Dealing with uncertainty and high prices of new medicines: A comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden

Ferrario, Alessandra; Kanavos, Panos

doi:10.1016/j.socscimed.2014.11.003

Cited by 148 publications

(149 citation statements)

References 22 publications

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“…In countries like Germany, England or Sweden, different methodologies have already been applied to regulate reimbursement policies for new treatment options. [22][23][24] Two instruments-managed entry agreements and value-based pricing-are options that are implemented ever more often to facilitate access to new therapies under uncertainty and to enforce pricing regulations. [24][25][26][27] In the last decade, several other authors have analysed high-priced anticancer drugs and their clinical benefits at the time of approval.…”

Section: Discussionmentioning

confidence: 99%

“…[22][23][24] Two instruments-managed entry agreements and value-based pricing-are options that are implemented ever more often to facilitate access to new therapies under uncertainty and to enforce pricing regulations. [24][25][26][27] In the last decade, several other authors have analysed high-priced anticancer drugs and their clinical benefits at the time of approval. 2 21 28 A 2015 study 10 showed that there is no correlation between survival improvements and the costs of anticancer therapies.…”

Section: Discussionmentioning

confidence: 99%

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Between January 2009 and April 2016, 134 novel anticancer therapies were approved: what is the level of knowledge concerning the clinical benefit at the time of approval?

Grössmann

Wild

2016

ESMO Open

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ObjectiveIn the last decade an increasing number of high-priced, new cancer treatments received marketing authorisation in Europe. What is actually known about the clinical benefit of those therapies at the time of approval needs to be elucidated in order to inform decisions about the use and reimbursement of these novel treatment options. Thus, the aim of the current analysis was to systematically investigate oncological therapies approved between January 2009 and April 2016 and extract as well as quantify the level of knowledge of the clinical benefit at the time of marketing authorisation.MethodsTo assess the benefit of new interventions as well as expanded indications, we extracted the median gain of the two study end points: progression-free survival (PFS) and overall survival (OS). Information is based on approval documents provided by the European Medicines Agency and assessments from the Austrian Horizon Scanning programme. We included all cancer therapies approved in Europe between 2009 (January 1) and 2016 (April 15).ResultsCancer drugs for 134 new indications approved since 2009 were identified. In the case of 37 indications (27%), no data were available for PFS or for OS. A positive difference in median OS was reached by 76 licensed indications (55.5%); 22 (16%) of them showed a difference of more than 3 months. Regarding the study end point PFS, an improvement was shown in 90 indications (65.2%).ConclusionScarce knowledge regarding the clinical benefit of anticancer therapies is available at the time of approval. In addition, the survival benefit of the approved indications is less than 3 months in the majority of approved therapies.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Between January 2009 and April 2016, 134 novel anticancer therapies were approved: what is the level of knowledge concerning the clinical benefit at the time of approval?

Grössmann

Wild

2016

ESMO Open

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“…They also allow for price discrimination without changing list prices. For policy-makers, MEA are a tool to manage uncertainty [78] and obtain lower prices than the list prices; how much lower is unknown as the prices are confidential. When performance-based MEA have been set up, together with patients registries, for instance, this allows collecting real-life clinical data that are needed to assess the treatment effect and take a more sound decision based on more robust evidence.…”

Section: Managed-entry Agreementmentioning

confidence: 99%

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries

Vogler

Paris

Ferrario

et al. 2017

Appl Health Econ Health Policy

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151

118

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Key points for Decision Makers: European countries apply different pharmaceutical pricing and reimbursement policies. These policies are frequently assessed against their financial consequences and their ability to contain costs but less so in terms of access to medicines. Policies should be accompanied by regular evaluations, facilitated by the use of the appropriate methodology and access to the relevant data. There appears to be a need for additional changes beyond traditional pharmaceutical pricing and reimbursement policies. Collaborative approaches (e.g. between countries or between regulatory authorities, pricing and reimbursement agencies) and more transparency in terms of real medicine prices, R+D costs and medicines in the pipeline are considered as possible pathways for the future. AbstractThe paper discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation, however implementing it has proven quite challenging. For high-priced medicines, managed-entry agreements are increasingly used. These agreements allow policy-makers to manage uncertainty and obtain lower prices. They can also facilitate earlier market access in case of limited evidence about added therapeutic value of the medicine. However, these agreements raise transparency concerns due to the confidentiality clause. Tendering as used in the 2 hospital and offpatent outpatient sectors has proven to reduce medicine prices but it requires a robust framework and appropriate design with clear strategic goals in order to prevent shortages. These pricing and reimbursement policies are supplemented by the widespread use of Health Technology Assessment to inform decision-making, and by strategies to improve the uptake of generics, and also biosimilars. While European countries have been implementing a set of policy options, there is a lack of thorough impact assessments of several pricing and reimbursement policies on affordable access. Increased cooperation between authorities, experience sharing, and improving transparency on price information, including the disclosure of confidential discounts, are opportunities to address current challenges.3

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“…Uncertainty in this type of rationing and regulatory context has been portrayed in different ways, with one approach suggesting the need to recognise but minimise it 23 and another suggesting the exploration of uncertainty should be portrayed in a more positive light as a means of making rationing decisions more transparent, accountable and democratic. 21 Uncertainty has been broadly the normal determinant or unsettled quality of a statement or knowledge claim .…”

Section: Conceptualising Uncertaintymentioning

confidence: 99%

Still Elegantly Muddling Through? NICE and Uncertainty in Decision Making About the Rationing of Expensive Medicines in England

2017

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Calnan, Michael .W. and Hashem, Ferhana and Brown, P (2017) Health and Care Excellence) as it regulates the provision of expensive new drugs within the English NHS on cost-effectiveness grounds. Ostensibly this is a highly rational process by which the regulatory mechanisms absorb uncertainty but in practice decision-making remains highly complex and uncertain. This paper draws on ethnographic data interviews with a range of stakeholders and decision-makers (n=41), observations of public and closed appraisal meetings, and documentary analysis regarding the decision-making processes involving three different pharmaceutical products. The study explores the various ways in which different forms of uncertainty are perceived and tackled within these Single Technology Appraisals (STAs). Difficulties of dealing with the various levels of uncertainty were manifest and often rendered straightforward decision-making problematic.Uncertainties associated with epistemology, procedures, interpersonal relations and technicality were particularly evident. The need to exercise discretion within a more formal institutional framework shaped a pragmatic combining of explicit and informal, collective and individual, strategies and tactics to navigate through the layers of complexity and uncertainty in making decisions.2

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Dealing with uncertainty and high prices of new medicines: A comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden

Cited by 148 publications

References 22 publications

Between January 2009 and April 2016, 134 novel anticancer therapies were approved: what is the level of knowledge concerning the clinical benefit at the time of approval?

Between January 2009 and April 2016, 134 novel anticancer therapies were approved: what is the level of knowledge concerning the clinical benefit at the time of approval?

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries

Still Elegantly Muddling Through? NICE and Uncertainty in Decision Making About the Rationing of Expensive Medicines in England

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