Laparoscopic approach at INDEX was protective compared to open surgery (OR 0.43,[0.39-0.46]). ConClusions: Adhesion related complications occurred in 5.7% of all patients within the first year after colon resection and have a substantial economic burden. Multiple patient and procedural characteristics increase the risk of these complications. Colon resections performed laparoscopically were associated with reduced adhesion related complications compared to open surgery.

OBJECTIVES: Few studies have evaluated the impact of GERD-symptoms on work productivity and no French data are available. The aim of this study was to evaluate the impact of GERD typical symptoms on work productivity and daily activities in patients with nocturnal compared to diurnal symptoms. METHODS: A prospective, multicenter, observational study was carried out in French primary care setting. Each physician had to include the first two consecutive adult patients on full-time job who had experienced GERD typical symptoms at least once during the 7 days/nights preceding the inclusion visit: 1 with exclusively diurnal symptoms and 1 with nocturnal symptoms. Data collected by physicians were: patients' characteristics, symptomatology and treatments. Work productivity loss was assessed using the validated self-administered Work Productivity and Activity Impairment questionnaire specific to GERD (WPAI-GERD). Predictors of work productivity loss were identified by multivariate regression models and its cost estimated. RESULTS: A total of 407 physicians included 716 eligible patients: 50.8% with nocturnal and 49.2% with exclusive diurnal symptoms (EDS). The mean age was 46.3 years (SD 8.7), 62.8% were men, and 58.3% of patients diagnosed before inclusion were treated for GERD. Work productivity and daily activities decreased by 31.4% and 32.6%, respectively. Decrease rates were higher in EDS-patients (pϽ0.001 each). Work productivity impairment was mostly due to impairment while working (presenteeism) rather than absenteeism. The symptoms intensity and composite intensity index, reflecting disease severity, were identified as the main predictors of decreased work productivity. The mean cost of work productivity loss per patient was estimated as €313/ week, also higher in EDS-patients (pϽ0.001). CONCLUSIONS: GERD incurs high work productivity loss which yields a substantial burden. Improving patients' outcomes, especially in those with moderate or severe disease, with most effective tailored treatments and care management could be expected to reduce work productivity loss and associated costs.

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, were collected and categorized according to: i) kind of innovativeness: full, conditional or no innovativeness; ii) orphan designation; iii) therapeutic area: oncological vs non-oncological drugs. For each single indication assessed for innovativeness, the ranking of the three criteria (therapeutic unmet need maximum to absent, added therapeutic value maximum to absent, and quality of evidences high to very low) was analyzed. Sub-analyses according to the three categories were also run. Results: Out of forty-one indications assessed by AIFA for innovativeness (and corresponding to 30 drugs), 12 (29%) were granted full innovative status, 14 (34%) obtained the conditional innovativeness and the remaining 15 (37%) were assessed as not innovative (7 orphan and 8 oncological indications). 50% of full innovative indications referred to orphan drugs (6/12) and 42% to oncological diseases (5/12); regarding conditionally innovative indications, 29% were for orphan drugs (4/14) and 79% (11/14) for oncological ones. Analysing innovativeness criteria application, AIFA have never recognized the maximum grading for added therapeutic value; moreover, focusing on fully innovative indications, 9 out of 12 (75%) did not meet all the three criteria thresholds stated by AIFA decree. Conclusions: This analysis highlighted that there is no strict matching between AIFA criteria (as reported by AIFA decree) and the granting of full innovative status. In fact, most of the analysed cases are borderline situations (full vs. conditional innovativeness) and have been assessed case-by-case, leaving a shade of subjectivity that gives innovativeness decision-making process a margin of flexibility. The limited sample does not let us make conclusions on the impact of orphan designation or oncological setting.

Objectives: The German healthcare system introduced an early benefit assessment for new active ingredients and successive price negotiations with payers in 2011. This paper analyzes how the assessment is in accordance with Porter's concept of value-based healthcare and which specific value-based starting points pharmaceutical companies possess during drug development and benefit assessment. It is further investigated which importance patient benefits possess for pharmaceutical companies and how the benefit assessment led to changes in strategies and structures. Future tendencies for development are discussed. MethOds: A literature review established the linkages between the value-based healthcare concept (Michael Porter) and the German market-access process. Seven in-depth, qualitative interviews were conducted with German executives from the research-driven pharmaceutical industry in May 2016 according to a semi-structured interview guideline. The data was coded and analyzed. Results: The market-access process and the value-based healthcare concept mainly match in aspects of clinical outcome measures, pricing approaches and cost-benefit-assessments. All pharmaceutical companies interviewed act patient-oriented. This influences study design by increasingly gathering quality of life data. Several companies are open to new healthcare models as well as new pricing models (f.i. outcome-based pricing; capitation). However, major challenges exist both internally and externally: discrepancies with payers about payback period (short-term financial planning of statutory health insurances), inconsistencies in the study design, marketing authorization and HTA requirements between different countries, and implicit as well as explicit organizational change on different hierarchy levels and departments. Market-access/HEOR departments are gaining importance while marketing/sales departments remain important (with changes in certain task areas). cOnclusiOns: The results reveal an increasing shift towards value-based elements in healthcare for pharmaceutical companies, payers and public authorities. However, major obstacles and methodological challenges still exist. More appreciation and respect for each other need to be developed in order to establish successful initiatives jointly which are focusing stronger on treatment outcomes of patients.