Publications

BACKGROUND: Many persons with opioid use disorder (OUD) initiate medication for opioid use disorder (MOUD) with one clinic and switch to another clinic during their course of treatment. These switches may occur for referrals or for unplanned reasons. It is unknown, however, what effect switching MOUD clinics has on continuity of MOUD treatment or on overdoses.

OBJECTIVE: To examine patterns of switching MOUD clinics and its association with the proportion of days covered (PDC) by MOUD, and opioid-related overdose.

DESIGN: Cross-sectional retrospective analysis of Pennsylvania Medicaid claims data.

MAIN MEASURES: MOUD clinic switches (i.e., filling a MOUD prescription from a prescriber located in a different clinic than the previous prescriber), PDC, and opioid-related overdose.

RESULTS: Among 14,107 enrollees, 43.2 % switched clinics for MOUD at least once during the 270 day period. In multivariate regression results, enrollees who were Non-Hispanic black (IRR = 1.43; 95 % CI = 1.24-1.65; p < 0.001), had previous methadone use (IRR = 1.32; 95 % CI = 1.13-1.55; p < 0.001), and a higher total number of office visits (IRR = 1.01; CI = 1.01-1.01; p < 0.001) had more switches. The number of clinic switches was positively associated with PDC (OR = 1.12; 95 % CI = 1.10-1.13). In secondary analyses, we found that switches for only one MOUD fill were associated with lower PDC (OR = 0.97; 95 % CI = 0.95-0.99), while switches for more than one MOUD fill were associated with higher PDC (OR = 1.40; 95 % CI = 1.36-1.44). We did not observe a relationship between opioid-related overdose and clinic switches.

CONCLUSIONS: Lack of prescriber continuity for receiving MOUD may not be problematic as it is for other conditions, insofar as it is related to overdose and PDC.

Objective: Atrial fibrillation (AF) may remain undiagnosed until the development of complications. We aimed to examine the epidemiology and racial/ethnic and rural/urban differences in the frequency of newly diagnosed AF manifesting as ischemic stroke in a nationally representative sample of Medicare beneficiaries. Methods: We used a 5% random sample of Medicare claims to identify patients newly diagnosed with AF in 2016. The primary dependent variable was stroke or transient ischemic attack (TIA) in the 7 days prior to the first AF diagnosis, i.e., stroke or TIA as the initial manifestation of AF. We constructed a multivariable logistic regression to quantify the association between race/ethnicity, urban/rural residence, and the primary dependent variable. Results: Among 39,409 patients newly diagnosed with AF (mean age 77 ± 10 years; 58% women; 7.2% Black, 87.8% White, 5.1% others), 2,819 (7.2%) had ischemic stroke or TIA in the 7 days prior to AF diagnosis. Black patients (adjusted OR [95% CI]: 1.21 [1.05, 1.40], vs. White) and urban residents (1.21 [1.08, 1.35], vs. rural) were at increased risk of stroke as the initial manifestation of AF. Racial differences were larger among patients aged ≥75 years, with adjusted ORs of 1.43 (1.19, 1.73) for Black vs. White patients, but non-significant for those aged <75 (P for interaction = 0.03). Conclusion: We observed significant and important differences in the risk of stroke as initial manifestation of AF between White and Black patients and between rural and urban residents. Our results suggest potential disparities in the identification AF across race/ethnicity groups and urban/rural areas.

OBJECTIVES: Shared decision making is essential to deprescribing unnecessary or harmful medications in older adults, yet patients' and caregivers' perspectives on medication value and how this affects their willingness to discontinue a medication are poorly understood. We sought to identify the most significant factors that impact the perceived value of a medication from the perspective of patients and caregivers.

DESIGN: Qualitative study using focus groups conducted in September and October 2018.

SETTING: Participants from the Pepper Geriatric Research Registry (patients) and the Pitt+Me Registry (caregivers) maintained by the University of Pittsburgh.

PARTICIPANTS: Six focus groups of community-dwelling adults aged 65 years or older, or their caregivers, prescribed five or more medications in the preceding 12 months.

MEASUREMENTS: We sought to identify (1) general views on medication value and what makes medication worth taking; (2) how specific features such as cost or side effects impact perceived value; and (3) reactions to clinical scenarios related to deprescribing.

RESULTS: We identified four themes. Perceived effectiveness was the primary factor that caused participants to consider a medication to be of high value. Participants considered a medication to be of low value if it adversely affected quality of life. Participants also cited cost when determining value, especially if it resulted in material sacrifices. Participants valued medications prescribed by providers with whom they had good relationships rather than valuing level of training. When presented with clinical scenarios, participants ably weighed these factors when determining the value of a medication and indicated whether they would adhere to a deprescribing recommendation.

CONCLUSION: We identified that perceived effectiveness, adverse effects on quality of life, cost, and a strong relationship with the prescriber influenced patients' and caregivers' views on medication value. These findings will enable prescribers to engage older patients in shared decision making when deprescribing unnecessary medications and will allow health systems to incorporate patient-centered assessment of value into systems-based deprescribing interventions. J Am Geriatr Soc 68:746-753, 2020.

BACKGROUND & AIMS: It is not clear what factors affect risk of chronic kidney disease (CKD) in patients with inflammatory bowel disease (IBD); increased risk has been inconsistently associated with use of 5-aminosalicylates (5-ASAs). We aimed to calculate the relative hazard of CKD among patients with IBD, adjusted for CKD risk factors, and to determine whether IBD medications are associated with change in estimated glomerular filtration rate (eGFR).

METHODS: We performed a retrospective cohort study of data from The Health Improvement Network. Patients with IBD (n = 17,807) were matched for age, sex, and practice to individuals without IBD (n = 63,466). The relative hazard of CKD, stages 3 through 5D, in patients with IBD was calculated using a Cox proportional hazards model adjusted for common CKD risk factors. We also evaluated the association of 5-ASAs, azathioprine, and methotrexate with change in eGFR using a longitudinal model.

RESULTS: After we controlled for risk factors associated with CKD, we found IBD to be associated with development of CKD in patients 16-77 years old. As patient age increased, the adjusted hazard ratio for CKD decreased monotonically, from 7.88 (95% CI, 2.56-24.19) at age 16 to 1.13 (95% CI, 1.01-1.25) at age 77. In the longitudinal analysis, exposure to 5-ASAs or methotrexate was not associated with change in eGFR, whereas azathioprine was associated with a slightly higher eGFR (0.32 mL/min/1.73 m2; 95% CI, 0.16-0.48).

CONCLUSIONS: In a retrospective study of more than 80,000 persons, we found that IBD is associated with increased risk of CKD, and the hazard ratio is highest among younger patients. Commonly used non-biologic therapeutic agents were not associated with lower eGFR.

BACKGROUND AND AIMS: There are limited data on the most cost-effective sequencing of biologics for ulcerative colitis [UC].

METHODS: We used Markov modelling to identify the most cost-effective position for vedolizumab among biologics for steroid-dependent UC, with a base-case of a 35-year-old male. We assessed three treatment algorithms, with vedolizumab use: prior to an initial anti-tumour necrosis factor alpha [anti-TNFα] and azathioprine [Algorithm 1]; prior to a second anti-TNF and azathioprine [Algorithm 2]; and prior to colectomy [Algorithm 3]. The initial anti-TNF could be either infliximab or adalimumab. Transition probabilities, costs, and quality-adjusted life-year estimates were derived from published estimates, Medicare, and the Nationwide Inpatient Sample. Primary analyses included 100 trials of 100 000 individuals over 1 year, with a willingness-to-pay threshold of US$100,000. Multiple sensitivity analyses were conducted to assess our findings.

RESULTS: From a population perspective, when both infliximab and adalimumab are available, vedolizumab was preferred as the first biologic if ≥14% of initial anti-TNF use was adalimumab. If infliximab is the primary biologic, vedolizumab use after infliximab [Algorithm 2] and prior to adalimumab was the most cost-effective strategy. All models were sensitive to biologic pricing.

CONCLUSIONS: This simulation demonstrated that the most cost-effective strategy in UC depends on the proportion of patients using adalimumab as the initial anti-TNF. If adalimumab was ≥14%, vedolizumab was preferred as the first biologic. When only infliximab was available for first-line therapy, the most cost-effective position of vedolizumab was prior to cycling to adalimumab.

IMPORTANCE: Most studies that have examined drug prices have focused on list prices, without accounting for manufacturer rebates and other discounts, which have substantially increased in the last decade.

OBJECTIVE: To describe changes in list prices, net prices, and discounts for branded pharmaceutical products for which US sales are reported by publicly traded companies, and to determine the extent to which list price increases were offset by increases in discounts.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective descriptive study using 2007-2018 pricing data from the investment firm SSR Health for branded products available before January 2007 with US sales reported by publicly traded companies (n = 602 drugs). Net prices were estimated by compiling company-reported sales for each product and number of units sold in the US.

EXPOSURES: Calendar year.

MAIN OUTCOMES AND MEASURES: Outcomes included list and net prices and discounts in Medicaid and other payers. List prices represent manufacturers' price to wholesalers or direct purchasers but do not account for discounts. Net prices represent revenue per unit of the product after all manufacturer concessions are accounted for (including rebates, coupon cards, and any other discount). Means of outcomes were calculated each year for the overall sample and 6 therapeutic classes, weighting each product by utilization and adjusting for inflation.

RESULTS: From 2007 to 2018, list prices increased by 159% (95% CI, 137%-181%), or 9.1% per year, while net prices increased by 60% (95% CI, 36%-84%), or 4.5% per year, with stable net prices between 2015 and 2018. Discounts increased from 40% to 76% in Medicaid and from 23% to 51% for other payers. Increases in discounts offset 62% of list price increases. There was large variability across classes. Multiple sclerosis treatments (n = 4) had the greatest increases in list (439%) and net (157%) prices. List prices of lipid-lowering agents (n = 11) increased by 278% and net prices by 95%. List prices of tumor necrosis factor inhibitors (n = 3) increased by 166% and net prices by 73%. List prices of insulins (n = 7) increased by 262%, and net prices by 51%. List prices of noninsulin antidiabetic agents (n = 10) increased by 165%, and net prices decreased by 1%. List price increases were lowest (59%) for antineoplastic agents (n = 44), but discounts only offset 41% of list price increases, leading to 35% increase in net prices.

CONCLUSIONS AND RELEVANCE: In this analysis of branded drugs in the US from 2007 to 2018, mean increases in list and net prices were substantial, although discounts offset an estimated 62% of list price increases with substantial variation across classes.

Value-based pharmaceutical contracts (VBPCs) are performance-based reimbursement agreements between healthcare payers and pharmaceutical manufacturers in which the price, amount, or nature of reimbursement is tied to value-based outcomes. VBPCs are often complex, and the nature of who benefits and in what ways can be unclear. We discuss how VBPCs compare with value-based payer-provider arrangements in terms of performance-based reimbursements and alignment of incentives. In addition, we examine how VBPCs can affect costs, clinical outcomes, and access to medications. Because these contracts are unlikely to reduce costs in isolation, we recommend taking a patient-centered approach when developing VBPCs and tying VBPCs to more overarching payer drug cost reduction strategies.