Cost-effectiveness of raltegravir in HIV/AIDS.

Raltegravir is a first-in-class HIV-1 integrase inhibitor with established antiviral efficacy in treatment-naive and treatment-experienced patients with multidrug-resistant HIV-1 infection. In this article, we summarize pharmacoeconomic evaluations of raltegravir-based treatment regimens, compared with alternative therapies, in the treatment of patients with HIV infection and/or AIDS. Cost-effectiveness evaluations of raltegravir in treatment-experienced patients conducted using a continuous-time, state-transition Markov cohort model suggest that raltegravir, combined with optimized background therapy, falls within the range that would generally be considered cost effective compared with optimized therapy alone in Spanish, Swiss and UK health systems. In treatment-naive populations, raltegravir was evaluated using a three-stage continuous-time state-transition cohort model. Raltegravir-based initiation treatment strategies (first-line raltegravir) were compared with protease inhibitor and non-nucleoside reverse-transcriptase inhibitor initiation strategies, in which raltegravir was retained for salvage therapy. First-line raltegravir was cost-effective versus retaining raltegravir for salvage therapy in several European populations. A separate economic model was used to evaluate first-line raltegravir against two alternative initiation regimens representing standard clinical practice in Australia; raltegravir proved to be cost effective in both scenarios. In all studies examined, results were sensitive to factors including treatment duration, mortality rate, analytic time horizon, health utility weights, cost of raltegravir and optimized therapy, incidence of opportunistic infection and discount rates. Nonetheless, raltegravir remained cost effective under most scenarios.

Cost-effectiveness of raltegravir in antiretroviral treatment-experienced HIV-1-infected patients in Switzerland.

OBJECTIVES: Raltegravir, a novel integrase inhibitor, has shown great efficacy in reducing HIV viral load among treatment-experienced patients. A cohort state-transition model was used to assess the long-term effect of raltegravir treatment on costs and quality-adjusted life expectancy from a Swiss perspective. METHODS: Patients were stratified into health states according to opportunistic infection status, HIV RNA level, and CD4 count, with each group assigned a treatment cost and utility (quality of life) score. Model inputs came from published studies, clinical trials, and database analyses. Results were used to calculate incremental cost-effectiveness ratio (ICER) of raltegravir use, expressed in Swiss francs (CHF) as incremental cost/quality-adjusted life-year (QALY) gained. Future costs and QALYs were discounted at 3% per year. RESULTS: Five years of raltegravir treatment increased discounted quality-adjusted life expectancy by 3.73 years over placebo, with additional discounted cost of CHF 170,347, resulting in an ICER of CHF 45,687/QALY. ICERs ranged from CHF 42,751 to 53,478/QALY for treatment duration of 3 and 10 years, respectively. Results were most sensitive to changes in raltegravir treatment duration, source of estimated quality of life weights, and raltegravir price. CONCLUSIONS: Adding raltegravir to optimized background therapy was a cost-effective strategy for treatment-experienced patients in Switzerland.

Cost-effectiveness analysis of raltegravir in treatment-experienced HIV type 1-infected patients in Spain.

Raltegravir, a novel HIV-1 integrase inhibitor, has superior efficacy with optimized background treatment (OBT) vs. placebo + OBT in treatment-experienced HIV-1 patients. This study assessed the long-term cost effectiveness of raltegravir from a Spanish National Healthcare System perspective. A cohort-state-transition model was used to estimate clinical and economic outcomes associated with raltegravir + OBT vs. OBT alone. Subjects were stratified into health states according to HIV RNA level, CD4 count, and opportunistic infection (OI) history, and could transition into different health states over time based on projected long-term efficacy. Each health state was associated with a distinct treatment cost and utility (QoL) score. Model inputs for mortality, resource utilization, unit costs, OI risk, and long-term durability of viral suppression were obtained from clinical trials, published studies, and database analyses. Model outcomes were reported as incremental cost-effectiveness ratios (ICERs) in 2007 Euros per quality-adjusted life-year (euro/QALY) gained. Costs and QALYs were discounted at 6% per year based on Spanish cost-effectiveness guidelines. Extensive sensitivity analyses were conducted. Five years of treatment with raltegravir + OBT resulted in an additional 4.5 years of undiscounted life expectancy vs. OBT alone. The ICER of raltegravir + OBT vs. OBT alone was euro22,908/QALY and euro31,431/QALY for 3- and 5-year use, respectively. Lower ICERs were observed with lower discount rates (3%) for costs and benefits, lower raltegravir price (20%), and shorter treatment duration (3 years). ICER was also sensitive to analytical time horizon and alternative sources of QoL scores. In treatment-experienced Spanish patients, raltegravir was projected to provide survival benefits and be cost effective.

Comparative costs of ertapenem and cefotetan as prophylaxis for elective colorectal surgery.

BACKGROUND AND PURPOSE: The costs of treating surgical site infections can be considerable. There is a cost associated with the prophylactic use of antibiotics; however, the use of prophylactic agents may reduce infection rates and lengths of stay, thus offsetting the overall treatment cost and potentially generating cost savings to hospitals. This project was intended to determine the potential cost impact of using ertapenem 1 g vs. cefotetan 2 g as prophylaxis for elective colorectal surgery. METHODS: Cost analysis using efficacy data from the PREVENT clinical trial and drug acquisition and total hospital costs in 2005 dollars from Premier's Perspective Comparative Database in patients > or = 18 year of age, evaluable at four weeks after elective surgery of the colon or rectum and prophylactic treatment with ertapenem (n = 338) or cefotetan (n = 334). The primary outcome measures were the rate of prophylactic drug failure and the difference between the ertapenem and cefotetan groups in costs related to and total hospital stay. Prophylactic failure was defined as a surgical site infection, unexplained antibiotic use, or anastomotic leak. RESULTS: Prophylactic failure occurred in 28.1% of the patients receiving ertapenem and 42.8% of those receiving cefotetan (p < 0.05). The most common prophylactic failure was surgical site infection: 18.3% for ertapenem, 31.1% for cefotetan, difference (95% confidence interval) -13.0% (-19.5, -6.5%) (p < 0.05). The mean +/- standard deviation length of stay for all patients, including prophylactic successes and failures, was 7.6 +/- 6.6 days for ertapenem and 8.7 +/- 9.5 days for cefotetan. The mean per-patient cost of prophylactic drugs and hospital room and board was $15,245 with ertapenem and $17,428 cefotetan, a net difference of -$2,181. CONCLUSIONS: Ertapenem used in prophylaxis for elective colorectal operations results in a lower rate of surgical site infection and a shorter average length of stay than cefotetan. The calculated net difference in prophylactic antibiotic drug and hospital costs represents a saving of $2,181 per patient with ertapenem relative to cefotetan.

Economic evaluation of caspofungin versus liposomal amphotericin B for empiric antifungal treatment in patients with neutropenic fever in Italy.

OBJECTIVE: To evaluate the cost-effectiveness of caspofungin versus liposomal amphotericin B as empiric antifungal treatment in patients with neutropenic fever in Italy. METHODS: The cost-effectiveness of caspofungin versus liposomal amphotericin B was evaluated using a decision-tree model. Patients were stratified by presence or absence of baseline infection. Model outcomes included success in terms of resolution of fever, resolution of baseline infection, absence of breakthrough infection, survival, and quality-adjusted life years (QALYs) saved. Discontinuation because of nephrotoxicity or other adverse events were included in the model. Efficacy and safety data were based on a randomized, double-blind, multinational trial of caspofungin compared to liposomal amphotericin B (Walsh 2004). Information on life expectancy, quality of life, medical resource consumption, and costs was obtained from the literature. RESULTS: The caspofungin estimated total treatment cost amounted to 8351 euros (95% uncertainty interval 7801 euros-8903 euros), which is 3470 euros (2575 euros-4382 euros) less than with liposomal amphotericin B. Treatment with caspofungin resulted in 0.25 (-0.11; 0.59) QALYs saved in comparison to treatment with liposomal amphotericin B. Probabilistic sensitivity analysis demonstrated a 93% probability that caspofungin was economically dominant, i.e., cost and QALY saving, and a probability of more than 99% that the costs per QALY saved were below 20,000 euros, a commonly accepted threshold for cost-effectiveness. Additional analyses with alternative doses of liposomal amphotericin B confirmed these findings. CONCLUSION: Given the underlying assumptions, our economic evaluation demonstrated that caspofungin is cost-effective compared to liposomal amphotericin B in empiric antifungal treatment of patients with neutropenic fever in Italy.

The association of consumer expectations, experiences and satisfaction with newly prescribed medications.

OBJECTIVE: To examine the association between medication expectations and subsequent experience on treatment satisfaction and intention to continue using the medication. METHODS: A longitudinal study with two surveys administered to each patient. Patients prescribed a new medication were recruited in pharmacies within Michigan. Medication-related expectations were evaluated at baseline. Experiences, satisfaction and intent to continue were evaluated a month later. Analyses used included factorial ANOVA models, multiple linear regressions and structural equation modeling (SEM). Impact of satisfaction on intention to continue was evaluated using correlation analysis and SEM. RESULTS: A total of 344 usable responses were obtained. SEM showed that expectation scores were not associated with both experience (path coefficient = 0.10) and satisfaction (path coefficient = 0.02, NS). On the other hand, experience was strongly associated with satisfaction (path coefficient = 0.89) and satisfaction was strongly associated with intent to continue using the new medication (path coefficient = 0.81). CONCLUSIONS: This study empirically supports the value of the patient's experience and its contribution to satisfaction, which in turn is associated with intended continued use mainly due to greater effectiveness of the newly prescribed medication. Satisfied consumers should be more adherent, thus enhancing the probability of positive therapeutic outcomes.

A cost-effectiveness analysis of caspofungin vs. liposomal amphotericin B for treatment of suspected fungal infections in the UK.

OBJECTIVE: To evaluate the cost-effectiveness of caspofungin vs. liposomal amphotericin B in the treatment of suspected fungal infections in the UK. METHODS: The cost-effectiveness of caspofungin vs. liposomal amphotericin B was evaluated using a decision-tree model. The decision tree was populated using both data and clinical definitions from published clinical studies. Model outcomes included success in terms of resolution of fever, baseline infection, absence of breakthrough infection, survival and quality adjusted life years (QALYs) saved. Discontinuation due to nephrotoxicity or other adverse events were included in the model. Efficacy and safety data were based on additional analyses of a randomised, double blind, multinational trial of caspofungin compared with liposomal amphotericin B. Information on life expectancy, quality of life, medical resource consumption and costs were obtained from peer-reviewed published data. RESULTS: The caspofungin mean total treatment cost was 9762 pounds (95% uncertainty interval 6955-12,577), which was 2033 pounds (-2489; 6779) less than liposomal amphotericin B. Treatment with caspofungin resulted in 0.40 (-0.12; 0.94) additional QALYs saved in comparison with liposomal amphotericin B. Probabilistic sensitivity analysis found a 95% probability of the incremental cost per QALY saved being within the generally accepted threshold for cost-effectiveness (30,000 pounds). Additional analyses with varying dose of caspofungin and liposomal amphotericin B confirmed these findings. CONCLUSION: Given the underlying assumptions, caspofungin is cost-effective compared with liposomal amphotericin B in the treatment of suspected fungal infections in the UK.

Direct health care costs of 4 common skin ulcers in New Mexico Medicaid fee-for-service patients.

OBJECTIVE: To determine health care costs associated with pressure ulcers, ulcers of the lower limbs, other chronic ulcers, and venous leg ulcers from the New Mexico Medicaid fee-for-service program perspective. DESIGN: Retrospective analysis of claims database MAIN OUTCOME MEASURES: Physician visit, hospital, and prescription costs were determined for New Mexico Medicaid patients with a primary and/or secondary diagnosis of 1 of 4 identified categories of skin ulcers from January 1, 1994, through December 31, 1998. Costs were determined in terms of mean and median annual cost per patient and total costs per year. Zero dollar claims were included within the cost calculations. All costs are expressed in 2000-dollar values. MAIN RESULTS: Mean annual physician visit costs per patient ranged from $71 (standard deviation [SD] = $60) for venous leg ulcers in 1998 to $520 (SD = $1228) for pressure ulcers in 1996. Mean annual hospital costs per patient ranged from $266 (SD = $348) for other chronic ulcers in 1998 to $15,760 (SD = $30,706) for pressure ulcers in 1998. Mean annual prescription costs per patient ranged from $145 (SD = $282) for other chronic ulcers in 1998 to $654 (SD = $1488) for pressure ulcers in 1994. CONCLUSION: The New Mexico Medicaid fee-for-service system incurred a total cost of approximately $11.6 million (in 2000 dollars) from 1994 through 1998 for the treatment of the 4 categories of skin ulcers studied. The data showed that the majority of wounds were coded as pressure ulcers, which had the highest associated costs.

Prescription drug use among elderly and nonelderly families.

OBJECTIVE: This study augments existing literature by examining characteristics associated with prescription drug utilization and makes an in-depth assessment of family prescription drug economic burden within the United States. The objective of this study was to examine differences in prescription drug use and prescription drug characteristics among elderly and nonelderly families. METHODS: A measure of out-of-pocket prescription drug burden associated with family prescription drug utilization was constructed using data from the 1996 Medical Expenditure Panel Survey (MEPS). Families were designated as the unit of analysis and further divided by age (<65 and e 65 years) of the reference person. The 1996 MEPS database provides medical expenditure data on a national sample of 8,917 families (22,601 individuals) and 147,308 drug episodes, i.e., prescription procurement. The ratio of family prescription out-of-pocket expenditures to family income was used to assign families to economic burden rank-ordered quintiles, each representing 20% of U.S. families in 1996. RESULTS: Prescription size, price, and drug use were higher among elderly families. Their proportion of generic use was higher compared to nonelderly families. Additionally, out-of-pocket prescription expenditures represented 23.7% and 45.6% of the total out-of-pocket medical care burden for nonelderly and elderly families, respectively. The average prescription drug burden (total prescription out-of-pocket costs/family income) was 0.4% for nonelderly and 1.9% for elderly households. CONCLUSION: The study results demonstrate an ability to identify populations with high economic burden for prescription medications. The presumption is that persons age 65 or older, lacking purchasing leverage, are more likely to pay full retail price and, consequently, higher prices. Our findings suggest that high prescription drug burden was a function of prescription size and cost per prescription, with prescription size showing more drastic differences between the high and low prescription drug burden subgroups. Future studies should continue to assess factors influencing families. prescription drug economic burden, and the information derived from these studies should be used by benefit planners in designing drug benefits within health insurance plans.

Quality assessment of economic analyses of pharmacological and nutritional therapy for hyperlipidemia.

Our objective was to evaluate the quality of published pharmacoeconomic studies of lipid-lowering therapies. A 13-item evaluation checklist was used to assess the quality of articles. Two reviewers assessed each article. Discrepancies in ratings were resolved using a third reviewer. Potential scores on each item ranged from 0 to 4 and 50 articles met our inclusion criteria. Mean quality scores ranged from 1.73 to 3.89. Treatment and policy implications are: secondary prevention is more cost-effective than primary prevention, the cost-effectiveness of lipid-lowering treatments correlates with risk-factors and statin drugs are more cost-effective than cholesterol-sequestering agents. This review provides a summarization of the literature regarding the cost-effectiveness of lipid-lowering therapies. Results from lower-quality studies may be less accurate because the most common criteria assessed as questionable or incorrect were perspective, measurement and analysis.