2020
DOI: 10.3389/fphar.2020.594446
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Abstract: 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 litera… Show more

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Cited by 22 publications
(34 citation statements)
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References 159 publications
(606 reference statements)
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“…[17] Governance: procurement processes, encompassing price, patient eligibility, outcomes, timeline and withdrawing mechanism, among others '[Governance] framework should entail a clear structure to initiate payments, specify the data collection process with attention to ownership of the data and foreseeing regular data audits, establish a defined management framework, define the funding arrangements of the agreement and clearly state the opportunities for appeal when requirements are not met (…) the governance procedures should indicate the standardised decision-making criteria that are used to support the adjustment of payments based on the outcomes achieved.' [14] Complexity: variation in the structure, components and implementation of outcomes-based schemes 'Responders perceived that the widespread adoption of risk-sharing agreements would lead to more complex protocols and clinical management of patients.' [20] Outcomes Treatment efficacy and safety: determination of treatment effects '[P]roven validated surrogate endpoints may not exist for all disease areas which complicates agreement between payer and developer on the chosen outcome.'…”
Section: Riskmentioning
confidence: 99%
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“…[17] Governance: procurement processes, encompassing price, patient eligibility, outcomes, timeline and withdrawing mechanism, among others '[Governance] framework should entail a clear structure to initiate payments, specify the data collection process with attention to ownership of the data and foreseeing regular data audits, establish a defined management framework, define the funding arrangements of the agreement and clearly state the opportunities for appeal when requirements are not met (…) the governance procedures should indicate the standardised decision-making criteria that are used to support the adjustment of payments based on the outcomes achieved.' [14] Complexity: variation in the structure, components and implementation of outcomes-based schemes 'Responders perceived that the widespread adoption of risk-sharing agreements would lead to more complex protocols and clinical management of patients.' [20] Outcomes Treatment efficacy and safety: determination of treatment effects '[P]roven validated surrogate endpoints may not exist for all disease areas which complicates agreement between payer and developer on the chosen outcome.'…”
Section: Riskmentioning
confidence: 99%
“…[20] Outcomes Treatment efficacy and safety: determination of treatment effects '[P]roven validated surrogate endpoints may not exist for all disease areas which complicates agreement between payer and developer on the chosen outcome.' [14] Patient outcomes: measurement of outcomes that matter for the patients 'Measuring the drugs' effects has proved difficult because of the varying course of the disease and because the measurement is subject to interrater variability.' [11] Time horizon: balance between optimum timescale for the condition and the scheme '[P]ayers are faced with the fact that effects of possibly curative therapies might only appear in the long-term while actionable outcomes are restricted to those measured in the short-term which is similar to the experienced difficulties of the United Kingdom MS scheme to provide conclusive answers on long-term functional outcomes.'…”
Section: Riskmentioning
confidence: 99%
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