Publications

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.

Value-based pharmaceutical contracts (VBPCs) are performance-based reimbursement agreements between health care payers and pharmaceutical manufacturers in which the price, quantity, or nature of reimbursement is tied to value-based outcomes. As value-based payment models have permeated through much of the health care payment landscape via reimbursement to payers and providers, VBPCs offer opportunities for manufacturers to similarly engage in performance-based models. This article compares 2 VBPC schemes: "pay-for-failure" schemes, in which manufacturers offer rebates or discounts to payers for treatment failure, and "pay-for-success" schemes, in which manufacturers offer rebates or discounts to payers for treatment success. Each method has its own short-term and long-term trade-offs, and both lead to some degree of misaligned incentives between payers and manufacturers. These incentive differences have important downstream effects, influencing patient selection, provision of wraparound services, and nature of reimbursements. This analysis contrasts potential benefits and disadvantages for each of these approaches and offers potential solutions to address misalignment. For example, although pay-for-success models may be more aligned between payers and manufacturers, pay-for-failure contracts can be innovative and effective in controlling costs and/or improving outcomes. To illustrate, VBPCs aimed to reduce costs could incorporate total cost of care reduction as a value-based outcome. The authors encourage payers and manufacturers to consider a blended alternative where pay-for-failure and pay-for-success outcomes could be incorporated as VBPC outcomes. Since little is known about the effect of each scheme on outcomes, further research on VBPCs is necessary to fully understand how differing incentives ultimately affect clinical outcomes and costs. DISCLOSURES: No outside funding supported the writing of this article. Good and Kelly are employed by the UPMC Centers for Value-Based Pharmacy Initiatives and High-Value Health Care, and Parekh was employed by the UPMC Centers for Value-Based Pharmacy Initiatives and High-Value Health Care at the time of this study. The authors have no other disclosures to report.

BACKGROUND: Direct-to-consumer advertising (DTCA) of prescription drugs impacts patients' requests for medications, and clinician prescribing. However, the impact of DTCA during the Super Bowl has not been previously described.

OBJECTIVE: Evaluate the impact of prescription drug DTCA during the Super Bowl on drug utilization using 2014-2016 Medicare data.

METHODS: Efinaconazole was advertised during Super Bowls XLIX (02/01/2015) and L (02/07/2016). The number of prescriptions for efinaconazole and for a comparator drug, tavaborole, were calculated in 31-day intervals from July 2014-December 2016. Interrupted time-series analysis models were created to test changes in trends of prescriptions for efinaconazole and tavaborole.

RESULTS: Following Super Bowl XLIX, the number of prescriptions per 100,000 Medicare beneficiaries increased by 91% for efinaconazole, and 275% for tavaborole. After Super Bowl L, the number of prescriptions increased significantly for efinaconazole (p-value<0.001), but not for tavaborole (p = 0.70). Interrupted time-series analyses estimated that, in the absence of DTCA during Super Bowl XLIX, prescriptions for efinaconazole would have increased by 40%, instead of the observed 91%. For tavaborole, prescriptions would have increased by 90% instead of 275%.

CONCLUSIONS: DTCA during the Super Bowl resulted in sharp increases in utilization of the prescription drug advertised, which supports further regulation of DTCA.