Penetration rates of new pharmaceutical products in Europe: A comparative study of several classes recently launched in type-2 diabetes.

BACKGROUND: Different countries have their own systems for evaluating new medicines, and they make decisions as to when and how each new medicine is adopted. PURPOSE: To compare the rate of uptake of new diabetes medicines (dipeptidyl peptidase-4 inhibitors [DPP-4Is], glucagon-like peptide-1 receptor agonists [GLP1-RAs], and sodium-glucose co-transporter-2 inhibitors [SGLT2Is]) in the five most populated European countries. METHODS: The monthly volume of sales of antidiabetic drugs was extracted for each country from the IQVIA™ MIDAS® database for the period 2007 to 2016 and the defined daily doses (DDDs) were calculated. For each new drug, market shares were expressed as a percentage of the total market of non-insulin antidiabetic agents. RESULTS: Sharp differences were observed between the countries. Overall, the highest and fastest rates of uptake were seen for Germany and Spain, compared to lower rates for the UK and Italy. This was especially marked for DPP-4Is, where the market share reached over 30% of non-insulin antidiabetic drugs in Germany and Spain, compared to around 10% in the UK and Italy. In France, there was an initial rapid uptake, which stabilized at around 20% after three years. Rates of uptake were lower for the other drugs, with the GLP1-RAs reaching a market share of 2.5-4.5% in Germany, Spain and France, compared to less than 2.5% in the UK and Italy. The SGLT2Is reached a market share of 5-8% in Spain and Germany, compared to less than 4% in the UK and Italy, and they were not launched at all in France in March 2020. CONCLUSION: The differences in the uptake of new antidiabetic drugs may reflect different methods for assessing and introducing new medicines, as well as cultural factors. The uptake of the new medicines would appear to be more cautious in the UK and Italy, perhaps due to concerns about cost-effectiveness, whereas in Germany and Spain, and possibly also France, a new medicine's potential benefits may be prioritized.

A health economic evaluation of needle-based confocal laser endomicroscopy for the diagnosis of pancreatic cysts.

BACKGROUND AND STUDY AIMS: The low sensitivity of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), especially for the diagnosis of serous cystadenomas (SCAs), can be associated with diagnostic uncertainty that can regularly lead to unnecessary surgical procedures. Needle-based confocal laser endomicroscopy (nCLE) used with EUS-FNA improves diagnostic accuracy, helping to reduce unnecessary surgery and patient follow-up. This study was conducted to evaluate the economic benefit of EUS-FNA + nCLE. PATIENTS AND METHODS: Probabilities used were derived from two studies representative of the two diagnostic strategies: a retrospective analysis of patients diagnosed by EUS-FNA alone and a prospective study of patients diagnosed by EUS-FNA + nCLE. Costs were based on French healthcare system rates; both private and public sector rates were included. A decision tree structure model used these probabilities and costs for two hypothetical cohorts of 1000 patients. RESULTS: EUS-FNA + nCLE resulted in a reduction of 23 % in the total rate of surgical intervention, which translated to a reduction in clinical costs of 13 % (public sector) and 14 % (private sector). Additionally, the reduced rate of surgery would save the lives of 4 in 1000 patients. A stochastic sensitivity analysis using 100 simulations showed that in all cases the number of interventions was less for EUS-FNA + nCLE than for EUS-FNA. There was also a reduction in the incidence of false negatives using EUS-FNA + nCLE. CONCLUSIONS: EUS-FNA + nCLE results in significant economic benefits by reducing the incidence of misdiagnosis through improved diagnostic accuracy.

Travel-Associated Rabies in Pets and Residual Rabies Risk, Western Europe.

In 2015, countries in western Europe were declared free of rabies in nonflying mammals. Surveillance data for 2001-2013 indicate that risk for residual rabies is not 0 because of pet importation from countries with enzootic rabies. However, the risk is so low (7.52 × 10(-10)) that it probably can be considered negligible.

Public health and budget impact of probiotics on common respiratory tract infections: a modelling study.

OBJECTIVES: Two recent meta-analyses by the York Health Economics Consortium (YHEC) and Cochrane demonstrated probiotic efficacy in reducing the duration and number of common respiratory tract infections (CRTI) and associated antibiotic prescriptions. A health-economic analysis was undertaken to estimate the public health and budget consequences of a generalized probiotic consumption in France. METHODS: A virtual age- and gender-standardized population was generated using a Markov microsimulation model. CRTI risk factors incorporated into this model were age, active/passive smoking and living in a community setting. Incidence rates and resource utilization were based on the 2011-2012 flu season and retrieved from the French GPs Sentinelles network. Results of both meta-analyses were independently applied to the French population to estimate CRTI events, assuming a generalized probiotic use compared to no probiotics during winter months: -0.77 days/CRTI episode (YHEC scenario) or odds-ratio 0.58 for ≥1 CRTI episode (Cochrane scenario) with vs. without probiotics. Economic perspectives were National Health System (NHS), society, family. Outcomes included cost savings related to the reduced numbers of CRTI episodes, days of illness, number of antibiotic courses, sick leave days, medical and indirect costs. RESULTS: For France, generalized probiotic use would save 2.4 million CRTI-days, 291,000 antibiotic courses and 581,000 sick leave days, based on YHEC data. Applying the Cochrane data, reductions were 6.6 million CRTI days, 473,000 antibiotic courses and 1.5 million sick days. From the NHS perspective, probiotics' economic impact was about €14.6 million saved according to YHEC and €37.7 million according to Cochrane. Higher savings were observed in children, active smokers and people with more frequent human contacts. CONCLUSIONS: Public health and budget impact of probiotics are substantial, whether they reduce CRTI episodes frequency or duration. Noteworthy, the 2011-12 winter CRTI incidence was low and this analysis focused on the fraction of CRTI patients consulting a practitioner.

Cost-effectiveness of rabies post-exposure prophylaxis in the context of very low rabies risk: A decision-tree model based on the experience of France.

INTRODUCTION: Benefit-risk of different anti-rabies post-exposure prophylaxis (PEP) strategies after scratches or bites from dogs with unknown rabies status is unknown in very low rabies risk settings. DESIGN AND SETTING: A cost-effectiveness analysis in metropolitan France using a decision-tree model and input data from 2001 to 2011. POPULATION: A cohort of 2807 patients, based on the mean annual number of patients exposed to category CII (minor scratches) or CIII (transdermal bite) dog attacks in metropolitan France between 2001 and 2011. INTERVENTIONS: Five PEP strategies: (A) no PEP for CII and CIII; (B) vaccine only for CIII; (C) vaccine for CII and CIII; (D) vaccine+ rabies immunoglobulin (RIG) only for CIII; and (E) vaccine for CII and vaccine+ RIG for CIII. MAIN OUTCOMES MEASURES: The number of deaths related to rabies and to traffic accidents on the way to anti-rabies centers (ARC), effectiveness in terms of years of life gained by reducing rabies cases and avoiding traffic accidents, costs, and incremental cost-effectiveness ratios (ICER) associated with each strategy. RESULTS: Strategy E led to the fewest rabies cases (3.6 × 10(-8)) and the highest costs (€ 1,606,000) but also to 1.7 × 10(-3) lethal traffic accidents. Strategy A was associated with the most rabies cases (4.8 × 10(-6)), but the risk of traffic accidents and costs were null; therefore, strategy A was the most effective and the least costly. The sensitivity analysis showed that, when the probability that a given dog is rabid a given day (PA) was > 1.4 × 10(-6), strategy D was more effective than strategy A; strategy B became cost-effective (i.e. ICER vs strategy A < 3 × French Gross Domestic Product per capita) when PA was > 1 .4 × 10(-4). CONCLUSIONS: In the metropolitan France's very low rabies prevalence context, PEP with rabies vaccine, administered alone or with RIG, is associated with significant and unnecessary costs and unfavourable benefit-risk ratios regardless to exposure category.

Pharmaceuticals: is there a just price for innovation? / Médicaments : quel juste prix pour l'innovation ?

Pharmaceuticals: is there a just price for innovation? The « Sovaldi case ¼, a very effective and very expensive drug targeting a relatively large population, marks an evolution of the «business model¼ of pharmaceutical innovations. This latter was traditionally split between expensive drugs in narrow indications (targeted treatments, orphan diseases) and drugs addressing a wider population at moderate costs, at least not commensurate with that of contemporary innovations. Even if these prices - resulting in from an undisputable financialization of advanced medical research - raise a legitimate emotion among health care professionals and in the public opinion, even if regulators impose price cuts, at least in Europe, these treatments - that can be «efficient¼ in a health economic sense - raise serious funding problems. The exacerbation of price competition between similar molecules arriving simultaneously on the market, an unusual phenomenon in the pharmaceuticals markets, the patent fall of the great innovations of the 2000s that impose currently an heavy burden on public funding, and the correlative launch of «biosimilars ¼, and the emergence of new pricing schemes involving the concept of «risk sharing¼ constitute some structural changes to face the stake of high prices to public health systems.

Médicaments : quel juste prix pour l'innovation ? Le « cas Sovaldi ¼, un médicament très efficace, très cher et s'adressant à une population cible relativement large, marque une évolution du modèle économique de l'innovation pharmaceutique, traditionnellement limitée soit à des médicaments chers dans des indications étroites (traitement ciblé, maladie orpheline), soit à des médicaments visant une large population à des coûts modérés, du moins sans commune mesure avec celui des innovations contemporaines. Même si ces prix ­ qui résultent d'une incontestable financiarisation de la recherche médicale de pointe ­ soulèvent une légitime émotion chez les professionnels de santé et dans l'opinion publique, même si les autorités de tutelle imposent des baisses de prix, du moins en Europe, ces traitements, qui peuvent être « efficients ¼ au sens de l'évaluation médico- économique, posent de graves problèmes de financement. L'exacerbation de la concurrence par les prix entre molécules semblables arrivant sur le marché simultanément, inhabituelle en matière pharmaceutique, la chute de brevets des grandes innovations des années 2000, qui sont actuellement les médicaments qui pèsent le plus sur les budgets publics, et le lancement corrélatif de « biosimilaires ¼, ainsi que l'émergence de nouveaux schémas de tarification impliquant la notion de « partage du risque ¼ constituent des éléments d'évolution structurelle en réponse à ce défi des prix élevés.

Biosimilar versus patented erythropoietins: learning from 5 years of European and Japanese experience.

BACKGROUND: Patent expiries on leading biologics are creating new momentum in the market for biosimilars (copies of off-patent biologics), paving the way for their development. However, little is known about the factors influencing the competition between biosimilars and their reference products (REF). OBJECTIVES: The aim of this study was to analyse key global erythropoietin (EPO) markets and factors affecting biosimilar EPO (BIOSIM-EPO) uptakes, and to identify countries where BIOSIM-EPOs have gained significant market shares. METHODS: Inclusion criteria for countries in the study were a biosimilar regulatory framework similar to the EU framework, and biological market value higher than US$2.5 billion. Factors evaluated included EPO market size, EPO retail/hospital distribution mix, national incentives to use biosimilars and BIOSIM-EPO/REF price differences. IMS Health provided EPO consumption in volumes, values, and EPO ex-manufacturer prices from 2007 to 2012. RESULTS: Japan: large-sized market, mixed retail/hospital distribution, no incentives, low BIOSIM-EPO uptake (6.8 % in 2012). France: large-sized market, dominant retail distribution, no incentives, low BIOSIM-EPO uptake (5.8 %). Spain and Italy: medium-sized market, dominant hospital distribution, no incentives, moderate BIOSIM-EPO uptakes (11.5 and 8.6 %). Germany: small-sized market, dominant retail distribution, presence of incentives, high BIOSIM-EPO uptake (30.4 %). UK: small-sized market, mixed retail/hospital distribution, no incentives, low BIOSIM-EPO uptake (2.0 %). BIOSIM-EPO/REF price differences play no role at a global level (-10.8 % in Germany and -26.9 % in Japan). CONCLUSIONS: EPO markets have proven to be highly country-specific. EPO market sizes, EPO retail/hospital distribution mixes and BIOSIM-EPO/REF price differences may not be determining factors of BIOSIM-EPO uptakes. Prescription and substitution incentives to use BIOSIM-EPO appear to be determining factors in Germany. The heterogeneity of national EPO markets makes it impossible to outline country profile types with significant BIOSIM-EPO penetrations.

[Evaluation of a workplace health promotion program]. / Évaluation d'un programme de promotion de la santé conduit en entreprise.

OBJECTIVE: Some studies suggest that a workplace prevention programme could reduce health inequalities related to education level and improve the health status of the employees. The objective of the study was to demonstrate the advantages for a company to implement a health prevention programme in the workplace in order to: 1-improve health literacy 2 - change health-related behaviours 3-improve the company image. METHODS: A "before - after" methodology was used in a population of 2153 employees of three companies. Three areas of prevention were considered: nutrition, physical activity and prevention of back pain. The successive steps of the EBS programme included general communication, group workshops and individual coaching. Data collection was carried out using anonymous questionnaires sent by e-mail. A global assessment was performed based on the companies' pooled data, with separate analysis according to the steps of the programme. RESULTS: The programme mobilized employees with participation rates ranging from 25% to 45.5%. After completion of the full programme, 77.5% of respondents reported an improvement of their health knowledge versus 50.3% of those who only received general communication. Behavioural modification was observed, especially in the fields of nutrition and back pain.. EBS can be considered to be a vector of the company image for almost 7 out of 10 employees. CONCLUSION: A health prevention education programme provided by the company in the workplace mobilizes employees and contributes to improvement of health knowledge and behaviour change. All approaches tested were important and applicable to various types of companies or workers.

Biosimilar granulocyte colony-stimulating factor uptakes in the EU-5 markets: a descriptive analysis.

BACKGROUND: Biosimilars are copies of biological reference medicines. Unlike generics (copies of chemical molecules), biologics are complex, expensive and complicated to produce. The knowledge of the factors affecting the competition following patent expiry for biologics remains limited. OBJECTIVES: The aims of this study were to analyse the EU-5 Granulocyte-Colony Stimulating Factor (G-CSF) markets and to determine the factors affecting the G-CSF biosimilar uptakes, particularly that of biosimilar prices relative to originators. METHODS: Data on medicine volumes, values, and ex-manufacturer prices for all G-CSF categories were provided by IMS Health. Volumes were calculated in defined daily doses (DDD) and prices in Euros per DDD. In the EU-5 countries, there is 5 years of experience with biosimilar G-CSFs (2007-2011). RESULTS: Two G-CSF market profiles exist: (1) countries with a high retail market distribution, which are the largest G-CSF markets with low global G-CSF biosimilar uptakes (5.4% in France and 8.5% in Germany in 2011); and (2) countries with a dominant hospital channel, which are the smallest markets with higher G-CSF biosimilar uptakes (12.4% in Spain and 20.4% in the UK). The more the decisions are decentralized, the more their uptakes are high. The price difference between G-CSF biosimilars and their reference plays a marginal role at a global level (price differences of +13.3% in the UK and -20.4% in France). CONCLUSION: The competition with G-CSF biosimilars varies significantly between EU-5 countries, probably because of G-CSF distribution channel differences. Currently, this competition is not mainly based on prices, but on local political options to stimulate tendering between them and recently branded second- or third-generation products.

Temporary authorization for use: does the French patient access programme for unlicensed medicines impact market access after formal licensing?

BACKGROUND: To reach the French market, a new drug requires a marketing authorization (MA) and price and reimbursement agreements. These hurdles could delay access to new and promising drugs. Since 1992, French law authorizes the use of unlicensed drugs on an exceptional and temporary basis through a compassionate-use programme, known as Temporary Authorization for Use (ATU). This programme was implemented to improve early access to drugs under development or authorized abroad. However, it is suspected to be inflationary, bypassing public bodies in charge of health technology assessment (HTA) and of pricing. OBJECTIVE: The aim of this study is to observe the market access after the formal licensing of drugs that went through this compassionate-use programme. METHODS: We included all ATUs that received an MA between 1 January 2005 and 30 June 2010. We first examined market access delays from these drugs using the standard administrative path. We positioned this result in relation to launch delays observed in France (for all outpatient drugs) and in other major European markets. Second, we assessed the bargaining power of a hospital purchaser after those drugs had obtained an MA by calculating the price growth rate after the approval. RESULTS: During the study period, 77 ATUs were formally licensed. The study concluded that, from the patient's perspective, licensing and public bodies' review time was shortened by a combined total of 36 months. The projected 11-month review time of public bodies may be longer than delays usually observed for outpatient drugs. Nonetheless, the study revealed significant benefits for French patient access based on comparable processing to launch time with those of other European countries with tight price control policies. In return, a 12 % premium, on average, is paid to pharmaceutical companies while drugs are under this status (sub-analysis on 56 drugs). CONCLUSIONS: In many instances, the ATU programme responds to a public health need by accelerating the availability of new drugs even though this study suggests an impact of the programme on the market access of these drugs for which the standard administrative path is longer than usual. In addition, pharmaceutical companies seem to market compassionate-use drugs with a presumed benefit/risk ratio at a price that guarantees a margin for future negotiation.

Efficiency of glaucoma drug regulation in 5 European countries: a 1995-2006 longitudinal prescription analysis.

PURPOSE: To compare the evolution of prostaglandin analog (PGA) and ß-blocker (BB) prescriptions across 5 European countries. METHODS: Data were extracted from various sources: (1) IMS data for France, Germany, Italy, Spain, and the United Kingdom, (2) glaucoma-treated patients from the United Kingdom General Practice Research Database (UK-GPRD), (3) prescriptions delivered by the territorial pharmaceutical service of Monselice of the Padova region (Italy). Drugs were grouped into 3 classes: PGAs, BBs, and other drugs. Yearly market shares were calculated. Treatment persistence survival curves were estimated for Italian and UK data, and the 3 drug groups were compared using the Cochran Mantel Haenszel test. RESULTS: According to Padova data, BBs decreased in market share, whereas PGAs increased. A linear extrapolation of these market shares, based on 1998 to 2003 data, predicted that the 2 curves should cross in 2005, a prediction reinforced by the European Medicines Agency authorization (2002) of PGAs as first-line glaucoma treatments. That this did not occur may be explained by Italy's refusal to reimburse PGAs as first-line therapy. IMS data identified Italy and Germany as 2 countries in which BBs are still more frequently prescribed than PGAs. Treatment persistence with PGAs as monotherapy, in PGA-naive patients, was longer than for BBs according to both Padova and UK-GPRD data. This held true for both first-line and second-line PGA prescriptions (UK-GPRD); the persistence of second-line PGA equalled first-line BB treatment. CONCLUSION: Health care regulations impacted upon glaucoma prescribing and may be one of the reasons for different annual evolution rates of PGA and BB prescriptions.

Daily costs of prostaglandin analogues as monotherapy or in fixed combinations with timolol, in Denmark, Finland, Germany and Sweden.

BACKGROUND: To compare the daily costs of 3 prostaglandin analogues (bimatoprost, latanoprost, travoprost), alone, and associated with timolol in 4 European countries (Denmark, Finland, Germany, and Sweden). METHODS: Six glaucoma products were sampled by buying 5 bottles from 1 suburban pharmacy in each of the 4 countries. Drops were weighed by a single operator at 1 site according to standardized procedures. Residual drops were then counted. Unit bottle costs were estimated from tariff lists. Eye-drop weights were entered into a nested analysis of variance comprising drug, instillation day, country, the interaction, and a sample factor nested within the country factor. Effectiveness was represented by treatment failure rates estimated from a meta-analysis and a general practitioner survey. RESULTS: Every drug bottle contained sufficient drops to treat 1 patient for 28/31 days. Drop-size heterogeneity between countries was observed for bimatoprost and bimatoprost/timolol. Mean travoprost and travoprost/timolol drop-sizes were the smallest, and drop-counts per bottle were the lowest for latanoprost, or latanoprost/timolol. In all 4 countries annual costs were least for travoprost and travoprost/timolol. CONCLUSIONS: On taking into account drug costs and effectiveness, travoprost and travoprost/timolol were cheaper and more effective than latanoprost and latanoprost/timolol and were cheaper than bimatoprost and bimatoprost/timolol.

Effectiveness of a lumbar belt in subacute low back pain: an open, multicentric, and randomized clinical study.

STUDY DESIGN: Multicentric, randomized, and controlled study of clinical evaluation of medical device in subacute low back pain. OBJECTIVE: To evaluate the effects of an elastic lumbar belt on functional capacity, pain intensity in low back pain treatment, and the benefice on medical cost. SUMMARY OF BACKGROUND DATA: There is limited evidence of efficiency of lumbar supports for treatment of low back pain. There is also a lack of the methodology in the studies reported on the efficiency of this device. METHODS: This study is randomized, multicentric, and controlled with 2 groups: a patient group treated with a lumbar belt (BWG) and a control group (CG). The main criteria of clinical evaluation were the physical restoration assessed with the EIFEL scale, the pain assessed by a visual analogic scale, the main economical criteria was the overall cost of associated medical treatments. RESULTS: One hundred ninety-seven patients have participated. The results show a higher decrease in EIFEL score in BWG than CG between days 0 and 90 (7.6 +/- 4.4 vs. de 6.1 +/- 4.7;P = 0.023). Respectively significant reduction in visual analogic scale was also noticed (41.5 +/- 21.4 vs. 32.0 +/- 20; P = 0.002). Pharmacologic consumption decreased at D90 (the proportion of patients who did not take any medication in BWG is 60.8% vs. 40% in CG;P = 0.029). CONCLUSION: Lumbar belt wearing is consequent in subacute low back pain to improve significantly the functional status, the pain level, and the pharmacologic consumption. This study may be useful to underline the interest of lumbar support as a complementary and nonpharmacologic treatment beside the classic medication use in low back pain treatment.

Medicoeconomic evaluation of hyaluronic acid for knee osteoarthritis in everyday practice: the MESSAGE study.

INTRODUCTION: Medicoeconomic data on treatments for osteoarthritis are scant. We investigated the impact of hyaluronic acid therapy on the cost of management of knee osteoarthritis. Our primary objective was to compare medical costs (admissions, outpatient visits, investigations, and treatments) and non-medical costs (sick leaves and transportation) from the perspective of the national health insurance system during the 3 months before and the 6 months after three intraarticular injections of hyaluronic acid. Our secondary objective was to evaluate treatment benefits in terms of pain, function, and quality of life. METHODS: Observational, multicenter, longitudinal, before-after study of the medical and economic effects of hyaluronic acid therapy for symptomatic knee osteoarthritis. RESULTS: Of the 296 assessable patients (mean age, 69 years; 30% with obesity; 65% women), only 5% of patients were withdrawn prematurely from the study. Significant improvements in the Lequesne index were found 3 and 6 months after treatment; the improvement was greater than 50% in over half the patients. Pain and quality-of-life scores improved significantly. Total cost of the disease decreased from 334 euros for the 3 pretreatment months to 295 euros and 233 euros for posttreatment months 1-3 and 4-6, respectively. CONCLUSION: The costs of knee osteoarthritis decreased during the 6 months after Suplasyn therapy, indicating that the cost of the medication was more than offset by the decreased need for other treatments. Concomitantly, clinical benefits were obtained. Under the conditions of everyday practice, hyaluronic acid may provide medical benefits at an acceptable cost.

Impact of irritable bowel syndrome (IBS) on health-related quality of life (HRQOL).

AIMS: To assess the impact of irritable bowel syndrome (IBS) on patient-reported health-related quality of life (HRQOL). METHODS: Two HRQOL instruments were administered by telephone interviews to a sample of 253 IBS French patients recruited from the general population. IBS was diagnosed according to the Manning, Rome I and Rome II criteria. Patients with organic diseases were excluded from the study. A generic instrument, the Short Form 36 (SF-36), and an IBS disease-specific instrument, the IBSQOL, were used. RESULTS: Patients with IBS had statistically significant (P<0.05) lower scores for all SF-36 QOL domains compared with the general French population. Women (N=192) reported significantly (P<0.05) poorer HRQOL on both the SF-36 and the IBSQOL scores than men (N=61) for all domains except energy on the SF36 and the sleep on the IBSQOL. HRQOL deteriorated with time since onset of IBS symptoms for some domains such as diet. For both instruments, a positive correlation was observed between low scores and intensity of pain and discomfort. IBS patients with a predominance of diarrhea (N=72) exhibited significantly greater impairment of HRQOL in the emotional domain than IBS persons with constipation predominance (N=65) (P

[Cost-effectiveness analysis of capecitabine in combination with docetaxel in comparison to docetaxel monotherapy in advanced or metastatic breast cancer in France]. / Analyse coût/efficacité de l'association capécitabine-docétaxel versus docétaxel en monothérapie dans le cancer du sein métastatique ou localement avancé en France.

Objective to estimate the cost-effectiveness ratio of adopting capecitabine/docetaxel combination therapy in place of docetaxel alone, in France, in patients with metastatic breast cancer (MBC), resistant to, or relapsing after anthracycline-containing therapy, The SO14999 trial is a multicenter trial, randomized, including 511 patients equitably divided between the two groups. In addition to efficacy data, medical resource consumption related to adverse events were also collected in this trial ("piggy-back" analysis). French cost were associated to each data in order to estimate the medical cost of the two strategies from a healthpayer perspective. Afterwards, incremental cost-effectiveness analysis was performed based on the overall survival outcome and progression free survival. The addition of capecitabine to docetaxel resulted in an increase in median survival of 90 days (442 versus 352 days; p = 0.0126) and increase in the duration of progression free survival of 58 days (186 versus 128 days; p = 0.0001) compared with docetaxel alone. The total medical cost by patient was evaluated at 11,786 on average IC95% = [10,982-12,591] in the arm in association versus 11,570 IC95% = [10,719-12,421] in the arm in monotherapy; that is to say a non-significant overcost of 216 under capecitabine (p = 0.642). Moreover, the additional cost per year of life saved was estimated at 952 and the one without progression of the disease was established at 1,198 . A combined treatment associating capecitabine and docetaxel proves to be a cost-effectiveness strategy compared with the use of docetaxel alone, in the treatment of locally advanced or metastatic breast cancer in France.

Financial cost of osteoarthritis in France. The "COART" France study.

OBJECTIVE: Osteoarthritis is the most common musculoskeletal disease, with about 9-10 million patients in France including 4.6 million with symptoms. The objective of the COART France study is to evaluate the cost of osteoarthritis in France from the societal point of view and to compare the results to those obtained in 1993 using the same methodology. MATERIALS AND METHODS: The cost of osteoarthritis was evaluated using the macroeconomic approach. Direct costs were estimated from healthcare resource use (physician visits, drug prescriptions, and hospital admissions) and indirect costs from doctor-prescribed sick-leave durations. RESULTS: Direct costs of osteoarthritis in 2002 exceeded 1.6 billion Euros, contributing about 1.7% of expenses of the French health insurance system, which covers all residents of France regardless of employment or documentation status. Hospital admissions were the greatest single contributor to direct costs, with more than 800 million Euros. Osteoarthritis led to 13 million physician visits, during which 570 million Euros worth of medications were prescribed. The 156% increase in direct medical costs compared to 1993 was chiefly related to an increase in the number of patients (+54%); the cost increase per patient was only 2.5% per year. CONCLUSION: Despite the large increase in the number of treated patients and the development of new costly medications, the rise in the cost of managing osteoarthritis seems well contained. The aging of the population, development of new technologies, and increasing patient expectations will probably govern the future economic impact of osteoarthritis, which remains a major public health burden.

Choice of GPIIb/IIIa antagonist in percutaneous coronary intervention: how should economic criteria be factored in?

OBJECTIVE: Three GPIIb/IIIa antagonists are available in the market. In France, as in many countries, their acquisition costs strongly differ. The objective of this study was to analyze how economic criteria-beyond the acquisition cost-should be factored in, when choosing a GPIIb/IIIa antagonist. METHOD: Both clinical and economic papers on the use of GPIIb/IIIa antagonists in percutaneous coronary interventions published in peer-review journals from 1994 to 2002 were reviewed and analyzed. RESULTS: Cost differentials between products strongly vary from one 'cost concept' to another, i.e., acquisition cost, administration cost, hospital cost, net treatment cost. The comparison of efficacy is even more complicated, as most of the time only indirect comparisons are available, based on different clinical studies, with different durations and definitions of outcomes. Finally, cost-effectiveness ratios range from US dollar 10,695 per avoided event for eptifibatide (IMPACT II study) to US dollar 74,047 for tirofiban (RESTORE study). CONCLUSION: The concept of cost, inevitably entering into the choice of a medicinal strategy, must be used with caution. The amplitude of the difference between products, and the product favored by the difference, vary according to the cost concept retained.