarding the misuse and abuse of prescription opioids. Abuse-deterrent formulation (ADF) opioids may be leveraged as an important tool for combating the current opioid crisis.ObjectivesTo evaluate the relationships between ADF opioid formulary coverage and the ADF utilization rate, the risk for opioid abuse or overdose, opioid abuse or overdose-related healthcare resource utilization, and medical costs within a calendar year.MethodsThis cross-sectional multiyear panel study included adults prescribed an opioid medication in 2015 or 2016. We analyzed the medical and pharmacy claims linked to health plan benefit design data. An ADF opioid-including reformulated oxycodone hydrochloride (HCl) controlled-release (CR; reformulated OxyContin), morphine sulfate and naltrexone HCl extended-release (ER; Embeda), and hydrocodone bitartrate ER (Hysingla ER)-was considered covered if it was listed on the health plan's formulary. Generalized linear models were used to assess the association between ADF opioid formulary coverage and the study outcomes.ResultsOf 1,350,607 eligible patients, those enrolled in health plans with coverage of ADF opioids were more likely to fill a prescription for an ADF opioid than those enrolled in plans that did not cover ADF opioids. The risk for opioid abuse or overdose was significantly lower among patients enrolled in plans with broader ADF coverage (adjusted odds ratio [OR], 0.91; 95% confidence interval [CI], 0.86-0.95 for oxycodone HCl CR only vs no ADF coverage; adjusted OR, 0.70; 95% CI, 0.67-0.73 for oxycodone HCl CR plus ≥1 ADF opiods vs no ADF; adjusted OR, 0.77; 95% CI, 0.73-0.81 for oxycodone HCl CR plus ≥1 ADF opiods vs oxycodone HCl CR only; all P <.0001). Approximately 15% and 25% reductions in the opioid abuse or overdose-related hospitalization rate and medical costs were observed for those in the oxycodone HCl CR plus ≥1 ADF opioids coverage group versus those without ADF opioid coverage.ConclusionsBroad formulary coverage of ADF opioids is associated with reduced rates of opioid abuse or overdose in real-world managed care populations. Health plan administrators and policymakers may consider improving the formulary coverage of ADF opioids as a strategy to ensure appropriate patient access to necessary pain medications while mitigating risk for opioid abuse or overdose.

Project description:ObjectivesThis post hoc analysis of data from a randomized, double-blind, placebo-controlled, enriched-enrollment randomized-withdrawal Phase III study evaluated the safety, tolerability, and analgesic efficacy of Oxycodone DETERx extended-release (ER), abuse-deterrent capsules (Xtampza® ER) in subjects with chronic low back pain who were successfully transitioned from immediate-release (IR) oxycodone.MethodsContinuous outcomes were analyzed using a mixed-model repeated-measures approach; binomial outcomes were analyzed using chi-squared; and time-to-event outcomes using Kaplan-Meier analyses.ResultsA total of 110 subjects previously prescribed IR oxycodone entered the Open-label Titration Phase. Forty-four subjects were randomized to Oxycodone DETERx (n=22) or placebo (n=22) in the 12-week Double-blind Maintenance Phase. Efficacy results in this subgroup showed a statistically significant difference between Oxycodone DETERx and placebo in average pain intensity scores from Randomization Baseline to Week 12 (least squares mean [± standard error], -1.88 [0.70]; P=0.0078). Additional efficacy results indicated that Oxycodone DETERx vs placebo was associated with a statistically significant benefit in durability of effect from Week 2 through Week 12 (P<0.01), numbers of subjects with a ≥30% (n [%] 10 [45.5%] vs 0 [0%]; P=0.0004) and ≥50% (10 [45.5%] vs 0 [0%]; P=0.0004) improvement in pain intensity, longer time-to-exit (P=0.0014), a greater number of subjects who completed the study (14 [63.6%] vs 4 [18.2%]), and less rescue medication use (acetaminophen; mean [SD], 163.5 [337.8] mg) vs 216.2 [377.3] mg). Adverse event profiles were consistent with opioid class effects and results from the original study; Oxycodone DETERx was well tolerated in subjects previously treated with short-acting oxycodone.ConclusionsOxycodone DETERx resulted in clinically meaningful and statistically significant efficacy in subjects with chronic low back pain who were previously prescribed IR oxycodone and were successfully switched to ER Oxycodone DETERx.

Project description:BackgroundPosterior spinal fusion for scoliosis is one of the most painful elective pediatric surgeries. Good postoperative pain control allows early ambulation and return of ability to tolerate oral intake. Options for analgesia in this patient population are suboptimal. We hypothesized that extended-release epidural morphine (EREM) would provide better pain control and less adverse effects compared to intrathecal (IT) morphine.MethodsThe primary outcome was total IV morphine consumption during 0-48 hours postoperatively. Secondary outcomes included time until first patient-controlled analgesia (PCA) demand, pain scores, and adverse opioid effects. After institutional review board approval, 71 subjects undergoing posterior spinal fusion for idiopathic scoliosis completed the study. The subjects were randomly allocated to 7.5 μg/kg IT morphine or 150 μg/kg EREM. The final IT morphine and EREM groups contained 37 and 34 subjects, respectively. Postoperative pain was treated with morphine PCA, ketorolac, oral oxycodone, and acetaminophen. Morphine consumption, pain scores, nausea and vomiting, pruritus, and respiratory depression were measured every 4 hours. Parents completed a caregiver questionnaire about their child's pain control regimen after the first postoperative day.ResultsThere was no difference in total morphine consumption over the first 48 hours between subjects in the EREM and IT morphine groups: median (range) 42.2 (5.5-123.0) and 34.0 (4.5-128.8) mg, respectively (P = .27). EREM and IT morphine groups had no difference in time until first PCA demand. Pain scores were no different between the groups from 8 to 24 hours after surgery. Compared to IT morphine, EREM subjects had lower pain scores from 28 to 36 hours after surgery. The reported incidence of pruritus was lower in the EREM subjects.ConclusionsThere was no difference in total morphine consumption or time until first PCA demand between the EREM and IT morphine groups. EREM provides a longer duration of analgesia after posterior spinal fusion for scoliosis and may be associated with less opioid-induced pruritus.

Dataset Information

Healthcare Resource Use and Cost: The Impact of Adopting an Abuse-Deterrent Formulation of Extended Release Morphine.

Publications

Healthcare Resource Use and Cost: The Impact of Adopting an Abuse-Deterrent Formulation of Extended Release Morphine.

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