Are Drugs Priced in Accordance With Value? A Comparison of Value-Based and Net Prices Using Institute for Clinical and Economic Review Reports.

OBJECTIVES: The Institute for Clinical and Economic Review (ICER) is an independent organization that reviews drugs and devices with a focus on emerging agents. As part of their evaluation, ICER estimates value-based prices (VBP) at $50 000 to $150 000 per quality-adjusted life-year (QALY) gained thresholds. We compared actual estimated net prices to ICER-estimated VBPs. METHODS: We reviewed ICER final evidence reports from November 2007 to October 2020. List prices were combined with average discounts obtained from SSR Health to estimate net prices. If a drug had been evaluated more than once for the same indication, only the more recent VBP was included. RESULTS: A total of 34 ICER reports provided unique VBPs for 102 drugs. The net price of 81% of drugs exceeded the $100 000 per QALY VBP and 71% exceeded the $150 000 per QALY VBP. The median change in net price needed to reach the $150 000 per QALY VBP was a 36% reduction. The median decrease in net price needed was highest for drugs targeting rare inherited disorders (n = 15; 62%) and lowest for cardiometabolic disorders (n = 6; 162% price increase). The reduction in net prices needed to reach ICER-estimated VBPs was higher for drugs evaluated for the first approved indication, rare diseases, less competitive markets, and if the drug approval occurred before the ICER report became available. CONCLUSION: Net prices are often above VBPs estimated by ICER. Although gaining awareness among decision makers, the long-term impact of ICER evaluations on pricing and access to new drugs continues to evolve.

A real-world data approach to determine the optimal dosing strategy for pembrolizumab.

INTRODUCTION: Cancer drug therapy costs continue to rise and threaten the sustainability of Canada's public healthcare system. Previous studies have calculated potential savings utilizing different dosing regimens of cancer treatments. Our objectives were to determine the financial impact of drug wastage and to explore cost-effective dosing regimens for pembrolizumab. METHODS: This was a retrospective study reviewing data for non-small cell lung cancer and melanoma patients at all six BC Cancer Regional Centres during fiscal years 2017 and 2018. Pembrolizumab waste amounts recorded in pharmacy wastage logs were totalled. Estimates of the number of vials used were compared between vial sharing and non-vial sharing practices to determine the cost differences. Costs for dosing regimens used during fiscal years 2017 and 2018 were compared to 2 mg/kg weight-based dosing (to a maximum of 200 mg), 2 mg/kg dosing rounding down within 5% and 10%, and flat dosing of 200 mg. RESULTS: There were a total of 202 non-small cell lung cancer and 182 melanoma patients with 2948 doses dispensed. Documented wastage was valued at $1,829,047.44 (8.65%) and across all six centres, vial sharing could reduce costs by $3,207,600.00 using the 100 mg vials. Compared to fiscal years 2017 and 2018, 2 mg/kg dosing (to a maximum of 200 mg) was the most cost-effective, decreasing costs by $222,719.20; flat dosing of 200 mg was the most expensive, increasing costs by $6,625,260.40. CONCLUSIONS: Having smaller vial sizes, practicing vial sharing, and using weight-based dosing all improve cost savings. Further investigations on the allocation of resources to optimize drug use and minimize wastage are needed.

Implementation of a chemotherapy stewardship process.

PURPOSE: To design and implement a chemotherapy stewardship process to optimize the location of chemotherapy administration in an effort to decrease the number of inappropriate inpatient anticancer regimen administrations and decrease institutional costs associated with inpatient administration. SUMMARY: As the costs of anticancer agents continue to rise, it is crucial that multidisciplinary efforts are aimed at managing anticancer medication utilization; this is especially important for high-cost medications, medications whose use requires increased monitoring due to safety concerns, and medications that do not exert effects quickly and, as such, can be more appropriately administered in the outpatient setting. It is imperative that pharmacists play a role in managing chemotherapy medication utilization, as pharmacists provide expertise in formulary management, a vast knowledge of financial impact and reimbursement processes, and clinical knowledge that can help predict the expected effectiveness and adverse effects of each anticancer regimen. Our institution sought to develop and implement a multidisciplinary chemotherapy stewardship program targeting the optimization of site of anticancer agent administration with a goal of decreasing both cost and inappropriate utilization of high-cost, high-risk anticancer agents. CONCLUSION: Implementation of a chemotherapy stewardship service may decrease the number of inappropriate inpatient anticancer regimen administrations and decrease inpatient resource use, thereby decreasing costs to institutions. The concept of a chemotherapy stewardship process was well received by multidisciplinary healthcare colleagues, and a collaborative approach should be used to design and implement such processes.

Introduction: Pharmacy Reimbursement.

DISCLOSURES: No funding supported the writing of this article. The author has nothing to disclose.

Trends in the Dispensing and Costs of Glucose-Lowering Medications Among Older Australians: Findings from National Claims Data.

BACKGROUND: Temporal changes in the dispensing of glucose-lowering drugs (GLD) and their associated costs among elderly populations is unclear. This information is especially relevant to countries in which medications are partly or fully government subsidized. OBJECTIVE: Our objective was to estimate the trends in prevalence, incidence and costs associated with GLD dispensed to older Australians. METHODS: We analysed Pharmaceutical Benefits Scheme data for 76,906 people aged ≥ 65 years dispensed diabetes medications over the period 2013-2016. RESULTS: Older males were dispensed more GLD than were older females, with the marginal difference increasing from 3.2% in 2013 (age-sex adjusted incidence rate ratio [aIRR] 1.032; 95% confidence interval [CI] 1.024-1.041; p < 0.001) to 3.9% in 2016 (aIRR 1.039; 95% CI 1.030-1.047; p < 0.001). The number of GLD dispensed per person was consistently lower in those aged ≥ 75 years than in those aged 65-74 years, with the gap widening over the years. More patients were initiated with sodium-glucose cotransporter-2 inhibitors, glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors over the study period, at the expense of older GLD. The proportion of users and attributed costs associated with the use of metformin, sulfonylureas, α-glucosidase inhibitors and thiazolidinediones decreased over time. The total subsidized costs of GLD is forecast to increase to $A395 million by 2020. CONCLUSIONS: The treatment landscape for diabetes in Australia is undergoing dynamic change. More patients were initiated with the newer but costlier GLD over the study period.

Review of purchases of unapproved medications by the Veterans Health Administration.

PURPOSE: Many medications that were marketed prior to 1962 but lack Food and Drug Administration (FDA) approval are prescribed in the United States. Usage patterns of these "unapproved medications" are poorly elucidated, which is concerning due to potential lack of data on safety and efficacy. The purpose of this project was to characterize purchases of unapproved medications within the Veterans Health Administration (VHA) by type, frequency, and cost. METHODS: VHA purchasing databases were used to create a list of all products with National Drug Codes (NDCs) purchased nationwide in fiscal year 2016 (FY16). This list was compared to FDA databases to identify unapproved prescription medications. For each identified combination of active pharmaceutical ingredient (API) and route of administration ("API/route combination"), numbers of packages purchased and associated costs were added. RESULTS: VHA pharmacy purchasing records contained 3,299 unapproved products with NDCs in FY16. After excluding equipment, nutrition products, compounding ingredients, nonmedication products, and duplicate NDCs, there were 600 unique NDCs associated with 130 distinct API/route combinations. The most commonly acquired product was prescription sodium fluoride dental paste (350,775 packages). The greatest pharmaceutical expenditure was for sodium hyaluronate injection ($24.5 million). Unapproved products accounted for less than 1% of overall VHA pharmacy purchasing in FY16. CONCLUSION: VHA purchased many unapproved prescription products in FY16 but is taking action to address use of such products in consideration of safety and efficacy data and available alternatives.

The technical and economic impact of veterinary interventions aimed at reducing antimicrobial use on broiler farms.

Antimicrobial resistance is a global threat for both human and animal health. One of the main drivers of antimicrobial resistance is inappropriate antimicrobial use in livestock production. The aim of this study was to examine the technical and economic impact of tailor-made interventions, aimed at reducing antimicrobial use in broiler production. Historical (i.e., before intervention) and observational (i.e., after intervention) data were collected at 20 broiler farms. Results indicate that average daily gain and mortality generally increased after intervention, whereas feed conversion and antimicrobial use decreased. Economic performance after interventions was generally higher than before the interventions. Sensitivity analyses on price changes confirm the robustness of the findings.

Cost-effectiveness of a clinical medication review in vulnerable older patients at hospital discharge, a randomized controlled trial.

Background Drug-related problems (DRP) following hospital discharge may cause morbidity, mortality and hospital re-admissions. It is unclear whether a clinical medication review (CMR) and counseling at discharge is a cost-effective method to reduce DRP. Objective To assess the effect of a CMR on health care utilization and to investigate whether CMR is a cost-effective method to reduce DRP in older polypharmacy patients discharged from hospital. Setting 24 community pharmacies in the Netherlands. Method A cluster-randomized controlled trial with an economic evaluation. Community pharmacies were randomized to those providing a CMR, counseling and follow-up at discharge and those providing usual care. Main outcome measures Change in the number of DRP after 1 year of follow-up and costs of health care utilization during follow-up. In 216 patients the use of health care was prospectively assessed. Missing data on effects and costs were imputed using multiple imputation techniques. Bootstrapping techniques were used to estimate the uncertainty around the differences in costs and incremental cost-effectiveness ratios. Results CMR resulted in a small reduction of DRP. The proportion of patients readmitted to the hospital during 6 months of follow-up was significantly higher in the intervention group than in the control group (46.4 vs. 20.9%; p < 0.05). Health care costs were higher in the intervention group, although not statistically significant. The costs of reducing one DRP by a CMR amounted to €8270. Conclusion A CMR in vulnerable older patients at hospital discharge led to a small reduction in DRP. Because of a significantly higher use of health care and higher number of re-hospitalisations post CMR, the present study data indicate that performing the intervention in this patient population is not cost-effective.

Payments from drug companies to physicians are associated with higher volume and more expensive opioid analgesic prescribing.

BACKGROUND: While the rise in opioid analgesic prescribing and overdose deaths was multifactorial, financial relationships between opioid drug manufacturers and physicians may be one important factor. METHODS: Using national data from 2013 to 2015, we conducted a retrospective cohort study linking the Open Payments database and Medicare Part D drug utilization data. We created two cohorts of physicians, those receiving opioid-related payments in 2014 and 2015, but not in 2013, and those receiving opioid-related payments in 2015 but not in 2013 and 2014. Our main outcome measures were expenditures on filled prescriptions, daily doses filled, and expenditures per daily dose. For each cohort, we created a comparison group that did not receive an opioid-related payment in any year and was matched on state, specialty, and baseline opioid expenditures. We used a difference-in-differences analysis with linear generalized estimating equations regression models. RESULTS: We identified 6,322 physicians who received opioid-related payments in 2014 and 2015, but not in 2013; they received a mean total of $251. Relative to comparison group physicians, they had a significantly larger increase in mean opioid expenditures ($6,171; 95% CI: 4,997 to 7,346), daily doses dispensed (1,574; 95%CI: 1,330 to 1,818) and mean expenditures per daily dose ($0.38; 95% CI: 0.29 to 0.47). We identified 8,669 physicians who received opioid-related payments in 2015, but not in 2013 or 2014; they received a mean total of $40. Relative to comparison physicians, they also had a larger increase in mean opioid expenditures ($1,031; 95% CI: 603 to 1,460), daily doses dispensed (557; 95% CI: 417 to 697), and expenditures per daily dose ($0.06; 95% CI: 0.002 to 0.13). CONCLUSIONS: Our findings add to the growing public policy concern that payments from opioid drug manufacturers can influence physician prescribing. Interventions are needed to reduce such promotional activities or to mitigate their influence.

Association Between Prescription Drug Insurance and Health Care Utilization Among Medicare Beneficiaries.

Medicare Part D was associated with reduced hospitalizations, yet little is known whether these effects varied across patients and how Part D was associated with length of stay and inpatient expenditures. We used Medicare claims and the Medicare Current Beneficiary Survey from 2002 to 2010 and an instrumental variables approach. Gaining drug insurance through Part D was associated with a statistically significant 8.0% reduction in likelihood of admission across conditions examined. Reductions were generally greater for younger, healthier, and male individuals. Across all conditions, mean length of stay decreased by 3.2% from a baseline of 5.1 days. Part D was associated with a 3.5% reduction in expenditures per admission, reflecting a decrease of $844 from a mean charge of $24,124 per admission prior to Part D. Thus, Part D was associated with statistically and clinically significant reductions in the probability of admission and length of stay for several common conditions.