Cost-effectiveness of clopidogrel in acute coronary syndromes in Sweden: a long-term model based on the CURE trial

OBJECTIVES: The purpose of this study was to evaluate the long-term cost-effectiveness of clopidogrel on top of standard therapy (including ASA) in patients with acute coronary syndromes without ST-segment elevation in Sweden. METHODS AND RESULTS: Incremental cost-effectiveness ratios (ICER) were assessed using a Markov model with transition probabilities estimated from the Swedish hospital discharge and cause of death registers. Patients were assumed to be treated for 1 year, with treatment effects (RR = 0.8) and costs taken from the Clopidogrel in Unstable Angina to prevent Recurrent ischaemic Events Trial. Two scenarios were analysed: with patients similar to those in the trial and with patients similar to those from the register. In the first scenario, the predicted net direct cost was 160 euro and the net total cost -54 euro, which with an incremental survival of 0.12 years give the ICER of 1365 euro per life-year gained from the health care payer perspective (including direct costs) and cost savings from the societal perspective (also including indirect costs). The net costs in the second scenario were 149 euro, giving an ICER of 1009 euro for both perspectives. CONCLUSIONS: Adding clopidogrel to standard therapy including ASA is cost-effective in the studied setting and compares favourably with other cardiovascular treatment and prevention strategies.     

Cost-effectiveness of salmeterol/fluticasone propionate combination product 50/250 microg twice daily and budesonide 800 microg twice daily in the treatment of adults and adolescents with asthma. International Study Group

Despite a good understanding of the disease and its treatments, asthma continues to place a large economic burden on healthcare systems. As such, it is important to consider the economic impact of alternative therapeutic options for the treatment of this condition to ensure that scarce resources are used in the most efficient manner possible. Thus, the aim of asthma management from an economic perspective is to reduce the burden of this disease through maximizing health gain with available resources. A prospective economic analysis was conducted as part of a multicentre, randomized, double-blind, comparative trial of salmeterol/fluticasone propionate combination product (SFC) 50/250 microg twice daily vs. budesonide (800 microg twice daily) in adults and adolescents with asthma who were symptomatic despite treatment with inhaled corticosteroids at doses of 800-1200 microg day(-1). Treatment effectiveness was measured in terms of successfully-treated weeks, defined as a > or =5% improvement in morning peak expiratory flow, episode-free days (a day without the need for rescue medication, no nocturnal awakening or adverse events) and symptom-free days. Cost-effectiveness analyses were performed using direct healthcare and drug costs, from the perspective of the Swedish healthcare system (1998 prices), with appropriate sensitivity analyses to test the robustness of the findings. Overall, SFC produced significantly higher (P<0.001) proportions of successfully-treated weeks, episode-free days and symptom-free days. Direct asthma management costs were similar between the two groups [SEK19.6 ($US2.4) for SFC vs. SEK18.5 (SUS2.2) for budesonide]. The cost per successfully-treated week was lower for SFC than for budesonide [SEK204 ($US24.8) vs. SEK300 ($US36.4) per week], as were the costs per episode-free day [SEK51.1 ($US6.2) vs. SEK75.1 ($US9.1) per day] and symptom-free day [SEK42.2 ($US5.1) vs. SEK53.0 ($US6.4) per day]. Incremental cost-effectiveness ratios showed that the additional costs to achieve additional benefits with SFC were minimal. Costs per additional successfully-treated week, symptom-free day and episode-free day with SFC were SEK31.6 ($US3.9), SEK9.2 ($US1.1) and SEK7.7 ($US0.9), respectively, relative to budesonide. Sensitivity analysis showed that the results were stable over a wide range of assumptions. The results suggest that SFC is a more cost-effective treatment than budesonide in the management of moderate to severe asthma.     

Adding formoterol to budesonide in moderate asthma--health economic results from the FACET study.

The FACET (Formoterol and Corticosteroid Establishing Therapy) study established that there is a clear clinical benefit in adding formoterol to budesonide therapy in patients who have persistent symptoms of asthma despite treatment with low to moderate doses of an inhaled corticosteroid. We combined the clinical results from the FACET study with an expert survey on average resource use in connection with mild and severe asthma exacerbations in the U.K., Sweden and Spain. The primary objective of this study was to assess the health economics of adding the inhaled long-acting beta2-agonist formoterol to the inhaled corticosteroid budesonide in the treatment of asthma. The extra costs of adding the inhaled beta2-agonist formoterol to the corticosteroid budesonide in asthmatic patients in Sweden were offset by savings from reduced use of resources for exacerbations. For Spain the picture was mixed. Adding formoterol to low dose budesonide generated savings, whereas for moderate doses of budesonide about 75% of the extra formoterol costs could be recouped. In the U.K., other savings offset about half of the extra cost of formoterol. All cost-effectiveness ratios are within accepted cost-effectiveness ranges reported from previous studies. If productivity losses were included, there were net savings in all three countries, ranging from Euro 267-1183 per patient per year. In conclusion, adding the inhaled, long-acting beta2-agonist formoterol to low-moderate doses of the inhaled corticosteroid budesonide generated significant gains in all outcome measures with partial or complete offset of costs. Adding formoterol to budesonide can thus be considered to be cost-effective.     

The cost-effectiveness of the use of clopidogrel in acute coronary syndromes in five countries based upon the CURE study.

BACKGROUND: The CURE study demonstrated that clopidogrel prevents a range of ischaemic cardiovascular events in patients with Acute Coronary Syndromes (unstable angina or non-ST-segment elevation MI). DESIGN: We undertook an economic analysis of the use of clopidogrel in the UK, USA, Sweden, France and Canada based on the CURE study. METHODS: The costs of hospitalization, study drug and other medications were calculated, based on resource utilization for all patients in CURE. Unit costs were obtained for all resource items for each country, and are reported in local currencies in 2001 prices. RESULTS: While hospitalization costs were lower in the clopidogrel group, when the acquisition cost of clopidogrel for 9 months is included, the average cost per patient is higher in the clopidogrel group than the placebo group in all countries [difference in costs (with 95% CI) 208 pounds sterling (119, 297), 451 US dollars (58, 845), SKr 2571 (728, 4412), 325 euros (85, 565), 161 Canadian dollars (-185, 506)]. The absolute reduction in the number of total primary events was 2.0%, resulting in an incremental cost-effectiveness ratio (ICER) of 10,366 pounds sterling in the UK, 22,484 US dollars in the USA, SKr 127,951 in Sweden, 16,186 euros in France, and 7973 Canadian dollars in Canada per primary event avoided with clopidogrel. CONCLUSIONS: Clopidogrel in CURE reduced hospitalization costs but the acquisition cost of clopidogrel creates an overall increase in direct health care costs over 9 months. Nevertheless, the cost-effectiveness is in a range comparable to other therapies currently utilized for acute coronary syndromes.     

An economic evaluation of combination treatment with budesonide and formoterol in patients with mild-to-moderate persistent asthma

Patients with mild asthma may benefit from increasing their inhaled corticosteroid dose, adding a long-acting beta2-agonist, or both. This study assessed the cost-effectiveness of these options. Patients aged > or = 12 years with mild-to-moderate persistent asthma (n = 1272) were randomised to twice-daily, double-blind treatment with budesonide 100 microg, budesonide 100 microg plus formoterol 4.5 microg, budesonide 200 microg, or budesonide 200 microg plus formoterol 4.5 microg for 12 months. Clinical variables included lung function, number of symptom-free days and number of severe exacerbations. Data on medication use, hospitalisation, visits to health professionals and time off work due to asthma were combined with Swedish unit cost data (1999) to estimate the mean annual cost per patient. Budesonide 200 microg plus formoterol 4.5 microg had the greatest efficacy and effectiveness. Budesonide 200 microg plus formoterol 4.5 microg was both more effective and less costly than budesonide 100 microg plus formoterol 4.5 microg, so a cost-effectiveness ratio was not calculated for this comparison. The cost-effectiveness ratio for budesonide 200 microg plus formoterol 4.5 microg compared with budesonide 200 microg alone was SEK 21 per symptom-free days gained. The combination of budesonide and formoterol in mild-to-moderate persistent asthma improved effectiveness at modest additional cost.     

Cost effectiveness analysis of disease modifying antirheumatic drugs in rheumatoid arthritis

The objective was to assess the cost-effectiveness of various DMARDs compared with antimalarials (AM) for rheumatoid arthritis (RA) treatment. The data on disease activity, functional status and societal costs were collected from a 1-year cohort of 152 patients with RA receiving at least one DMARD for ≥ 6 months. Incremental cost effectiveness ratio (ICER) was calculated from the societal costs of DMARD treatment compared with AM per one unit of HAQ improvement. All costs were presented in 2001 US dollars. Mean (SD) societal cost of AM treatment was US$ 2,285 (1,154) per patient per year. MTX + AM was less costly and more effective than AM, as the ICER of this combination would save US$ 834 per 1 U of HAQ improvement. MTX + SSZ, leflunomide, and triple therapy (AM + MTX + SSZ) were more effective than AM with additional costs. RA treatment with non MTX-based DMARDs was not cost-effective.     

Cost-utility analysis of second-generation direct-acting antivirals for hepatitis C: a systematic review

ABSTRACT

Introduction: High prices of second-generation direct-acting antivirals (DAAs) in the treatment of chronic hepatitis C virus (HCV) patients led to reimbursement decisions based on cost per quality-adjusted life year (QALY).

Areas covered: We performed a systematic review of cost-utility analyses (CUA) comparing interventions with second-generation DAA therapies with no treatment, and with previous therapies for chronic HCV patients until July 2017. A total of 36 studies were included: 30 studies from the perspective of the healthcare payer, 3 from the societal perspective, and 3 did not report the perspective. For genotype 1, the highest number of ICER comparison corresponds to sofosbuvir (SOF) triple therapy and SOF-based combinations which reported a cost per QALY systematically ranging from negative to lower than US$100,000 when compared with no treatment or dual therapy or Simeprevir triple therapy.

Expert commentary: Selected studies may be overestimating the true cost per QALY of second-generation DAAs in the treatment of HCV, mainly because of neglecting non-healthcare costs, using official list prices which are higher than actual transaction prices and not adopting the long run drug price in a dynamic approach. In addition, the impact of important price reductions of several DAAs in recent years on cost per QALY should be considered.     

Cost and cost threshold analyses for 12 innovative US HIV linkage and retention in care programs

Out of >1,000,000 people living with HIV in the USA, an estimated 60% were not adequately engaged in medical care in 2011. In response, AIDS United spearheaded 12 HIV linkage and retention in care programs. These programs were supported by the Social Innovation Fund, a White House initiative. Each program reflected the needs of its local population living with HIV. Economic analyses of such programs, such as cost and cost threshold analyses, provide important information for policy-makers and others allocating resources or planning programs. Implementation costs were examined from societal and payer perspectives. This paper presents the results of cost threshold analyses, which provide an estimated number of HIV transmissions that would have to be averted for each program to be considered cost-saving and cost-effective. The methods were adapted from the US Panel on Cost-effectiveness in Health and Medicine. Per client program costs ranged from $1109.45 to $7602.54 from a societal perspective. The cost-saving thresholds ranged from 0.32 to 1.19 infections averted, and the cost-effectiveness thresholds ranged from 0.11 to 0.43 infections averted by the programs. These results suggest that such programs are a sound and efficient investment towards supporting goals set by US HIV policy-makers. Cost-utility data are pending.     

Cost-effectiveness of budesonide Turbuhaler in the treatment of mild-to-moderate asthma in Japan

Asthma therapy including inhaled corticosteroids (ICS) has been shown to be effective in many parts of the world, but its use is still limited in Japan. A 6-week, randomized, placebo-controlled, clinical trial was therefore undertaken to assess the efficacy of the ICS budesonide Turbuhaler (budesonide administered via the dry-powder inhaler Turbuhaler) in patients in Japan with mild-to-moderate asthma. Prior to, and during, the study, all concomitant medications, except corticosteroid preparations, were allowed (i.e. all pre-study medication was to be maintained throughout the study). In total, 218 patients randomized to receive budesonide Turbuhaler 200 μg/day (n = 53), 400 μg/day (n = 55), 800 μg/day (n = 57) or placebo (n = 53) were included in the analysis. Due to the increased demand and interest for health economic data in Japan, this retrospective cost-effectiveness analysis reports on the economic impact of budesonide Turbuhaler compared with placebo (i.e. usual care), based on this clinical trial. At each dosage, budesonide Turbuhaler was significantly more effective than the placebo, according to the number of symptom-free and episode-free days. The number of emergency visits, days of lost production and days of hospitalization were all lower in the budesonide Turbuhaler groups, leading to significantly (P < 0.05) reduced total health-care and productivity costs compared with placebo. These findings were generally stable to sensitivity analysis. However, this reduction in costs will obviously have to be compared with the acquisition cost of budesonide Turbuhaler (which was excluded in the analysis as a price had not been determined) when it becomes available on the market. Budesonide Turbuhaler, while improving the health of patients, could thus have a considerable impact on the costs of treating asthma in Japan, by shifting large hospital care costs towards relatively small out-patient medication costs.     

Cost-effectiveness analysis of budesonide/formoterol compared with fluticasone in moderate-persistent asthma

In this economic evaluation, conducted alongside a randomized, double-blind clinical trial, economic data were collected from 339 patients with moderate-persistent asthma randomized to receive twice-daily, double-blind treatment with budesonide/formoterol 160/4.5 microg in a single inhaler (n=166) or fluticasone propionate 250 microg (n=173) for 12 weeks. The mean number of episode-free days (EFD) per patient was significantly greater in the budesonide/formoterol group than the fluticasone group (48.71 compared with 42.34, P=0.0185). Data on medication use, visits to healthcare professionals, and hospitalization were pooled across all six countries and combined with German and Dutch unit cost data to calculate total healthcare costs. Using German unit costs, budesonide/formoterol was associated with significantly lower total healthcare costs per patient over the 12-week period compared with fluticasone (euro 131 compared with euro 210, P=0.0043). Using Dutch unit costs, total healthcare costs were slightly numerically lower in the budesonide/formoterol group than the fluticasone group (euro 102 compared with euro 104), but the difference did not reach statistical significance. Budesonide/formoterol in a single inhaler is more effective than a higher microgram dose of fluticasone alone. It is cost-neutral and may provide cost-savings in some countries.     

The cost-effectiveness of infliximab (Remicade) in the treatment of ankylosing spondylitis in Canada

OBJECTIVE: To estimate the cost-effectiveness of the treatment of ankylosing spondylitis (AS) with infliximab (Remicade) in Canada over the long term, with both international and Canadian treatment regimens. METHODS: A previously published disease model based on functional capacity and disease activity was adapted to the Canadian setting. Current resource consumption from a cross-sectional bottom-up burden-of-illness study in 545 patients at different levels of severity of AS in 4 Canadian provinces was incorporated into the model. Cost-effectiveness estimates were based on a 3-month placebo-controlled clinical trial with 2-year open extension as well as a 4-year followup study of clinical practice in Canada. In the cost-effectiveness model, patients with insufficient response to treatment at 12 weeks (> or = 50% reduction in Bath Ankylosing Spondylitis Disease Activity Index) discontinue treatment. In view of the long disease duration, simulations over a 30-year timeframe were performed, incorporating disease progression from cohort studies and assumptions about treatment continuation beyond the clinical trial from the trial extension period. Results are presented in Canadian dollars, from the societal and healthcare payer perspectives, with both costs and effects discounted at 5%. RESULTS: Over a 30-year timeframe, with the assumption that patients' disease would remain stable while on treatment, the cost per quality-adjusted life-year (QALY) gained in the societal perspective is $37,491, using the treatment regimen in the clinical trial (5 mg/kg every 6 weeks). Using the dosing regimen of the Canadian study (75% at 3 mg/kg every 8 weeks, 15% at 3 mg/kg every 6 weeks, and 10% at 5 mg/kg every 8 weeks) the cost per QALY is dollar 10,264. Assuming that patients on treatment progress at half the rate of untreated patients, the cost-effectiveness ratios are dollar 45,121 and dollar 13,883, respectively, while the most conservative assumption that progression is the same in both arms, the ratios are dollar 54,137 and dollar 18,712, respectively. The results are sensitive to the dosing regimen adopted, the discontinuation rate, and assumptions concerning disease progression while on treatment. CONCLUSION: Our results indicate that infliximab therapy for patients with active AS would be cost-effective (ranges dollar 10,264-dollar 54,137 per QALY) in a Canadian setting.     

Cost-effectiveness of continuous positive airway pressure therapy in patients with obstructive sleep apnea-hypopnea in British Columbia

BACKGROUND:

Obstructive sleep apnea-hypopnea (OSAH) is a common disorder characterized by recurrent collapse of the upper airway during sleep. Patients experience a reduced quality of life and an increased risk of motor vehicle crashes (MVCs). Continuous positive airway pressure (CPAP), which is the first-line therapy for OSAH, improves sleepiness, vigilance and quality of life.

OBJECTIVE:

To assess the cost-effectiveness of CPAP therapy versus no treatment for OSAH patients who are drivers.

METHODS:

A Markov decision analytical model with a five-year time horizon was used. The study population consisted of male and female patients, between 30 and 59 years of age, who were newly diagnosed with moderate to severe OSAH. The model evaluated the cost-effectiveness of CPAP therapy in reducing rates of MVCs and improving quality of life. Utility values were obtained from previously published studies. Rates of MVCs under the CPAP and no CPAP scenarios were calculated from Insurance Corporation of British Columbia data and a systematic review of published studies. MVCs, equipment and physician costs were obtained from the British Columbia Medical Association, published cost-of-illness studies and the price lists of established vendors of CPAP equipment in British Columbia. Findings were examined from the perspectives of a third-party payer and society.

RESULTS:

From the third-party payer perspective, CPAP therapy was more effective but more costly than no CPAP (incremental cost-effectiveness ratio [ICER] of $3,626 per quality-adjusted life year). From the societal perspective, the ICER was similar ($2,979 per quality-adjusted life year). The ICER was most dependent on preference elicitation method used to obtain utility values, varying almost sixfold under alternative assumptions from the base-case analysis.

CONCLUSION:

After considering costs and impact on quality of life, as well as the risk of MVCs in individuals with OSAH, CPAP therapy for OSAH patients is a highly efficient use of health care resources. Provincial governments who do not provide funding for CPAP therapy should reconsider.     

The cost-effectiveness of inhaled fluticasone propionate and budesonide in the treatment of asthma in adults and children.

Inhaled corticosteroids form the mainstay of the treatment and management of asthma and the results of a meta-analysis comparing two of the most frequently prescribed inhaled corticosteroids, fluticasone propionate and budesonide, administered in a clinically equivalent 1:2 dose ratio to 1980 patients with asthma, demonstrated that fluticasone propionate had an improved efficacy:safety ratio. However, limited data are available on the relative economic benefits of fluticasone propionate and budesonide. The database for clinically relevant parameters, for which the efficacy:safety meta-analysis had demonstrated statistical significance between the two corticosteroids, was used for this pharmacoeconomic analysis. Treatment with fluticasone propionate was more cost-effective than budesonide with respect to improvement in morning peak expiratory flow rate, successfully treated weeks, symptom-free days, symptom-free 24 h and episode-free days. The costs of treatment for fluticasone propionate and budesonide were 7.78 Pounds per week and 12.33 Pounds per week, respectively. The main contributing factor to the higher costs of budesonide was the higher cost of health care contacts, which were 4.53 Pounds per week for budesonide and 0.57 Pounds per week for fluticasone propionate. The pharmacoeconomic difference increased in favour of fluticasone propionate as the criteria for success were made more stringent. These results demonstrate that, for asthma patients requiring modification of therapy treatment with fluticasone propionate is more effective and also cheaper, in terms of overall health-care costs, than treatment with budesonide.     

A multi-country health-economic evaluation of highly concentrated n-3 polyunsaturated fatty acids in the secondary prevention after myocardial infarction

Patients who survive an acute myocardial infarction (MI) are at increased risk of subsequent major cardiovascular events and cardiac (often sudden) death. The use of highly concentrated and purified omega-3 polyunsaturated fatty acids (n-3 PUFAs), in addition to standard secondary prevention after MI, results in a significant reduction in the risk of sudden death. This study assessed the cost-effectiveness of adding n-3 PUFAs to the current secondary prevention treatment after acute MI in 5 countries: Australia, Belgium, Canada, Germany, Poland. Based on the clinical outcomes of GISSI-Prevenzione (MI, stroke, revascularisation rate and mortality), a decision-model was built in DataPROTM. The implications of adding n-3 PUFAs to standard treatment in patients with a recent history of MI were analysed from the health care payer's perspective. The time horizon was 3.5 years (identical to GISSI-Prevenzione). Event costs were based on literature data. Life expectancy data for survivors of cardiac disease were taken from the Saskatchewan database and then country-adjusted. Results are expressed as extra cost (Euro) per life-year gained (LYG). Annual discounting of 5% was applied to health effects and costs. Treatment with highly concentrated n-3 PUFAs yielded between 0.260 (Poland) and 0.284 (Australia) LYG, at an additional cost of Euro 807 (Canada) to Euro 1,451 (Belgium). The incremental cost-effectiveness ratio (ICER) varied between Euro 2,867 (Canada) and Euro 5,154 (Belgium) per LYG. Sensitivity analyses on effectiveness, cost of complications and discounting proved the robustness of the results. A 2nd order Monte Carlo simulation based on the 95% CIs obtained from GISSI showed that highly concentrated n-3 PUFAs are cost-effective in more than 99% of patients (assuming societal willingness to pay threshold of Euro 20,000/LYG). Including health care costs incurred during the remaining life-years considerably increased total costs, but had no impact on the ICER-based treatment recommendation. Adding highly concentrated n-3 PUFAs to standard treatment in the secondary prevention after MI appears to be cost-effective in the 5 countries studied.     

Cost-effectiveness analysis of patient self-testing therapy of oral anticoagulation

Patient Self-testing (PST) could be an option for present anticoagulation therapy monitoring, but current evidence on its cost-effectiveness is limited. This study aims to estimate the cost-effectiveness of PST to other different care approaches for anticoagulation therapy in Thailand, a low-to-middle income country (LMIC). A Markov model was used to compare lifetime costs and quality-adjusted life years (QALYs) accrued to patients receiving warfarin through PST or either anticoagulation clinic (AC) or usual care (UC). The model was populated with relevant information from literature, network meta-analysis, and database analyses. Incremental cost-effectiveness ratios (ICERs) were presented as the year 2015 values. A base-case analysis was performed for patients at age 45-year-old. Sensitivity analyses including one-way and probabilistic sensitivity analyses (PSA) were constructed to determine the robustness of the findings. From societal perspective, PST increased QALY by 0.87 and costs by 112,461 THB compared with UC. Compared with AC, PST increased QALY by 0.161 and costs by 21,019 THB. The ICER with PST was 128,697 (3625 USD) and 130,493 THB (3676 USD) per QALY gained compared with UC and AC, respectively. The probability of PST being cost-effective is 74.1% and 51.9%, compared to UC and AC, respectively, in Thai context. Results were sensitive to the efficacy of PST, age and frequency of hospital visit or self-testing. This analysis suggested that PST is highly cost-effective compared with usual care and less cost-effective against anticoagulation clinic. Patient self-testing strategy appears to be economically valuable to include into healthcare system within the LMIC context.     

Cost-effectiveness of fluticasone propionate administered via metered-dose inhaler plus babyhaler spacer in the treatment of asthma in preschool-aged children.

STUDY OBJECTIVES: To evaluate the cost-effectiveness of inhaled fluticasone propionate (FP) in children aged 12 to 47 months with asthma symptoms. DESIGN: A retrospective economic analysis conducted from the perspective of the Danish health-care system, based on clinical data from a 12-week study. SETTING: Thirty-three outpatient centers in nine countries. PATIENTS: Two hundred thirty-seven children aged 12 to 47 months with documented history of recurrent wheeze or asthma symptoms. INTERVENTIONS: Two dosages of FP, 100 microg/d and 200 microg/d, and placebo administered in two divided doses via a metered-dose inhaler and a Babyhaler (Glaxo Wellcome; Middlesex, UK) spacer device. MEASUREMENTS: Effectiveness in terms of asthma exacerbations, control of cough and wheeze symptoms, symptom-free days, overall direct costs of asthma management in Danish kroner at 1999 prices, and mean and incremental cost-effectiveness ratios. RESULTS: FP, 200 microg/d, was significantly more effective than placebo treatment in terms of the proportion of exacerbation-free patients (73.7% vs 59.8%; p = 0.025) and patients experiencing a > or = 25% improvement in cough symptoms (57.9% vs 39.0%; p = 0.018). The costs per exacerbation-free patient, per patient with a > or = 25% improvement in cough and wheeze symptoms from baseline, and per symptom-free day were lower in the FP groups than in the placebo group. The incremental cost-effectiveness ratios for these end points indicated that the additional benefits of FP, 200 microg/d, were achieved at a lower overall cost compared with placebo treatment. CONCLUSIONS: From the perspective of the Danish health-care system, FP, 100 microg bid, administered via the Babyhaler inhalation device was cost-effective relative to standard therapy with bronchodilators alone.     

Cost-effectiveness of rituximab (MabThera) in diffuse large B-cell lymphoma in The Netherlands

OBJECTIVE: To determine the incremental cost-effectiveness ratio (ICER) of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) vs. CHOP plus rituximab (R-CHOP) in diffuse large B-cell lymphoma (DLBCL) patients in the Netherlands. METHODS: A state transition model was developed to estimate the clinical course, costs and quality of life of patients with stage II, III or IV DLBCL receiving initial treatment with CHOP or R-CHOP to arrive at the ICER. The base year for the cost analysis was 2002 and was performed from the societal perspective. Only direct medical costs were included. The time horizon of the model was 15 yr and both costs and effects were discounted at 4%. Sensitivity analyses were performed to determine the effect of varying base-line assumptions of the model. RESULTS: The incremental gain in quality adjusted life years (QALYs) was 0.88 in both the younger and the older patient groups. The costs were 12 343 higher in the younger group of patients and 15 860 in the older patients. This resulted in an ICER of 13 983 for the younger and 17 933 for the older patients per QALY gained. These results were sensitive to the time horizon of the model, other variations had a marginal impact on the outcome. CONCLUSION: The addition of rituximab to standard therapy for DLBCL results in a gain of 0.88 QALYs. The ICER of 13 983 for younger and 17 933 for older patients per QALY gained should, seen in the light of disease severity, be considered acceptable by most policy makers in priority setting for budget allocation.     

Cost‐effectiveness of budesonide/formoterol for maintenance and reliever asthma therapy in Denmark – Cost‐effectiveness analysis based on five randomised controlled trials

Background and Aims: Budesonide/formoterol maintenance and reliever therapy (Symbicort SMART®) is an effective asthma‐management regime where patients use budesonide/formoterol both as maintenance treatment and as additional doses as needed to improve overall asthma control by reducing symptoms and exacerbations. The aim of this study was to determine the cost‐effectiveness of the Symbicort SMART® regime in Denmark vs higher dose inhaled corticosteroid (ICS) plus reliever medication, similar dose inhaled corticosteroid/long‐acting β₂‐agonist (ICS/LABA) combination therapy plus reliever medication or higher dose of inhaled ICS/LABA combination therapy plus reliever medication. Methods: The cost‐effectiveness analyses were based on effectiveness and resource utilisation data, which were prospectively collected during the treatment period in five randomised clinical trials (duration: 24 weeks, 26 weeks or 1 year). Economic analyses were conducted from both a health care sector (direct costs) and a societal perspective [total costs, i.e direct costs + indirect costs (sick leave)]. The time horizon for the economic analyses was 1 year. The effectiveness measure used was the number of avoided severe exacerbations per patient per year. Results: Patients treated with budesonide/formoterol maintenance and reliever therapy showed statistically significant fewer severe exacerbations per patient compared with the alternative treatment regimes in all comparisons. Budesonide/formoterol maintenance and reliever therapy was a dominant treatment option when compared with higher dose ICS or higher dose ICS/LABA, i.e. it was more effective at a lower total cost. In two of the three comparisons with a similar ICS/LABA dose, Symbicort SMART® was dominant. Conclusion: Cost‐effectiveness analyses of budesonide/formoterol maintenance and reliever therapy show that the significant reduction in the number of severe exacerbations observed in all the included clinical studies is predominately obtained at lower costs compared with alternative treatment regimes. This indicates that budesonide/formoterol maintenance and reliever therapy is a cost‐effective treatment option in a Danish setting. Please cite this paper as: Wickstrøm J, Dam N, Malmberg I, Hansen BB and Lange P. Cost‐effectiveness of budesonide/formoterol for maintenance and reliever asthma therapy in Denmark – Cost‐effectiveness analysis based on five randomised controlled trials. The Clinical Respiratory Journal 2009; 3: 169–180.     

Cost effectiveness of adalimumab for the treatment of ankylosing spondylitis in the United Kingdom

OBJECTIVES: This study evaluated the cost effectiveness of adalimumab vs conventional therapy in patients with active ankylosing spondylitis (AS). METHODS: The analysis was based on pooled data from two Phase III studies of adalimumab in active AS. Patients with an inadequate response to >/=1 NSAID received adalimumab 40 mg every other week (n = 246) or placebo (n = 151) for 24 weeks. A microsimulation model was developed with patients being treated with adalimumab according to the International ASAS Consensus Statement and BSR guidelines. The pooled adalimumab data, as well as data from the Outcome Assessment in AS International Study (OASIS) database and the literature, were used to model patients' BASDAI and BASFI scores and costs and health-related quality of life associated with various degrees of disease activity. Costs (in 2004 British pound) of AS, drug, administration, monitoring, hospitalization and AEs were calculated from the perspective of the UK NHS. Discounting was applied at 3.5% per year for costs and benefits as per the NICE reference case for economic evaluations. Uncertainty was addressed via sensitivity analyses. RESULTS: The incremental cost-effectiveness ratio (ICER) of adalimumab vs conventional therapy was estimated to improve with longer time horizons (48 weeks to 5 and 30 yrs). The central estimate was that, over 30 yrs, adalimumab therapy yielded 1.03 more quality-adjusted life-years (QALYs) per patient initiating therapy. Some AS treatment-related costs were estimated to be offset by adalimumab (at 10,750 pounds/patient), leaving a total incremental cost (adalimumab vs conventional therapy) at 23,857 pounds per patient. The 30-yr ICER of adalimumab vs conventional therapy was estimated at 23 pounds 097/QALY. Sensitivity analyses demonstrated robustness of results. When indirect costs were also included (analysis from societal perspective), ICER improved to 5093 pounds/QALY. CONCLUSIONS: This analysis indicates that adalimumab, when used according to UK treatment guidelines, is cost-effective vs conventional therapy for treating AS patients.