Improving the managed introduction of new medicines: sharing experiences to aid authorities across Europe

Matusewicz, W; Godman, Brian; Pedersen, Hanne Bak; Fürst, Jurij; Gulbinovič, Jolanta; Mack, Asbjørn; Selke, Gisbert; Timoney, Angela; Warmińska, Ewa; Malmström, Rickard E.

doi:10.1586/14737167.2015.1085803

Cited by 43 publications

(52 citation statements)

References 12 publications

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“…This is similar to the situation seen in the management of patients with rheumatoid arthritis [2, 14, 15]. This may change with the advent of the first biosimilars for infliximab at considerably lower prices compared with the parent compound [10, 16]. …”

Section: Introductionsupporting

confidence: 52%

“…The case of improving patient care in a cost-efficient manner should be strengthened by the availability of biosimilars. For example, infliximab is now available at approximately 30 % of the price of the originator in Norway [16], with a recent study demonstrating the potential for considerable savings with the biosimilar infliximab in patients with Crohn’s disease among a number of Central and Eastern European countries [8]. There have been concerns about the effectiveness and safety of biosimilar infliximab.…”

Section: Discussionmentioning

confidence: 99%

“…There have been concerns about the effectiveness and safety of biosimilar infliximab. However, ongoing studies in patients in Central, Eastern and Western European countries as well as South Korea are showing that biosimilar infliximab is effective and well tolerated [8, 16, 30]. This provides hope for the future.…”

Section: Discussionmentioning

confidence: 99%

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Inflammatory Bowel Diseases (Crohn´s Disease and Ulcerative Colitis): Cost of Treatment in Serbia and the Implications

Kostić

Djakovic

Šujić

et al. 2016

Appl Health Econ Health Policy

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BackgroundAlthough the costs of treating inflammatory bowel disease (IBD) in developed countries are well established, they remain largely unknown in countries with recent histories of socio-economic transition including Serbia.ObjectiveTo estimate the costs of treatment including the resources used by patients with IBD in Serbia from a societal perspective. This includes both Crohn’s disease and ulcerative colitis.MethodsThis cost-of-illness study was conducted to identify direct, indirect and out-of-pocket costs of treating patients with IBD in Serbia. Patients with IBD (n = 112) completed a semi-structured questionnaire with data concerning their utilisation of heath-care resources and illness-related expenditures. All costs were calculated in Republic of Serbia dinars (RSD) at a 1-year level (2014) and subsequently converted to Euros. Median values and ranges were reported to avoid potential distortions associated with mean costs.ResultsMedian total direct costs and total indirect costs per patient per year in patients with Crohn’s disease were 192,614.32RSD (€1602.97) and 28,014.00RSD (€233.13) and 142,267.15RSD (€1183.97) and 21,436.00RSD (€178.39), respectively, in patients with ulcerative colitis. In both groups, the greatest component of direct costs was hospitalisation.ConclusionsCosts of IBD in Serbia are lower than in more developed countries for two reasons. These include the fact that expensive biological therapy is currently under-utilised in Serbia and prices of health services are largely controlled by the State at a low level. The under-utilisation of biologicals may change with the advent of biosimilars at increasingly lower prices.Electronic supplementary materialThe online version of this article (doi:10.1007/s40258-016-0272-z) contains supplementary material, which is available to authorized users.

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Section: Introductionsupporting

confidence: 52%

Section: Discussionmentioning

confidence: 99%

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Inflammatory Bowel Diseases (Crohn´s Disease and Ulcerative Colitis): Cost of Treatment in Serbia and the Implications

Kostić

Djakovic

Šujić

et al. 2016

Appl Health Econ Health Policy

Self Cite

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“…This is currently not the case even with the new procurement process. In addition, there should be regular monitoring of the use of medicines and the expenditure on them in practice against an agreed single guidance, rather than multiple guidances, to improve future care efficiently, as seen in other countries such as Sweden [2, 11, 43]. There are serious concerns relating to different guidances from different national and international groups giving conflicting advice [44] as this is not in the best interest of any key stakeholder group.…”

Section: Discussionmentioning

confidence: 99%

“…There is growing concern worldwide regarding these drugs, with prices of cancer medicines rising up to tenfold during the past 10 years in some countries despite often limited health gains [7, 8]. This causes particular concern in countries with fixed budgets, with the resultant opportunity cost implications for patients with cancer and other diseases [9, 10] leading to prescribing restrictions and other measures to limit their use and reduce the prices of new cancer medicines [11, 12]. Consequently, in European countries with appreciable pressure on resources such as Kosovo, there is an imperative need to review current utilization and expenditure patterns for cancer medicines, as well as the selection process for new anti-cancer medicines, to make sure available resources are being optimally used.…”

Section: Introductionmentioning

confidence: 99%

Utilization and Expenditure of Anti-cancer Medicines in Kosovo: Findings and Implications

Jakupi

Godman

Martin

et al. 2018

PharmacoEconomics Open

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Background and ObjectiveThe Ministry of Health (MoH) leads and organizes health policy in Kosovo, which includes procurement and provision of medicines, including anti-cancer medicines, which compose a special group of medicines. However, there has been limited analysis of the utilization and expenditure on anti-cancer medicines in Kosovo; consequently, the objective of this study is to undertake research to provide future guidance on the use of anti-cancer medicines.MethodNational drug utilization data is available in Kosovo. Utilization and expenditure on anti-cancer medicines [Anatomical Therapeutic Chemical (ATC) code L], initially from 2011 to 2013, especially for anti-cancer medicines on the essential medicines list was analysed from national data. In addition, current systems for procuring and managing anti-cancer medicines in Kosovo was documented.ResultsThere was appreciable variability in the utilization of anti-cancer medicines over the years, with low or limited use of some anti-cancer medicines on the Essential Medicine List. This is a concern in view of their essential medicine status. From 2011 to 2013, €16.49 million was spent on anti-cancer medicines (ATC L). The process of selection of new medicines begins with suggestions from doctors at the University Clinical Centre in Kosovo.ConclusionThe analysis has shown appreciable variation with current utilization patterns for anti-cancer medicines in Kosovo. This needs to be addressed as part of improving the drug management process to optimize patient care within available resources. Future years and reforms need to be assessed to improve current utilization and expenditure patterns.

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Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab

Pontes

Zara

Torrent-Farnell

et al. 2019

Appl Health Econ Health Policy

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The potential benefits of early patient access to new medicines in areas of high unmet medical need are recognised, but uncertainties concerning effectiveness, safety, and added value when new medicines are authorised and subsequently funded based on initial preliminary data only have important implications. In 2016, olaratumab received accelerated conditional approval from both the EMA and FDA for the treatment of soft tissue sarcoma based on the claims of a substantial reduction in the risk of death with an 11.8 month improvement in median overall survival in a phase II trial in combination with doxorubicin versus doxorubicin alone. The failure to confirm these benefits in the post authorisation pivotal trial has highlighted key concerns regarding early access and conditional approvals for new medicines. Concerns include potentially considerable opportunity clinical and economical costs, so that patients may have received suboptimal treatment and money spent has foregone the opportunity to improve access to effective treatments. As a result, it seems reasonable to reconsider current marketing authorisation models and approaches. Potential ways forward include closer collaboration between regulators, pharmaceutical companies and payers to enhance the generation of rapid and comparative confirmatory trials in a safe and fair way with minimal patient exposure to achieve robust evidence. Also, it may be time to review early access systems and to explore new avenues regarding who should pay or part pay for new treatments whilst information is being collected as part of any obligations for conditional marketing authorisation. Greater co-operation between countries regarding the collection of data in routine clinical care, and further research on post marketing data analysis and interpretation, may also contribute to improved appraisal and continued access to new innovative cancer treatments.

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Improving the managed introduction of new medicines: sharing experiences to aid authorities across Europe

Cited by 43 publications

References 12 publications

Inflammatory Bowel Diseases (Crohn´s Disease and Ulcerative Colitis): Cost of Treatment in Serbia and the Implications

Inflammatory Bowel Diseases (Crohn´s Disease and Ulcerative Colitis): Cost of Treatment in Serbia and the Implications

Utilization and Expenditure of Anti-cancer Medicines in Kosovo: Findings and Implications

Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab

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