Risk-Sharing Arrangements That Link Payment For Drugs To Health Outcomes Are Proving Hard To Implement

Neumann, Peter J.; Chambers, James D.; Simon, Françoise; Meckley, Lisa M.

doi:10.1377/hlthaff.2010.1147

Cited by 89 publications

(88 citation statements)

References 17 publications

(6 reference statements)

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“…Italy, UK) used them at a much higher scale than others. It also showed that most countries opted for financial MEA that are easier to handle, than performance-based MEA [76]. Since that study, more MEA have been implemented for new products, and even European countries (e.g.…”

Section: Managed-entry Agreementmentioning

confidence: 98%

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

135

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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Section: Managed-entry Agreementmentioning

confidence: 98%

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

135

118

View full text Add to dashboard Cite

show abstract

“…Over the past few years, such schemes have become more common in Europe and the US. 29,30 Managed entry agreements can take many forms and can be incorporated into novel regulatory pathways, including adaptive licensing. For example, a new anti-diabetic medication could be "Approved for Randomisation" whereby the HTA agency asks a pharmaceutical company to gather more evidence about the long-term cardiovascular benefits and harms of its product -relative to other drugs in the same therapeutic class -in low-cost, head-to-head randomised trials.…”

Section: Raising the Bar For Market Entry By Health Technology Assessmentioning

confidence: 99%

“…At present, changing the coverage status of a previously-reimbursed drug -or withdrawing an already approved product -can pose significant political challenges for HTA agencies. 30 Such agreements may also be operationally complex, costly, and difficult to implement. However, efforts are underway to improve the data infrastructure to collect valid information on relevant outcomes.…”

Section: Raising the Bar For Market Entry By Health Technology Assessmentioning

confidence: 99%

Rethinking the appraisal and approval of drugs for type 2 diabetes:

Naci

Lehman

Wouters

et al. 2015

BMJ

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The process for approving new drugs for type 2 diabetes illustrates the significant shortcomings of the regulatory standards for licensing, reimbursing, and adopting new drugs. Regulatory reform is needed to improve the real-world therapeutic value of anti-diabetic drugs. BackgroundThe overarching aim of drug regulation is to ensure that only effective and safe treatments reach patients. Ideally, regulatory decisions are based on good quality data from large trials measuring real-world, patient-centred outcomes. Licensing agencies, however, routinely permit the market entry of treatments on the basis of small placebo-controlled trials evaluating short-term, surrogate endpoints in selected populations. Consequently, medicines are commonly prescribed in the absence of good quality data on their long-term benefits and harms.1,2 Current licensing standards are inadequate to predict the real-world therapeutic value of new medications.

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“…(Pelchat 2012). One reason may be that clinically based agreements are difficult to implement (Neumann et al 2011). Another reason may be that because financial PLAs are confidential, private insurers, and consequently the individuals they insure, do not benefit from the discount granted by the manufacturer to the government.…”

Section: Other Provincesmentioning

confidence: 99%

Product Listing Agreements (PLAs): A New Tool for Reaching Quebec's Pharmaceutical Policy Objectives?

Noël

2013

hcpol

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Product listing agreements (PLAs) with pharmaceutical manufacturers are increasingly viewed as an innovative and useful tool in the effort to control drug expenditures. To date, Quebec is the only province that has been reluctant to enter into such agreements, arguing that their confidential nature may lead to a disparity in coverage between individuals covered by the public plan and those covered by private insurance. While PLAs may, in fact, present such a risk, in this paper we will argue that when used correctly, these agreements are actually tools that could help attain all four of the objectives set out in Quebec' s policy on medications, namely: (a) improved access to drugs, (b) fair and reasonable drug pricing, (c) optimal drug use and (d) maintaining a dynamic biopharmaceutical industry in Quebec. RésuméLes ententes relatives à l'inscription des produits (EIP) avec les fabricants de médicaments sont de plus en plus considérées comme des outils pratiques et novateurs pour le contrôle des dépenses pour les médicaments. À ce jour, le Québec est la seule province qui s' est montrée réticente à prendre part à de telles ententes, sous prétexte que leur caractère confidentiel peut mener à des inégalités entre les personnes qui bénéficient d'un régime public et celles qui ont un régime d' assurance privé. Bien que les EIP puissent effectivement présenter un tel risque, nous soutenons dans cet article que si elles sont employées correctement, ces ententes constituent des outils qui peuvent aider à atteindre les quatre objectifs formulés dans la politique québécoise du médicament, c' est-à-dire (a) l' accessibilité aux médicaments, (b) un prix juste et raisonnable, (c) une utilisation optimale des médicaments et (d) le maintien d'une industrie biopharmaceutique dynamique au Québec.

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Risk-Sharing Arrangements That Link Payment For Drugs To Health Outcomes Are Proving Hard To Implement

Cited by 89 publications

References 17 publications

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

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

Rethinking the appraisal and approval of drugs for type 2 diabetes:

Product Listing Agreements (PLAs): A New Tool for Reaching Quebec's Pharmaceutical Policy Objectives?

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