Tendering for off-patent outpatient medicines: lessons learned from experiences in Belgium, Denmark and the Netherlands

Vogler, Sabine; Gombocz, Margit; Zimmermann, Nina

doi:10.1111/jphs.12180

Cited by 25 publications

(27 citation statements)

References 44 publications

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“…Switzerland is the only country where tenders are limited to pandemic supplies and vaccines for military hospitals. A recent report on tendering concluded that tendering in Europe can contribute to cost containment if embedded in a robust legal and organizational framework with appropriate stakeholder management protecting the users against potential risks [ 13 ]. There are European directives, which regulate the use of tenders for public sector procurements in general and specifically, for HC purchasing in Europe [ 14 ].…”

Section: Resultsmentioning

confidence: 99%

“…Mostly, tenders are conducted in a 1-year cycle, but they may occur less frequent (e.g., 2–3 years in Germany) or on an irregular basis as in the case of Lithuania [ 7 , 13 ].…”

Section: Resultsmentioning

confidence: 99%

“…Many authors agree that tendering effectively reduces prices and contributes to cost containment in the short term [ 6 – 8 , 13 , 17 , 20 , 21 , 23 – 29 ]. This seems to be more evident when there is more competition in the tender [ 30 ].…”

Section: Resultsmentioning

confidence: 99%

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Shaping Pharmaceutical Tenders for Effectiveness and Sustainability in Countries with Expanding Healthcare Coverage

Maniadakis

Holtorf²,

Corrêa³

et al. 2018

Appl Health Econ Health Policy

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Policy makers in countries, aiming to build and expand their healthcare systems and coverage, need effective procedures to support the most efficient use of limited financial resources. Tendering is commonly deployed to minimize and fix the purchasing price for the contract duration, especially for off-patent pharmaceuticals. While tenders can reduce acquisition costs, they may also expose the healthcare systems to risks including drug shortages, quality trade-offs, and ultimately, compromised patient health outcomes. Careful planning is therefore required. The effectiveness and impact of tendering were examined in different healthcare settings to establish good tender practices and to develop guidance for tender stakeholders in countries with expanding healthcare coverage for the effective conduct. The literature was reviewed for tender practices and outcomes in all countries, and tender experts from one multi-national pharmaceutical company in 17 countries with expanding healthcare coverage were surveyed on current tender practices. Tendering is a common practice for multisource pharmaceuticals in most countries worldwide. However, countries with expanding healthcare coverage specifically are vulnerable to the risks of defective tendering practices. Risk factors include non-transparent tender practices, a lack of consistency, unclear tender award criteria, a focus on lowest price only, single-winner tendering, and generally, a lack of impact monitoring. If well planned, managed, and conducted, tenders can be advantageous. Countries with expanding healthcare coverage should approach tenders strategically to achieve the desired improvements in healthcare. The good tender practices derived from this study may guide policy makers and purchasers in countries with expanding healthcare coverage on how to expand access to healthcare at an affordable cost. These include the use of multiple selection criteria and performance monitoring. Plain Language Summary Decision makers in countries aiming to expand their healthcare systems must best use the limited money available for healthcare. Tendering is commonly deployed for pharmaceuticals produced by multiple manufacturers (so-called multisource pharmaceuticals), to choose the product with the lowest price. Through tenders, purchasers request offers from suppliers for the needed products.The ultimate purpose of our research was to develop a guidance on robust tender processes. Therefore, we reviewed the literature to examine the effectiveness and impact of current tendering practices. In addition, we conducted a survey among tender experts from one pharmaceutical company in 17 countries with expanding healthcare coverage.In both the survey and the literature review, we confirmed that worldwide, tendering is a common practice for multisource pharmaceuticals. However, defective tendering practices may increase the vulnerability for some risks including abuse due to intransparent processes, lack of consistency, unclear tender award criteria, a focus on lowest price only, singl...

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Section: Resultsmentioning

confidence: 99%

“…Mostly, tenders are conducted in a 1-year cycle, but they may occur less frequent (e.g., 2–3 years in Germany) or on an irregular basis as in the case of Lithuania [ 7 , 13 ].…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Shaping Pharmaceutical Tenders for Effectiveness and Sustainability in Countries with Expanding Healthcare Coverage

Maniadakis

Holtorf²,

Corrêa³

et al. 2018

Appl Health Econ Health Policy

View full text Add to dashboard Cite

show abstract

“…However, it can be discussed whether, or not, a policy of a 'race to the bottom' is an intended objective of EPR that is a pricing policy usually applied for new medicines. As an alternative, opportunities for savings could rather be achieved from off-patent medicines, as evidence on the price-reducing character of generic competition (40)(41)(42)(43)(44) and of tendering (45)(46)(47)(48)(49) is available.…”

Section: Discussionmentioning

confidence: 99%

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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“…For instance, high investment costs and development risks, coupled with low profit margins, may discourage participation by biosimilar manufacturers and ultimately undermine competition [15]. In the Netherlands, for example, the low prices of off-patent outpatienttendered medicines (generics and biosimilars) were perceived by stakeholder groups (including competent pricing authorities, public payers, patients/consumers, generic industry, and pharmacists) to discourage manufacturers and wholesalers from maintaining stocks, resulting in incidences of drug shortages [2,16]. Economic considerations alone may also lead to mandatory switching of patients from the originator biologic to a biosimilar, without patient or physician input.…”

Section: Introductionmentioning

confidence: 99%

Tendering and biosimilars: what role for value-added services?

Simoens

Cheung

2019

Journal of Market Access & Health Policy

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Background: Access to biologic medicines (including biosimilars) across Europe is largely governed by a process of tendering conducted by health authorities. Over-reliance on treatment costs in awarding tenders has the potential to hinder competition and undermine the long-term sustainability of biosimilars. Objective: To assess the extent and impact of consideration of 'value-added services' (VAS) in tendering for biosimilars, we conducted a narrative review of published literature. Results: Findings from survey-based publications indicated that tendering practices for biosimilars are widely used, with cost being the main determinant of success and little detail being available on other criteria where these apply. Criteria (of therapeutic and technical interest) beyond price were included in one tendering specification for infliximab (originator and biosimilars), while a separate tender for the same product included VAS in the form of therapeutic drug monitoring, measurement of antibodies and calprotectin. Conclusions: Published evidence concerning inclusion of VAS in tendering for biosimilars is lacking. Development and implementation of standardized criteria and methods of assessment for tenders may avoid manufacturers facing segmented markets, encourage competition and the longer-term sustainability of biosimilars, and realize the healthcare system and patient benefits these treatments can bring. ARTICLE HISTORY

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Tendering for off-patent outpatient medicines: lessons learned from experiences in Belgium, Denmark and the Netherlands

Cited by 25 publications

References 44 publications

Shaping Pharmaceutical Tenders for Effectiveness and Sustainability in Countries with Expanding Healthcare Coverage

Shaping Pharmaceutical Tenders for Effectiveness and Sustainability in Countries with Expanding Healthcare Coverage

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

Tendering and biosimilars: what role for value-added services?

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