scholarly journals Pricing and Reimbursement Pathways of New Orphan Drugs in South Korea: A Longitudinal Comparison

Healthcare ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 296
Author(s):  
Jong Hyuk Lee

This study aimed to analyze four current pathways affecting the listing and post-listing prices of new orphan drugs (ODs) in South Korea. These mechanisms were: (1) essential OD, (2) pharmacoeconomic evaluation (PE) waiver OD, (3) weighted average price OD, and (4) PE OD. We analyzed the ratio of the listing price of 48 new ODs to the average adjusted price (AAP) of seven advanced countries and examined the change in the post-listing price. Descriptive statistics were used to analyze the listing and post-listing price changes. The mean and median ratios of the listing price of total new OD to AAP were calculated to be 69.4% and 65.4%, respectively. Essential OD showed the highest mean (93.8%) and median (80.8%) ratios. The mean cumulative price discount rate of the new OD was 7.2% in the third year and 5.7% in the fifth year. The rarity of diseases impacts the listing price of OD, but the political effects of the benefits of OD on the post-listing price of these drugs could not be verified. Further research should be conducted to develop measures that facilitate the practical sharing of budget risks and increase patient access to new ODs.

Author(s):  
Kristina Dietz

The article explores the political effects of popular consultations as a means of direct democracy in struggles over mining. Building on concepts from participatory and materialist democracy theory, it shows the transformative potentials of processes of direct democracy towards democratization and emancipation under, and beyond, capitalist and liberal democratic conditions. Empirically the analysis is based on a case study on the protests against the La Colosa gold mining project in Colombia. The analysis reveals that although processes of direct democracy in conflicts over mining cannot transform existing class inequalities and social power relations fundamentally, they can nevertheless alter elements thereof. These are for example the relationship between local and national governments, changes of the political agenda of mining and the opening of new spaces for political participation, where previously there were none. It is here where it’s emancipatory potential can be found.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 49.2-49
Author(s):  
J. K. Ahn ◽  
J. Hwang ◽  
J. Lee ◽  
H. Kim ◽  
G. H. Seo

Background:Palindromic rheumatism (PR) has known to be three patterns of disease course: clinical remission of attacks, persistent attacks, and evolution to chronic arthritis or systemic disease. The spectrum in progression to chronic diseases of PR, however, is quite variable; rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren’s syndrome (SjS), ankylosing spondylitis (AS), relapsing polychondritis (RP), Behçet’s disease (BD), sarcoidosis, and psoriatic spondylitis and arthropathy. Because of the small numbers in case-control studies and too aged investigations, now we needs to shed new light on the fate of PR.Objectives:The aim was to investigate the epidemiology of PR and the risk of developing various rheumatic diseases compared with non-PR individuals, employing the National Health Insurance Service (NHIS) medical claims data, which covers all medical institutions of South Korea.Methods:The study used 2007-2018 claims data from the Korean Health Insurance Review and Assessment Service (HIRA). The identified 19,724 PR patients from 2010 to 2016 were assessed for the incidence rate (IR) compared with the population in the given year by 100,000 person-year (py). The date of diagnosis was the index date. After matching with non-PR individuals (1:10) for age, sex and the year of index date, we calculated the hazard ratios (HRs) with 95% confidence intervals (CIs). The risk of developing the various rheumatic diseases and adult immunodeficiency syndrome (AIDS) as the outcome diseases in PR cohort was estimated. This risk was compared with that of matched non-PR cohort.Results:Of 19,724 PR patients (8,665 males and 11,059 females), the mean age was 50.2 ± 14.9 years (47.7 ± 14.4 years in males and 52.6 ± 14.9 years in females,p< 0.001). The ratio of male to female patients with PR was approximately 1:1.28. The annual IR of PR was 7.02 (6.92-7.12) per 100,000 py (6.22 (6.09-6.35) and 7.80 (7.66-7.95) per 100,000 py in males and females, respectively). The mean duration to develop the outcome diseases was significantly shorter in PR cohort compared that of non-PR cohort (19.4 vs. 35.8 months,p< 0.001). The most common outcome disease was RA (7.34% of PR patients; 80.0% of total outcome diseases), followed by AS, SLE, BD, SjS, MCTD, DM/PM, SSc, RP, psoriatic arthropathy, and AIDS in PR cohort. The patients with PR had an increased risk of RA (HR 46.6, 95% CI [41.1-52.7]), psoriatic arthropathy (44.79 [15.2-132.4]), SLE (24.5 [16.2-37.2]), MCTD (22.0 [7.7-63.3]), BD (21.0 [13.8-32.1]), SjS (12.4 [8.5-17.9]), AS (9.0 [6.7-12.2]), DM/PM (6.1 [2.6-14.8]), and SSc (3.8 [1.5-9.6]) but not of AIDS. The risk of developing RA was greater in male patients (HR 58.9, 95% CI [45.6-76.2] vs. 43.2 [37.4-49.8],pfor interaction = 0.037) while female patients encountered a higher risk of developing AS (15.8 [8.9-28.1] vs. 7.2 [5.0-10.3],pfor interaction = 0.023). The risk of developing RA, SLE, SjS, and BD were significantly more highly affected in younger age (pfor interaction < 0.001, = 0.003, 0.002, and 0.017, at each).Conclusion:This nationwide, population-based cohort study demonstrated that patients with PR had an increased risk of developing various rheumatic diseases, not only RA but also psoriatic arthropathy. Therefore, patients with PR needs to be cautiously followed up for their potential of diverse outcome other than RA: RA, SLE, SjS, and BD in younger patients, RA in males, and AS in females, in particular.Disclosure of Interests:None declared


2021 ◽  
Vol 7 (3) ◽  
pp. 46
Author(s):  
Jiajun Zhang ◽  
Georgina Cosma ◽  
Jason Watkins

Demand for wind power has grown, and this has increased wind turbine blade (WTB) inspections and defect repairs. This paper empirically investigates the performance of state-of-the-art deep learning algorithms, namely, YOLOv3, YOLOv4, and Mask R-CNN for detecting and classifying defects by type. The paper proposes new performance evaluation measures suitable for defect detection tasks, and these are: Prediction Box Accuracy, Recognition Rate, and False Label Rate. Experiments were carried out using a dataset, provided by the industrial partner, that contains images from WTB inspections. Three variations of the dataset were constructed using different image augmentation settings. Results of the experiments revealed that on average, across all proposed evaluation measures, Mask R-CNN outperformed all other algorithms when transformation-based augmentations (i.e., rotation and flipping) were applied. In particular, when using the best dataset, the mean Weighted Average (mWA) values (i.e., mWA is the average of the proposed measures) achieved were: Mask R-CNN: 86.74%, YOLOv3: 70.08%, and YOLOv4: 78.28%. The paper also proposes a new defect detection pipeline, called Image Enhanced Mask R-CNN (IE Mask R-CNN), that includes the best combination of image enhancement and augmentation techniques for pre-processing the dataset, and a Mask R-CNN model tuned for the task of WTB defect detection and classification.


Diabetologia ◽  
2021 ◽  
Author(s):  
David Beran ◽  
Maria Lazo-Porras ◽  
Camille M. Mba ◽  
Jean Claude Mbanya

AbstractThe discovery of insulin in 1921 changed the prognosis for people with type 1 diabetes. A century later, availability and affordability of insulin remain a challenge in many parts of the globe. Using the WHO’s framework on understanding the life cycle of medicines, this review details the global and national challenges that affect patients’ abilities to access and afford insulin. Current research and development in diabetes has seen some innovations, but none of these have truly been game-changing. Currently, three multinational companies control over 95% of global insulin supply. The inclusion of insulin on the WHO’s Prequalification Programme is an opportunity to facilitate entry of new companies into the market. Many governments lack policies on the selection, procurement, supply, pricing and reimbursement of insulin. Moreover, mark-ups in the supply chain also affect the final price to the consumer. Whilst expenses related to diabetes are mostly covered by insurance in high-income countries, many patients from low- and middle-income countries have to pay out of their own pockets. The organisation of diabetes management within the healthcare system also affects patient access to insulin. The challenges affecting access to insulin are complex and require a wide range of solutions. Given that 2021 marks the centenary of the discovery of insulin, there is need for global advocacy to ensure that the benefits of insulin and innovations in diabetes care reach all individuals living with diabetes. Graphical abstract


2019 ◽  
Vol 35 (S1) ◽  
pp. 16-16
Author(s):  
Orla Maguire ◽  
Laura McCullagh ◽  
Cara Usher ◽  
Michael Barry

IntroductionThere is ongoing debate as to whether conventional pharmacoeconomic evaluation (PE) methods are appropriate for orphan medicinal products (OMPs). The National Centre for Pharmacoeconomics (NCPE) in Ireland has a well-defined process for conducting pharmacoeconomic evaluations of pharmaceuticals, which is the same for OMPs and non-OMPs. The objective of this study was to identify whether supplementary criteria considered in the pharmacoeconomic evaluation of OMPs would affect final reimbursement recommendations.MethodsA literature search was conducted to identify criteria. Orphan drug pharmacoeconomic evaluations completed by the NCPE between January 2015 and December 2017 were identified and supplementary criteria, where feasible, were applied.ResultsFourteen pharmacoeconomic evaluations were included in the study. Three criteria that could feasibly be applied to the NCPE evaluation process were identified, all three of which essentially broadened the economic perspective of the pharmacoeconomic evaluation. Higher cost-effectiveness threshold: Despite being arbitrarily raised from EUR 45,000/QALY to EUR 100,000/QALY, only one orphan drug demonstrated cost-effectiveness at this higher threshold. Weighted QALY gain: here, a weighted gain of between one and three is applied to drugs demonstrating QALY gains between 10 and 30, respectively. No OMPs included in the study showed a QALY gain of more than 10. Thirteen demonstrated QALY gains less than 10 and one could not be evaluated. Societal perspective: six submissions incorporated societal perspective as a scenario analysis. Despite incremental cost-effectiveness ratios (ICERs) being reduced between 4 percent and 58 percent, only two OMPs demonstrated cost-effectiveness at the higher threshold (EUR 100,000/QALY).ConclusionsApplication of supplementary criteria to the pharmacoeconomic evaluation of OMPs had a minor effect on three products assessed. However, for the majority, the final cost-effectiveness outcomes remained the same. The study highlights that other criteria are being considered in the decision to reimburse.


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