Stéphanie Payet

Budget impact model of rituximab after failure of one or more TNFα 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.

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

BackgroundRecombinant 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.MethodsWe 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.ResultsIn 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 versus €36,717, P < 0.05). The incremental cost-effectiveness ratios gained were as follows: €20,278 per life-year gained and €33,797 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 per life-year gained. The probability was 64.3% if there were willingness to pay €50,000 per quality-adjusted life-year gained.ConclusionThis 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 per life-year gained is 74.5%.

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 ≤20, 21–23 and ≥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 €51, resulting in an incremental cost-effectiveness ratio without treatment change of €95 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 ≤20, 21–23 and ≥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 €140, €45 and €123 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.

PIN1 ASSESSING THE EXTERNAL VALIDITY OF DROTRECOGIN ALFA (ACTIVATED) CLINICAL TRIALS IN AN OBSERVATIONAL STUDY USING PROPENSITY SCORE MATCHING TO REDUCE RECRUITMENT BIAS

PIH11 WORK AND HEALTH CONDITIONS DURING PREGNANCY IN WOMEN OF THE MEXICAN SOCIAL SECURITY INSTITUTE Torres-Arreola LDP,Villa-Barragán JP Instituto Mexicano del Seguro Social, México D.F, Mexico; Instituto Nacional de Pediatría, México, D.F, Mexico OBJECTIVES: To compare socio-demographic, reproductive and prenatal attention conditions among women who perform work outside the home (as opposed to housework); in the case of those going out to work, to describe the conditions of such work; and finally to show whether health-related differences exist that correlate with working situation (at home vs. outside the home). METHODS: Transversal study (pilot) carried out in a family medicine unit of the Mexican Social Security Institute (IMSS) between April and July 2003, during which period interviews were effected with 537 pregnant women engaged in either paid work, housework, or both, and registered with the Family Medicine external consultation services. A questionnaire was applied in order to establish demographic and reproductive characteristics, as well as variables related with prenatal control and the existence of symptoms before and after pregnancy; finally, to provide information on characteristics of both domestic and extra-domestic work. RESULTS: In total, 36.5% were women with paid work (A), the rest having exclusively domestic work (63.5%) (B). Of those with extra-domestic work (A), 78.6% had clerical or similar jobs, mainly in service activities (45%), and 18.9% were industrial workers. Stress at work is present in 74% of cases interviewed. On analyzing the effect of work on women’s health conditions, it was observed that women who do not go out to work show a higher risk of muscular-skeletal alterations than those who do so (RM: 4.3 IC95% 1.6–11.4). The presence of genitourinary symptoms is greater for those who claim to have had more than three children and who remain at home. CONCLUSIONS: The monitoring of domestic work is important in view of the need for attention to the conditions in which such work is carried out; it also helps identify potential risks for health.