Average Wholesale Price Research Articles

Financial impact of oral chemotherapy wastage on society and the patient

Targeted oral agents are now increasingly being utilized in cancer treatment, but are expensive. Changing the dose of these medications due to toxicity or discontinuation secondary to disease progression or death causes waste from unused medication. Limiting waste is an important goal, as waste has a substantial financial impact on patients and insurance companies. Patients started on oral targeted agents' sunitinib, everolimus, axitinib, or vemurafenib between January 2012 and February 2015 who obtained their medications at Holden Comprehensive Cancer Center specialty pharmacy were included in the analysis. We acquired dispensing data retrospectively for each of the agents and reviewed patient charts. Wasted tablets/capsules were calculated from their last fill to the dates of stoppage or dose adjustment. The amount associated with the wastage was calculated using the average wholesale price. Repository drug usage data during the same time period was obtained. Eighty-eight patients had their prescriptions filled at Holden Comprehensive Cancer Center during the study time period. Waste occurred in 41% of all patients with primary reasons attributed to cancer progression in 25 patients, death in five patients, toxicity in five patients and increase in dosage of targeted therapy in two patients. A total of 1179 tablets or capsules were wasted from all causes, priced at a total of $248,595.69. Oral chemotherapy medications are associated with wastage, which is a significant financial burden to society. Progression of disease emerged as the single most important factor accounting for wastage. Novel ideas are needed to prevent wastage, thereby reducing healthcare costs.

Increased topical generic prices by manufacturers

There is limited data regarding generic medication prices. Recent studies have shown price changes at the retail level, but much is not known about the pharmaceutical supply chain or price changes at the manufacturer level. We sought to examine the extent of price changes for topical generic medications. A comprehensive review of average wholesale prices (AWPs) and manufacturers of topical generics and available corresponding branded medications was conducted for 2005 and 2016. A total of 51 topical chemical entities were examined. Between 2005 and 2016, the AWP of topical generic medications increased by 273% and the AWP of topical branded medications increased by 379%. The topical generic with the greatest price change increased by 2529%. Eight of the top 20 topical generic medications with the greatest increases in AWP also had an increase in the number of manufacturers. These findings are not generalizable to medications used in other areas of medicine. Topical generic prices are rapidly increasing at the manufacturer level.

Economic and Practical Considerations in the Treatment of Oral Mucosal Chronic Graft-Versus-Host Disease

Chronic graft-versus-host disease (cGVHD) frequently affects the oral mucosa and is generally responsive to topical immunomodulatory therapies. Clinicians may benefit from guidance in choosing the most appropriate therapy with respect to practicality and cost. To assess the economic considerations related to topical immunomodulatory treatments for management of oral mucosal cGVHD and their practical implications. Topical treatments used for management of oral cGVHD were obtained from the National Institutes of Health Consensus document for ancillary and supportive care. Cost data for a standard 1-month prescription was obtained from national databases for commercially available formulations and from compounding pharmacies for formulations requiring compounding. There are numerous topical preparations used for the management of oral cGVHD, many of which require compounding. The average wholesale price of the commercially available agents ranges from $5 to $277/month, and the cost of the compounded preparations ranges from $43 to $499/month. Costs can be influenced by drug-, patient-, and pharmacy-related factors. The costs associated with topical treatment of oral cGVHD are substantial, particularly because the disease is chronic and expenses accumulate over time. Rational prescribing according to a proposed algorithm, including de-escalation of therapy when indicated, can help to minimize associated costs. This has practical implications for patients, physicians, pharmacies, and insurance providers.

Application of the ASCO Value Framework and ESMO Magnitude of Clinical Benefit Scale to assess the value of abiraterone acetate (AA) and enzalutamide (E) in advanced prostate cancer: clinical value and cost considerations.

276 Background: AA and E improve overall survival (OS) in metastatic castration resistant prostate cancer (mCRPC). AA also improves OS in metastatic castration sensitive disease (mCSPC). However, concerns exist over the cost implications of earlier treatment versus the clinical benefit gained. We aimed to quantify and compare the clinical value of AA and E and their drug costs in both the mCRPC and mCSPC settings. Methods: We identified 6 randomized Phase 3 trials of AA and E in mCRPC and mCSPC. Net clinical benefit was quantified by the ASCO Value Framework version 2 (range < 180) and ESMO MCBS version 1.1 (range 1-5)—both consider benefits in overall survival, progression free survival, and quality of life, against increase in drug toxicity. A higher score indicates greater value. Incremental cancer drug costs were also calculated, using average wholesale price from the REDBOOK and the trials’ reported duration of treatment. Results: (Table). Conclusions: AA and E administered in early mCSPC do not provide consistent increases in net clinical benefit compared to mCRPC, but they incur exponential cost considerations. Alternatives such as chemotherapy, which may provide similar net clinical benefit at less incremental costs, still warrant major consideration for clinicians and patients. Until more information is available to define the optimal sequencing of AA, E and other available treatment modalities, current cost implications may hinder moving these agents to earlier treatment settings.[Table: see text]

Differentiation of wholesale prices for organic agricultural products

The urgency of the study is based on the fact that for a long time, there have been disputes in the scientific world about methods and models for determining the value of prices, on the basis of which the economic accessibility of various kinds of organic products depends. It is especially important to resolve the issue of setting prices for agricultural cooperatives, which have developed in the Russian market economy. The purpose of the study is to find a method for setting wholesale prices for organic products, the consumer demand for which has increased over the past two years and exceeded the level established by the Russian Academy of Medical Sciences. The following methods were used in the study: analytical, systemic, comparative, economic and mathematical, hypothetical, questionnaires, etc. The study conducted an excursus into the field of basic theories of determining prices created by scientists, on the basis of which it was concluded that there is no single approach to determining their values. The prices for organic agricultural products sold by large retailers are analyzed. Using a sample of closest prices of various agricultural producers, average wholesale prices for agricultural products were determined for three regions of the Central Federal District. As a result of the conducted study, the wholesale price for organic agricultural products (on the example of potatoes) purchased by wholesale distribution centers providing the needs of the population of Moscow and the Moscow region was substantiated.

The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.

Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. To examine the clinical evidence for approval and association with prices and shortages of previously unapproved prescription drugs after being addressed by the UDI. Previously unapproved prescription drugs that faced UDI regulatory action or with at least 1 product that received FDA approval through manufacturers' voluntary compliance with the UDI between 2006 and 2015 were identified. The clinical evidence was categorized as either newly conducted clinical trials or use of previously published literature and/or bioequivalence studies to demonstrate safety and efficacy. We determined the change in average wholesale price, presence of shortage, and duration of shortage for each drug during the 2 years before and after UDI regulatory action or approval through voluntary compliance. Between 2006 and 2015, 34 previously unapproved prescription drugs were addressed by the UDI. Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. Among the 26 drugs with available pricing data, average wholesale price during the 2 years before and after voluntary approval or UDI action increased by a median of 37% (interquartile range [IQR] = 23%-204%; P < 0.001). The number of drugs in shortage increased from 17 (50.0%) to 25 (73.5%) during the 2 years before and after, respectively (P = 0.046). The median shortage duration in the 2 years before and after voluntary approval or UDI action increased from 31 days (IQR = 0-339) to 217 days (IQR = 0-406; P = 0.053). The UDI was associated with higher drug prices and more frequent drug shortages when compared with the period before UDI action, while the approval process for these drugs did not necessarily require new clinical evidence to establish safety or efficacy. This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholars program. Ross reports receiving research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing; from Medtronic and the FDA to develop methods for postmarket surveillance of medical devices; from the FDA to establish the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency at Yale. Fox reports travel support from Oklahoma Society of Health System Pharmacists, Premier Oncology Hematology Management Society, and SEHA-United Arab Emirates. Vizient provides some financial support to the University of Utah Drug Information Service to provide summaries of drug shortage information. Gupta and Ross were responsible for the conception and design of this work, drafted the manuscript, and conducted the statistical analysis. Gupta and Fox were responsible for acquisition of data. Ross provided supervision. All authors participated in the analysis and interpretation of the data and critically revised the manuscript for important intellectual content.

Cost comparison of commonly used postoperative topical ophthalmic antibiotics

To provide information on the actual fill level and cost ofcurrently available antibiotic drops used perioperatively. Prospective laboratory investigation. Robert Cizik Eye Clinic, Houston, Texas USA. The following 9 medications were tested: moxifloxacin, gatifloxacin(branded and generic), besifloxacin, levofloxacin, ciprofloxacin, ofloxacin, trimethoprim/polymyxin B, tobramycin, and gentamicin. Actual bottle-fill volume and number of drops per bottle were measured using 10 bottles of each formulation. The percentage of the bottle used and the perioperative cost (using average wholesale price) were calculated for 3 times a day and 4 times a day dosing for 7-day, 10-day, and 14-day courses. Formulations were compared using 1-way analysis of variance with Tukey multiple comparisons. For medications with sticker volumes of at least 5mL, all but 2 medications (ofloxacin, 4 times a day for 14days; gentamicin, 4 times a day for 14days) covered 2 perioperative courses. Besifloxacin had a fill volume less than thesticker volume.The most cost-effective perioperative antibiotic prophylaxis was trimethoprim-polymyxin B (4 times a day: $12.87 for 7-day, 10-day, and 14-day courses, and $46.88 for 4-day course; 3 times a day: $12.87 for 7-day, 10-day, and 14-day courses). Most antibiotics had an actual fill volume greater than sticker volume, which is a sufficient drug regimen for 2 perioperative courses. The costs of common postoperative topical antibiotic regimens vary widely depending on the drug and dosing regimen. Cost considerations for perioperative antibiotics will be increasingly important because the number of cataract surgeriesis expectedto increase with the growing and aging population.

A Comparison of Clofarabine-based (GCLAC) and Cladribine-based (CLAG) Salvage Chemotherapy for Relapsed/Refractory AML

BackgroundSalvage regimens for patients with relapsed/refractory acute myeloid leukemia (rrAML) lack comparative data for superiority. Thus, we conducted a retrospective analysis of clofarabine-based (GCLAC; granulocyte colony-stimulating factor [filgrastim], clofarabine, high-dose cytarabine) versus cladribine-based (CLAG; cladribine, cytarabine, granulocyte colony-stimulating factor [filgrastim]) regimens in rrAML. Patients and MethodsWe identified 41 consecutive patients with rrAML who had received either GCLAC or CLAG from 2011 to 2014. The primary outcome measure was the complete remission (CR) rate defined according to the International Working Group criteria. The secondary outcomes included the proportion of patients who underwent allogenic stem cell transplantation and the rate of relapse-free survival and overall survival. ResultsWe found no significant differences in the baseline characteristics of the patients treated with GCLAC (n = 22) or CLAG (n = 19). The outcomes with these 2 regimens were not significantly different. Patients treated with GCLAC had a CR/CR with incomplete blood count recovery rate of 64% compared with 47% for the patients treated with CLAG (P = .36). Of the GCLAC patients, 45% underwent allogeneic stem cell transplantation compared with 26% of the CLAG patients (P = .32). The median relapse-free survival after GCLAC and CLAG was 1.59 years and 1.03 years, respectively (P = .75). The median overall survival after GCLAG and CLAG was 1.03 years and 0.70 years, respectively (P = .08). The drug costs were significantly different for GCLAC versus CLAG. Using an average wholesale price, the cost per patient per cycle was $60,821.60 for GCLAC and $4910.60 for CLAG. ConclusionA single-institutional retrospective analysis found no significant differences in the outcomes between GCLAC and CLAG for rrAML patients, although formal comparisons should be performed in a randomized clinical trial. The cost of GCLAC was greater than that of CLAG, which should be considered when evaluating the choice for the salvage chemotherapy options.

No correlation between the prices of oncology orphan drugs in the US and their patient population sizes

BackgroundWe sought to assess if orphan oncology drugs that target smaller populations are costlier than those that target larger ones. MethodsA list of orphan drugs designated by the FDA and diseases prevalence was retrieved from the FDA. Average Wholesale Prices per unit were obtained from the Red book database. FindingBetween June 2011 and June 2016, the FDA approved 31 unique regimens. Their annual treatment costs ranged from $9474 to $230,400, with a median of $140,893. InterpretationThere was no linear or exponential relationship between drug price and the size of their patient population. Further research is needed to bring more transparency of drug pricing in the US and align the prices of orphan drugs with the target population size and other relevant factors.

Retrospective cross-sectional pilot study of rifaximin dosing for the prevention of recurrent hepatic encephalopathy.

Standard treatment for hepatic encephalopathy (HE) includes medications that reduce ammonia and bacterial translocation in the gut. Rifaximin can be used off-label for the reduction of overt HE. The study purpose was to determine efficacy of traditional rifaximin dosing (400mg three times daily) compared with newer dosing (550mg twice daily) via readmission rates for the prevention of recurrent HE. This was a retrospective, observational, cross-sectional pilot study conducted in a tertiary medical center. A total of 226 patients 18-89years of age with documentation of HE via ICD-9 code who started rifaximin therapy while inpatient between April 2009 and June 2014 were evaluated. Data collected included rifaximin dosing, other medications used to treat HE, duration of therapy, time to readmission, and various laboratory values. There were no differences in readmission rates at 30days, 60days, or 6months between treatment groups. Additionally, there was no difference in the odds of readmission between the treatment groups (OR=0.77, 95% CI: [0.201, 4.365], P=0.718). Patients had a low overall probability of readmission over the observational period. Based on average wholesale price data, the cost for a 9-day supply of rifaximin for the 400-mg dosing regimen is $952.56 versus $605.16 for the 550-mg dosing regimen. The rifaximin 550-mg dosing strategy should be utilized in hospitalized patients for the prevention of recurrent HE as there was no difference in readmission rate or time to readmission between dosing groups. The 550-mg regimen had a lower acquisition cost for a 9-day duration of treatment in the studied institution.

Clevidipine versus sodium nitroprusside in acute aortic dissection: A retrospective chart review

AimIntravenous vasodilators are often added to beta-blocking agents to reach blood pressure (BP) goals in aortic dissection. Control of BP using clevidipine has been described in hypertensive emergencies and cardiac surgery but not in aortic dissection. The aim of this study was to compare clevidipine versus sodium nitroprusside (SNP) as adjunct agents to esmolol for BP management in aortic dissection. MethodsA single-center retrospective chart review evaluated patients diagnosed with aortic dissection. The primary outcome measure was time to reach patient specific systolic blood pressure (SBPPT) goals after initiation of esmolol infusion. Efficacy of clevidipine and SNP was assessed using area under the curve analysis of positive and negative excursions outside of SBPPT goals (AUCSBPe). Cost data was calculated using average wholesale price in U.S. dollars. ResultsFourteen patients were included in final analyses. Median systolic BP immediately prior to initiation of esmolol was 162mm Hg vs 161mm Hg for clevidipine and SNP groups, respectively (p=0.99). Median time to reach SBPPT goal was similar between clevidipine and SNP (1.68 versus 1.03h [p=0.99]). Median AUCSBPe was similar for clevidipine and SNP (206.9 versus 538.9 mm Hg∗min∗hr−1 [p=0.11]). Cost was significantly reduced using clevidipine versus SNP ($1223.28/day versus $7674.24/day [p<0.001]). ConclusionsClevidipine administration during initial medical management of aortic dissection showed similar efficacy compared to SNP when used as adjunct therapy to esmolol. These data suggest clevidipine is a less costly, reasonable alternative to SNP in acute aortic dissection as adjunct therapy to esmolol. Further studies are needed to validate these results.

Delivery of meaningful cancer care: a retrospective cohort study assessing cost and benefit with the ASCO and ESMO frameworks

The American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) have developed frameworks that quantify survival gains in light of toxicity and quality of life to assess the benefits of cancer therapies. We applied these frameworks to a cohort of contemporary randomised controlled trials to explore agreement between the two approaches and to assess the relation between treatment benefit and cost. We identified all randomised controlled trials of systemic therapies in non-small-cell lung cancer, breast cancer, colorectal cancer, and pancreatic cancer published between Jan 1, 2011, and Dec 31, 2015, and assessed their abstracts and methods. Trials were eligible for inclusion in our cohort if significant differences favouring the experimental group in a prespecified primary or secondary outcome were reported (secondary outcomes were assessed only if primary outcomes were not significant). We assessed trial endpoints with the ASCO and ESMO frameworks at two timepoints 3 months apart to confirm intra-rater reliability. Cohen's κ statistic was calculated to establish agreement between the two frameworks on the basis of the median ASCO score, which was used as an arbitrary threshold of benefit, and the framework-recommended ESMO threshold. Differences in monthly drug cost between the experimental and control groups of each randomised controlled trial (ie, incremental drug cost) were derived from 2016 average wholesale prices. 109 randomised controlled trials were eligible for inclusion, 42 (39%) in non-small-cell lung cancer, 36 (33%) in breast cancer, 25 (23%) in colorectal cancer, and six (6%) in pancreatic cancer. ASCO scores ranged from 2 to 77; median score was 25 (IQR 16-35). 41 (38%) trials met the benefit thresholds in the ESMO framework. Agreement between the two frameworks was fair (κ=0·326). Among the 100 randomised controlled trials for which drug costing data were available, ASCO benefit score and monthly incremental drug costs were negatively correlated (ρ=-0·207; p=0·039). Treatments that met ESMO benefit thresholds had a lower median incremental drug cost than did those that did not meet benefit thresholds (US$2981 [IQR 320-9059] vs $8621 [1174-13 930]; p=0·018). There is only fair correlation between these two major value care frameworks, and negative correlations between framework outputs and drug costs. Delivery of optimal cancer care in a sustainable health system will necessitate future oncologists, investigators, and policy makers to reconcile the disconnect between drug cost and clinical benefit. None.

Delivery of meaningful cancer care: Evaluating benefit and cost of cancer therapies using ASCO and ESMO frameworks.

6609 Background: ASCO and ESMO have developed frameworks to evaluate the benefit of cancer therapies. Here, we apply the frameworks to a cohort of contemporary randomized controlled trials (RCTs) to explore agreement and to evaluate the relationship between treatment benefit and cost. Methods: Characteristic and outcome data from RCTs evaluating systemic therapies in non-small cell lung cancer (NSCLC), breast cancer, colorectal cancer (CRC), and pancreatic cancer published and cited in PubMed between 2011-2015 were abstracted. Trial endpoints were evaluated using ASCO and ESMO frameworks. Cohen’s kappa statistic was calculated to determine agreement between the two frameworks, using the median ASCO score as a benefit threshold. Differences in monthly drug cost between RCT experimental and control arms were derived from 2016 average wholesale prices. Analyses included Pearson chi-square tests, Fisher’s Exact tests, independent samples t-tests, and Pearson correlation to assess the association between continuous variables. Results: Fifty percent (136/271) of published RCTs favoured the experimental arm; scoring rubrics were applicable to 109 RCTs (39% NSCLC, 33% breast, 23% CRC, 5% pancreas). ASCO scores ranged from 2 to 72; median score was 25. Thirty seven percent (40/109) of RCTs met benefit thresholds using the ESMO framework. Agreement between frameworks was fair at best (κ = 0.28, p = 0.002). When stratified by treatment intent (19 curative, 90 palliative RCTs), agreement remained poor (κ = 0.23, p = 0.115; κ = 0.34, p &lt; 0.001). Major differences leading to limited agreement includes the relative weights each framework places on HR, endpoints, and toxicity/QOL analysis. Smaller RCT sample size was the only trial characteristic associated with higher ASCO scores (p = 0.015). Among the 100 RCTs for whom drug costing data were available, there was no association between ASCO benefit score and monthly drug costs (r = -0.12, p = 0.22); those meeting ESMO thresholds had a lower mean drug cost than those who did not (p = 0.046). Conclusions: There is only fair correlation between ASCO and ESMO clinical benefit frameworks. Drug costs are not associated with ESMO/ASCO measures of magnitude of clinical benefit.

Trends in and relation between hip fracture incidence and osteoporosis medication utilization and prices in Estonia in 2004-2015.

Osteoporosis is a major cause of morbidity and mortality in the modern world. Our study aims to describe the trends in incidence of hip fractures in relation to drug utilization patterns and the average price of antiosteoporotic medicines in Estonia. Data on hip fractures was obtained from the medical claims database of Estonian Health Insurance Fund (EHIF). Consumption and price data was obtained from the Estonian State Agency of Medicines (SAM).Consumption is presented using WHO defined daily doses methodology, and the prices reflect the average wholesale price of medicines. From 2004 to 2010 there was a non-significant increasing trend in standardized hip fracture incidence in Estonia, but from 2010 to 2015, the trend turned to a significant decrease of 4.5% per year. The consumption of osteoporosis medication increased significantly from 2004 to 2009 by yearly average of 41.2%. After 2009, the consumption levelled. On contrast, the average price of one daily dose of osteoporosis medication decreased significantly from 2004 to 2009 by 16.9% per year and the decrease also levelled after 2009. This gives a very strong negative correlation of -0.93 (p<0.001) between the consumption of antiosteoporotic medication and the average price of a daily dose of medication during the study period. The statistically significant decline of standardized incidence of hip fractures from 2010 onward could at least in part be the result of the high increase in consumption of antiosteoporotic medicines which in turn is strongly negatively correlated with the average price of osteoporosis medicines.

Comprehensive assessment of the effective scope of modernization of thermal power plants to substantiate the rational structure of the generating capacities for the future until 2035

The article deals with issues of technical and economic substantiation of priorities and scopes of modernizing the existing thermal power plants (TPPs) in Russia to work out long-term forecasts of the development of the industry. The current situation in the TPP modernization trends is analyzed. The updated initial figures of the capital and operation costs are presented and the obtained estimates of the comparative efficiency of various investment decisions on modernization and equipment replacement at gas-and-oil-burning and coal-fired TPPs with regard to the main zones of the national Unified Power System (UPS) of Russia are cited. The results of optimization of the generating capacity structure underlie a study of alternative TPP modernization strategies that differ in the scope of switching to new technologies, capital intensity, and energy efficiency (decrease in the average heat rate). To provide an integral economic assessment of the above strategies, the authors modified the traditional approach based on determination of the overall discounted costs of power supply (least-cost planning) supplemented with a comparison by the weighted average wholesale price of the electricity. A method for prediction of the wholesale price is proposed reasoning from the direct and dual solutions of the optimization problem. The method can be adapted to various combinations of the mechanisms of payment for the electricity and the capacity on the basis of marginal and average costs. Energy and economic analysis showed that the opposite effects of reduction in the capital investment and fuel saving change in a nonlinear way as the scope of the switch to more advanced power generation technologies at the TPPs increases. As a consequence, a strategy for modernization of the existing power plants rational with respect to total costs of the power supply and wholesale electricity prices has been formulated. The strategy combines decisions on upgrade and replacement of the equipment at the existing power plants of various types. The basic parameters of the strategy for the future until 2035 are provided.

Potential cost savings by dose down-rounding of monoclonal antibodies in a community cancer center.

Purpose Increasing new cancer cases and approval of effective but expensive new drugs extending survival have led to unsustainable cancer care costs. Potential cost savings by a hypothetical dose down-rounding project of monoclonal antibodies at a community-based cancer center is presented. Methods From October 2014 through October 2015, metastatic cancer patients receiving monoclonal antibodies at CHI-Health St Francis Cancer Treatment Center in Grand Island, Nebraska, were identified through electronic health records. A total of 11 different types of monoclonal antibodies that were administered during the study period were identified. Trastuzumab, ofatumumab, and obinutuzumab did not require dose-rounding; thus, they were excluded from the analyses. Available vial size(s) and costs per milligram per average wholesale price for each monoclonal antibody were recorded. Costs of actual amounts prescribed were compared to the costs of theoretically reduced ≤5% and ≤10% doses rounded to the nearest vial sizes. Reduced doses resulting in a decreased number of opened vials qualified for meaningful dose down-rounding and were included in the analysis. Average actual dose reduction percentage resulting in cost savings for both groups was also calculated. Results A total of 728 doses of eight monoclonal antibodies suitable for dose down-rounding were identified. Vial sizes of pembrolizumab and ipilimumab did not allow for a meaningful dose down-rounding. At the ≤5% dose down-rounding, 255 of 728 doses (35%) qualified with a potential annual cost savings of $220,793.80. At the ≤10% dose down-rounding, 526 of 728 doses (72%) qualified with a potential annual cost savings of $454,461.00. The average actual dose reduction was 2.4% for the ≤5% dose reduction group and 4.9% for the ≤10% dose reduction group. Overall average cost savings per qualifying dose reduction was around $865.00. More doses qualified for cost savings in the ≤10% dose reduction group. Significant differences between different monoclonal antibodies for dose rounding at either ≤5% (p = 0.002) or ≤10% (p < 0.001) were observed. Conclusion A practical dose down-rounding procedure may allow significant cost reduction in metastatic cancer setting, where the cure is not the goal. Drug waste can be avoided by convenient vial sizes or can even be eliminated by lyophilized forms like in trastuzumab. Our data reflect the monoclonal antibody use and potential cost savings with the proposed dose down-rounding approach in a community-based cancer program.

Rising cost of antidotes in the U.S.: cost comparison from 2010 to 2015

Context: Our poison control center observed a large increase in the cost of many antidotes over the past several years. The high cost of antidotes has previously been cited as a factor leading to inadequate antidote supply at some hospitals. Continued increases in the cost of antidotes may lead to further reductions in antidote supply and represent serious concerns. This research aims to quantify recent trends in the costs of antidotes in the U.S.Methods: Antidotes and minimum stocking recommendations were retrieved from published guidelines. RED BOOK Online® was used to identify the U.S. average wholesale price (AWP) of each antidote in 2010 and 2015. The AWP in 2010 was adjusted using the U.S. Consumer Price Index to adjust for inflation. The cost of minimum stocking levels for each antidote was calculated and compared between the year 2010 and 2015.Results: The cost of stocking many antidotes demonstrated a large increase in AWP from 2010 to 2015. Of the antidotes evaluated, 15 out of 33 had greater than 50% increase in AWP and 8 out of 33 had greater than $1000 increase in AWP. Only four antidotes demonstrated decreases in AWP greater than 10% and only one antidote had its cost of stocking decrease in AWP by more than $1000.Discussion: The price increase over the last 5 years may further hinder the willingness of hospitals to stock recommended antidotes at adequate quantities. This may impede timely treatment of patients, and negatively impact poisoning outcomes.Conclusions: The price of many antidotes substantially increased in the United States from 2010 to 2015. Strategies should be investigated to help decrease the cost associated with stocking and use of antidotes, including dose rounding, consignment, and regional sharing.

ДИНАМІЧНИЙ МАРКЕТИНГОВИЙ АНАЛІЗ ВІТЧИЗНЯНОГО РИНКУ ПРОТИВІРУСНИХ ЛІКАРСЬКИХ ЗАСОБІВ ГРУП J05AB01, J05AХ05, J05AХ10

У статті висвітлені результати маркетингового аналізу груп противірусних препаратів, які рекомендовано для лікування хворих на дитячі вірусні інфекції (вітряну віспу, кір, краснуху). Упродовж 42 місяців - з 01.01.2013 до 01.07.2016 р. - був проведений щомісячний моніторинг їх асортименту, середніх оптово-відпускних цін, коефіцієнтів ліквідності та платоспроможності населення. Встановлено, що противірусні препарати груп ацикловіру У05ДВ01), інозинпранобексу^05ДХ05) та інших противірусних У05ДХ10: амізону, протефлазіду, флавозіду) є достатньо представлені на вітчизняному фармацевтичному ринку, доступність яких зросла наприкінці моніторингу. Найнижчою їх оптово-відпускна ціна була у січні 2013 р., а найвищою - у жовтні - листопаді 2014 та 2015 рр., березні - квітні 2016 р. Не спостерігається прямої залежності між динамікою оптової ціни препаратів і динамікою курсу гривні відносно до долара, оскільки стрибки підйому оптово-відпускних цін випереджували ріст долара на 1-3 місяці для одних ліків, а для інших, навпаки, на тлі загального росту відбулося різке зниження ціни. Тому на даний час цей сегмент оптового фармацевтичного ринку лікарських засобів не можна вважати достатньо прогнозованим.

Use of a Sulfa Desensitization Protocol in Solid Organ Transplant Recipients

BackgroundTrimethoprim–sulfamethoxazole (TMP-SMX) is first-line for pneumocystis prophylaxis in solid organ transplant (SOT) recipients. TMP-SMX also offers the advantage of urinary tract infection (UTI) prophylaxis (for kidney recipients) and activity against other opportunistic infections. Alternatives for sulfa allergic patients are inferior from the standpoint of pneumocystis protection, activity against other opportunistic infections and cost.MethodsIn 2013, our SOT program adopted a system-wide protocol for TMP-SMX desensitization during the index transplant hospitalization. Patients with a historical non-anaphylactic allergy were exposed to increasing doses of TMP-SMX and monitored for allergic reaction. If tolerated, they received standard prophylaxis with TMP-SMX. We completed a retrospective chart review of all patients identified for desensitization. We performed a cost analysis to estimate cost savings associated with the protocol.ResultsForty-three patients were identified and consented for the desensitization protocol. Thirty-eight (88%) were kidney recipients and the remainder were liver or heart recipients. See Figure 1 for pre-desensitization historical allergies. Thirty-six (84%) did not have an allergic reaction during desensitization; 33 ultimately completed 3 months of TMP-SMX prophylaxis; 7 had non-serious allergic or other reactions either during desensitization or before completing 3 months of prophylaxis (Figure 2). See Table 1 for details of reactions. Based off approximate average wholesale prices for 3 months of standard prophylaxis dosing of TMP-SMX ($65), pentamidine ($600) and nitrofurantoin ($220), we estimated a savings of $755 per kidney recipient, comparing TMP-SMX to an alternative of pentamidine and nitrofurantoin (for UTI prophylaxis for kidney recipients).ConclusionSystematic, protocol-driven TMP-SMX desensitization during index transplant hospitalization is safe and effective in SOT recipients, with resultant cost savings and broader spectrum coverage than second line agents.Table 1Allergic responses n = 7Occurred during protocol resulting in discontinuation4Occurred during index hospital stay6Resulted in higher acuity of care or prolonged admission0Hives2Other reaction5Disclosures L. Strasfeld, Merck: Independent Contractor, Salary

Cost-effectiveness of anticoagulants for suspected heparin-induced thrombocytopenia in the United States

Despite the availability of multiple nonheparin anticoagulants for the treatment of heparin-induced thrombocytopenia (HIT), few data are available comparing the cost-effectiveness of these agents. This analysis is particularly important when considering differences in the risk of adverse effects, routes of administration, requirements for phlebotomy and laboratory monitoring, and overall drug costs. We conducted a cost-effectiveness analysis of argatroban, bivalirudin, and fondaparinux for the treatment of suspected HIT from the institutional perspective. A 3-arm decision-tree model was developed that employs standard practices for anticoagulation monitoring. We incorporated published data on drug efficacy and probability of HIT-related thromboembolism and major bleeding. We considered both institutional costs and average wholesale price (AWP) and performed probabilistic sensitivity analyses (PSA) to address any uncertainty in model parameters. Using institutional costs, fondaparinux prevailed over both argatroban and bivalirudin in terms of cost ($151 vs $1250 and $1466, respectively) and adverse events averted (0.9989 vs 0.9957 and 0.9947, respectively). Results were consistent when AWP was used, with fondaparinux being less expensive ($555 vs $3081 and $2187, respectively) and more effective in terms of adverse events averted (0.9989 vs 0.9957 and 0.9947, respectively). The PSA confirmed our findings using both institutional costs and AWP. In conclusion, fondaparinux subcutaneous injection afforded significant advantages in terms of cost savings and adverse events averted compared with IV argatroban or bivalirudin infusions. Our data strongly suggest potential cost savings with fondaparinux and underscore the critical need for larger clinical studies of fondaparinux in the treatment of suspected HIT.