Innovative pharmaceutical pricing agreements in five European markets: A survey of stakeholder attitudes and experience

Dunlop, W.; Staufer, A; Lévy, Pierre; Edwards, Guy J.

doi:10.1016/j.healthpol.2018.02.008

Cited by 26 publications

(36 citation statements)

References 13 publications

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“…Our findings for Spain seem to be in line with the findings of some studies that have recently remarked that health care payers consider price-volume agreements to be the most common type of contract (77% had experience with these contracts, as also found by Dunlop [32]); less than half had experience with paying-for-performance contracts –in their text “innovative agreements”-; oncology was also the area where these contracts are more frequently applied, as detected in our study; the majority of the responders held a positive view about the potential of this type of agreement to increase certainty, manage budgets and provide additional knowledge on the value of the drugs. The study by Nazareth [34] (that only included one Spanish participant in the sample) also highlighted the increasing trend in the use of these contracts in the EU’s five largest countries, again, pointing out that 60% of all contracts signed in the last 20 years addressed cancer drugs, mainly motivated by their growing cost per patient.…”

Section: Discussionsupporting

confidence: 92%

“…Their duration, the sales thresholds, the drugs covered, the related discounts and their impact on cost savings were not usually reported. In addition, Dunlop et al [32], based on 66 responders for five EU countries, remarked that stakeholders considered that these agreements were useful managerial tools and their number would increase in the future.…”

Section: Discussionmentioning

confidence: 99%

“…duration, monitoring, data protection and patient records), their objectives, financial terms, and health outcomes. In order to improve the knowledge of the specific features of these contracts, a recent study investigated the perceptions of pharmaceutical decision makers from the five largest EU countries (France, Germany, Italy, Spain and the UK) on several key elements of these agreements [32]. Another study by Nazareth [34] assessed the activity related to these contracts as well as the perceptions of stakeholders in the USA and the same five large EU countries.…”

Section: Introductionmentioning

confidence: 99%

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Implementation of risk-sharing contracts as perceived by Spanish hospital pharmacists

2019

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BackgroundConcerns about financial sustainability of health systems have promoted the adoption of risk-sharing agreements. Nevertheless, few insights have been derived, due to their confidentiality. The purpose of this study is to analyze to what extent these agreements have been implemented in Spain and the importance of several clinical and management variables concerning their use. We also explore whether risk-sharing agreements promote the adoption of personalized medicine. We give a descriptive analysis based on a questionnaire sent to members of the Spanish Society of Hospital Pharmacy, asking about the implementation of risk-sharing contracts in their hospitals.ResultsThere were 80 replies. Implementation of risk-sharing agreements was high (90%), being oncology, neurology, dermatology and infectious diseases the main specialties. The most relevant variables were the number of units of medication per year (89%) in price-volume agreements, and the efficacy and uncertainty of treatments (over 75%) in pay-for-performance agreements. Price-volume agreements were suitable for both conventional and personalized medicine and pay-for-performance more specific for personalized medicine. Paying for performance promotes genetic testing (85%).ConclusionsThe results suggest health authorities should encourage the assessment of financial and health outcomes of real-world contracts of conventional and personalized medicine to better know the variables influencing their use.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Implementation of risk-sharing contracts as perceived by Spanish hospital pharmacists

2019

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“…Such assumption is supported by the fact that many interviewed healthcare professionals in Spain and European pharmaceutical decision makers and stakeholders, expect MEA to increase in the future, in particular PLRs [33]. The main reasons are the greater reduction in total cost and the increase in uncertainty management that these agreements provide [34]. Although global trends have varied over time and seem to be back on the rise after a slowdown in 2013-2014, the number of RSAs in the UK has decreased, opting more often for confidential discounts [15].…”

Section: Discussionmentioning

confidence: 99%

The current performance-linked and risk sharing agreement scene in the Spanish region of Catalonia

Darbà

Ascanio

2019

Expert Review of Pharmacoeconomics & Outcomes Research

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Background: Traditional drug payment schemes in Catalonia are generally based on the negotiation of fixed prices; however, disadvantages arise in the case of innovative therapies. Risk sharing agreements distribute potential health and economic uncertainties and high prices on access across the interested parts. Objectives: To identify, characterize and analyze current publicly available agreement reports signed by the Catalan Health Service and different pharmaceutical companies evaluating the current market access scene for new drugs in Catalonia. Methods: A database of agreements implemented between 2013 and 2018 was developed by using publicly available data. Data analysis was performed in a descriptive way, presenting summaries in datasheets. Results: A total of 7 managed entry agreements were analyzed. Two extensions regarding previous agreements were also taken into account. The main involved disease area is oncology (57%) and the most common length is 1 year, whereas the longest is 3 years. Conclusions: Managed entry agreements are gaining popularity and are viewed as positive schemes by stakeholders, payers and health services, leading to a general increase of accords during the last years. However, there are hardly any studies regarding the impact of RSA post-implementation, a field of great relevance regarding health policies.

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“…Similar to the previous pricing system in Japan, there is limited opportunity under the new system for industry to negotiate once prices are set, which may exclude benefits that can arise from tendering, risk-sharing agreements, and price-volume agreements, particularly for innovative drugs for which the clinical benefit in practice has not been well established 11,20,21 . Differential pricing for indications is an alternate solution for the methodological problems encountered with weighted ICERs.…”

Section: Cost-effectiveness Outcomesmentioning

confidence: 99%

Health technology assessment in Japan: a work in progress

Kamae

Thwaites

Hamada

et al. 2020

Journal of Medical Economics

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Background: In Japan, pharmacoeconomic requirements for list-price adjustment were institutionalized in April 2019 following provisional implementation of a new Health Technology Assessment (HTA) program 2016-2019. Since April 2019, submission of cost-effectiveness evidence to the Central Social Insurance Medical Council (Chuikyo) as part of the Japanese Ministry of Health, Labour, and Welfare has been mandatory for selected pharmaceuticals and medical devices. Methods: Based on a review of publications and commentaries since April 2019, together with views from a group of experts on key issues to be addressed, this report provides an update on recent HTA developments and key challenges still to be addressed. Results and Discussion: Japan's new HTA program is a first step toward development of a universal healthcare system that can be sustainable for many years into the future. Currently, Japan's HTA program requires provision of incremental cost-effectiveness ratios (ICERs) as evidence, with quality-adjusted life years as the preferred outcome measure. Prices can be adjusted both upward and downward according to the degree of the ICER estimate. Japan is the first country to have adopted an algorithmic method for "ICER-based" pricing; however, HTA measures that extend beyond a single ICER estimate are needed to take full advantage of HTA in the future. In particular, generation of evidence of value should support changes to the healthcare system so that incentives for innovation are not diminished while industry and government are not overburdened by the generation or assessment of evidence. There is a need to ensure scientifically sound HTA expertise across all sectors in Japan, and therefore enhancement of HTA literacy and capability among healthcare professionals, academia, government, and industry should be a priority.

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Innovative pharmaceutical pricing agreements in five European markets: A survey of stakeholder attitudes and experience

Abstract: Given payer expectations, pharmaceutical companies should continue to take a role in ensuring that they have sufficient capacity to support payers in the design and implementation of innovative pricing agreements.

Cited by 26 publications

References 13 publications

Implementation of risk-sharing contracts as perceived by Spanish hospital pharmacists

Implementation of risk-sharing contracts as perceived by Spanish hospital pharmacists

The current performance-linked and risk sharing agreement scene in the Spanish region of Catalonia

Health technology assessment in Japan: a work in progress

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