Cost comparison of four venous catheters: Short peripheral catheter, Long peripheral line, Midline, and PICC for peripheral infusion.

INTRODUCTION: The use of midline catheters for patients requiring a peripheral IV infusion is sometimes limited by their cost. Although decision trees allow them to be positioned in relation to short peripheral cannulas (SPC), Midlines, and PICCs, their economic impact has not yet been evaluated. A study was conducted to estimate and compare the actual costs of using the three types of catheters for durations of 7, 14, and 21 days. METHODS: A budget impact analysis compared midlines or mini-midlines/long peripheral cannulas (LPCs) with SPCs and PICCs for typical medical indications excluding indications requiring central line (infusion of irritant or vesicant drugs): treatment of peritonitis over 7 days, cystic fibrosis infection over 14 days, and meningitis over 21 days. A micro-costing study identified resources used during catheter care procedures (consumables, medical/nursing care, examinations, mechanical complications). The cost of remote systemic complications was estimated from the French national cost study. Literature review compared data based on published complication frequencies. RESULTS: Midline is more economic than the SPC (saving of 39€ over 7 days and 174€ over 14 days), and than the PICC (saving of 102€ over 14 days and 95€ over 21 days). DISCUSSION: Despite a much higher acquisition cost of the Midline than a SPC, the cost of using a Midline is lower. Although this approach cannot be the only argument for choosing a medical device, it can contribute to it in a tense economic context. The micro-costing has been performed in a center placing PICCline using fluoroscopy for catheter tip positioning. The implantation of a PICC with ECG technique does not require an interventional radiology facility and involves significantly lower logistical and personnel costs. This factor is a limitation in this study. However, even with the use of EGC, the cost difference is in favor of Midline.

Barriers and Expectations for Patients in Post-Osteoporotic Fracture Care in France: The EFFEL Study.

OBJECTIVES: This study aimed to quantify the relative importance of barriers to better secondary prevention of osteoporotic fractures and of care expectations expressed by patients with osteoporotic fractures in France. METHODS: A qualitative exploration of potential barriers to care and expectations was undertaken through a systematic literature review and in-depth patients interviews. A list of 21 barriers and 21 expectations was identified. These were presented to 324 subjects with osteoporotic fractures, identified in a representative sample of the French population, in the form of best-worst scaling questionnaires. Patients rated the relative importance of the attributes, and arithmetic mean importance scores were calculated and ranked. A Bayesian hierarchical model was also performed to generate a relative importance score. Latent class analysis was performed to identify potential subgroups of patients with different response profiles. RESULTS: A total of 7 barriers were rated as the most important, relating to awareness of osteoporosis and coordination of care. The highest-ranked barrier, "my fracture is not related to osteoporosis," was significantly more important than all the others (mean importance score 0.45; 95% confidence interval 0.33-0.56). A similar ranking of attributes was obtained with both the arithmetic and the Bayesian approach. For expectations, no clear hierarchy of attributes was identified. Latent class analysis discriminated 3 classes of respondents with significant differences in response profiles (the educated environmentalists, the unaware, and the victims of the system). CONCLUSIONS: Better quality of care of osteoporosis and effective secondary fracture prevention will require improvements in patient education, training of healthcare professionals, and coordination of care.

Cost-effectiveness of Emollients in the Prevention of Relapse among French Patients with Atopic Dermatitis.

Atopic dermatitis affects up to 20% of children and quite frequently persists in adulthood. Follow-up, treatment, and prevention of relapses have an impact on healthcare spending. The aim of this study was to assess the cost-effectiveness of different emollients prescribed for patients with atopic dermatitis in France. A 3-health state Markov model was designed, using French data for resource utilization, price and transition probabilities. The effects of the use of 5 different emollients (A, B, C, D, E) or no emollient were compared. The selected outcome was time (years) without flare-up (YWFU). The 5-year cost for emollient A is 1,575.64€, and the effectiveness is 3.89 YWFU. Strategy A is the most effective. Compared with treatment E, which was the least expensive emollient, A is more expensive (+481.84€) and more effective (0.082 YWFU). The incremental cost-effectiveness ratio is 5,877.48€/YWFU. In conclusion, treating atopic dermatitis with emollients is a cost-effective strategy.

Cost Effectiveness of Emollients in the Prevention of Relapses in Atopic Dermatitis.

INTRODUCTION: Atopic dermatitis (AD) is chronic inflammatory skin condition, characterized by its remission-relapse cycles. This predominantly pediatric disease is becoming more and more prevalent. Emollients are part of the therapeutic management and particularly a way to increase time between relapses. The follow-up of AD and relapses have a great impact on patient's quality of life, expenditures and society costs. The aim of this study is to assess the cost-effectiveness of different emollients prescribed to AD patients. METHODS: A three-state Markov simulation model was developed over a six-year period with 28 days cycles. Two perspectives were adopted, a health care system perspective and a societal perspective. Four different emollients (A, B, C, D) were compared with no emollient use. Time without flare-up was the key endpoint of the study. quality adjusted life-years (QALYs) were assessed as a secondary outcome. Cost and effectiveness data were derived from (i) randomized clinical trials and literature review for the efficacy of treatments, (ii) resource utilization and quality of life data, and (iii) unit prices from official price lists. RESULTS: The six-year health care costs associated with emollient A amount to £1844.23 and generate 4.58 years-without flare-up. Compared to emollient B, emollient A is costlier (Δ £41) but more effective (0.097 years). The ICER is £428.30 per year without flare-up. Emollient A is the dominant strategy compared to no treatment (£2,251.01; 3.99 years without flare-ups). When accounting for the societal costs, emollient A is the dominant strategy. DISCUSSION: According to the analysis, treatment with preventive emollient was a cost-effective option compared with no treatment in adult AD patients. In this comparative study, emollient A is the most efficient strategy from a willingness to pay £200 with a probability of 49%.

Real-world care for individuals aged over fifty with fractures in France: Evidence for a wide care gap-The EPIFRACT Study.

OBJECTIVES: To describe the care trajectories of adults aged ≥50 years with fragility fractures in France. METHODS: A postal questionnaire was sent to 15,000 individuals aged ≥50 years extracted from a representative panel of the French population (METASKOPE) in April-May 2018. Respondents experiencing a single fragility fracture in the previous three years constituted the study population. Information was collected regarding diagnosis, hospitalisations, physician visits and treatment related to the fractures. RESULTS: 13,914 participants returned a questionnaire (92.8%), of whom 436 reported a single fragility fracture. Their mean age was 68.7±10.3 years. 11.9% of this sample had undergone bone densitometry (DXA) prior to the fracture and 11.9% had received a diagnostic of osteoporosis. Following the fracture, a further 17.4% underwent DXA and 8.5% were diagnosed with osteoporosis. 74.3% of fractures were initially managed in an emergency department and 29.6% led to immediate hospitalisation. Prior to fracture, 3.4% received a specific anti-osteoporotic treatment, 10.1% vitamin D and 6.4% calcium supplementation. After the fracture, these figures rose to 10.8%, 26.8% and 19.0% respectively. 86.2% participants made at least one follow-up visit to a physician. CONCLUSIONS: The rate of DXA screening following fragility fractures in subjects over fifty is very low. Most patients with fragility fractures did not receive a diagnosis of osteoporosis. The proportion of patients treated with a specific anti-osteoporotic treatment after a fracture is low even though around half consulted their general practitioner after the fracture. Practice guidelines are thus not being adhered to in everyday clinical practice in France.

Fragility fractures in France: epidemiology, characteristics and quality of life (the EPIFRACT study).

Between 1 and 2% of people aged 50 years and over living at home in France are likely to experience a fragility fracture each year. Three-quarters of these individuals are not diagnosed with osteoporosis and lose the opportunity for appropriate care. PURPOSE: To estimate the incidence of fragility fractures in France and to describe the characteristics of individuals with such fractures and of their fractures. METHODS: In April-May 2018, a postal survey was performed in France targeting a representative panel of 15,000 individuals aged ≥ 50 years, who were invited to complete a questionnaire. If they reported experiencing a fracture in the previous 3 years, they were asked to provide information on demographics, fracture type, risk factors for fractures and osteoporosis diagnosis. Only fragility fractures were considered, and these were classified as major (associated with increased mortality) or minor, based on the fracture site. RESULTS: Around 13,914 panellists returned an exploitable questionnaire (92.8%). About 425 participants reported ≥ 1 fragility fracture (453 fractures), corresponding to a 12-month incidence rate of 1.4% [95%CI: 1.2, 1.6]. Incidence was higher in women (1.99% [1.87, 2.05]) than in men (0.69% [0.38, 0.86]) and increased with age. Around 157 fractures (34.6%) were classified as major. Participants reporting major fractures were older than those reporting minor fractures (mean age: 72.6 ± 11.3 vs 67.1 ± 10.6) and more likely to report previous corticosteroid use (odds ratio: 1.90 [95%CI: 1.13, 3.18]). No other patient characteristic was associated with fracture severity. About 117 participants with fractures (27.5%) had undergone bone densitometry, and 97 (22.8%) declared having received a diagnosis of osteoporosis. CONCLUSIONS: Around 340,000 people aged ≥ 50 years living at home in France are estimated to experience osteoporotic fractures each year. However, > 75% of panellists reporting fractures were never diagnosed with osteoporosis and thus did not have the opportunity to receive appropriate care.

Cost-effectiveness analysis of rifaximin-α administration for the reduction of episodes of overt hepatic encephalopathy in recurrence compared with standard treatment in France.

BACKGROUND: Hepatic encephalopathy (HE) is a complex neuropsychiatric syndrome that occurs most often in a context of acute or chronic liver disease. Despite the seriousness of the pathology, only a few treatments have been developed for improving its management. Rifaximin-α is the first treatment that has been clinically developed for overt HE (OHE) episodes. Recent results of clinical studies demonstrated its significant improvement in the health-related quality of life. The objective of the current study was to estimate the long-term cost-effectiveness of rifaximin-α used in combination with lactulose compared with lactulose monotherapy in cirrhotic patients, who have experienced at least two prior OHE events. METHODS: A Markov model was used to estimate rifaximin-α cost-effectiveness, evaluating it from the perspective of all contributors as recommended by French health technology assessment guidelines. Costs were based on current French treatment practices. The transition between health states was based on the reanalysis of the rifaximin-α pivotal clinical trials RFHE3001 and RFHE3002. The main outcome of the model was cost per quality adjusted life year (QALY). RESULTS: The results indicate that rifaximin-α is a cost-effective treatment option with an incremental cost per QALY gained of €19,187 and €18,517 over two different time horizons (2 and 5 years). The robustness of the model was studied using probabilistic sensitivity analysis. CONCLUSION: For the societal willingness to pay threshold of €27,000 per QALY gained, rifaximin-α in combination with lactulose is a cost-effective and affordable treatment for patients who have experienced at least two prior overt HE episodes.

Health-related quality-of-life scales specific for chronic venous disorders of the lower limbs.

OBJECTIVE: We conducted a systematic review of the literature about quality-of-life (QOL) scales in chronic venous disorders (CVDs) comprising leg ulcers to identify the respective advantages and deficits of existing tools. METHODS: A research protocol was built following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and the PICO (population, intervention, comparator, and outcome) criteria. The following databases were screened: MEDLINE, SCOPUS, EMBASE, CINHAL, and Cochrane. Psychometric and linguistic validation studies in English were included, as were clinical trials that have used QOL scales in CVDs. The data search was up to date as of October 31, 2013. RESULTS: Inclusion criteria were met in 103 of the 511 recorded references, in which 10 scales were identified: two for the full spectrum of CVDs, three for patients with CVDs without leg ulceration, four for leg ulcers, and one exclusively for patients with varicose veins. Among them, the ChronIc Venous Insufficiency Questionnaire (CIVIQ), Aberdeen Varicose Vein Questionnaire (AVVQ), and VEnous INsufficiency Epidemiological and Economic Study on Quality of Life (VEINES-QOL) scales were the most highly used according to the literature, and CIVIQ and VEINES-QOL were the most extensively validated scales and had the longest iterative validation process. A total of 31 psychometric and linguistic validations of the 10 QOL scales and 66 clinical trials that have used these scales were identified. The validation studies were based on acceptability, content validity, construct validity, reliability, and responsiveness. The clinical trials were composed of 25 randomized controlled trials and 41 observational studies. Only the randomized controlled trials are considered in the present article. CONCLUSIONS: This systematic review confirmed that CVDs have an important effect on QOL. The majority of the studies addressed the application rather than the validation of the 10 identified scales. Two scales, CIVIQ and VEINES-QOL, emerged as being thoroughly validated instruments, although factorial stability was not demonstrated for the VEINES-QOL. Our findings confirm a paucity of validation studies.

Systematic review and bivariate/HSROC random-effect meta-analysis of immunochemical and guaiac-based fecal occult blood tests for colorectal cancer screening.

BACKGROUND: Current literature evidences higher accuracy of immunological (iFOBT) vis-à-vis guaiac-based (gFOBT) fecal occult blood tests for colorectal cancer (CRC) screening. Few well-designed head-to-head comparisons exist. AIM: This meta-analysis assesses the performances of two iFOBTs compared with an established gFOBT using colonoscopy as the gold standard. METHODS: We mobilized a bivariate and a hierarchical summary receiver operating characteristic (HSROC) model. Positive likelihood ratio (LR) and negative likelihood ratio (LR) and diagnostic odds ratios were back-calculated. We constructed bivariate credibility ellipses in the HSROC space and calculated areas under the curve to obtain a global measure of test performance. Estimates are presented at 95% credibility levels. RESULTS: We included and analyzed 21 studies. OC-Sensor was the best test for CRC screening, with high sensitivity (0.87; 95% credibility interval: 0.73-0.95) and specificity (0.93; 95% credibility interval: 0.84-0.96), optimal LR (12.01) and LR (0.14), and a high diagnostic odds ratio (88.05). Bivariate credibility ellipses showed OC-Sensor's dominance over Hemoccult (sensitivity: 0.47; 95% credibility interval: 0.37-0.58; specificity: 0.93; 95% credibility interval: 0.91-0.95). CONCLUSION: Our findings support the use of OC-Sensor for CRC detection. The diagnostic estimates obtained may be extended to derive model parameters for economic decision models and to offer insight for future clinical and public health decision making. Our findings could influence the future of FOBTs within the CRC screening arsenal.

Health economic value of an innovation: delimiting the scope and framework of future market entry agreements.

BACKGROUND AND OBJECTIVES: The objective of our paper is to offer a new, payer-friendly taxonomy of market entry agreements (MEAs) that aims to twin contracts with their methodological designs in an effort to clarify the distinction between contracts that are based on performance and those that are based on demonstrated effect. METHODS: Our analysis proceeds in two stages: First, we delimit the scope and framework of pay for performance (P4P) and pay for demonstrated effect (P4E) agreements. Second, we distinguish the methodological designs supporting the implementation of each of these contracts. RESULTS: We elucidate why P4P contracts prevent the payer from funding the true effectiveness of an innovation by expanding on their limitations. These include: 1) the normative nature of comparisons, 2) the impossibility of true effect imputability for each individual, and 3) the use of intermediary outcome measures. We then explore three main criticisms that payers must take into account when reasoning in terms of performance rather than in terms of the product effectiveness. CONCLUSION: The potential effect that performance-based reimbursements may have on dissociating the components of the cost-effectiveness ratio constitutes an obstacle to a true health economic reasoning.

Primary prevention of colorectal cancer with low-dose aspirin in combination with endoscopy: a cost-effectiveness analysis.

OBJECTIVE: Low-dose aspirin reduces colorectal cancer (CRC) incidence and mortality. Recently, the aspirin effect has been shown to occur primarily in the proximal colon. Colonoscopy has been either less effective or ineffective in the proximal compared to the distal colon. The authors assessed the cost-effectiveness of adding low-dose aspirin to a simulated screening with colonoscopy or sigmoidoscopy. DESIGN: A Markov model comparing the strategies of 10-year colonoscopy or sigmoidoscopy screening and the combination of either of the two with low-dose aspirin in 100,000 subjects aged 50 years until death was constructed. Proximal and distal CRC prevention rates with endoscopy or aspirin were extracted from the literature. Screening and aspirin prevention were simulated to stop at 80 years. The cost of aspirin and aspirin-related complications, as well as aspirin-related mortality, was included. Incremental cost-effectiveness ratios between the different strategies were calculated. Sensitivity and probabilistic analyses were also performed. RESULTS: The addition of low-dose aspirin to colonoscopy and sigmoidoscopy screening increased the CRC death prevention rate from 68% and 39% to 81% and 69%, respectively. Lifetime aspirin-related mortality appeared to be 0.1%. Because of the substantial reduction in CRC care, the addition of aspirin to colonoscopy and sigmoidoscopy screening was cost-effective (incremental cost-effectiveness ratio: US$5413 per life-year saved) and cost saving (US$278 per person), respectively. When the proximal CRC prevention rate with colonoscopy was increased 56% to 73% from the baseline, the addition of aspirin was no longer cost-effective. The addition of aspirin to colonoscopy and sigmoidoscopy was a cost-effective strategy in 52% and 94% of the scenarios at probabilistic analysis. CONCLUSIONS: When assuming a suboptimal efficacy of endoscopy in preventing CRC, the addition of low-dose aspirin may be an effective and cost-effective strategy, mainly because of its high efficacy in preventing proximal CRC.

Comparison of certolizumab pegol with other anticytokine agents for treatment of rheumatoid arthritis: a multiple-treatment Bayesian metaanalysis.

OBJECTIVE: To compare the clinical efficacy of certolizumab pegol (CZP) with that of other anticytokine agents indicated for the treatment of rheumatoid arthritis (RA) with identical therapeutic indication (anti-tumor necrosis factor-α, anti-interleukin 1 or 6), with the objective of determining the noninferiority of CZP. METHODS: A systematic review was performed to identify randomized controlled trials that assessed the efficacy of anticytokine agents in combination with conventional disease-modifying antirheumatic drugs (DMARD) after 6 months of treatment, using the American College of Rheumatology (ACR) response criteria, in patients with RA who have shown inadequate response to DMARD including methotrexate. Indirect treatment comparisons were carried out by a multiple-treatment Bayesian random-effects metaanalysis. Data were analyzed using the Markov chain Monte Carlo simulation. Noninferiority of CZP was assessed in comparison with a predefined equivalence margin of 5%. RESULTS: Nineteen placebo-controlled studies were identified: 14 evaluated the efficacy of 5 anti-TNF-α agents (infliximab, etanercept, adalimumab, golimumab, CZP) and 5 evaluated efficacy of 2 anti-interleukin agents (anakinra, tocilizumab). Every treatment showed significant efficacy versus placebo in individual studies. The multiple-treatment metaanalysis showed a highest OR for CZP on ACR20 response. Metaanalysis indicates that the efficacy of CZP according to ACR20 response is superior to that of infliximab, adalimumab, and anakinra, and equivalent or superior to that of etanercept, golimumab, and tocilizumab. According to ACR50 response, the efficacy of CZP is equivalent or superior to that of all other anticytokines. CONCLUSION: Results of this original multiple-treatment Bayesian metaanalysis indicate that certolizumab pegol is at least as efficacious as the preexisting antirheumatic anticytokine biotherapies.

Costs of managing severe immune thrombocytopenia in adults: a retrospective analysis.

This study aims to report resource utilisation and annual cost for chronic immune thrombocytopenia (ITP) patients enrolled consecutively and followed for 1 year. A single-centre, single-arm, retrospective 1-year observational cohort study of adult patients with chronic ITP from a French hospital was conducted. Healthcare resource utilisation and mean cost per patient (with 95% confidence intervals) were estimated for the whole group. Patients requiring at least one hospitalisation formed subgroup 1. Patients with the most severe category of disease formed subgroup 2 [defined as hospitalised patients with ≥1 immunoglobulin (IVIg) infusion (usually reserved for those with bleeding score>8)]. Fifty-seven patients (42F/15M) with a mean age of 48 years (SD=19) at ITP diagnosis were studied. Mean platelet count at diagnosis was 28±26×109/L. Mean duration of ITP was 3.1 years (SD=2); eight patients had undergone splenectomy at baseline. Subgroup 1 included 27 patients who were hospitalised (full hospitalisation, n=23; and/or day hospitalisation, n=8). Of those, 12 patients received at least one IVIg infusion during hospitalisation (subgroup 2). Total mean cost per patient for the 1-year study period was €7,293 (95% CI=3,369-13,584) for the whole group, €15,334 (95% CI=7,876-27,459) for subgroup 1 and €26,581 (95% CI=12,241-50,578) for subgroup 2. IVIg accounted for 33% of costs for subgroup 1 and up to 43% of costs for patients with more severe disease (subgroup 2). Management of adults with chronic ITP is costly in France, especially for patients with severe disease. IVIg use was a major cost driver.

Budget impact model of rituximab after failure of one or more TNFalpha inhibitor therapies in the treatment of rheumatoid arthritis.

OBJECTIVES: To estimate the budget impact implied by the introduction of rituximab after failure of one or more anti-TNFalpha therapies in the perspective of the French health care system. METHODS: A Markov model reproduced the course, over 4years, of patients treated either by infliximab, etanercept, adalimumab or RTX, after failure of one or more anti-TNFalpha therapies, in a multicentric study. A sensitivity analysis was developed to account for patients in 3rd and subsequent lines of treatment who are expected to consume more healthcare resources. RESULTS: When RTX is not used, total annual medical cost is euro16,555 per patient, euro13,206 of which are dedicated to drug acquisition. When RTX is the only treatment in use, these costs decrease respectively to euro11,444 and euro7469. Total savings per patient and per year is euro5000. Over 4 years, total savings for the targeted population reach euro118M. In the sensitivity analysis, the difference between H2 and H2-coeff 2 (20%) reaches euro5,400,000 in total direct costs during the first year of simulation. This difference decreases along the period, to reach euro2,400,000 the fourth year of simulation, and is due to the fact that rituximab acquisition costs are independent from the treatment line. CONCLUSION: If TNFalpha inhibitors were the only treatment available, the annual global cost of treatment would be euro16,555 per patient versus euro11,444 for patients treated exclusively with rituximab. RTX is expected to produce important savings (-31%) if used after failure of one or more TNFalpha therapies. This is mainly due to its lower drug acquisition cost. These savings could increase with the development of rituximab in earlier stages of treatment.

Drotrecogin alfa's impact on intensive care workload in real life practice: a propensity score approach.

OBJECTIVES: To estimate the impact of drotrecogin alfa (DA) on intensive care workload in an observational study while illustrating the use of propensity score (PS) matching to control for recruitment bias. METHODS: PREMISS is a prospective, multicenter pre-post study. Its goal was to evaluate DA in the treatment of severe sepsis with multiple organ failure. Inclusions took place before (control patients) and after (DA-treated patients) the drug's market authorization. Workload was measured in euros using the French classification of medical procedures. It was compared between the groups via random effects gamma regression using two techniques: 1) regression adjusting for the patients' initial characteristics on the whole population; and 2) PS matching. A structural equation model was used to explore the pathways leading to a workload increase. RESULTS: Drotrecogin alfa is estimated to increase intensive care unit (ICU) workload by 20% (P = 0.045) according to the multivariate model and 34% (P = 0.002) according to the PS-matched one. In the structural equation model fitted, only DA's direct effect on the occurrence of bleeding events reaches significance (P = 0.024). CONCLUSIONS: We found a significant effect of DA on ICU workload with both standard methods of adjustment and PS matching. This effect appears to be mainly due to DA's effect on bleeding events. The analysis illustrated the usefulness of PS methods in the analysis of observational data, as it leads to conclusions similar to the traditional multivariate regression approaches while avoiding making too many adjustments, allowing focusing on the treatment effect.

Assessment of the cost effectiveness of travoprost versus latanoprost as single agents for treatment of glaucoma in France.

BACKGROUND AND OBJECTIVE: Control of intraocular pressure (IOP) is a major factor in avoiding visual impairment related to glaucoma. Both the cost and the effectiveness of therapy should be considered when initiating this lifelong treatment. The aim of this study was to assess the cost effectiveness of travoprost versus latanoprost as single agents for the treatment of glaucoma in France. METHODS: Two surveys, one documenting efficacy and the other costs, were used to provide data for a Markov model. The model reproduced the 5-year course of patients receiving a prostaglandin analogue, travoprost or latanoprost, as monotherapy. The effectiveness criterion was fitted with a Weibull distribution from a national study. Transition probabilities and costs per treatment line were extracted from two French observational databases. Bootstrap techniques were implemented to drive the probabilistic sensitivity analyses. The study compared both treatments given once daily as monotherapy to ambulatory patients with primary open-angle glaucoma or ocular hypertension. The main outcome measure was mean time to treatment change (MTTC). Possible treatment changes were the addition of adjunctive medication, treatment substitution, laser therapy or surgery. After laser therapy or surgery, patients could continue with no treatment or proceed to prostaglandin analogue as monotherapy or treatment substitution. IOP was stratified at treatment onset as < or =20, 21-23 and > or =24 mmHg, respectively. All costs were expressed in 2005 euros. RESULTS: MTTC was 44.3 months for travoprost and 37.8 for latanoprost. Additional 5-year costs for travoprost were euro51, resulting in an incremental cost-effectiveness ratio without treatment change of euro95 per year. Of patients treated with latanoprost, 1.9% underwent laser therapy or surgery, compared with 1.2% of patients treated with travoprost. The results differed with baseline IOP values, such that 55.6%, 53.9% and 50.4% of patients with pretreatment IOP values of < or =20, 21-23 and > or =24 mmHg, respectively, continued to receive travoprost treatment at 5 years, compared with 32.3%, 26.1% and 26.1% of patients, respectively, receiving latanoprost. Thus, incremental cost-effectiveness ratios (ICERs) without treatment change were euro140, euro45 and euro123 per year, respectively. CONCLUSION: Travoprost demonstrated a longer effectiveness profile than latanoprost and minimized early treatment changes. The smaller proportion of patients needing a new treatment, laser therapy or surgery virtually compensated for the higher travoprost acquisition cost. Overall, travoprost is cost effective compared with latanoprost, and is most cost effective in patients with pretreatment IOPs between 21 and 23 mmHg.

An economic evaluation of cetuximab combined with radiotherapy for patients with locally advanced head and neck cancer in Belgium, France, Italy, Switzerland, and the United Kingdom.

OBJECTIVES: A phase III randomized trial that compared the combination of cetuximab and radiotherapy to radiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck provided a platform for a comprehensive economic evaluation. The study was conducted to estimate the cost-effectiveness of cetuximab in combination with radiotherapy compared to radiotherapy alone, for the treatment of locally advanced head and neck cancer in patients for whom chemoradiotherapy is inappropriate or intolerable. METHODS: Separate economic analyses were conducted for Belgium, France, Italy, Switzerland, and the United Kingdom. The economic model was based on individual patient data extracted from an international phase III trial. Country-specific costs of care from official sources were applied in each analysis. Clinical expert panels supplemented resource use estimates from the phase III trial and validated assumptions used to extrapolate costs and health outcomes beyond the follow-up of the phase III trial. RESULTS: In the base-case analysis, the incremental cost per quality-adjusted life-year for patients receiving radiotherapy in combination with cetuximab compared to radiotherapy alone among all countries was in the range of 7538 euros to 10,836 euros. Sensitivity analysis showed the results to be robust. CONCLUSION: This cost-effectiveness analysis indicated that the addition of cetuximab to high-dose radiotherapy offers a good value-for-money alternative to radiotherapy alone in the treatment of locally advanced head and neck cancer in five European countries.

Cost-effectiveness of activated protein C in real-life clinical practice.

BACKGROUND: Recombinant human activated protein C (rhAPC) has been reported to be cost-effective in severely ill septic patients in studies using data from a pivotal randomized trial. We evaluated the cost-effectiveness of rhAPC in patients with severe sepsis and multiple organ failure in real-life intensive care practice. METHODS: We conducted a prospective observational study involving adult patients recruited before and after licensure of rhAPC in France. Inclusion criteria were applied according to the label approved in Europe. The expected recruitment bias was controlled by building a sample of patients matched for propensity score. Complete hospitalization costs were quantified using a regression equation involving intensive care units variables. rhAPC acquisition costs were added, assuming that all costs associated with rhAPC were already included in the equation. Cost comparisons were conducted using the nonparametric bootstrap method. Cost-effectiveness quadrants and acceptability curves were used to assess uncertainty of the cost-effectiveness ratio. RESULTS: In the initial cohort (n = 1096), post-license patients were younger, had less co-morbid conditions and had failure of more organs than did pre-license patients (for all: P < 0.0001). In the matched sample (n = 840) the mean age was 62.4 +/- 14.9 years, Simplified Acute Physiology Score II was 56.7 +/- 18.5, and the number of organ failures was 3.20 +/- 0.83. When rhAPC was used, 28-day mortality tended to be reduced (34.1% post-license versus 37.4% pre-license, P = 0.34), bleeding events were more frequent (21.7% versus 13.6%, P = 0.002) and hospital costs were higher (47,870 euros versus 36,717 euros, P < 0.05). The incremental cost-effectiveness ratios gained were as follows: 20,278 euros per life-year gained and 33,797 euros per quality-adjusted life-year gained. There was a 74.5% probability that rhAPC would be cost-effective if there were willingness to pay 50,000 euros per life-year gained. The probability was 64.3% if there were willingness to pay 50,000 euros per quality-adjusted life-year gained. CONCLUSION: This study, conducted in matched patient populations, demonstrated that in real-life clinical practice the probability that rhAPC will be cost-effective if one is willing to pay 50,000 euros per life-year gained is 74.5%.

[Economic aspects of telemedicine]. / Les aspects économiques de la télémédecine.

The aim of health technology assessments is to study the incremental impact of health interventions within a complex care system characterised by a multitude of individual behaviours and institutions. Most frameworks available for telemedicine evaluation simply examine financial costs relative to face-to-face consultations. Current data collection systems are poorly suited to rigorous analyses of new networks in everyday situations. Randomised trials are designed to remove sources of interference that could mask a causal relationship between a new organization and a set of results. Their methodology, which introduces the term ceteris paribus into the principles of good practice, is poorly suited to analyzing individual behaviours. Observational studies attempt to describe actual treatment situations as accurately as possible. By definition, however, they assume that the natural course of events is not deviated by interventions. The absence of an experimental plan increases the likelihood of bias and makes it more difficult to test for causal relationships. These approaches are poorly suited to testing for incremental effectiveness. Quasi-experimental studies and a staged approach would be more suited to a comprehensive assessment of telemedicine initiatives. In this way its impact on effectiveness, integration of care, quality of life and social costs may be identified in normal conditions of use.