Cost effectiveness of adding leflunomide to a 5-year strategy of conventional disease-modifying antirheumatic drugs in patients with rheumatoid arthritis.
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OBJECTIVE: To estimate, from a public payer's perspective, the 5-year cost effectiveness of adding leflunomide (LEF) to a sequence of disease-modifying antirheumatic drugs (DMARDs) representative of a typical rheumatoid arthritis (RA) management approach adopted by Canadian rheumatologists. METHODS: A DMARD sequence including LEF was compared with one excluding it, using a 5-year simulation model where patients with RA cycle through different treatment regimens. Data were obtained through a systematic literature search (drug withdrawal rates, number and type of adverse events, American College of Rheumatology 20% responder status) and separately conducted surveys (choice of DMARD sequence, management of adverse events). Costs for adverse event management were calculated using the Ontario Schedule of Benefits, and monitoring costs were calculated according to official Canadian product monograph recommendations. Wholesale prices of all drugs were adjusted by the allowable markup and prescription fees. Utilities (as measured by the standard gamble [SG] and rating scale [RS] techniques) were obtained from 482 patients who participated in a 1-year randomized controlled trial that compared LEF, methotrexate, and placebo. Costs and utilities were discounted by 3%. Probabilistic sensitivity analysis was performed. RESULTS: Adding LEF to a conventional strategy of DMARDs increased the 5-year management costs by $1,231 compared with the strategy without LEF, which results in a cost-effectiveness ratio of $13,096 per additional year of response to treatment, and cost-utility ratios of $54,229 (RS) and $71,988 (SG) per quality-adjusted life-year gained. CONCLUSION: Adding LEF as a new option to a conventional sequence of DMARDs extends the time patients may benefit from DMARD therapy at a reasonable cost effectiveness and cost utility. LEF data are limited to clinical trials; data from observational studies would be needed to corroborate these findings. (+info)
Economic analysis of oral and topical therapies for onychomycosis of the toenails and fingernails.
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OBJECTIVE: Several antifungal agents are indicated for onychomycosis, a fungal infection of the toenails and fingernails. These agents differ in their dosing regimen, efficacy, adverse events profile, potential for drug interaction, and cost. We conducted a pharmacoeconomic analysis of oral and topical therapies for onychomycosis from the perspective of a hypothetical managed care payer to determine the most cost-effective agent. DESIGN: A decision analytic model was developed to evaluate the pharmacoeconomic profiles of itraconazole-continuous (Sporanox, Janssen Pharmaceutica), itraconazole-pulse (Sporanox, Janssen Pharmaceutica), terbinafine (Lamisil, Novartis Pharmaceuticals), and ciclopirox (Penlac, Dermik Laboratories) in the treatment of fingernail and toenail onychomycosis. METHODOLOGY: We conducted a meta-analysis of the available literature to populate the decision analytic model with clinical point estimates for success, failure, and relapse. A panel of expert dermatologists defined resources consumed during the onychomycosis treatment process. These resources were then assigned values, using publicly available data sources, to reflect the U.S. managed care perspective. These clinical and economic data elements were integrated in the decision analytic model to arrive at the expected cost of treatment for each drug. Additionally, incremental cost-effectiveness was calculated for treatment success and disease-free days achieved by each therapy. Finally, a policy-level analysis of the budgetary impact of using the therapies for onychomycosis in a managed care setting was conducted. RESULTS: The meta-analysis demonstrated terbinafine to be the therapeutic alternative with the highest success rate for both fingernails (96.55 percent) and toenails (81.15 percent). Terbinafine also had the lowest relapse rate (6.42 percent) and the highest number of disease-free days for both fingernails and toenails. Subsequently, in terms of cost-effectiveness, terbinafine dominated all other comparators for fingernails and toenails. CONCLUSIONS: Based on the patient-level analysis, we concluded that terbinafine is the most cost-effective therapy in the treatment of onychomycosis from a managed care perspective. Furthermore, at the policy level, increased utilization of terbinafine among onychomycosis patients is likely to reduce the managed care organizations' per member per month cost. (+info)
Cost-minimisation analysis of pegylated liposomal doxorubicin hydrochloride versus topotecan in the treatment of patients with recurrent epithelial ovarian cancer in Spain.
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The study consisted of a cost-minimisation analysis since the findings from a multicentre randomised phase III trial showed that pegylated liposomal doxorubicin hydrochloride was at least as efficacious as topotecan. An economic model from the Spanish hospitals perspective was constructed to compare the costs derived from the treatment using both drugs in patients with recurrent epithelial ovarian cancer who failed a first-line platinum-containing regimen. The cost evaluation included direct medical costs: drug, drug administration and costs of managing adverse events. Estimation of resources used in managing adverse events was made retrospectively through an expert panel. Results obtained per patient were: cost of drug and administration, 8647.70 euros for pegylated liposomal doxorubicin hydrochloride and 8519.94 euros for topotecan, while cost of managing adverse events was 967.02 euros in the pegylated liposomal doxorubicin hydrochloride arm and 3304.75 euros for topotecan. The total cost per patient was therefore estimated to be 9614.72 euros for pegylated liposomal doxorubicin hydrochloride and 11 824.69 euros for topotecan, showing that pegylated liposomal doxorubicin hydrochloride produces a cost saving of 2209.97 euros per patient in comparison to topotecan. Sensitivity analyses verified the robustness of the results. These findings suggest that pegylated liposomal doxorubicin hydrochloride is an efficient therapy and can be used as a cost-saving option for treatment of patients with recurrent epithelial ovarian cancer who have failed a first-line platinum-containing regimen. (+info)
The costs of conducting clinical research.
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PURPOSE: Physicians frequently receive payment for enrolling subjects onto clinical trials. Some view these payments as conflicts of interest. Others contend that these payments are necessary reimbursements for conducting clinical research. We evaluated the clinical and nonclinical hours and costs associated with conducting a mock phase III clinical research trial. METHODS: We collected data from representatives of 21 clinical sites, on the numbers of hours associated with 13 activities necessary to the conduct of clinical research. The hours were based on enrolling 20 patients in a 12-month randomized placebo-controlled trial of a new chemotherapeutic agent. The outcome measures were disease progression and quality-of-life reports. These costs were evaluated for both government and pharmaceutical industry-sponsored trials. RESULTS: On average, 4,012 hours (range, 1,512 to 13,319 hours) were required for a government-sponsored trial, and 3,998 hours (range: 1735 to 15,699) were required for a pharmaceutical industry-sponsored trial involving 20 subjects with 17 office visits, or approximately 200 hours per subject. Thirty-two percent of the hours were devoted to nonclinical activities, such as institutional review board submission and completion of clinical reporting forms. On average, excluding overhead expenses, it cost slightly more than 6,094 dollars (range, 2,098 dollars to 19,285 dollars) per enrolled subject for an industry-sponsored trial, including 1,999 dollars devoted to nonclinical costs. CONCLUSION: Based on the results of our mock trial, the time required for nontreatment trial activities is considerable, and the associated costs are substantial. (+info)
The use of health economic information by reimbursement authorities.
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The increasing costs of health-care and the need for cost containment have resulted in a 'fourth hurdle' in the establishment of drug approval and reimbursement policies. This hurdle is the demonstration of a drug's cost-effectiveness through the process of economic evaluation. The role of models in the economic evaluation of pharmaceuticals is becoming increasingly accepted with the recent trend towards developing models with greater transparency and clinical relevance. However, health-care decisions do not, and should not, rely solely on the cost-effectiveness of a drug or intervention. Factors such as disease severity, availability of alternative treatment strategies, cost of drugs to patients, compliance with therapy and patients' satisfaction with overall treatment effectiveness should also be considered, and in some cases can be incorporated into economic evaluation. The Arthritis Cost Consequences Evaluation System (ACCES) is provided as an example of the attributes and limitations that should be considered in determining the usefulness of a model for economic evaluations with the purpose of determining reimbursement policy decisions. (+info)
Industry's perception of presenting pharmacoeconomic models to managed care organizations.
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BACKGROUND: Previous research has shown that pharmacoeconomic (PE) data are considered important but may not be optimally utilized by decision makers. No research has compared the effectiveness of different types of PE models. OBJECTIVES: The purpose of this study was to examine the perceived value and understanding of PE models among decision makers in managed care organizations. The perspective of this study was from research scientists working in the pharmaceutical industry who present PE models to managed care clients. The study objectives were to (1) examine what types of models are best received by decision makers, (2) investigate the barriers to using PE models, and (3) recommend methods for improving PE models. METHODS: A telephone survey of 39 items was conducted with 20 PE research scientists from various U.S. pharmaceutical and biotechnology companies. Topics addressed included factors contributing to how well PE models are received, barriers to using PE models, and recommendations for improving PE models. RESULTS: Models have an impact on health policy decision making. Nineteen of 20 respondents had at least one experience where a PE model played a role in optimizing the formulary positioning of a product. No single model format (e.g., decision analytic tools, spreadsheet analyses, Markov models, multivariate regression models) was regarded as the most effective model type. Although 7 of 20 respondents said simple spreadsheet models were most effective, well-designed, scientifically sound regression models were also reported to be very effective. CONCLUSIONS: The respondents commonly used models to share PE information, which was said to play a role in making health policy decisions by decision makers in managed care. There was no consensus regarding the type of model that was most effective. Study participants indicated that a variety of model designs are effective, ranging from simple spreadsheet models to multivariate regression models. Recommendations for improving PE models include (1) producing scientifically sound models, (2) customizing models where possible, (3) making models transparent, (4) making models user friendly, and (5) involving a nonbiased third party for model development. (+info)
Examining the value and quality of health economic analyses: implications of utilizing the QHES.
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OBJECTIVE: To examine the increasing use of health economic studies and practical implications of evaluating their quality utilizing the Quality of Health Economic Studies (QHES) instrument. METHODS: We first reviewed secondary references to examine ways in which health economic analyses are used in different health care settings, the manner in which these data are appraised and evaluated, and their relevance and value in decision making. The QHES, a new instrument designed to support fast, accurate initial assessments of study quality, was then introduced and validated. A case study was performed using the QHES to score the quality of 30 cost-effectiveness studies in gastroesophageal reflux disease (GERD) published since 1985. Areas where additional research could guide efforts to identify and enhance the use of higher-quality cost-effectiveness studies were suggested. RESULTS: Results from the published validation study of the QHES demonstrated the validity of this new instrument. The resulting QHES scores in the case study of GERD papers ranged from 43 to 91 with a mean of 63.6 (SD=14.7). Approximately 27% of the studies rated had scores less than 50, and 27% had scores above or equal to 75. All 30 studies made conclusions and recommendations and justified them based on their study results. Most studies used appropriate cost and health outcome measures. Very few studies stated the perspective of their analysis and reasons for its selection. The majority of the studies did not perform incremental analysis. CONCLUSION: An examination of the QHES validation study and the case study in GERD suggests that there is a rationale and potential utility to use a quality scoring system for cost-effectiveness studies. The QHES may play an important role in discriminating higher-quality cost-effectiveness information to enhance decision making. The QHES can also serve as a guideline for conducting and reporting future cost-effectiveness studies, as an aid in the editorial process, and for stratification in systematic reviews. Complex decisions regarding resource allocation rarely rely solely on economic considerations but do increasingly use health economic analyses. To the extent that such analyses are used, the QHES may help ensure that higher-quality analyses receive more analytic attention and greater weight in the decision-making process. (+info)
Do decision-analytic models identify cost-effective treatments? A retrospective look at helicobacter pylori eradication.
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BACKGROUND: Pharmacoeconomic models of Helicobacter (H) pylori eradication have been frequently cited but never validated. OBJECTIVE: Examine retrospectively whether H pylori pharmacoeconomic models direct decision makers to cost-effective therapeutic choices. METHODS: We first replicated and then validated 2 models, replacing model assumptions with empirical data from a multipayer claims database. Database subjects were 435 commercially insured U.S. patients treated with bismuthmetronidazole- tetracycline (BMT), proton pump inhibitor (PPI)-clarithromycin, or PPI-amoxicillin. Patients met >1 clinical requirement (ulcer disease, gastritis/duodenitis, stomach function disorder, abdominal pain, H pylori infection, endoscopy, or H pylori assay). Sensitivity analyses included only patients with ulcer diagnosis or gastrointestinal specialist care. Outcome measures were: (1) rates of eradication retreatment; (2) use of office visits, hospitalizations, endoscopies, and antisecretory medication; and (3) cost per effectively treated (nonretreated) patient. RESULTS: Model results overstated the cost-effectiveness of PPI-clarithromycin and underestimated the cost-effectiveness of BMT. Prior to empirical adjustment, costs per effectively treated patient were 1,001 US dollars, 980 US dollars, and 1,730 US dollars for BMT, PPIclarithromycin, and PPI-amoxicillin, respectively. Estimates after adjustment were US dollars for BMT, 1,118 US dollars for PPI-clarithromycin, and 1,131 US dollars for PPI-amoxicillin. Key model assumptions that proved retrospectively incorrect were largely unsupported by either empirical evidence or systematic assessment of expert opinion. CONCLUSIONS: Organizations with access to medical and pharmacy claims databases should test key assumptions of influential models to determine their validity. Journal peer-review processes should pay particular attention to the basis of model assumptions. (+info)