The cost-effectiveness of bimatoprost,latanoprost and timolol in treatment of primary open angle glaucoma in five European countries

ABSTRACT

Objective: The objective of this cost-effectiveness analysis is to evaluate cost-effectiveness ratios of the intraocular pressure (IOP)-lowering agents bimatoprost, latanoprost and timolol in five major European countries: France, Germany, Italy, Spain and the UK.

Methods: The cost-effectiveness analysis is based on achievement of IOP targets between 13 and 18?mm Hg. Thus, the cost-effectiveness ratios express the costs of having one patient successfully achieving IOP target. The perspective of the analysis is that of the health care sector payer, including costs of medicine and costs of ophthalmologist visits. The time frame is first year of glaucoma treatment. Four treatment strategies are analysed: Timolol as first line with add-on latanoprost or bimatoprost if IOP targets are not met, and latanoprost and bimatoprost as first line with add-on timolol.

Results: In the UK, Spain, Italy and Germany the timolol first with add-on of bimatoprost is the least expensive treatment. This strategy dominates both strategies involving latanoprost (as add-on to timolol or as first line) in these four countries. The incremental cost-effectiveness ratio of bimatoprost first-line therapy versus timolol with add-on bimatoprost varies from each country and target (from £305 to €43 720 per patient). In France the timolol first line and latanoprost add-on is not dominated and is the cheapest alternative. The incremental cost-effectiveness ratio of timolol with add-on bimatoprost versus add-on latanoprost lies between £71 and €355 per patient depending on target (18 and 13?mm Hg, respectively).

Conclusion: First-line treatment of latanoprost is dominated in all countries. In four out of five countries the timolol first-line therapy with add-on latanoprost is also dominated. Based on this pharmacoeconomic analysis, the most costeffective strategy seems to be timolol first line with add-on bimatoprost if target is not met after 3 months.     

Clopidogrel versus aspirin in patients with atherothrombosis: CAPRIE-based calculation of cost-effectiveness for Germany

ABSTRACT

Objectives: To model the 2-year cost-effectiveness of secondary prevention with clopidogrel versus aspirin (acetylsalicylic acid) (ASS) in German patients with myocardial infarction (MI), ischaemic stroke (IS) or diagnosed with peripheral arterial disease (PAD), based on CAPRIE trial data and from the perspective of German third party payers (TPP).

Methods: An existing Markov model was adapted to Germany by using German cost data. The model was extended by using different datasets for cardiovascular event survival times (Framingham vs. Saskatchewan health databases) and in two separate scenarios.

Results: The treatment with clopidogrel leads to a reduction of 13.19 vascular events per 1000 patients, of which 2.21 are vascular deaths. The overall incremental costs for the 2-year management of atherothrombotic patients with clopidogrel instead of ASS are calculated to be about €1 241 440 per 1000 patients. The number of life-years saved (LYS) has been calculated as the difference in the number of life-years lost due to vascular death or events with ASS versus clopidogrel: it is 86.35 LYS when analysis is based on Framingham data and 66.07 LYS with Saskatchewan-based survival data. The incremental costs per LYS are €14 380 and €18 790, respectively. Cost-effectiveness is sensitive to changes in survival data, discounting and daily costs of clopidogrel, but stable against substantial (± 25%) changes in all other cost data.

Conclusion: The findings for Germany are in line with published results for Belgium (€13 390 per LYS) and also with results for Italy (€17 500 per LYS), both based on Saskatchewan data, and with a French analysis based on Framingham data (€15 907 per LYS). Even if no officially accepted cost-effectiveness threshold exists for Germany at present, incremental cost-effectiveness results of less than €20 000 per LYS for the treatment with clopidogrel can be assumed to be acceptable for German third party payers.     

Review of the cost of diabetes complications in Australia,Canada, France,Germany, Italy and Spain

ABSTRACT

Objectives: To provide a comprehensive source document on previously published cost data for diabetic complications in Australia, Canada, France, Germany, Italy and Spain for use in a peer-reviewed, validated diabetes model.

Methods: A search for published cost of diabetes complications data was performed in peer-reviewed journals listed in PubMed and health economic conference proceedings from 1994 to March 2005. Where country specific data were not available, we referred to government websites and local cost experts. All costs were inflated to 2003 Euros (€). Major complication costs are presented.

Results: First year costs of non-fatal myocardial infarction varied between €19?277 in Spain and €12?292 in Australia. In subsequent years of treatment, this range was €1226 (France) to €203 (Australia). Angina costs were similar across all four countries: €1716 in Australia; €2218 in Canada; €2613 in France; €3342 in Germany; €2297 in Italy; and €2207 in Spain. Event costs of non-fatal stroke were higher in Canada (€23?173) than in other countries (Australia €13?443; France €11?754; Germany €19?399; Italy €6583; Spain €4638). Event costs of end-stage renal disease varied depending on the type of dialysis: in Australia (€17?188–27?552); Canada (€33?811–58?159); France (€24?608–56?487); Germany (€46?296–68?175); Italy (€43?075–56?717); and Spain (€28?370–32?706). Lower extremity amputation costs were: €18?547 (Australia); €17?130 (Canada); €31?998 (France); €22?096 (Germany); €10?177 (Italy); and €14?787 (Spain).

Conclusions: Overall, our search showed costs are well documented in Australia, Canada, France and Germany, but revealed a paucity of data for Spain and Italy. Spanish costs, collected by contacting local experts and from government reports, generally appeared to be lower for treating cardiovascular complications than in other countries. Italian costs reported in the literature were primarily hospitalization costs derived from diagnosis-related groups, and therefore likely to misrepresent the cost of specific complications. Additional research is required to document complication costs in Spain and Italy. Australian and German values were collected primarily by referring to diagnostic related group (DRG) tariffs and, as a result, there may be a need for future economic evaluations measuring the accuracy of the costs and resource utilization in the reported values. These cost data are essential to create models of diabetes that are able to accurately simulate the cumulative costs associated with the progression of the disease and its complications.     

Cost-effectiveness in Italy of preventive treatment with ramipril in patients at high risk of cardiovascular events

ABSTRACT

Objectives: A cost-effectiveness analysis was conducted in Italy of preventive treatment with ramipril (an angiotensin converting enzyme [ACE] inhibitor) compared to no treatment in patients at high risk of cardiovascular death. The analysis was based on data extracted from the HOPE trial.

Methods: The current life table method was used in order to model a lifetime time horizon for outcomes and costs. The cohorts used were 1000 subjects on ramipril, and 1000 subjects on placebo enrolled in the HOPE trial. Kaplan–Meier curves at 5 years of the clinical study were fitted using an exponential model over a lifetime horizon, the outcome variables being myocardial infarction, stroke, revascularization and death. Total direct medical costs have been considered from a third-party payer's perspective – the Italian National Health Service. Resources involved in each event/activity were estimated using the modified Delphi technique with a panel of six clinicians. Types of resources reported included drug therapies, laboratory and imaging tests, physician visits, outpatient and inpatient rehabilitation, as well as medical and surgical hospital admissions. The incremental cost per life year gained was the main measure of the analysis.

Results: ICER (incremental cost-effectiveness ratio) decreases with the length of the treatment period. After the first year the ICER is €55?062 and subsequently decreases to about €12?770 at 5 years, €5945 at 10 years and €3726 at 20 years. The two ways sensitivity analysis showed that at 5 years ICERs range from a saving of €4059 to a cost of €22?929 (at 20 years they are €1814 and €4434), mainly depending on the cost of drug and cost of events. Previous analyses in other countries based on the HOPE study obtained ICER values which are comparable with our results, when taking into account the different cost structure of the health care systems.

Conclusions: On the basis of these results, the use of ramipril is likely to represent an efficient use of public health expenditure in the Italian healthcare system.     

The costs of Crohn's disease in the United States and other Western countries: a systematic review

ABSTRACT

Objective: To conduct a critical and systematic literature review of the costs of Crohn's disease (CD) in Western industrialized countries.

Research design and methods: Studies published in English that described the cost of CD in Western industrialized countries were identified using three major databases (Medline, EMBASE, and ISI Web of Science). Studies were reviewed and rated based on their relevance to cost of illness and the reliability of the estimates. All costs were adjusted for inflation to 2006 values.

Results: Estimated direct medical costs were $18 022–18 932 per patient with CD per year in the United States, and €2898–6960 in other Western countries. Hospital­izations accounted for 53–66% of direct medical costs, with an average cost-per-hospitalization of $37?459 in the United States. Estimated indirect costs accounted for 28% of the total cost in the United States and 64–69% in Europe. Costs differed greatly by disease severity. Costs of patients with severe disease were 3- to 9-fold higher than patients in remission. Direct medical costs in the United States for patients in the top 25% of total costs averaged $60?582 per year; costs of patients in the top 2% averaged more than $300?000 per year. Combining prevalence rates, the total economic burden of CD was $10.9–15.5 billion in the United States and €2.1–16.7 billion in Europe.

Limitations: This review is limited by the research quality and variations of the individual studies reviewed, and only includes English articles.

Conclusions: This updated literature synthesis demonstrated the substantial total cost burden of CD, of which hospital­izations accounted for more than half of direct medical costs.     

A cost-minimisation analysis comparing moxifloxacin with levofloxacin plus ceftriaxone for the treatment of patients with community-acquired pneumonia in Germany: results from the MOTIV trial

ABSTRACT

Objective: This study presents a cost-minimisation analysis of moxifloxacin compared to combination treatment with levofloxacin and ceftriaxone in patients hospitalised with community-acquired pneumonia (CAP) in Germany.

Research design and methods: In the MOTIV study, 738 adult patients with CAP requiring hospitalisation and initial parenteral antibiotic therapy were randomised to sequential IV/oral therapy with either moxifloxacin (n?=?368), or levofloxacin and ceftriaxone (n?=?365). The primary effectiveness endpoint was the proportion of patients demonstrating clinical improvement 5–7 days after the completion of study treatment. Subgroup analysis considered patients with severe CAP according to pneumonia severity index (PSI) risk class IV and V, microbiologically proven infection, a history of chronic obstructive pulmonary disease, and a history of cardiovascular disease. The analysis included the cost of study medication, hospital stay, readmission and inpatient procedures and diagnostics. Event frequency in the study was multiplied by German unit costs to estimate per-patient expenditure. The analysis was conducted from a hospital perspective. Sensitivity analysis investigated the effect of costing from an insurer perspective.

Results: No significant difference was found in the percentage of successfully treated patients. Average per patient cost was €2190 for the moxifloxacin group, and €2619 for the levofloxacin + ceftriaxone group (difference –€430, 95% CI: –€138, –€740; p?<?0.05). Variability in total costs was wide, with some patients accruing up to €18?000. Medication cost was significantly lower with moxifloxacin than levofloxacin + ceftriaxone (–€470, 95% CI: –€522, –€421), and accounted for between 15 and 30% of total costs.

Conclusions: In this analysis of patients hospitalised with CAP in Germany, treatment with moxifloxacin was significantly less costly than treatment with levofloxacin and ceftriaxone.     

Cost-effectiveness of statins in the prevention of coronary heart disease events in middle-aged Finnish men

ABSTRACT

Objective: This study evaluated the long-term cost-effectiveness of atorvastatin 20?mg, rosuvastatin 10?mg and simvastatin 40?mg in primary and secondary prevention of CHD in Finland.

Research design and methods: The effect of statin therapy on the incidence of CHD and the expected total costs of the disease were described using a Markov state transition model. Due to the limited amount of evidence concerning mortality and morbidity for rosuvastatin, the model was used to transmute the efficiency data of all statins (decrease in total cholesterol) into long-term endpoints (myocardial infarction, death) using risk functions of the FINRISK and 4S studies. The study followed a characterized cohort of 55-year-old Finnish men with an average 3.3–6.6?%?baseline risk of dying from cardiovascular disease within a 10-year period.

Main outcome measures: Incremental cost-effectiveness ratios (ICERs) for atorvastatin and rosuvastatin, compared with simvastatin, measured as cost of life years gained (€/LYG) and cost of quality adjusted life years gained (€/QALY).

Results: The use of rosuvastatin increased the life expectancy by 0.27 years on average (LYG) compared with simvastatin, producing additional 0.08 quality-adjusted life-years (QALYs). Compared with simvastatin, the cost of one LYG with rosuvastatin was €10 834 and the cost of one QALY gained was €36 548 (discount rate 5?%?per annum). Corresponding figures for atorvastatin were €31 286/LYG and €105 599/QALY.

Conclusions: If the decision makers’ willingness to pay for a QALY gained is around €40 000 there is a high probability (?>?50?%?) that rosuvastatin represents a cost-effective form of therapy in the prevention of CHD in middle-aged men with an average 3.3–6.6?%?risk of dying within 10 years from cardiovascular disease. However, the true clinical impact of these results needs confirmation from on-going clinical trials, as the role of rosuvastatin in reducing clinical events is pending, but for simvastatin and atorvastatin established.     

Treatment patterns and associated costs for genital warts in Italy

ABSTRACT

Objective: Genital warts are caused by human papillomavirus (HPV), principally types 6 and 11, and are highly contagious. This study assessed treatment patterns and costs of management of genital warts in Italy.

Research design and methods: This was a retrospective, observational study conducted among gynaecologists, dermatologists, and specialists at sexually transmitted disease clinics in Italy. Resource-use data related to genital warts were collected for patients at risk in the age range 14–64 years examined during 2005. Unit costs were assigned to resource use to provide estimates of the direct, indirect and total costs per case of genital warts.

Results: Twenty-eight investigators enrolled 341 patients aged 15–64 years, including 194 (56.9%), 81 (23.7%) and 66 (19.4%) patients with newly diagnosed, recurrent and resistant genital warts, respectively. Most patients (333/341; 97.7%) had at least one outpatient visit, while 43 (12.6%) patients were hospitalised, including 39 patients without an overnight stay (day-hospital cases, 11.4%). Self-applied medication was prescribed for 124 (36.4%) patients. Most outpatient cases (267/333; 80.2%) underwent an office-based procedure. Mean annual direct medical costs per patient, which were funded predominantly by the Italian National Health Service (there was some patient co-payment), were €242 for men and €332 for women. When productivity losses were included, mean total annual costs were €325 for men and €464 for women.

Conclusions: This is the first study of treatment patterns and costs for genital warts in Italy. Treatment patterns differ in some respects from those observed in other European countries, but costs generally appear similar. Despite the limitations of physician selection bias and over-representation of North Italy in the patient sample, the findings of this study may be useful in estimating the cost-effectiveness of introducing a quadrivalent HPV vaccination programme in Italy.     

Cost-effectiveness analysis of budesonide/formoterol maintenance and reliever therapy versus fixed combination treatments for asthma in Finland

ABSTRACT

Background: Budesonide/formoterol maintenance and reliever therapy has shown its effectiveness as a treatment for moderate-to-severe asthma.

Objective: To explore the cost-effectiveness of budesonide/formoterol maintenance and reliever therapy as compared to fixed combination therapies (budesonide/formoterol and salmeterol/fluticasone) with terbutaline as needed in the treatment of asthma in Finland.

Methods: Patients without asthma exacerbations during a 6-month period were used as the effectiveness variable in the within-trial economic analysis. Finnish unit costs were applied to pooled resource use data, and multinomial cost-effectiveness plane and acceptability curves were formed based on bootstrapping.

Results: Use of budesonide/formoterol maintenance and reliever therapy significantly reduced the rate of severe asthma exacerbations as compared with a fixed dose of budesonide/formoterol or salmeterol/fluticasone and terbutaline as needed. Total costs over 6 months were €496 per patient for those who used the budesonide/formoterol maintenance and reliever therapy treatment model, which was €78–101 lower than the cost of fixed combinations of salmeterol/fluticasone or budesonide/formoterol with terbutaline as needed. The results indicate that the budesonide/formoterol maintenance and reliever therapy achieves a high probability (> 93%) of cost effectiveness irrespective of willingness to pay level.

Conclusions: Budesonide/formoterol maintenance and reliever therapy may be considered in the treatment of moderate-to-severe asthma instead of conventional treatment with combination products in view of its good clinical efficacy and a high probability of cost-effectiveness in the Finnish setting. However, a cost-effectiveness analysis with a longer time horizon, more Finnish-specific data, and ICS + short/long-acting inhaled β₂-agonist as an additional comparator is still warranted.     

A cost-effectiveness model of smoking cessation based on a randomised controlled trial of varenicline versus placebo in patients with chronic obstructive pulmonary disease

Objectives: Smoking is an important risk factor in chronic obstructive pulmonary disease (COPD). A recent clinical trial demonstrated the efficacy of varenicline versus placebo as an aid to smoking cessation in patients with COPD. This study examines the cost-effectiveness of varenicline from the perspective of the healthcare systems of Spain (base case), the UK, France, Germany, Greece and Italy.

Methods: A Markov model was developed to determine the cost-effectiveness of varenicline as an aid to smoking cessation, compared to a placebo, in a COPD population. Cost-effectiveness was determined by the incremental cost per quality-adjusted life year (QALY) gained.

Results: In the Spanish base case varenicline had an incremental cost of €1021/person for an average of 0.24 life years (0.17 QALYs), gained over the lifetime of a cohort of COPD patients, resulting in an incremental cost-effectiveness ratio (ICER) of €5,566. In the other European countries, the ICER varied between €4,519 (UK) and €10,167 (Italy). Probabilistic sensitivity analysis suggested varenicline had a high probability (>95%) of being cost-effective at a threshold of €30,000/QALY.

Conclusions: Varenicline is expected to be a cost-effective aid to smoking cessation in COPD patients in all of the countries studied.     

Cost–effectiveness analysis of sacral neuromodulation (SNM) with Interstim for fecal incontinence patients in Spain

ABSTRACT

Introduction: Fecal incontinence (FI) is a condition with a high impact on the psychological and social life of healthy people. Interstim, the sacral neuromodulation (SNM) therapy, has shown higher effectiveness and safety rates than surgical procedures like dynamic graciloplasty or artificial anal sphincter in patients with intact anal sphincter (IAS) and after sphincteroplasty in patients with structurally deficient anal sphincter (SDAS).

Objective: To assess the cost-effectiveness of FI management in two scenarios – with and without SNM – and to estimate the potential budget impact of its progressive introduction in the Spanish setting.

Methods: Two decision analytical models were developed (IAS and SDAS patients) representing the possible clinical paths for each of the scenarios (with and without SNM), as well as its clinical and economic consequences in the mid-to long term with a Markov model. Clinical and resource use data were retrieved from the literature and validated by a clinician expert panel. Effectiveness was measured with both QALYs and symptom-free years (SFY). A 3% discount rate was used for future costs and benefits (time horizon = 5 years). Prevalence figures were combined with Interstim sales forecasts to estimate the total number of patients to receive therapy over the next 5 years and the associated budget impact.

Results: The introduction of Interstim in the therapeutic management of FI has an associated cost-effectiveness of €16?181 (IAS patients) and €22?195 (SDAS patients) per QALY gained. The progressive introduction of Interstim in 75 to 100 patients/year will have an estimated budget impact of 0.1% of incremental costs in patients with FI.

Conclusions: Introducing Interstim in the management of FI in IAS and SDAS patients in the Spanish setting has shown to be an efficient measure with an incremental cost–effectiveness ratio below the accepted Spanish threshold (around €35?000/QALY), and with a relatively low additional cost for the Spanish NHS.     

Acute coronary syndromes in Europe: 1-year costs and outcomes

ABSTRACT

Objective: This study aims to estimate costs (including medications prescribed, intervention rates and hospital utilization) and health outcomes of acute coronary syndromes (ACS) during the first year following diagnosis.

Research design and methods: Treatment pathways for ACS patients were developed and country-specific resource use was multiplied by unit costs. Countries examined were the United Kingdom (UK), France, Germany, Italy and Spain. Patients with unstable angina and acute myocardial infarction (ST-segment elevation and non-ST-segment elevation with/without Q-wave) were considered. The study models the incidence of ACS, 1-year mortality, investigations, revascularisation, pharmaceutical use and medical management. Economic outcomes were direct healthcare costs (in 2004 Euros), including total cost, cost per patient with ACS and cost per capita.

Results: The estimated number of deaths in the first year following ACS diagnosis ranged from around 22?500 in Spain to over 90?000 in Germany. The largest contributors to total costs are hospital stay and revascularisation procedures. Pharmaceuticals were estimated at 14–25% of ACS total cost. The total cost of ACS in the UK is estimated around €1.9 billion, compared with €1.3 billion in France, €3.3 billion in Germany, €3.1 billion in Italy and €1.0 billion in Spain. The cost per ACS patient ranges from €7009 (in the UK) to €12?086 (Italy).

Conclusions: Countries with higher expenditure on ACS patients tended to have lower case-fatality rates, and countries with the lowest incidence of ACS also had the lowest cost per capita. The costs of ACS constitute a large proportion of total healthcare expenditure of Western European economies.     

Cost-effectiveness analysis of pregabalin versus gabapentin in the management of neuropathic pain due to diabetic polyneuropathy or post-herpetic neuralgia

ABSTRACT

Objective: To estimate the cost-effectiveness of branded pregabalin (PGB) versus generic gabapentin (GBP) in patients with neuropathic pain (NeP) due to painful diabetic polyneuropathy (DPN) or post-herpetic neuralgia (PHN) in Spain.

Methods: Using stochastic simulation, we estimated the cost-effectiveness of PGB 150–600?mg/d vs. GBP 900–3600?mg/d in a hypothetical cohort of 1000 patients. The model used data from three randomized controlled clinical trials. Pain was evaluated using a 0–10 scale. Mean baseline pain was 6.9 in both treatment groups. The model assigned untreated pain scores over 84 days. Treated scores were calculated using weekly changes in pain scores from trials. Outcomes included the numbers of days with no or mild pain (score < 4), days with ≥ 30% and ≥ 50% reductions in pain intensity, quality-adjusted life-years (QALYs), and estimated health costs.

Results: Compared with GBP, PGB yielded an estimated mean of 8 (standard error, 0.4) additional days with no or mild pain, 6 (0.4) days with ≥ 30% reduction in pain intensity, 9 (0.5) days with ≥ 50% reduction in pain intensity, and a gain of 0.1186 (0.0002) QALYs for 12 weeks. The estimated total health costs of therapies were €1049 (€35) for PGB and €951 (€38) for GBP, respectively. Incremental cost-effectiveness ratio (ICER) for PGB versus GBP were a mean of €12 (95% confidence interval, €1–24) per additional day with no or mild pain, €431 (dominant–€876) per additional patient with no or mild pain, and €20?535 (€1607–40?345) per QALY gained.

Conclusions: According with data used in this modeling in patients with NeP due to DPN and/or PHN, PGB was shown to be more cost-effective than generic gabapentin in Spain.     

Economic evaluation of voriconazole in the treatment of invasive aspergillosis in the Netherlands

ABSTRACT

Objective: To asses the cost-effectiveness of voriconazole in comparison to conventional amphotericin B and itraconazole for the treatment of invasive aspergillosis in the Netherlands.

Methods: The cost-effectiveness of voriconazole in comparison to conventional amphotericin B or itraconazole was evaluated with a decision tree model followed by a life-time Markov model, focusing on long-term survival of patients treated for invasive aspergillosis. Efficacy after 12 weeks of treatment from clinical trials was used to estimate long-term effectiveness by extrapolating these short-term results over time. Information on medical resource consumption, treatment pathways and switch proportions were obtained from both the literature and Experts. Probabilistic analysis was used to compare the cost-effectiveness among the regimens.

Results: With voriconazole, the mean cost for treating invasive aspergillosis per patient was €32?651 (2.5th percentile and 97.5th of uncertainty distribution: €30?037; €36?859), compared to €33?616 (€30?920; €39?633) for conventional amphotericin B and €29?115 (€23?537; €61?414) for itraconazole. The mean survival of patients treated with voriconazole was 174.0 life weeks (160.1; 188.8), compared to 116.1 life weeks (104.8; 128.0) for conventional amphotericin B and 150.4 life weeks (109.1; 194.4) for itraconazole. The beneficial effects of voriconazole on both cost and effectiveness compared with conventional amphotericin B resulted in a probability of 69.8% that voriconazole was a dominant treatment (i.e. less costs and longer survival). The incremental cost-effectiveness ratio of voriconazole versus itraconazole was €150 per life week (i.e. 7800 euros per life-year gained). Depending on the willingness to pay (WTP) the probability of being cost-effective vs. itraconazole increased to a maximum probability of 70%.

Conclusion: In the treatment of invasive aspergillosis, voriconazole is dominant over amphotericin B and cost-effective in comparison to itraconazole.     

Cost-effectiveness of continuous combined hormone replacement therapy in long-term use: economic evaluation based on a 9‑year study in Finland

ABSTRACT

Objectives: To investigate the cost-effectiveness of continuous combined hormone replacement therapy (ccHRT) (Indivina) in postmenopausal women in Finland treated for up to nine consecutive years in the course of a randomised controlled trial.

Methods: In-study event data were accrued for cardiac and vascular events, cancers and fractures. These event incidence data were applied to first-year direct medical costs for these events, derived from published sources. Reference event incidence data were derived from hospital discharge records and relevant national registries for age-matched women (aged 50–70 years) in Finland with an assumed HRT usage rate of 40%. Cost-effectiveness was expressed as additional cost per quality-adjusted life year (QALY) gained for women on ccHRT compared with the general population. All input data were discounted at 3% per annum.

Results: The additional cost per QALY gained for ccHRT was less than €5000 throughout the nine calendar years examined and remained well below the threshold of acceptability of €50?000 in a range of sensitivity analyses. The lowest dose-combination of ccHRT examined improved quality of life at no greater cost than no treatment.

Conclusions: This appraisal, based on event data from a uniquely long study of ccHRT, indicates that this intervention is cost-effective for the relief of symptoms of menopause.     

Projected economic impact of clinical findings of generic entry of topiramate on G4 European countries

ABSTRACT

Objectives: To explore the effects of generic substitution of the antiepileptic drug (AED) topiramate (Topamax in Canada; to convert observed Canadian costs into the settings of France, Germany, Italy, and the United Kingdom (UK); and to forecast the economic impact of generic topiramate entry in these four European countries.

Research design and methods: Health claims from Régie de l'assurance maladie du Québec (RAMQ) plan (1/2006–9/2008) and IMS Health data (1998–2008) were used. Patients with epilepsy and ≥2 topiramate dispensings were selected. An open-cohort design was used to classify observation into mutually-exclusive periods of branded versus generic use of topiramate. Canadian healthcare utilization and costs (2007 CAN$/person-year) were compared between periods using multivariate models. Annualized per-patient costs (2007€ or 2007£/person-year) were converted using Canadian utilization rates, European prices and service-use ratios. Non-parametric bootstrap served to assess statistical significance of cost differences. Topiramate market was forecasted following generic entry (09/2009–09/2010) using autoregressive models based on the European experience. The economic impact of generic topiramate entry was estimated for each country.

Results: A total of 1164 patients (mean age: 39.8 years, 61.7% female) were observed for 2.6 years on average. After covariates adjustment, generic-use periods were associated with increased pharmacy dispensings (other AEDs: +0.95/person-year, non-AEDs: +12.28/person-year, p?<?0.001), hospitalizations (?+?0.08/person-year, p?=?0.015), and lengths of hospital stays (+0.51 days/person-year, p?<?0.001). Adjusted costs, excluding topiramate, were CAN$1060/person-year higher during generic use (p?=?0.005). Converted per-patient costs excluding topiramate were significantly higher for generic relative to brand periods in all European countries (adjusted cost differences per person-year: €706–815, p?<?0.001 for all comparisons). System-wide costs would increase from 3.5 to 24.4% one year after generic entry.

Limitations: Study limitations include the absence of indirect costs, possible claim inaccuracies, and IMS data limitations.

Conclusions: Higher health costs were projected for G4 European countries from the Canadian experience following the generic entry of topiramate.     

Economic evaluation of tiotropium and salmeterol in the treatment of chronic obstructive pulmonary disease (COPD) in Greece

ABSTRACT

Objective: The objective of the study was to assess the cost-effectiveness of two therapeutic alternatives for chronic obstructive pulmonary disease in the Greek National Health Service (NHS) setting.

Methods: A Markov probabilistic model was used to compare tiotropium with salmeterol. A Monte Carlo simulation with 5000 cases was run in the probabilistic analysis. The model was designed to compute the expected time spent in each state, the expected number of exacerbations occurring and the expected treatment cost per patient. Probabilities were extracted from clinical trials, resource utilisation and cost data from a Greek university hospital.

Results: Quality adjusted life years were 0.70 (95% Uncertainty Interval [UI]: 0.63 to 0.77) in the tiotropium arm and 0.68 (95% UI: 0.60 to 0.75) in the salmeterol arm; a difference of 0.02 (95% UI: –0.08 to 0.13). Exacerbations reached 0.85 (95% UI: 0.80 to 0.91) in the tiotropium arm and 1.02 (95% UI: 0.84 to 1.21) in the salmeterol arm, a difference of –0.17 (95% UI: –0.37 to 0.02). Estimates of the mean annual cost per patient were €2504 (€2122 to €2965) in the tiotropium arm and €2655 (€2111 to €3324) in the salmeterol arm, a difference of –€151 (–€926 to €580). Stochastic analysis showed that tiotropium may have an advantage in reducing exacerbations. The probability that tiotropium is cost-effective was 65% at a ceiling value of €0 and reached 77% at a ceiling ratio of €1000. Results stay fairly constant in various sensitivity analyses.

Conclusion: Even though tiotropium is more expensive to buy than salmeterol in the Greek NHS (using Greek costs there was no statistically significant difference in total costs between tiotropium and salmeterol), overall, during the course of a year, it is actually associated with a lower prevalence of exacerbations and lower treatment costs and thus may represent a viable and cost-effective alternative in the Greek NHS setting.     

Cost-effectiveness analysis of escitalopram: a new SSRI in the first-line treatment of major depressive disorder in Austria

SUMMARY

Objectives: To compare the cost-effectiveness of escitalopram, a new selective serotonin reuptake inhibitor (SSRI), with (generic) citalopram in the first-line treatment of major depressive disorder (MDD) in Austria.

Methods: A two-path decision analytic model with a 6-month horizon was adapted to the Austrian setting using Austrian clinical guidelines. All patients (aged ≥ 18?years) started at the primary care path and were referred to specialist care in the secondary care path in case of insufficient response. Model inputs included drug-specific probabilities from head-to-head trial data, literature and expert opinion. The main outcome measure was success (i.e., remission defined as Montgomery–Åsberg Depression Rating Scale (MADRS) score ≤ 12) and costs of treatment (i.e., drug costs and medical care). The analysis was performed from the Austrian societal and Social Healthcare Insurance System (SHIS) perspectives. The Human Capital approach was used to estimate the societal costs of lost productivity.

Results: Treatment with escitalopram yielded lower expected cost and greater effectiveness compared with citalopram. The expected success rate was higher for escitalopram (64.5%) compared to citalopram (59.1%). From the SHIS perspective, the total expected cost per successfully treated patient was lower (€115) for escitalopram (€608) compared with citalopram (€723). From the societal perspective, these expected costs were €3034 and €3269 respectively. Sensitivity analyses on unit costs and probabilities demonstrated the robustness of the results. From the societal perspective, escitalopram remained the dominant treatment option, even at a cost of €0 for (generic) citalopram.

Conclusion: Escitalopram is a cost-effective alternative compared to (generic) citalopram in the first-line treatment of MDD in Austria.     

Acarbose in addition to existing treatments in patients with type 2 diabetes: health economic analysis in a German setting

ABSTRACT

Objective: A recent retrospective meta-analysis of cardiovascular events from long-term studies with acarbose in type 2 diabetes showed that treatment was associated with a significant reduction in the risk of cardiovascular events, supporting the hypothesis that postprandial hyperglycemia is a risk factor for cardiovascular disease. The aim of the present study was to assess the cost-effectiveness of acarbose, given in addition to existing treatments, in type 2 diabetes patients, based on these findings, in the German setting.

Methods: The CORE Diabetes Model, a published, validated computer simulation model, was used to project long-term clinical and cost outcomes in type 2 diabetes patients receiving acarbose or placebo in addition to existing treatments. Direct costs were retrieved from published sources and projected over patient lifetimes from a third party payer perspective. Costs and clinical benefits were discounted at 5% annually. Extensive sensitivity analyses were performed.

Results: Acarbose treatment was associated with improvements in discounted life expectancy (0.21 years) and quality-adjusted life expectancy (QALE) (0.19 QALYs) but was on average marginally more expensive than treatment in the placebo arm (€135 per patient). This led to incremental cost-effectiveness ratios of €633 per life year and €692 per quality-adjusted life year gained. Sensitivity analysis showed that these findings were robust under variation in a range of assumptions.

Conclusions: Addition of acarbose to existing treatment was associated with improvements in life expectancy and quality-adjusted life expectancy, and provides excellent value for money over patient lifetimes in the German setting.