Suchergebnisse

Part 2: Services and Interoperability ; International audience ; The local governments of the OECD countries have attempted a number of sourcing practices over the past decades, including corporatization and collaborative arrangements. Sharing services is one of the latest options to emerge to cast a new actor, the shared service organization (SSO), in a lead role. To deliver services to the client councils these special-purpose vehicles adopt an alternative model that has prompted Information and Communication Technology (ICT) providers to evolve into this new species of enterprise, and to discard models based on publicly funded collaboration arrangements or the usual ICT outsourcing practices. This case study analyses the route taken by an Italian public company that reengineered its approach into that of an SSO to become a reference point for its customers and their ICT strategies. The article's general reflection on the changes under way supports the continuity of the basic organizational logics that inform the practices of public SSOs.

Introduction: Generic entry is a well-known driver of competition and cost containment. Objectives: We aim to measure the market exclusivity of originator drugs and to determine what influences the entry of generics in South Korea. Methods: A list of originator drugs approved by the authority from 2000 to 2013 and their corresponding generics were paired. An event history model was applied for a statistical estimation for the duration until generic entry and to identify abbreviating or prolonging factors on the duration. Results: A total of 2,061 pairs of originator and generics were identified. The market exclusivity for the originator drugs, including NDAs and non-NDAs, has not notably changed. However, competition among non-NDAs was less common than we expected. We found delayed time to entry of generics in the long run, particularly for non-NDAs in injection forms and biologics, and this finding is partially associated with market attractiveness. Conclusion: The authority should address the delayed availability of certain types of generic drugs. The government could provide information on off-patent pharmaceuticals with no generic competition, designate their corresponding submissions as prioritized in the review process, and provide additional market exclusivity when entering the market via a long period of exclusivity.

In the United States, housing policies focused on assisting low-income families toward homeownership have resulted in the creation of publicly subsidized affordable mortgage programs. Private lenders and their employees (loan originators) are often the key point of contact to connect low-income borrowers to public programs. But why would loan originators offer borrowers public loan programs, particularly when such programs provide no additional (and sometimes reduced) direct financial compensation to the private lenders and potentially increased workloads? One possible rationale, and the one investigated here, is that loan originators may be diversely motivated toward the advancement of the public interest. Situating the analysis within the theoretical insights of public service motivation in the public sector and corporate social responsibility in the private sector, we propose and test a "Model of Public Service in the Private Sector." We draw from surveys of private lenders to test hypotheses about how private lenders' associations, perceptions, and values are related to voluntary participation in a government program. Our analysis highlights the importance of public associations, perceptions of government, and public values in explaining the behavior of private sector employees. Our findings contribute to the literature on public service and public values and our understanding of how private organizations access government programs to advance the public good. Adapted from the source document.

Abstract
Generic and biosimilar medicines are fiscally advantageous products in relation to which the generally applicable EU rules governing comparative advertising seemingly conflict with national healthcare policy. This article argues that the permissive stance of the French courts on the use of the trademarked names of originator medicines in advertising for generics appears inconsistent with the case law of the Court of Justice of the European Union as it stands in relation to Art. 4(f) of Directive 2006/114/EC on misleading and comparative advertising. This gives rise to an undesirable divergence in the application of the Directive between Member States, suggesting that further guidance is needed on the application of the provision to generic-originator comparisons. It is submitted that treating generic drugs with particular leniency is unjustified given the detrimental effect the use of originator trademarks by the marketers of generics and biosimilars may have on the ability of the originator trademark to stimulate investment into manufacturing quality. The issue of the degree to which the use of originator trademarks in advertising promoting generics and biosimilars should be permitted serves as a poignant example of the delicate balance required for comparative advertising to increase consumer choice whilst simultaneously protecting competitors from advertising that may ultimately be detrimental to undistorted competition in the Single Market.

INTRODUCTION: To save costs to the healthcare system, forced non-medical switch (NMS) policies that cut drug coverage for originator biologics and fund only less expensive biosimilars are being implemented. However, costs related to the impact of NMS on healthcare resource utilization (HCRU) must also be considered. This study aims to summarize the evidence on the economic impact of an originator-to-biosimilar NMS. METHODS: A systematic literature review (SLR) was conducted. Publications reporting on HCRU or costs associated with originator-to-biosimilar NMS in the real-world setting were searched in MEDLINE and EMBASE from January 2008 to February 2020. In addition to hand searching the reference lists of relevant publications and SLRs, key conference websites, PubMed, and various government sites were also searched for the 2 years preceding the search (2018–2020). RESULTS: A total of 1845 citations were identified, of which 49 were retained for data extraction. Most studies reporting on the HCRU associated with NMS reported on post-NMS HCRU alone without a comparison pre-NMS. However, four studies described a difference in HCRU (i.e., investigations pre- vs post-switch or between non-switchers vs switchers), all of which reported a relative increase in HCRU, including laboratory testing, imaging, medical visits, and hospitalizations, amongst patients who underwent an originator-to-biosimilar NMS. Most studies reporting on the costs associated with NMS reported significant savings following NMS on the basis of drug costs alone. However, four studies specifically reporting on the difference of costs following originator-to-biosimilar NMS all demonstrated an increase in HCRU-related costs associated with NMS (increase in HCRU-related costs of 4–37% or 148–2234 2020 Canadian dollars). CONCLUSION: Amongst the studies that reported on the difference in HCRU pre- vs post-switch or between non-switchers and switchers, all showed an increase in HCRU and related costs associated with NMS, suggesting that the expected ...

Background and objectives The 52‐week, randomized, double‐blind, noninferiority, government‐funded NOR‐SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT‐P13 was not inferior to continued treatment with infliximab originator. The NOR‐SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT‐P13 throughout the 78‐week study period (maintenance group) versus patients switched to CT‐P13 at week 52 (switch group). The primary outcome was disease worsening during follow‐up based on disease‐specific composite measures. Methods Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis. Results Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per‐protocol set). Adjusted risk difference was 5.9% (95% CI −1.1 to 12.9). Frequency of adverse events, anti‐drug antibodies, changes in generic disease variables and disease‐specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases. Conclusion The NOR‐SWITCH extension showed no difference in safety and efficacy between patients who maintained CT‐P13 and patients who switched from originator infliximab to CT‐P13, supporting that switching from originator infliximab to CT‐P13 is safe and efficacious.