Distribution of Abatement Funds Arising From US Opioid Litigation.

This Viewpoint discusses the settlement agreements reached against several major pharmaceutical distributors resulting from the US opioid epidemic and how those funds will be distributed amongst the states.

Variation in Initiation, Engagement, and Retention on Medications for Opioid Use Disorder Based on Health Insurance Plan Design.

BACKGROUND: The association between cost-sharing and receipt of medication for opioid use disorder (MOUD) is unknown. METHODS: We constructed a cohort of 10,513 commercially insured individuals with a new diagnosis of opioid use disorder and information on insurance cost-sharing in a large national deidentified claims database. We examined 4 cost-sharing measures: (1) pharmacy deductible; (2) medical service deductible; (3) pharmacy medication copay; and (4) medical office copay. We measured MOUD (naltrexone, buprenorphine, or methadone) initiation (within 14 d of diagnosis), engagement (second receipt within 34 d of first), and 6-month retention (continuous receipt without 14-d gap). We used multivariable logistic regression to assess the association between cost-sharing and MOUD initiation, engagement, and retention. We calculated total out-of-pocket costs in the 30 days following MOUD initiation for each type of MOUD. RESULTS: Of 10,513 individuals with incident opioid use disorder, 1202 (11%) initiated MOUD, 742 (7%) engaged, and 253 (2%) were retained in MOUD at 6 months. A high ($1000+) medical deductible was associated with a lower odds of initiation compared with no deductible (odds ratio: 0.85, 95% confidence interval: 0.74-0.98). We found no significant associations between other cost-sharing measures for initiation, engagement, or retention. Median initial 30-day out-of-pocket costs ranged from $100 for methadone to $710 for extended-release naltrexone. CONCLUSIONS: Among insurance plan cost-sharing measures, only medical services deductible showed an association with decreased MOUD initiation. Policy and benefit design should consider ways to reduce cost barriers to initiation and retention in MOUD.

Profile of Medicaid enrollees with sickle cell disease: A high need, high cost population.

Sickle cell disease is a progressively debilitating genetic condition that affects red blood cells and can result in a variety of serious medical complications, reduced life expectancy, and diminished quality of life. Medicaid nationwide covered 66 percent of sickle cell disease hospitalizations in 2004 and 58 percent of emergency department visits for the disease between 1999 and 2007. Using Medicaid data from four states with large populations that account for more than one-third of Medicaid program enrollment, we examined the characteristics of those with sickle cell disease. We found instances of mortality rates more than nine times the age-adjusted population average (in Texas, a mortality rate for Medicaid enrollees with SCD of 1.11 percent compared to 0.12 percent overall); rates of disability-related eligibility-which is associated with long-term Medicaid enrollment-of up to 69 percent; and half or more of affected enrollees having (all-cause) hospital stays, emergency department visits, and opioid prescription fills. With gene therapies on the horizon that will spur discussions of treatment coverage, costs, and outcomes for people with sickle cell disease, it is important for relevant stakeholders to understand the affected populations.

Opioid Prescribing in United States Health Systems, 2015 to 2019.

OBJECTIVES: Health systems (nonfederal hospitals and clinics) are the second major source for drug expenditure in the United States. Opioids prescribed in these healthcare settings are commonly short-acting opioids that can lead to persistent opioid use. Nevertheless, there are no national data that describe trends in opioid use and the associated expenditure in health systems. Therefore, the objective of this article was to describe opioid use and expenditures in US health systems from 2015 to 2019. METHODS: We used data from IQVIA National Sales Perspectives to describe prescription opioid expenditure and use in health systems (nonfederal hospitals and clinics). RESULTS: Over the 5-year study period, health systems dispensed a total of 6.55 billion units of opioids (26.88% decrease) with an associated expenditure of $3.33 billion (26.78% decrease). Relative to all opioid formulations in our study, oxycodone, hydrocodone, and fentanyl were the opioids with the highest use in US health systems. All opioid prescriptions decreased except fentanyl use, which increased by 29.80% in clinics. The use of abuse-deterrent formulations of opioids decreased by 51.00% over the study period, although the decrease seems to be driven mainly by long-acting oxycodone (brand name Oxycontin). CONCLUSIONS: Opioid use and expenditures in health systems have been decreasing following national trends from retail pharmacies. Nevertheless, fentanyl use increased in clinics and was prescribed at higher proportions in nonfederal hospitals than other opioids, which warrants further investigation.

Implementation of formal prescription guidelines reduces the economic cost of unused opioids after orthopedic surgery.

BACKGROUND: Prior literature has reported on the concerning emergence of opioid overprescribing, yet there remains a lack of knowledge in understanding the cost of waste of this over-prescription and underconsumption of opioids. As such, further investigating the cost of waste of opioids following orthopedic surgery is of interest to patients, providers, and payors. In one of the largest private orthopedic practices in the United States, opioid prescribing and consumption patterns were tracked prior to, and after the implementation of, formal prescription guidelines. OBJECTIVES: To (1) establish the cost of waste of unused opioids before the implementation of formal prescription guidelines and (2) examine how the cost of unused opioids may be reduced after implementation of formal internal prescription guidelines. METHODS: Two separate phases (Phase I and Phase II) were implemented at different time intervals throughout a two-year period. Implementation of prescription guidelines occurred between Phases I and II, and data from Phase I (pre-implementation) was compared to that from Phase II (postimplementation). Data collection included type, dosage, quantity of opioids prescribed and consumed after elective outpatient procedures in ambulatory surgery centers, in addition to patient interviews/surveys within two weeks after surgery to measure consumption. From these data, the cost of waste was calculated by taking the total cost of prescribed opioids (sum of each prescription × Average Wholesale Price (AWP) minus 60%) per 1,000 patients, and subtracting the total cost of consumed opioids per 1,000 patients, calculated in a similar manner. Further analysis was performed to describe differences in the cost of waste of individual opioids between each of the phases. RESULTS: In Phase I, prior to implementation of formal internal prescription guidelines, there was a sizable cost of waste of unused opioids (per 1,000 patients, AWP minus 60%) of $11,299.51. The cost of waste in Phase II, after implementation of formal internal prescription guidelines, was $6,117.12, which was a significant decrease of 45.9% ($5,182.39) from Phase I (P < 0.001). Furthermore, both the average number of morphine equivalent units prescribed and consumed per patient decreased from Phase I to Phase II (294.6 vs 187.8, P < 0.001; and 144.9 vs 96.0, P < 0.001, respectively). Finally, in describing individual medications, there was a significant decrease in cost of waste (per 1,000 patients, AWP minus 60%) between Phases I and II for- Hydrocodone with APAP 5/525 mg (P< 0.001), Oxycodone CR 10 mg (P< 0.001), Morphine CR 15 mg (P=0.001), and Tramadol 50 mg (P = 0.014). CONCLUSIONS: The results of this study suggest that there is a significant cost of waste associated with differences in prescribed versus consumed opioids following elective orthopedic surgery. This cost of waste was significantly reduced following the introduction and implementation of formal prescription guidelines. DISCLOSURES: This study was funded internally by Revo Health and Twin Cities Orthopedics. Giveans reports consulting fees from Medtrak, Inc., and Superior Medical Experts. The other authors have nothing to disclose.

Real-world changes in US health system hospital-based services following treatment with a prescription digital therapeutic for opioid use disorder.

Outcomes associated with buprenorphine therapy for the treatment of opioid use disorder (OUD) are suboptimal. reSET-O is an FDA-authorized prescription digital therapeutic (PDT) delivering neurobehavioral therapy via mobile devices to patients with OUD treated with buprenorphine. This analysis evaluated the net impact of reSET-O on medical costs among actively-engaged reSET-O patients using real-world observations. This real-world retrospective analysis of health care claims between October 2018 and October 2019 evaluated health care resource utilization up to 6 months before and 6 months after the initiation of a reSET-O prescription after accounting for the subset of patients not continuing on therapy after week 1 (non-engaged patients). Repeated-measures negative binomial models compared incidences of hospital-based encounters/procedures adjusted for days in each period as well as associated costs. The number needed to treat (NNT) to avoid an inpatient visit was calculated. Of the 351 patients who were prescribed reSET-O, 321 met the criteria of active engagement. Treatment with reSET-O was associated with a substantial reduction in medical costs of -$765,450 (-$2,385/patient, $235/patient greater than a previous analysis in which non-engaged patients were included) in the 6-month period after initiation. The gross reSET-O prescription cost of $584,415 ($1,665/patient) was substantially offset by $49,950 ($142.31/patient) in refunds to payers. The medical cost reduction in engaged patients offset the cost of the therapeutic resulting in an overall cost reduction of -$230,985 in this cohort (net savings of -$720 per patient). The number needed to treat to avoid an inpatient visit was 4.8. Engagement and continued treatment with reSET-O in patients with OUD treated with buprenorphine is associated with substantial real-world reductions in medical costs in the 6-month period following the initiation of the reSET-O prescription.

Predictors of shortages of opioid analgesics in the US: Are the characteristics of the drug company the missing puzzle piece?

BACKGROUND: Shortages of opioid analgesics are increasingly common, interfere with patient care and increase healthcare cost. This study characterized the incidence of shortages of opioid analgesics in the period 2015-2019 and evaluated potential predictors to forecast the risk of shortages. METHODS: This was an observational retrospective study using the US Food and Drug Administration (FDA) drug shortages data. All FDA approved opioids were included in the study. Opioid analgesics were identified using the FDA National Drug Codes (NDC) and classified according to the Drug Enforcement Administration (DEA) schedule. We conducted Least Absolute Shrinkage and Selection Operator logistic regression analysis to assess direction of the association between risk of shortage and potential predictors. We used multivariable penalized logistic regression analysis to model predictors of shortages. We split the dataset into training and validation sets to evaluate the performance of the model. FINDINGS: The FDA approved 8,207 unique NDCs for opioid analgesics; 3,017 (36.8%) were in the market as of April 30, 2019 and 91(3.0%) of them were listed as in shortage by the FDA. All NDCs in shortage were schedule II opioids; 86 (94.5%) were injectable and 84 (92.3%) generics. There were 418 companies with at least one opioid NDC listed by the FDA. Three companies accounted for more than 4 in 5 of the schedule II active injectable opioids. For each unit increase in the number of prior instances of shortages of a company, the likelihood of an NDC shortage for that company increased by 3.4%. For each unit increase in number of NDCs marketed by a company, the odds of an NDC shortage for that company decreased by 1%. CONCLUSIONS: In the period 2015-2019, shortages of opioid analgesics disproportionally impacted schedule II and injectable opioids. The risk of shortage of opioid analgesics significantly increased with the incidence of previous instances of shortages of a manufacturing company and decreased with the number of NDCs marketed by a company. The characteristics of the manufacturing company, rather than the number of companies, might be the missing piece to the complex puzzle of drug shortages in the US.

Opioid Prescribing Patterns Among Facial Plastic and Reconstructive Surgeons in the Medicare Population.

Objective: To evaluate opioid prescribing patterns among American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) members in the Medicare population. Methods: Retrospective cohort study of AAFPRS members in the Medicare Part D Prescriber dataset. Results: From 2014 to 2016, there was a significant decrease in the number of days of opioids supplied per beneficiary (5.9 vs. 4.9 days, p < 0.005), as well as the opioid prescription cost per beneficiary ($14.52 vs. $11.79, p = 0.005). The highest prescription rate was found in the Midwest (20.5%) and lowest in the Northeast (14.0%), however, the difference between geographic regions was not significant (p = 0.11). There was a significant decrease in the number of total opioid days supplied per beneficiary in the South (p = 0.001), Midwest (p = 0.05), and West regions (p < 0.001). There was no significant difference in opioid prescription rate (p = 0.89) or total opioid days supplied per beneficiary (p = 0.26) when states were stratified by age-adjusted opioid-specific death rate. Conclusion: This study demonstrates a national trend toward fewer opioid days supplied and less opioid cost per Medicare beneficiary among AAFPRS members between 2014 and 2016.

Increased health care costs associated with new persistent opioid use after major surgery in opioid-naive patients.

BACKGROUND: Opioid use after surgery is associated with increased health care utilization and costs. Although some studies show that surgical patients may later become persistent opioid users, data on the association between new persistent opioid use after surgery and health care utilization and costs are lacking. OBJECTIVE: To compare health care utilization and costs after major inpatient or METHODS: The IBM MarketScan Research databases were used to identify opioid-naive patients with major inpatient or outpatient surgeries and at least 1 year of continuous enrollment before and after this index surgery. Cohorts were stratified by new persistent opioid utilization status, setting of surgery (inpatient, outpatient), and payer (commercial, Medicare, Medicaid). Patients were considered new persistent opioid users if they had at least 1 opioid claim 4-90 days after index surgery and at least 1 opioid claim 91-180 days after index surgery. Patients with opioid prescription claims between 1 year and 15 days before their index event were excluded. Health care utilization and costs (excluding index surgery) were measured in the 1-year period after surgery. Predicted costs and cost ratios were estimated using multivariable log-linked gamma-family generalized linear models. RESULTS: In the inpatient cohorts, 827,583 commercial, 186,154 Medicare, and 104,734 Medicaid patients were included in the study, and the incidence of new persistent opioid use in these cohorts was 4.1%, 5.6%, and 7.1%, respectively. In the outpatient cohorts, 1,542,565 commercial, 390,876 Medicare, and 94,878 Medicaid patients were selected, with 2.0%, 1.5%, and 6.4% new persistent opioid use, respectively. Across all 3 payers in both surgical settings, patients with new persistent opioid use had a higher comorbidity burden and more use of concomitant medications in the baseline period. In the 1-year period after index surgery, patients with new persistent opioid use had more inpatient admissions, emergency department visits, and ambulance/paramedic service use than patients without persistent use, regardless of payer and setting. Patients with new persistent opioid use had approximately 5 times more opioid prescriptions and also had more nonopioid pharmacy claims than those without persistent use across all cohorts. After covariate adjustment, predicted 1-year total health care costs were significantly higher for patients with new persistent opioid use compared with those without persistent use for all comparisons (commercial inpatient: $29,499 vs. $11,798; Medicare inpatient: $34,455 vs. $21,313; Medicaid inpatient: $14,622 vs. $6,678; commercial outpatient: $18,751 vs. $7,517; Medicare outpatient ($26,411 vs. $13,577; Medicaid outpatient: $12,381 vs. $6,784; all P < 0.001). CONCLUSIONS: New persistent opioid use after major surgery in opioid-naive patients is associated with increased health care utilization and costs in the year after surgery across all surgical settings and payers. DISCLOSURES: Funding for this study was provided by Heron Therapeutics, which participated in analysis and interpretation of data, drafting, reviewing, and approving the publication. All authors contributed to the analysis and interpretation of the data and development of the publication and maintained control over the final content. England and Evans-Shields are employees of Heron Therapeutics. Kong, Lew, Zimmerman, and Henriques are employees of IBM Watson Health, which was compensated by Heron Therapeutics for conducting this research. Brummett is a paid consultant for Heron Therapeutics, Vertex Pharmaceuticals, and Alosa Health and provides expert testimony. He further reports receipt of research funding from MDHHS (Sub K Michigan Open), NIDA (Centralized Pain Opioid Non-Responsiveness R01 DA038261-05), NIH0DHHS-US-16 PAF 07628 (R01 NR017096-05), NIH-DHHS (P50 AR070600-05 CORT), NIH-DHHS-US (K23 DA038718-04), NIH-DHHS-US-16-PAF06270 (R01 HD088712-05), NIH-DHHS-US-17-PAF02680 (R01 DA042859-05), and UM Michigan Genomics Initiative and holds a patent for peripheral perineural dexmedetomidine. Sun reports funding from the National Institute on Drug Abuse (K08DA042314) as well as consulting fees from the Mission Lisa Foundation that are unrelated to this work.

Opioid Prescriptions by Pain Medicine Physicians in the Medicare Part D Program: A Cross-Sectional Study.

BACKGROUND: Pain medicine physicians (PMP) are a group of physicians with background training in various primary specialties with interest and expertise in managing chronic pain disorders. Our objective is to analyze prescription drug (PD) claims from the Medicare Part D program associated with PMP to gain insights into patterns, associated costs, and potential cost savings areas. METHODS: The primary data source for Part D claims data is the Centers for Medicare and Medicaid Services (CMS) Chronic Conditions Data Warehouse, which contains Medicare Part D prescription drug events (PDE) records received through the claims submission cutoff date. Only providers with taxonomies of pain management (PM) and interventional pain management (IPM) were included in the study. The analysis of PDE was restricted to drugs with >250 claims. The distribution of claims and costs were analyzed based on drug class and provider specialty. Subsequently, we explored claims and expenses for opioid drug prescriptions in detail. Prescribing characteristics of the top 5% of providers by costs and claims were examined to gain additional insights. The costs and claims were explored for the top 10 drugs prescribed by PMP in 2017. RESULTS: There were a total of unique 3280 PMP-prescribed drugs with an associated expense of 652 million dollars in the 2017 Medicare Part D program. Prescriptions related to PMP account for a tiny fraction of the program's drug expenditure (0.4%). Opioids, anticonvulsants, and gabapentinoids were associated with the largest number of claims and the largest expenses within this fraction. Among opioid drug prescriptions, brand-named drugs account for a small fraction of claims (8%) compared to generic drugs. However, the expenses associated with brand name drugs were higher than generic drugs. Prescribers in the top 5% by PD costs had a higher number of claims, prescribed a higher proportion of branded medications, and had prescriptions associated with longer day supply compared to an average PMP. There were several opioid medications in the top 10 PD list by cost associated with PMP. CONCLUSIONS: Opioids were the most common medications among Medicare part D claims prescribed by PMP. Only 12% of the total opioid PD claims were by PMP. The top 5% of PMP prescribers had 10 times more claims than the average PMP.

Changes in For-Profit Medication-Assisted Therapy Clinics in an Appalachian City.

OBJECTIVES: This study is a follow-up to previous research regarding buprenorphine medication-assisted therapy (MAT) in Johnson City, Tennessee. For-profit MAT clinics were surveyed to determine changes in tapering practice patterns and insurance coverage during the last 3 years. METHODS: Johnson City for-profit MAT clinics; also called office based opioid treatment centers, were surveyed by telephone. Clinic representatives were asked questions regarding patient costs for therapy, insurance coverage, counseling offered onsite, and opportunities for tapering while pregnant. RESULTS: All of the MAT clinics representatives indicated that tapering in pregnancy could be considered even though tapering in pregnancy is contrary to current national guidelines. Forty-three percent of the clinics now accept insurance as compared with 0% in the 2016 study. The average weekly cost per visit remained consistent. CONCLUSIONS: The concept of tapering buprenorphine during pregnancy appears to have become a standard of care for this community, as representatives state it is offered at all of the clinics that were contacted. Representatives from three clinics stated the clinics require tapering, even though national organizations such as the American College of Obstetricians and Gynecologists and the American Society of Addiction Medicine do not recommend this approach. Although patients who have government or other insurance are now able to obtain buprenorphine with no expense at numerous clinics, the high cost for uninsured patients continues to create an environment conducive to buprenorphine diversion.

Development and Impact of an Institutional Enhanced Recovery Program on Opioid Use, Length of Stay, and Hospital Costs Within an Academic Medical Center: A Cohort Analysis of 7774 Patients.

BACKGROUND: Enhanced Recovery (ER) is a change management framework in which a multidisciplinary team of stakeholders utilizes evidence-based medicine to protocolize all aspects of a surgical care to allow more rapid return of function. While service-specific reports of ER adoption are common, institutional-wide adoption is complex, and reports of institution-wide ER adoption are lacking in the United States. We hypothesized that ER principles were generalizable across an institution and could be implemented across a multitude of surgical disciplines with improvements in length of stay, opioid consumption, and cost of care. METHODS: Following the establishment of a formal institutional ER program, ER was adopted in 9 distinct surgical subspecialties over 5 years at an academic medical center. We compared length of stay, opioid consumption, and total cost of care in all surgical subspecialties as a function of time using a segmented regression/interrupted time series statistical model. RESULTS: There were 7774 patients among 9 distinct surgical populations including 2155 patients in the pre-ER cohort and 5619 patients in the post-ER cohort. The introduction of an ER protocol was associated with several significant changes: a reduction in length of stay in 5 of 9 specialties; reduction in opioid consumption in 8 specialties; no change or reduction in maximum patient-reported pain scores; and reduction or no change in hospital costs in all specialties. The ER program was associated with an aggregate increase in profit over the study period. CONCLUSIONS: Institution-wide efforts to adopt ER can generate significant improvements in patient care, opioid consumption, hospital capacity, and profitability within a large academic medical center.

Financial and Clinical Ramifications of Introducing a Novel Pediatric Enhanced Recovery After Surgery Pathway for Pediatric Complex Hip Reconstructive Surgery.

BACKGROUND: Enhanced recovery after surgery pathways confer significant perioperative benefits to patients and are currently well described for adult patients undergoing a variety of surgical procedures. Robust data to support enhanced recovery pathway use in children are relatively lacking in the medical literature, though clinical benefits are reported in targeted pediatric surgical populations. Surgery for complex hip pathology in the adolescent patient is painful, often requiring prolonged courses of opioid analgesia. Postoperative opioid-related side effects may lead to prolonged recovery periods and suboptimal postoperative physical function. Excessive opioid use in the perioperative period is also a major risk factor for the development of opioid misuse in adolescents. Perioperative opioid reduction strategies in this vulnerable population will help to mitigate this risk. METHODS: A total of 85 adolescents undergoing complex hip reconstructive surgery were enrolled into an enhanced recovery after surgery pathway (October 2015 to December 2018) and were compared with 110 patients undergoing similar procedures in previous years (March 2010 to September 2015). The primary outcome was total perioperative opioid consumption. Secondary outcomes included hospital length of stay, postoperative nausea, intraoperative blood loss, and other perioperative outcomes. Total cost of care and specific charge sectors were also assessed. Segmented regression was used to assess the effects of pathway implementation on outcomes, adjusting for potential confounders, including the preimplementation trend over time. RESULTS: Before pathway implementation, there was a significant downward trend over time in average perioperative opioid consumption (-0.10 mg total morphine equivalents/90 days; 95% confidence interval [CI], -0.20 to 0.00) and several secondary perioperative outcomes. However, there was no evidence that pathway implementation by itself significantly altered the prepathway trend in perioperative opioid consumption (ie, the preceding trend continued). For postanesthesia care unit time, the downward trend leveled off significantly (pre: -5.25 min/90 d; 95% CI, -6.13 to -4.36; post: 1.04 min/90 d; 95% CI, -0.47 to 2.56; Change: 6.29; 95% CI, 4.53-8.06). Clinical, laboratory, pharmacy, operating room, and total charges were significantly associated with pathway implementation. There was no evidence that pathway implementation significantly altered the prepathway trend in other secondary outcomes. CONCLUSIONS: The impacts of our pediatric enhanced recovery pathway for adolescents undergoing complex hip reconstruction are consistent with the ongoing improvement in perioperative metrics at our institution but are difficult to distinguish from the impacts of other initiatives and evolving practice patterns in a pragmatic setting. The ERAS pathway helped codify and organize this new pattern of care, promoting multidisciplinary evidence-based care patterns and sustaining positive preexisting trends in financial and clinical metrics.

The Influence of Opioid Use Disorder on Open Reduction and Internal Fixation Following Ankle Fracture.

BACKGROUND: Ankle fractures are common and may require open reduction and internal fixation (ORIF). Literature is scarce evaluating the associations of opioid use disorder (OUD) with ORIF postoperative outcomes. This study investigates whether OUD patients have increased (1) costs of care, (2) emergency room visits, and (3) readmission rates. METHODS: ORIF patients with a 90-day history of OUD were identified using an administrative claims database. OUD patients were matched (1:4) to controls by age, sex, and medical comorbidities. The Welch t-test determined the significance of cost of care. Logistic regression yielded odds ratios (ORs) for emergency room visits and 90-day readmission rates. RESULTS: A total of 2183 patients underwent ORIF (n = 485 with OUD vs n = 1698 without OUD). OUD patients incurred significantly higher costs of care compared with controls ($5921.59 vs $5128.22, P < .0001). OUD patients had a higher incidence and odds of emergency room visits compared with controls (3.50% vs 0.64%; OR = 5.57, 95% CI = 2.59-11.97, P < .0001). The 90-day readmission rates were not significantly different between patients with and without OUD (8.65% vs 7.30%; OR = 1.20, 95% CI = 0.83-1.73, P = .320). CONCLUSION: OUD patients have greater costs of care and odds of emergency room visits within 90 days following ORIF.Levels of Evidence: Level III: Retrospective cohort study.

Persistent Opioid Use After Open Aortic Surgery: Risk Factors, Costs, and Consequences.

BACKGROUND: The incidence and financial impact of persistent opioid use (POU) after open aortic surgery is undefined. METHODS: Insurance claim data from opioid-naïve patients who underwent aortic root replacement, ascending aortic replacement, or transverse arch replacement from 2011 to 2017 were evaluated. POU was defined as filling an opioid prescription in the perioperative period and between 90 and 180 days postoperatively. Postoperative opioid prescriptions, emergency department visits, readmissions, and health care costs were quantified. Multivariable logistic regression identified risk factors for POU, and quantile regression quantified the impact of POU on postoperative health care costs. RESULTS: Among 3240 opioid-naïve patients undergoing open aortic surgery, 169 patients (5.2%) had POU. In the univariate analysis, patients with POU were prescribed more perioperative opioids (375 vs 225 morphine milligram equivalents, P < .001), had more emergency department visits (45.6% vs 25.4%, P < .001), and had significantly higher health care payments in the 6 months postoperatively ($10,947 vs $7223, P < .001). Independent risk factors for POU in the multivariable logistic regression included preoperative nicotine use and more opioids in the first perioperative prescription (all P < .05). After risk adjustment, POU was associated with a $2439 increase in total health care costs in the 6 months postoperatively. CONCLUSIONS: POU is a challenge after open aortic operations and can have longer-term impacts on health care payments and emergency department visits in the 6 months after surgery. Strategies to reduce outpatient opioid use after aortic surgery should be encouraged when feasible.

The role of fentanyl in the treatment of breakthrough cancer pain: Different biotechnologies, different results and different drug costs.

The aim of this paper was to assess the drug costs of the different biotechnologies (intranasal fentanyl spray (INFS), oral transmucosal fentanyl citrate (OTFC) and fentanyl buccal tablet (FBT)) in the treatment of breakthrough cancer pain (BTCP). We have calculated the mean drug costs (expressed in euros (€)) for patients treated for BTCP. INFS resulted the less expensive towards OTFC and FBT, with 697 440 €versus (vs.) 809 552 €vs. 779 662 €every 100 patients treated for BTCP, respectively. In conclusion, combining drug costs of different biotechnologies (INFS, OTFC and FBT) with the measure of efficacy represented by the reduction of BTCP avoided (incremental cost-effectiveness ratio, ICER), INFS resulted in better cost-effectiveness.

The impact of high-risk and chronic opioid use among commercially insured endometriosis patients on health care resource utilization and costs in the United States.

OBJECTIVES: Evaluate all-cause and endometriosis-related health care resource utilization and costs among newly diagnosed endometriosis patients with high-risk versus low-risk opioid use or patients with chronic versus non-chronic opioid use. METHODS: A retrospective analysis of IBM MarketScan® Commercial Claims data from 2009 to 2018 was performed for females aged 18 to 49 with newly diagnosed endometriosis (International Classification of Diseases, Ninth Edition code: 617.xx; International Classification of Diseases, Tenth Edition code: N80.xx). Two sub-cohorts were identified: high-risk (⩾1 day with ⩾90 morphine milligram equivalents per day or ⩾1-day concomitant benzodiazepine use) or chronic opioid utilization (⩾90-day supply prescribed or ⩾10 opioid prescriptions). High-risk or chronic utilization was evaluated during the 12-month assessment period after the index date. Index date was the first opioid prescription within 12 months following endometriosis diagnosis. All outcomes were assessed over 12-month post-assessment period while adjusting for demographic and clinical characteristics. RESULTS: Out of 61,019 patients identified, 18,239 had high-risk opioid use and 5001 chronic opioid use. Health care resource utilization drivers were outpatient visits and pharmacy fills, which were higher among high-risk versus low-risk patients (outpatient visits: 17.49 vs 15.51; pharmacy fills: 19.58 vs 16.88, p < 0.0001). Chronic opioid users had a higher number of outpatient visits (19.53 vs 15.00, p < 0.0001) and pharmacy fills (23.18 vs 16.43, p < 0.0001) compared to non-chronic opioid users. High-risk opioid users had significantly higher all-cause health care costs compared to low-risk opioid users (US$16,377 vs US$13,153; p < 0.0001). Chronic opioid users also had significantly higher all-cause health care costs compared to non-chronic opioid users (US$20,930 vs US$12,272; p < 0.0001). Similar patterns were observed among endometriosis-related HCRU, except pharmacy fills among high-risk and chronic sub-cohorts. CONCLUSION: This analysis demonstrates significantly higher all-cause and endometriosis-related health care resource utilization and total costs for high-risk opioid users compared to low-risk opioid users among newly diagnosed endometriosis patients over 1 year. Similar trends were observed for comparing chronic opioid users with non-chronic opioid users, except for endometriosis-related pharmacy fills and associated costs.

Association Between Preoperative Benzodiazepine Use and Postoperative Opioid Use and Health Care Costs.

Importance: The association between preoperative benzodiazepine use and long-term postoperative outcomes is not well understood. Objective: To characterize the association between preoperative benzodiazepine use and postoperative opioid use and health care costs. Design, Setting, and Participants: In this cohort study, retrospective analysis of private health insurance claims data on 946 561 opioid-naive patients (no opioid prescriptions filled in the year before surgery) throughout the US was conducted. Patients underwent 1 of 11 common surgical procedures between January 1, 2004, and December 31, 2016; data analysis was performed January 9, 2020. Exposures: Benzodiazepine use, defined as long term (≥10 prescriptions filled or ≥120 days supplied in the year before surgery) or intermittent (any use not meeting the criteria for long term). Main Outcomes and Measures: The primary outcome was opioid use 91 to 365 days after surgery. Secondary outcomes included opioid use 0 to 90 days after surgery and health care costs 0 to 30 days after surgery. Results: In this sample of 946 561 patients, the mean age was 59.8 years (range, 18-89 years); 615 065 were women (65.0%). Of these, 23 484 patients (2.5%) met the criteria for long-term preoperative benzodiazepine use and 47 669 patients (5.0%) met the criteria for intermittent use. After adjusting for confounders, long-term (odds ratio [OR], 1.59; 95% CI, 1.54-1.65; P < .001) and intermittent (OR, 1.47; 95% CI, 1.44-1.51; P < .001) benzodiazepine use were associated with an increased probability of any opioid use during postoperative days 91 to 365. For patients who used opioids in postoperative days 91 to 365, long-term benzodiazepine use was associated with a 44% increase in opioid dose (additional 0.6 mean daily morphine milligram equivalents [MMEs]; 95% CI, 0.3-0.8 MMEs; P < .001), although intermittent benzodiazepine use was not significantly different (0.0 average daily MMEs; 95% CI, -0.2 to 0.2 MMEs; P = .65). Preoperative benzodiazepine use was also associated with increased opioid use in postoperative days 0 to 90 for both long-term (32% increase, additional 1.9 average daily MMEs; 95% CI, 1.6-2.1 MMEs; P < .001) and intermittent (9% increase, additional 0.5 average daily MMEs; 95% CI, 0.4-0.6 MMEs; P < .001) users. Intermittent benzodiazepine use was associated with an increase in 30-day health care costs ($1155; 95% CI, $938-$1372; P < .001), while no significant difference was observed for long-term benzodiazepine use. Conclusions and Relevance: The findings of this study suggest that, among opioid-naive patients, preoperative benzodiazepine use may be associated with an increased risk of developing long-term opioid use and increased opioid dosages postoperatively, and also may be associated with increased health care costs.

A comparison of trends in opioid dispensing patterns between Medicaid pharmacy claims and prescription drug monitoring program data.

PURPOSE: Public and private payers have implemented benefit limitations to reduce high-risk opioid prescriptions. The effect of these policies on the increase of out-pocket payment is unclear. To understand this gap, we compared the discrepancies in trends between opioid prescription fills vs claims among Medicaid beneficiaries. METHODS: Data from the Oregon Prescription Drug Monitoring Program (PDMP) and Oregon Medicaid administrative claims were used to identify Medicaid beneficiaries 18 years and older enrolled at least one full month from 2015 to 2017. Generalized linear models assessed the trends in the monthly rates of opioid PDMP prescription fills and pharmacy claims per 1000 eligible members. Rates by morphine equivalent dose (MED) tier (<50, 50-89, 90-120, >120 MED) and co-prescribed opioid and benzodiazepine were also assessed. RESULTS: During the study period, an average of 495 355 Medicaid members had 2 797 054 opioid PDMP fills and 2 472 155 opioid Medicaid pharmacy claims. Study participants had 15.4 (95% confidence interval [CI] 13.6 to 17.0; P < .001) more prescriptions per 1000 member per month in the PDMP data (114.1 [SD 7.4]) compared with the Medicaid claims data (98.7 [SD 7.9]). Similarly, there were 1.9 more co-occurring opioid/benzodiazepine prescriptions per 1000 members per month observed in the PDMP data than the Medicaid claims data (95% CI 1.7 to 2.1; P < .001). At each MED tier, the PDMP fills were consistently higher than the claims (P < .001). CONCLUSIONS: Higher rate of fills in the PDMP compared to pharmacy claims suggests that there may be an increasing trend of out-of-pocket payment among Medicaid beneficiaries.