Stakeholder preferences about policy objectives and measures of pharmaceutical pricing and reimbursement

Vogler, Sabine; Zimmermann, Nina; Habimana, Katharina

doi:10.1016/j.hlpt.2016.03.009

Cited by 17 publications

(18 citation statements)

References 33 publications

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“…As a related aspect, it has to be decided whether, or not, there is a need to have large country baskets. This has also to be seen in connection with the resources required for surveying medicine price data to perform EPR, which can be substantial in case of large country baskets (52). In any case, the study findings confirm the importance of a strategic selection of the reference countries: a well-chosen small country basket is not only less resource-intensive but may also achieve lower prices.…”

Section: Discussionsupporting

confidence: 63%

Impact of changes in the methodology of external price referencing on medicine prices: discrete-event simulation

Vogler

Schneider

Lepuschütz

2020

Preprint

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Background: Several governments apply the policy of external price referencing (EPR), which considers the prices of a medicine in one or more other countries for the purpose of setting the price in the own country. Different methodological choices can be taken to design the EPR policy. The study aimed to analyse whether, or not, and how changes in the methodology of EPR can impact medicine prices.Methods: The real-life EPR methodology as of Q1/2015 was surveyed in all European Union Member States, Iceland, Norway and Switzerland through a questionnaire responded by national pricing authorities. Different scenarios were developed related to the parameters of the EPR methodology. Discrete-event simulations of fictitious prices in the 28 countries of the study that had EPR in place were run for a period of 10 years. The continuation of the real-life EPR methodology in the countries as surveyed in 2015, without any change, served as base case.Results: Consideration of discounts (an assumed 20% discount in five large economies and the mandatory discount in Germany, Greece and Ireland) and determining the reference price based on the lowest price in the country basket would result in higher price reductions (on average -47.2% and -34.2% compared to the base case). An adjustment of medicine price data of the reference countries by purchasing power parities would lead to higher prices in some more affluent countries (e.g. Switzerland, Norway) and lower prices in lower-income economies (Bulgaria, Romania, Hungary, Poland). Regular price revisions and changes in the basket of reference countries would also impact medicine prices, however to a lesser extent.Conclusions: EPR has some potential for cost-containment. Medicine prices could be decreased further if certain parameters of the EPR methodology were changed. If public payers aim to apply EPR to keep medicine prices at more affordable levels, they are encouraged to explore the cost-containment potential of this policy and to take appropriate methodological choices in the design of EPR.

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Section: Discussionsupporting

confidence: 63%

Impact of changes in the methodology of external price referencing on medicine prices: discrete-event simulation

Vogler

Schneider

Lepuschütz

2020

Preprint

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“…As stated, currently there are different mechanisms for pricing of medicines in Member States (Vogler, 2008 ; Simoens, 2010 ; Godman et al, 2013a , 2016a ; Vogler et al, 2014 ; Permanand and Pedersen, 2015 ). Pricing negotiations with pharmaceutical companies are conducted by one or more entities within each Member State.…”

Section: Framework Initiatives and Tools Supporting The Early Accessmentioning

confidence: 99%

Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation

et al. 2017

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Medicines receiving a conditional marketing authorization through Medicines Adaptive Pathways to Patients (MAPPs) will be a challenge for payers. The “introduction” of MAPPs is already seen by the European Medicines Agency (EMA) as a fait accompli, with payers not consulted or involved. However, once medicines are approved through MAPPs, they will be evaluated for funding by payers through different activities. These include Health Technology Assessment (HTA) with often immature clinical data and high uncertainty, financial considerations, and negotiations through different types of agreements, which can require monitoring post launch. Payers have experience with new medicines approved through conditional approval, and the fact that MAPPs present additional challenges is a concern from their perspective. There may be some activities where payers can collaborate. The final decisions on whether to reimburse a new medicine via MAPPs will have more variation than for medicines licensed via conventional processes. This is due not only to increasing uncertainty associated with medicines authorized through MAPPs but also differences in legal frameworks between member states. Moreover, if the financial and side-effect burden from the period of conditional approval until granting full marketing authorization is shifted to the post-authorization phase, payers may have to bear such burdens. Collection of robust data during routine clinical use is challenging along with high prices for new medicines during data collection. This paper presents the concept of MAPPs and possible challenges. Concerns and potential ways forward are discussed and a number of recommendations are presented from the perspective of payers.

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“…From the literature, we found little direct research on how policy makers should build consensus around promising policies to address branded drug spending in the U.S. Some international studies have examined the priorities of key stakeholders and policy makers, and suggest consensus building based on alignment of values [ 9 , 24 ]. Others have discussed specific policies and their pros and cons of these policies [ 25 ].…”

Section: Discussionmentioning

confidence: 99%

“…Given the multitude of policy options available, policy makers should be able to choose and institute appropriate policy; however, there has been no major legislation targeting drug spending in the U.S since the Drug Price Competition and Patent Term Restoration Act of 1984 [ 8 ] (informally known as Hatch-Waxman of 1984). One reason may be the discordance of priorities across stakeholders which makes consensus building difficult [ 9 ]. Another potential reason behind the lack of policy is that there are too many different proposals for policy makers to compare and build consensus around.…”

Section: Introductionmentioning

confidence: 99%

Branded prescription drug spending: a framework to evaluate policy options

Ballreich

Alexander

Socal

et al. 2017

J of Pharm Policy and Pract

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BackgroundHigh drug spending is a concern for policy makers due to limits on access for patients. Numerous policies have been proposed to address high drug spending. The existence of multifarious proposals makes it difficult for policy makers to consider all the alternatives. We developed an approach to select the most viable options to present to policy makers.MethodsWe identified 41 different proposals in the peer-reviewed literature to reduce the level of spending or change the incentives for branded prescription drugs; ten of which we identified as promising proposals. Based on criterion used to assess various legislative proposals regarding branded pharmaceuticals we developed a framework to evaluate the ten promising proposals. We then used a modified Delphi technique to iteratively evaluate these ten proposals starting with the initial criterion. During each iteration, five researchers independently evaluated the ten policies based on available criterion and assessed how to modify the criterion to achieve consensus on what attributes the criterion were intended to measure. We highlight areas of disagreement to show where modifications to existing criterion are needed.ResultsWe found general agreement for most policy-criterion combinations after three iterations. Areas with the greatest remaining disagreement include possible unintended consequences, the concept of value implied by many of the policies, and secondary effects by the pharmaceutical industry, insurers, and the FDA.ConclusionsOur analysis provides an approach that can be applied to evaluate policy proposals. It also suggests factors that policy analysts and researchers should consider when they propose policy options and where additional research is needed to assess policy impacts. Developing an objective approach to compare alternatives may facilitate the adoption of policies for branded prescription drugs in the U.S. by allowing policy makers to focus on the most viable options.Electronic supplementary materialThe online version of this article (10.1186/s40545-017-0115-9) contains supplementary material, which is available to authorized users.

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Stakeholder preferences about policy objectives and measures of pharmaceutical pricing and reimbursement

Cited by 17 publications

References 33 publications

Impact of changes in the methodology of external price referencing on medicine prices: discrete-event simulation

Impact of changes in the methodology of external price referencing on medicine prices: discrete-event simulation

Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation

Branded prescription drug spending: a framework to evaluate policy options

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