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.

[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.

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.

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

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.

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.

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.

The burden of age-related macular degeneration: results of a cohort study in two French referral centres.

OBJECTIVE: To describe the economic impact of age-related macular degeneration (AMD) and to assess its medical and non-medical costs. DESIGN AND SETTINGS: An observational study was carried out in 105 patients in two French centres in a sample of 105 French patients. All consecutive patients, consulting during a 3-week period, were included provided they were 60 years of age or older and they presented an exudative form of AMD with a distant visual acuity in the best eye < or = 20/40. Data collected included clinical items, treatment modalities, medical follow-up, transport costs, impact of AMD on living conditions and welfare payments related to visual impairment. Costs were presented in 2000 values. PERSPECTIVE: General payer perspective (Social Security, private health insurance and patient). RESULTS: Mean age was 79.3 years and ranged from 62.8-95 years. Average length of disease evolution was 3.5 years. During a 3-month period, patients had a mean of 2.6 visits to the ophthalmologist. Thirty percent of the patients used vascular medications and 72.4% had been previously treated by laser photocoagulation. Only 10% had benefited from visual rehabilitation. Annual AMD cost per patient was 3660.29 euros (EUR) [95% CI: 2881.92-4438.62]. Half of these annual costs were medical costs. Other major cost components were home help costs EUR904.91 [95% CI: 478.88-1330.94] and transport costs for care EUR542.73 [95% CI: 146.31-939.14]. Non-medical costs were significantly higher for patients with more severe disease. CONCLUSIONS: The economic argument that costs are higher in patients with the lowest visual acuity emphasises the necessity of early detection and treatment of patients with AMD.

Cost-minimisation study of dorzolamide versus brinzolamide in the treatment of ocular hypertension and primary open-angle glaucoma: in four European countries.

OBJECTIVE: Cost is an issue when prescribing two drugs with equivalent efficacy. We compared the direct medical costs of topical brinzolamide 1% (twice a day or three times daily) with topical dorzolamide 2% (twice a day or three times daily) in France, Italy, Portugal and Spain in patients with ocular hypertension or primary open-angle glaucoma. DESIGN AND SETTING: Three double-blind, controlled, randomised trials (with a study duration of 3 months) compared the response rate of brinzolamide twice a day or three times daily versus dorzolamide three times daily, and the response rate of brinzolamide-timolol twice a day versus a dorzolamide-timolol combination twice a day. A fourth double-blind randomised trial (with a duration of 12 months) compared brinzolamide twice a day and three times daily with timolol monotherapy. Local tolerance was compared in two dedicated studies. Rates of switching to a new medication regimen were evaluated through a US health maintenance organisation database. In case of treatment failure, the patients were treated with latanoprost. A model was developed to value direct medical costs over 3 months. The economic perspective was that of the third-party payer and the patient, and included direct medical costs (reimbursed part plus co-payment). PATIENTS: Patients with ocular hypertension and/or primary open-angle glaucoma who had not responded to or could not tolerate beta-blocker therapy. OUTCOME MEASURE: The daily direct medical costs of therapy with the two drugs. RESULTS: As monotherapy, brinzolamide twice daily and three times daily was found to be as efficacious as dorzolamide three times a day. Brinzolamide twice daily plus timolol was also as efficacious as a combination of dorzolamide and timolol twice a day. Stinging of the eye upon instillation with brinzolamide was experienced by fewer patients than with dorzolamide (p < 0.0001). The likelihood of patients treated with dorzolamide changing therapy was 1.28 times greater than that for those treated with brinzolamide. The size of the brinzolamide drop is 18.7% smaller than that of dorzolamide allowing seven more therapy days per bottle with brinzolamide twice daily than with dorzolamide monotherapy, and five more days when brinzolamide is used three times a day. The direct medical costs for patients treated with brinzolamide were lower in all four European countries when drop size was taken into account than for those treated with dorzolamide. Sensitivity analyses confirmed the robustness of our findings. CONCLUSION: Because brinzolamide can be prescribed twice daily in monotherapy and because fewer patients treated with brinzolamide switch therapy due to local intolerance, our model suggests that brinzolamide is a cost-saving alternative to dorzolamide.

Prevalence of irritable bowel syndrome (IBS) and variability of diagnostic criteria.

OBJECTIVES: The main objectives of this study were to assess whether the use of different definitions of irritable bowel syndrome (IBS) could influence measurements of its prevalence and characterize the patient population fulfilling these different diagnostic criteria. METHOD: A telephone survey was carried out by contacting 8,221 subjects aged >or=18 Years representative of the French population. A "screening" questionnaire based on three algorithms of IBS classification (Manning, with or without a notion of a minimal duration of symptoms, Rome I and Rome II) was used by specialised inquirers. RESULTS: Twenty three percent of the subjects interviewed stated that they had suffered from abdominal pain during the previous 12 Months. The prevalence of IBS considerably varied, depending on the diagnostic criteria used: 12% based on Manning criteria without reference to the duration of symptoms; 2.5% if the notion of duration of symptoms was added to the Manning criteria, and 2.1% and 1.1% based on the Rome I and Rome II criteria, respectively (the latter including the same notion of duration). In total, 212 subjects (2.6%) met at least one of the criteria including a minimal duration of symptoms, with a predominance for women (sex-ratio close to 2). CONCLUSION: The prevalence of IBS is strongly dependent on the classification algorithm employed. The requirement of a minimum duration of symptoms eliminates IBS in a large number of subjects complaining of abdominal disorders. Once these methodological variations were taken into account, the prevalence of IBS in France was found to be comparable to that published in international literature.

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.

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.