BACKGROUND AND OBJECTIVES:The objective of this study is to assess spatial and socioeconomic disparities in cervical cancer screening (CCS) coverage in France before the implementation of the national organized screening program. MATERIALS AND METHODS:This ecological study analyzed CCS coverage among 17.2 million women aged 25-65 years residing in ∼35,000 municipalities in mainland France from January 2016 to June 2019. Screening coverage was estimated using universal health insurance data. Socioeconomic deprivation was measured using the French Deprivation Index (FDep), and access to care was assessed using the Access to General Practitioner (AGP) index. Descriptive spatial analyses and a generalized hierarchical binomial model were used to examine the impact of deprivation and healthcare provision on screening participation, while accounting for geographic variability. RESULTS:Screening coverage varied widely across departments (47.5%-68.0%) and within departments, with a strong social gradient (62.5% in the least deprived quintile vs. 52.4% in the most deprived). FDep explained 34.1% of municipal variations in screening, but a significant portion remained unexplained (random effect: 21 percentage points). The AGP index was weakly associated with participation (+2.2 percentage points between the 90th and 10th percentiles. The screening gap related to deprivation (11.3 percentage points) was smaller than the unexplained variability (15.6). CONCLUSION:Our study highlights significant spatial and social disparities in CCS participation before the national program rollout. While organized screening programs were associated with higher participation, inequalities persisted. Addressing these disparities requires targeted interventions and structural changes in the CCS programme. Future evaluations will be essential to determine whether the national CCS program reduces these disparities and improves screening equity.

Le taux de recours à l'hystérectomie est un des indicateurs de l'OCDE, il est retenu comme priorité nationale de pertinence des actes chirurgicaux. Il fait partie des indicateurs de mesure de performance des services de santé, la variabilité géographique de cet indicateur ne pouvant s'expliquer par des différences de l’état de santé ou par des préférences individuelles. L'objectif de ce travail est de décrire les pratiques de l'hystérectomie de 2005 à 2021 en France. Un algorithme de sélection a été développé à partir des bases de données nationales PMSI de 2005 à 2021: les séjours des femmes mentionnant un acte d'hystérectomie totale, sub-totale ou de trachélectomie ont été retenus. Dans le cas où plusieurs actes étaient mentionnés pour une même femme sur la période, l'hystérectomie totale est conservée. Les années 2020 et 2021 sont présentées mais ne seront pas analysées compte-tenu de leurs particularités liées au contexte sanitaire. Sur la période 2005-2021, 1 100 228 femmes ont subies une intervention (1 103 032 interventions observées): 90 % avaient eu une hystérectomie totale et la moitié des femmes avaient entre 40 et 54 ans. Les âges médian et moyen de l'intervention sont respectivement de 51 et de 54 ans. Dans 79 % des cas, l'acte a été réalisé suite à un diagnostic de pathologies bénignes (tumeurs bénignes, maladies de l'appareil génito-urinaire) et dans 17 % d'un cancer. Le nombre de femmes hystérectomisées augmente jusqu'en 2007 (72 443 actes) puis diminue jusqu'en 2019 (59 800 actes). Pour l'année 2019, environ 172 femmes sur 100 000 ont eu une hystérectomie au cours de l'année (max=641 chez les femmes de 45 à 50 ans). Les taux régionaux standardisés montrent un gradient allant de 145 (pour l'Ile-de-France) à 194 (pour les Hauts-de-France) femmes ayant eu une hystérectomie pour 100 000 femmes. Ces premiers résultats suggèrent une tendance à la baisse des taux de recours à l'hystérectomie depuis 2007 et une disparité des pratiques au niveau national. Hystérectomies ; France ; PMSI Les auteurs déclarent ne pas avoir de liens d'intérêts.

OBJECTIVE:In France, the national breast cancer screening programme (NBCSP), targeting women aged 50-74 years was rolled out nationwide in 2004. It aims at reducing breast cancer mortality. In addition to the NBCSP, the use of opportunistic screening is permitted in France. The objective of this study is to estimate both opportunistic use and overall coverage rates of breast cancer screening, among women 40-84 years of age, in France.METHODS:The French medico-administrative health data system (SNDS) was used to identify women performing an opportunistic or organised mammography screening in France in 2016-2017.RESULTS:The two-yearly opportunistic mammography screening is 18 % among women aged 40-84; it is 11 % among women aged 50-74, i.e., the target age range for organised screening, 36 % among women aged 40-49 and 13 % among women aged 75-84. The overall two-yearly screening coverage is 48 % for all women aged 40-84; it is 60 % among women aged 50-74, 36 % among women 40-49 and 16 % for those aged 75-84. Geographical variations in screening are lessened when the two screening strategies are considered, as they balance each other.CONCLUSION:Although coverage in the NBCSP is around 50 % in France, more than one third of the women make use of opportunistic screening within and outside the target age range. Organized screening appears to improve equity of access to mammography screening service. The lack of data on opportunistic screening practices hinders the evaluation of French screening practices as a whole.

Introduction A national organized cytology-based cervical cancer screening program was launched in 2018 and rollout is ongoing. Concomitantly, the High Authority for Health (HAS) recently assessed new evidence on primary HPV testing to update screening recommendations. Methods The HAS commissioned systematic reviews and meta-analyses to evaluate the effectiveness of primary HPV screening; accuracy of HPV testing on self-samples; effectiveness of self-sampling to reach underscreened women; and triage strategies to manage HPV-positive women. Recommendations developed by the HAS were reviewed by a multidisciplinary group. Results Compared with cytology screening, HPV screening is more sensitive to detect precancers but less specific. In women aged ≥30, if the test is negative, HPV screening greatly reduces the risk of developing precancer and cancer for at least 5 years. HPV testing, using validated PCR-based assays, is as sensitive and slightly less specific on self-samples than on clinician-taken samples. Self-sampling is more effective to reach underscreened women than sending invitations to have a specimen taken by a clinician. Two-time triage strategies ensure a sufficiently high risk if triage-positive to justify referral and low risk if triage-negative allowing release to routine screening. Conclusions The HAS recommends three-yearly cytology screening for women aged 25–29 and HPV screening for those aged 30–65 with an extension of the screening interval to 5 years if the HPV test is negative. Self-sampling should be offered to underscreened women aged ≥30. HPV-positive women should be triaged with cytology. Those with abnormal cytology should be referred for colposcopy and those with normal cytology re-tested for HPV 12 months later. Recommendations for implementation of HPV-based screening in the organized program are provided.

Background The purpose of this study was to compare cervical cancer screening by pap smear (PS) versus preliminary HPV testing based on self-collected samples (SC-HPV). Methods Interventional study among underprivileged women from 25 to 65 years old in four French cities. The control group (CG) was referred for a PS. The experimental group (EG) conducted a SC-HPV test followed by a PS in case of positivity. Differences on screening completion and cytological abnormalities were analysed by logistic and Cox regression. Results 383 women were assigned to the EG and 304 to the CG. The screening completion proportion was 39.5% in the CG compared to 71.3% in the EG (HR = 2.48 (CI 95% [1.99–3.08]; p < 0.001). The proportion of cytological abnormalities was 2.0% in the CG and 2.3% in the EG (OR = 1.20 (CI 95% [0.42–3.40]; p = 0.7). The proportion of participants lost to follow-up was 60.5% in the CG and 63.2% in the EG HPV positive ( p = 0.18). Conclusion Providing an SC-HPV-test increased the participation of underprivileged women in CCS. Nevertheless, the significant number of lost to follow-up in both groups can undermine the initial benefits of the strategy for HPV positive women. Registration: Clinicaltrials.gov: NCT03118258.

Le recours au dépistage du Cancer du Col de l'Utérus (CCU) est particulièrement faible en France chez les femmes en situation socioéconomique défavorisée. L'objectif de l'étude était de comparer la proportion de femmes ayant complété un parcours de dépistage par frottis cervico utérin (FCU) versus un dépistage initial par Auto-Prélèvement vaginal (APV) permettant la détection des Papillomavirus (HPV). L'étude était une étude interventionnelle, multicentrique, comparative et randomisée, menée auprès de populations précaires dans quatre villes (sept programmes). Les femmes âgées de 25 à 65 ans non à jour de leur dépistage du CCU (Pas de FCU dans les 3 années précédentes) étaient inclues dans l'étude. La stratégie de contrôle était la stratégie « orientation directe pour réalisation d'un FCU ». La stratégie expérimentale était une proposition d'APV-HPV, puis réalisation d'un FCU en cas de détection d'HPV. La comparaison des taux de complétude de dépistage a été effectuée par régression logistique et de Cox. Un total de 383 femmes ont été randomisées dans le bras expérimental et 304 dans le bras contrôle. Dans le bras expérimental, 95,3 % des femmes ont initié un dépistage en réalisant l'APV-HPV, permettant de détecter la présence de l'HPV dans 34,4 % des cas. Dans le bras contrôle (FCU direct), 39,5 % des femmes avaient complété la procédure de dépistage contre 71,3 % (p < 0,001) dans le bras expérimental. Le hasard ratio (HR) était de 2,48 (IC à 95 % (1,99–3,08) ; p < 0,001). Dans le bras expérimental, 63,2 % des femmes ayant un test HPV positif étaient perdues de vue sans que l'on sache si elles avaient complété le processus de dépistage par réalisation d'un FCU complémentaire. La disponibilité d'un kit d'APV-HPV permet de favoriser l'accès au dépistage du CCU des femmes en situation de précarité en France. Néanmoins, le nombre élevé de perdues de vue post- test HPV positif limite le bénéfice de cette stratégie de dépistage.

trophoresis. Patterns were compared visually with reference patterns (6). From January 1, 2003, to March 31, 2004, a total of 44 of 124 male rectal swabs were positive for C. trachomatis. Of those, 38 were identified as belonging to the L2 serotype, which confirms the diagnosis of rectal LGV. Epidemiologic information was retrospectively obtained by clinicians through review of medical records, telephone interview, or both. A complete history was available for 14 of the 38 cases. All 14 men reported unprotected anal sex with anonymous male sex partners in France, and none reported a stay in an LGV-endemic area. Their mean age was 40 years (31–50); 8 were HIV-infected, and 9 had another concomitant STD. The mean duration of symptoms before LGV diagnosis was 50 days (range 11–120 days). All 14 patients had symptoms of acute proctitis, including rectal pain, discharge, and tenesmus, and 3 (all HIV-infected) had fever. Deep, extended rectal ulcerations were reported in 8 patients, 3 of whom were HIV-infected and had lesions suggestive of rectal carcinoma. In 1 patient in whom a late diagnosis was made 4 months after the onset of symptoms, a rectal tumorlike stricture was observed. All 14 patients were treated with tetracycline for a mean duration of 16 days (range 10–60 days). An information campaign among microbiologists and clinicians and a sentinel LGV surveillance system were launched in April 2004. Subsequently, LGV was diagnosed in 65 additional male patients, some retrospectively. In total, rectal LGV was diagnosed in 103 patients from July 2002 to August 2004 (Figure). Prompt diagnosis and treatment is indeed paramount to prevention and control. Diagnosis may be further hampered because rectal LGV may mimic other conditions such as rectal carcinoma or Crohn disease. Treatment duration should be no shorter than 21 days, and follow-up examinations should be conducted until all signs and symptoms have resolved (7,8). If left untreated, rectal LGV could lead to serious complications such as rectal stricture (1). If recently exposed to infection, sexual contacts should receive prophylactic treatment to prevent reinfection and to eliminate a potential reservoir. The emergence of rectal LGV, characterized by deep mucosal ulcerations and frequently occurring in HIV-infected men who have sex with men, is a serious concern for the gay community in Europe.

Évaluer les variations géographiques de la participation au programme national de dépistage organisé du cancer du sein en fonction de la défavorisation sociale dans l'ensemble de la France métropolitaine. Les données de 4 805 390 femmes vivant dans 36 209 communes de 95 départements et participant au programme de dépistage organisé en 2013–2014 ont été analysées en utilisant un indice écologique français de défavorisation sociale (FDep–« French Deprivation Index »). Les taux de participation au dépistage organisé ont été décrits par quintiles de déprivation, et analysés dans un modèle de Poisson à effets aléatoire dans lequel le FDep était introduit comme un effet continu non linéaire. Ce dernier modèle permettait par ailleurs de quantifier les variations de la participation entre les communes et les départements. Le taux de participation standardisé était le plus élevé dans les quintiles intermédiaires (55 %). Il était de 45 % pour le quintile le moins défavorisé et de 52 % pour le quintile le plus défavorisé. L'utilisation du modèle confirme qu'en moyenne, la relation entre la participation au programme de dépistage organisé et la défavorisation sociale de la commune de résidence est en forme de U inversé : la participation était plus faible pour les communes les moins et les plus défavorisées. Cette forme a également été observée pour chacune des deux sous-populations – communes urbaines et rurales – considérées séparément. Ce profil était cependant variable d'un département à un autre. Malgré la prise en compte du FDep dans le modèle, les variations géographiques inexpliquées des taux de participation entre les départements et entre les communes restaient plus importantes que celles expliquées par le FDep. Notre étude a mis en évidence des disparités importantes dans les taux de participation départementaux et les profils de la relation entre défavorisation et participation. Cependant, la défavorisation sociale ne semble avoir qu'une faible influence sur la variation géographique des taux de participation au niveau de la France métropolitaine. Il s'avère nécessaire de mieux comprendre les facteurs qui affectent les variations géographiques des taux de participation, en particulier le recours à des pratiques de dépistage « hors programme ».

Basu et al. published an excellent report on the implementation and organisation of cancer screening in the European Union member states as of 2016.1 However, the article contains a few inaccuracies on the French organized cancer screening programmes, which we would like to rectify while also providing some clarifications and further information on these programmes. Colorectal cancer screening is nationwide and not regional as indicated in the report.1 France was indeed among the first countries to implement a population-based organized colorectal cancer screening programme,2 which was fully rolled out nationwide by 2009. In 2015, the immunochemical test (FIT) replaced the conventional guaiac faecal occult blood test (gFOBT), based on the evidence generated in one pilot district, Calvados, that FIT is superior to gFOBT.3 A population-based nationwide cervical cancer screening programme was launched end 2016. Rollout is ongoing. The organizational model is based on that of a pilot intervention implemented in selected geographic areas during 2010–2014.4 Invitations exclude women who have been screened opportunistically in the past 3 years but all screenings – opportunistic and invitational – are integrated into the screening programme monitoring and evaluation system. Screening is cytology-based but a shift to primary HPV testing is foreseen in the future.5 The population-based breast cancer screening programme co-exists with substantial use of opportunistic screening and, as in some other countries, is subject to a vibrant debate. A public consultation was carried out in 2015–2016 to seek opinions from the public, health professionals, scientists and other stakeholders on breast cancer screening.6 The consultation report recommended to either end the organized breast cancer screening programme or to reform it radically, including by providing women with information to enable them to make their own decision about breast cancer screening, developing research on the natural history of breast cancer and improving screening evaluation. Based on these recommendations, the Ministry of Health published an action plan to revamp the programme.7

The objective was to quantify the relationship between deprivation and national breast cancer screening programme (NBCSP) participation at an ecological level in mainland France. Data from 4,805,390 women-living in 36,209 municipalities within 95 departments-participating in the 2013-2014 NBCSP were analysed using the French Deprivation Index (FDep). FDep population quintiles by municipality were computed to describe NBCSP participation according to deprivation. To better examine the relationship between continuous value of deprivation index and participation rates at the municipality level, we built a generalized linear mixed model. Geographical variations in participation rates were marked. The national standardized participation rate was higher in the intermediate quintiles (55%), 45% for the least deprived one and 52% for the most deprived one. Using our model, we also obtained an inverted U-curve for the relationship between NBCSP participation and municipality deprivation: participation was lower for both the least and most deprived municipalities. This relationship was also observed for each of the two subpopulations-urban municipalities and rural ones-considered separately. Introducing the FDep in the model reduced slightly the unexplained variations in participation rates between departments and between municipalities (with a proportional change in variance of 14% and 12% respectively). We highlight major disparities in departmental participation rates and FDep/participation profiles. However, deprivation appears to have only little influence on geographical variation in participation rates. There is a need to further understand the factors affecting geographical variation in participation rates, in particular the use of opportunistic screening.

Background: Our aim was to review the selection and methods used for deriving health state utility (HSU) estimates included in the cost-utility analyses (CUA) submitted by manufacturers to the National Authority for Health (HAS) during the first 2years after the introduction of the economic evaluation for price setting in France.Methods: We reviewed all manufacturers' submissions that included a CUA and were assessed by HAS by the end of October 2015 (N=34). We reviewed the identification, selection, and methods used to estimate HSU and compared them with those recommended by HAS.Results: A literature review to identify HSU was reported in only 13 (38%) submissions. The instruments for describing HSU were a preference-based generic instrument in 20 (59%) submissions; vignettes in five (15%); a condition-specific instrument in three (9%); and a combination of instruments in six (18%). The valuation perspective was the general population in 26 (76%) submissions; in only nine (26%) submissions, the valuation set was derived from the French general population.Conclusions: We identified numerous concerns in the selection, valuation and use of HSU, as well as a frequent lack of clarity in the methods used. Most submissions (79%) included HSU that did not meet HAS recommendations.

In France, cervical cancer screening is recommended every 3 years for women aged 25-65 years. With the exception of a few local organized programs, screening is mainly opportunistic. In view of setting up a nationwide population-based organized screening program, a pilot intervention was implemented in nine geographic areas using a common protocol. Women aged 25-65 years who had not undergone a cytological screening in the past 3 years were invited for screening during 2010-2012 and reminded up to 1 year after the initial invitation. Cytological results and follow-up data were collected up to the end of 2014 for all women screened irrespective of whether spontaneously or following invitation. Aggregate data were centralized nationally. Among the 2.4 million women from the total target population aged 25-65 years, 1.3 million were invited for screening. The overall screening coverage during 2010-2012 was 62.3%, with wide variations across geographic areas, ranging from 41.6 to 72.5%. Initial invitations and reminders enabled nearly 280 000 women to be screened, corresponding to an estimated increase in coverage of 12% points. Overall, 4.2% of the women screened had an abnormal smear. A total of 5180 high-grade cervical precancers and 323 invasive cervical cancers were reported, corresponding to detection rates of, respectively, 623 and 39 per 100 000 women screened 3-yearly. This study indicates that such organized screening may markedly improve the uptake of cervical cancer screening. On the basis of this pilot program, nationwide organized cervical cancer screening is currently being rolled out in France.

The objective of this paper was to evaluate how uncertainty has been accounted for in the cost-effectiveness analyses (CEAs) submitted by manufacturers to the French National Authority for Health (HAS) and to identify recurring concerns in these submissions.

The objectives of this study were to review current methodological guidelines for economic evaluations of all types of technologies in the 33 countries with organizations involved in the European Network for Health Technology Assessment (EUnetHTA), and to provide a general framework for economic evaluation at a European level.

Economic evaluation of pharmaceuticals and medical devices has been introduced in France in October 2013. Economic evaluations by HAS are based on critical appraisals of manufacturers’ submissions. We reviewed the selection and use of health utility values for cost-utility analyses (CUA) submitted to HAS. A review of manufacturers’ CUA submitted to and assessed by HAS by end of May 2015 was undertaken to review the identification and selection of data and the methods used for deriving utility estimates. The methods used were compared with those recommended in the HAS methodological guideline on economic evaluation. Of the 27 submissions, 16 (56%) included utility values from previously published studies, only 4 of which reported a systematic literature review; 10 (37%) from the clinical trials informing the clinical effectiveness; 2 (7%) from a mixture of sources. To describe health states, 21 (78%) submissions used a preference-based generic instrument, mostly the EQ-5D; 5 (19%) used vignettes; 3 used a condition-specific instrument. Several submissions used different types of instrument. In most (85%) submissions, the valuation method was the time-trade off. The valuation perspective was the general population in 23 (85%) submissions; in only 5 (19%) submissions, the valuation set was derived from the French general population. In 14 (52%) submissions, further adjustments to utility values were made, mostly to account for adverse events. We identified numerous concerns in the selection, valuation and use of utility values, and a frequent lack of clarity in the description of the methods used. Many submissions included utility values that did not meet the HAS reference case for economic evaluation. There is a need to strengthen early dialogues between manufacturers and HTA bodies to generate robust utility data. Economic evaluation of pharmaceuticals in France will follow a learning curve for both the manufacturers and for HAS.

Since October 2013 HAS is required to provide the inter-ministerial pricing committee (CEPS) with an economic evaluation on innovative drugs and medical devices likely to have a significant impact on national health insurance expenditure. HAS’ evaluation involves a critical appraisal of cost-effectiveness analyses (CEA) submitted by manufacturers. Although budget impact analysis (BIA) is currently not required by HAS, it may be provided as an optional complement to CEA. Our objective was to assess how BIA was undertaken in manufacturers’ submissions. We used a qualitative approach to assess manufacturers’ submissions by end of April 2015 (n=49). As currently there is no formal HAS guideline on BIA, we used the recommendations of the French Collège des économistes de la santé as well as ISPOR Task Force Principles on Good Practices for BIA as an analytical framework, including perspective, time horizon, discounting, size of eligible populations, current comparators, anticipated uptake of the new technology, and cost of treatments. Eleven (22%) submissions included a BIA along with the CEA. Compliance with ISPOR Task Force principles was generally fair for perspective, time horizon and discounting. The selection of current comparators was considered problematic in 7 (64%) of these submissions. Regarding costs of treatments, the majority of BIA failed to include adverse events as well as follow-up costs. In most cases, there was a lack of transparency on BIA modelling and eligible population size estimates. Furthermore, in 9 (80%) BIA, scenarios were not explored through adequate sensitivity analyses. Although based on a small number of submissions, our study identified concerns about population size estimates, comparators, identification of costs beyond treatment acquisition and administration, BIA interpretation and scenarios sensitivity analyses. This raises the need to include explicit recommendations on BIA in the next, updated version of the HAS guideline on economic evaluation.

HIV testing constitutes an important strategy to control the HIV epidemic, which therefore merits an observation of HIV testing practices to help improve testing effectiveness. In 2008, a cross-sectional survey among recently diagnosed (≤ 3 years) HIV-infected patients was conducted in Belgium, Estonia, Finland and Portugal. Participants were questioned about reasons for HIV testing, testing place and testing conditions. Univariate and multivariate analyses were performed. Out of 1460 eligible participants, 629 (43%) were included. Forty-one per cent were diagnosed late and 55% had never undergone a previous HIV test with perceived low risk being the primary reason for not having been tested earlier. Heterogeneity in HIV testing practices was observed across countries. Overall, tests were most frequently conducted in primary care (38%) and specialised clinics (21%), primarily on the initiative of the health care provider (65%). Sixty-one per cent were tested with informed consent, 31% received pretest counselling, 78% received post-test counselling, 71% were involved in partner notification and 92% were in care three months after diagnosis. The results showed that HIV testing is done in a variety of settings suggesting that multiple pathways to HIV testing are provided. HIV testing practice is being normalised, with less focus on pretest counselling, yet with emphasis on post-test follow-up. Major barriers to testing are centred on the denial of risk. Efforts are needed to concurrently promote public awareness about HIV risk and benefits of HIV testing and train clinicians to be more proactive in offering HIV testing.

Background: Chlamydia is the most commonly reported bacterial sexually transmitted infection in Europe. The objective of the Screening for Chlamydia in Europe (SCREen) project was to describe current and planned chlamydia control activities in Europe. Methods: The authors sent a questionnaire asking about different aspects of chlamydia epidemiology and control to public health and clinical experts in each country in 2007. The principles of sexually transmitted infection control were used to develop a typology comprising five categories of chlamydia control activities. Each country was assigned to a category, based on responses to the questionnaire. Results: Experts in 29 of 33 (88%) invited countries responded. Thirteen of 29 countries (45%) had no current chlamydia control activities. Six countries in this group stated that there were plans to introduce chlamydia screening programmes. There were five countries (17%) with case management guidelines only. Three countries (10%) also recommended case finding amongst partners of diagnosed chlamydia cases or people with another sexually transmitted infection. Six countries (21%) further specified groups of asymptomatic people eligible for opportunistic chlamydia testing. Two countries (7%) reported a chlamydia screening programme. There was no consistent association between the per capita gross domestic product of a country and the intensity of chlamydia control activities (P = 0.816). Conclusion: A newly developed classification system allowed the breadth of ongoing national chlamydia control activities to be described and categorized. Chlamydia control strategies should ensure that clinical guidelines to optimize chlamydia diagnosis and case management have been implemented before considering the appropriateness of screening programmes.

BACKGROUND:Five diseases are currently screened on dried blood spots in France through the national newborn screening programme. Tandem mass spectrometry (MS/MS) is a technology that is increasingly used to screen newborns for an increasing number of hereditary metabolic diseases. Medium chain acyl-CoA dehydrogenase deficiency (MCADD) is among these diseases. We sought to evaluate the cost-effectiveness of introducing MCADD screening in France.METHODS:We developed a decision model to evaluate, from a societal perspective and a lifetime horizon, the cost-effectiveness of expanding the French newborn screening programme to include MCADD. Published and, where available, routine data sources were used. Both costs and health consequences were discounted at an annual rate of 4%. The model was applied to a French birth cohort. One-way sensitivity analyses and worst-case scenario simulation were performed.RESULTS:We estimate that MCADD newborn screening in France would prevent each year five deaths and the occurrence of neurological sequelae in two children under 5 years, resulting in a gain of 128 life years or 138 quality-adjusted life years (QALY). The incremental cost per year is estimated at €2.5 million, down to €1 million if this expansion is combined with a replacement of the technology currently used for phenylketonuria screening by MS/MS. The resulting incremental cost-effectiveness ratio (ICER) is estimated at €7 580/QALY. Sensitivity analyses indicate that while the results are robust to variations in the parameters, the model is most sensitive to the cost of neurological sequelae, MCADD prevalence, screening effectiveness and screening test cost. The worst-case scenario suggests an ICER of €72 000/QALY gained.CONCLUSIONS:Although France has not defined any threshold for judging whether the implementation of a health intervention is an efficient allocation of public resources, we conclude that the expansion of the French newborn screening programme to MCADD would appear to be cost-effective. The results of this analysis have been used to produce recommendations for the introduction of universal newborn screening for MCADD in France.