Php354 - The Impact of Data Privacy Regulations on Drug Utilization Data Sharing for Innovative Pricing Arrangements

Menner, J.; Lewandowska, Paulina

doi:10.1016/j.jval.2018.09.1248

Cited by 2 publications

(2 citation statements)

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“…Additionally, contractual terms of OBAs may require sharing of identifiable personal data to allow for adjustment of payments. Therefore, additional risk management may be needed to ensure that personal data protection remains guaranteed ( Menner and Lewandowska, 2018 ; Maes et al, 2019 ) especially for agreements based on individual patient data where the need for identifiable patient data is higher than agreements dependent on aggregated population-level data ( Gerkens et al, 2017 ). In both cases, correct provisions for data protection and sharing are needed with adequate safeguards determining which parties will have access to the data and in which form ( Faulkner et al, 2016 ; Gerkens et al, 2017 ; Sachs et al, 2018 ; Jorgensen and Kefalas, 2019 ; FoCUS, 2019b ; Maes et al, 2019 ).…”

Section: Resultsmentioning

confidence: 99%

“…Outcome correction of spread payments on population-level can be proportional to the difference between real-world and clinical trial performance as measured with a core set of (validated surrogate) outcomes used in clinical trials ( Garrison Jr et al, 2013 ; Yeung et al, 2017 ; Cole et al, 2019 ; Maes et al, 2019 ). While adjusting installment payments on an individual-level can occur in real-time, population-based payment adjustment can only occur once per payment period but may inform product performance in the whole population ( Launois et al, 2014 ; Wenzl and Chapman, 2019 ) and may better comply with GDPR regulations since only aggregated patient data will need to be shared ( Menner and Lewandowska, 2018 ; Alliance for Regenerative Medicine, 2019 ). The duration of spread payments should be limited in time in order not to burden future generations and be edged on the expected and measured duration of benefit ( Edlin et al, 2014 ; Maes et al, 2019 ).…”

Section: Discussionmentioning

confidence: 99%

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Barriers and Opportunities for Implementation of Outcome-Based Spread Payments for High-Cost, One-Shot Curative Therapies

et al. 2020

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Background: The challenging market access of high-cost one-time curative therapies has inspired the development of alternative reimbursement structures, such as outcome-based spread payments, to mitigate their unaffordability and answer remaining uncertainties. This study aimed to provide a broad overview of barriers and possible opportunities for the practical implementation of outcome-based spread payments for the reimbursement of one-shot therapies in European healthcare systems.Methods: A systematic literature review was performed investigating published literature and publicly available documents to identify barriers and implementation opportunities for both spreading payments and for implementing outcome-based agreements. Data was analyzed via qualitative content analysis by extracting data with a reporting template.Results: A total of 1,503 publications were screened and 174 were included. Main identified barriers for the implementation of spread payments are reaching an agreement on financial terms while considering 12-months budget cycles and the possible violation of corresponding international accounting rules. Furthermore, outcome correction of payments is currently hindered by the need for additional data collection, the lack of clear governance structures and the resulting administrative burden and cost. The use of spread payments adjusted by population- or individual-level data collected within automated registries and overseen by a governance committee and external advisory board may alleviate several barriers and may support the reimbursement of highly innovative therapies.Conclusion: High-cost advanced therapy medicinal products pose a substantial affordability challenge on healthcare systems worldwide. Outcome-based spread payments may mitigate the initial budget impact and alleviate existing uncertainties; however, their effective implementation still faces several barriers and will be facilitated by realizing the required organizational changes.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Barriers and Opportunities for Implementation of Outcome-Based Spread Payments for High-Cost, One-Shot Curative Therapies

et al. 2020

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Challenges in Data Capturing and Collection for Physiological Detection of Dementia-Related Difficulties and Proposed Solutions

Harper

Ghali

Hussain

et al. 2021

Intelligent Computing Theories and Application

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Dementia is a neurodegenerative disease which leads to the individual experiencing difficulties in their daily lives. Often these difficulties cause a large amount of stress, frustration and upset in the individual, however identifying when the difficulties are occurring or beginning can be difficult for caregivers, until the difficulty has caused problematic behavior or undeniable difficulty to the person with dementia. Therefore, a system for identifying the onset of dementia-related difficulties would be helpful in the management of dementia. Previous work highlighted wearable computing-based systems for analyzing physiological data as particularly promising. In this paper, we outline the methodology used to perform a systematic search for a relevant dataset. However, no such dataset was found. As such, a methodology for collecting such a dataset and making it publicly available is proposed, as well as for using it to train classification models that can predict difficulties from the physiological data. Several solutions to overcome the lack of available data are identified and discussed: data collection experiments to collect novel datasets; anonymization and pseudonymization to remove all identifiable data from the dataset; and synthetic data generation to produce a larger, anonymous training dataset. In conclusion, a combination of all the identified methods should ideally be employed in future solutions. Future work should focus on the conductance of the proposed experiment and the sharing of the collected data in the manner proposed, with data ideally being collected from as many people as possible with as many different types of dementia as possible.

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Php354 - The Impact of Data Privacy Regulations on Drug Utilization Data Sharing for Innovative Pricing Arrangements

Cited by 2 publications

References 0 publications

Barriers and Opportunities for Implementation of Outcome-Based Spread Payments for High-Cost, One-Shot Curative Therapies

Barriers and Opportunities for Implementation of Outcome-Based Spread Payments for High-Cost, One-Shot Curative Therapies

Challenges in Data Capturing and Collection for Physiological Detection of Dementia-Related Difficulties and Proposed Solutions

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