Sabine Vogler

• Mag. rer. soc. ec., PhD
• Head of Department at Gesundheit Österreich GmbH

On 25–26 April 2024, the 5th PPRI (Pharmaceutical Pricing and Reimbursement Information) Conference on ensuring equitable access to affordable medicines took place in Vienna (Austria). Twenty-four accepted contributions were presented either as oral presentations or posters, adding to invited keynote lectures, stakeholder debates and workshops. The...

Securing sustainable access to existing antibiotics optimises agent choice for individual treatments and is crucial to curb antibiotic resistance. Access to antibiotics is often restricted in many countries, due to general market unavailability or episodic shortages. This article outlines key policy options to maintain availability of existing anti...

Introduction Diagnostics can contribute to the improved quality of antibiotic prescribing. However, there is potential to enhance the use of point-of-care tests (POCTs) in general practice. This paper presents fit-for-purpose policy recommendations related to funding and pricing for POCTs applied for community-acquired acute respiratory tract infec...

Fostering market entry of novel antibiotics and enhanced use of diagnostics to improve the quality of antibiotic prescribing are avenues to tackle antimicrobial resistance (AMR), which is a major public health threat. Pricing, procurement and reimbursement policies may work as AMR ‘pull incentives’ to support these objectives. This paper studies pu...

Sustainable access to affordable medicines remains a public health issue globally, including for high-income countries. To foster the debate on avenues for the future, the fifth PPRI Conference held in Vienna on 25 and 26 April 2024 will offer a forum for the debate on innovating pharmaceutical policymaking to develop and implement futureproof poli...

Collections of abstracts from the 5th PPRI conference 2024: ensuring access to affordable medicines through innovative policies, Vienna, Austria, 25–26 April 2024

This paper reviews the main pricing policies in Latin American countries, discussing their shortcomings. It also gives an overview of the most common pricing and reimbursement policies in Europe and describes in detail three well-established approaches — international price referencing, value-based pricing, including setting up of health technology...

Antimicrobial resistance is a major global health threat, which is increased by the irrational use of antibiotics, for example, in the treatment of respiratory tract infections in community care. By using rapid point-of-care diagnostics, overuse can be avoided. However, the diagnostic tests are rarely used in most European countries. We mapped pote...

The study aimed to investigate medicine shortages of critical relevance in the pandemic. A total of 487 active substances for the treatment of COVID-19-related symptoms and therapeutically similar medicines were reviewed as to whether or not a shortage had been notified in Austria, Italy, and Spain for February 2020, March 2020, April 2020 (first w...

Introduction: Pharmaceutical systems are frequently characterized by fragmentation, and competences for outpatient and inpatient sectors sit with different authorities, payers and purchasers. This fragmentation of responsibilities can incentivize shifting expensive therapies and thus patients from one sector to the other. Areas covered: Reimburs...

Background: Most cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings. The study examined whether characteristics of available evidence at FDA approval influenced time-to-marketing authorisation (MA) in Brazil, and price differences between...

European countries have been experiencing medicine shortages due to disruptions in the supply chain. Reshoring the productions of active pharmaceutical ingredients (APIs) is considered as an approach to secure the supply. This study informs about the state-of-play of API production in the European Union, including reshoring initiatives. Studying po...

Biosimilars gelten als ein vielversprechender Ansatz, um leistbaren und nachhaltigen Zugang zu biologischen Arzneimitteln zu ermöglichen. Um den Einsatz von preisgünstigeren Biosimilars zu fördern, wenden europäische Länder unterschiedliche Marktsteuerungsmechanismen an, die zum einen am Angebot (Preise) und zum anderen an der Nachfrage nach Biosim...

Public procurement of medicines (PPM) is a strategic policy option to foster competition and improve access to medicines, as well as addressing important further policy objectives, including ensuring security of supply, protecting the environment, and improving crisis preparedness. In this study, PPM practices across 32 European countries (EU-27 pl...

Background There is limited evidence on within-country discrepancies in biosimilar uptake. This study analyzes differences in timing and diffusion of biosimilar uptake across Portuguese NHS hospitals and explores possible determinants. Research design and methods We analyzed publicly accessible consumption data of originator biologic and biosimila...

Equitable and sustainable access to medicines is a global challenge, including for high-income countries. Over the last two decades, launch prices of new medicines have considerably increased, making some medicines unaffordable for many countries. This article is based on a presentation held by the author at the IQWiG Autumn Symposium in November 2...

Background Recently, among others due to the COVID-19 pandemic and the war in Ukraine, European countries have been experiencing rising inflation. Value-added taxes (VAT) on essential goods have gained public attention, and abolishing VAT for these goods has been discussed as a measure to prevent poverty and inequities. The study aims to investigat...

Transparency is important for good governance and evidence-informed policy-making for access to medicines. Based on a document review and validation of findings by national authorities, this report examines whether the public authorities, and in some cases, the public in Member States in the WHO European Region can access information about medicine...

This Oslo Medicines Initiative technical report presents existing policy options for payers that support innovation and access to medicines in the WHO European Region. It identifies innovation incentives, such as early assessment schemes, managed entry agreements and dedicated budgets (so-called innovation funds), across 48 countries in the Region....

Point-of-care diagnostic tests for community-acquired acute respiratory tract infections (CA-ARTI) can support doctors by improving antibiotic prescribing. However, little is known about health technology assessment (HTA), pricing and funding policies for CA-ARTI diagnostics. Thus, this study investigated these policies for this group of devices ap...

In 2020, Brazil joined Pharmaceutical Pricing and Reimbursement Information (PPRI). PPRI is a network of public authorities responsible for pharmaceutical pricing and reimbursement policies from 50, mainly European, countries. It offers a platform to its members to share information and experiences regarding pricing and reimbursement policies for m...

Several European countries have introduced centralised procurement for all or some medicines. This article comparatively describes key features of national centralised pharmaceutical procurement (CPP) systems of six European countries (Cyprus, Denmark, Estonia, Italy, Norway and Portugal). Additionally, it aims to identify benefits, challenges and...

Background: Horizon scanning aims to systematically identify upcoming health technologies and thus allows policy-makers to be better prepared for the entry of new medicines with possibly high price tags into the national health system. The aim of this study is to survey the existence of national and cross-national horizon scanning systems for medic...

Austria is a middle-sized, high-income country in Central Europe with universal health coverage and a highly fragmented health care system. Medicines for outpatient use that are reimbursed by the social health insurance are price-regulated, whereas medicines for inpatient use are neither subject to price regulation nor to health technology assessme...

Objective: The study aimed to evaluate centralised procurement of medicines (CPM) in Portugal. Methods: Data were collected through different methods, including a review of the literature and (procurement) documents and an analysis of selected bids. Thirty-seven face-to-face interviews with representatives of public authorities, users (hospitals...

Auf einen Blick Biosimilars gelten als ein vielversprechender Ansatz, um leistbaren und nachhaltigen Zugang zu biologischen Arzneimitteln zu ermöglichen. Um den Einsatz von preisgünstigeren Biosimilars zu fördern, wenden europäische Länder unterschiedliche Marktsteuerungsmechanismen an, die zum einen an den Preisen und zum anderen an der Nachfrage...

Zusammenfassung Zusammenfassung Im europäischen und internationalen Vergleich ist das deutsche Preisniveau von Arzneimitteln hoch – insbesondere das von neuen patentgeschützten Medikamenten. Preisregulierungen können dazu beitragen, die nachhaltige Finanzierung des Solidarsystems zu sichern. In diesem Beitrag werden Preisregulierungen im internati...

To ensure equitable access to medicines and vaccines, organizational efforts and purchase volumes have been pooled in joint procurements and negotiations for decades in some regions of the world, as well as globally through supranational procurement mechanisms. In Europe, countries started to collaborate on procurement and negotiations recently whe...

This article illustrates a consensus opinion of an expert panel on the need and usefulness of a framework for price and reimbursement (P&R) process and managed entry agreements (MEAs) for orphan medicines in Italy. This opinion was gathered in three rounds: an introductory document was sent to the panel and discussed during a recorded online meeti...

Background There are concerns that high prices of cancer medicines may limit patient access. Since information on prices for cancer medicines and their impact on affordability is lacking for several countries, particularly for lower income countries, this study surveys prices of originator cancer medicines in Europe and Latin America and assesses t...

Introduction: Biosimilar medicines are considered promising alternatives to new biologicals with high price tags. The extent of savings resulting from biosimilar use depends on their price and uptake, which are largely shaped by pricing, reimbursement, and demand-side policies. This article informs about different policy measures employed by Europe...

The 4th PPRI Conference, held in Vienna in October 2019, addressed issues related to equitable and affordable access to medicines. A multi-stakeholder audience from around the globe discussed solutions and best practice models for current challenges such as high-priced medicines, limitations of current pricing and reimbursement policies and tight b...

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 EPR. The study aimed to analyse whether, or not, and how changes in the methodol...

Background and objective Little is known about how much public payers spend on orphan medicines. This study aimed at identifying information on orphan medicine expenditure incurred by public payers that was published in literature globally and at possibly synthesising their shares as portion of the total pharmaceutical expenditure. Methods A liter...

https://www.dak.de/dak/download/report-2335144.pdf

Auf einen Blick In Biosimilars werden hohe Erwartungen hinsichtlich ihres Einsparpotenzials gesetzt. Um den Einsatz von Biosimilars zu fördern, wenden europäische Länder verschiedene Marktsteuerungsmaßnahmen an. Ein Vergleich mit 15 europäischen Ländern zeigt hierbei meist ähnliche Zugänge bei den analysierten Ländern und auch im Vergleich zu Deuts...

Shortages of medicines have become a major public health challenge. The aim of this study was to survey national measures to manage and combat these shortages. A questionnaire survey was conducted with public authorities involved in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network. Reponses relating to measures as of March /...

Background Several countries have seen an increase in medicines shortages that constitute a major public health threat as they can negatively impact the health outcomes of patients. The study aims to survey measures that European countries apply or consider introducing to address medicines shortages. Methods A questionnaire was sent to the public...

This report assesses five government-led, voluntary cross-country collaborations in the WHO European Region that aim to improve access to essential medicines through joint activities: the Baltic Procurement Initiative, Beneluxa Initiative, Fair and Affordable Pricing, Nordic Pharmaceutical Forum and Valletta Declaration. These cover activities incl...

Managed entry agreements (MEAs) have been used for several years, with the aim of curbing the growth of pharmaceutical expenditure and enhancing patient access to innovation. Yet, much remains to be understood about their economic implications. This paper studies the impact of MEAs on list prices, that is, prices before the deduction of any discoun...

Medicine price regulation aims to contribute to more affordable access to medicines for both patients and public payers. While there is strong evidence for its achievements, high prices remain a barrier to access, increasingly also in high-income countries. This chapter discusses existing medicine pricing policies, particularly for new medicines, s...

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...

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 EPR. The study aimed to analyse whether, or not, and how changes in the methodo...

The study “Medicine shortages: international evidence and recommendations” informs about the extent of shortages, their causes and possible measures. The situation with regard to medicine shortages and actions taken to manage, reduce and prevent shortages in four European countries (Finland, Italy, the Netherlands and Sweden) is presented as case s...

Questo contributo si propone come commento al documento “Prezzo, rimborso e accesso ai farmaci in Italia: le proposte di riforma di quattro panel di esperti“ (in questo stesso numero di Politiche sanitarie, pp. 168-179), che sintetizza i risultati del lavoro di un gruppo di esperti articolato in quattro panel nell’ambito di un seminario residenzial...

The PPRI Report 2018aims to provideinformation of currently existing pharmaceutical pricing and reimbursement policies in the 47 PPRI member countries. https://ppri.goeg.at/sites/ppri.goeg.at/files/inline-files/PPRI%20Report2018_2nd_edition_final.pdf

Abstracts from the 4th International PPRI Conference 2019: Medicines access challenge – The value of pricing and reimbursement policies

Objective The study aimed to analyse the financial burden that co-payments for prescribed and reimbursed medicines pose on patients in European countries. Methods Five medicines used in acute conditions (antibiotic, analgesic) and in chronic care (hypertension, asthma, diabetes) were selected. Co-payments (standard and five defined population grou...

The study aimed to explore the priorities of authorities and payers related to policy options for pharmaceutical pricing and reimbursement and to understand the rationale of their preferences. Representatives of competent authorities for pharmaceutical pricing and reimbursement and public payers of the 28 EU Member States were invited to express th...

Background: Out-of-pocket (OOP) payments can constitute a major barrier for affordable and equitable access to essential medicines. Household surveys in Kyrgyzstan pointed to a perceived growth in OOP payments for outpatient medicines, including those covered by the benefits package scheme (the Additional Drug Package, ADP). The study aimed to exp...

Objectives There is no established methodology to assess the feasibility of medicine price data sources. Against this backdrop, a framework to guide the selection of most appropriate price data sources for pharmacoeconomic research has been developed. Methods A targeted literature review was carried out. Dimensions discussed in literature as relev...

Background There are indications of staggered market entry of medicines in the national markets, with medicines being marketed first in countries with high prices. This study aimed to analyse the availability and evolution of medicine prices in the European Union (EU). Methods This research was performed for an illustrative sample of five medicine...

Background: Medicine purchasing and pricing decisions usually rely on officially published prices. Literature has reported evaluations of publicly stated prices. However, due to the frequent use of confidential price arrangements there are indications for paucity of data on actual medicine prices. Therefore, the study aimed to systematically revie...

The chapter presents studies that investigated developments in medicine prices and/or analysed medicine price data over time in order to assess effects of policy measures, patent expiry or other events (impact assessments). A range of methods was used. Most commonly used ones include descriptive analysis, time-series analysis and regression analysi...

External price referencing (EPR) describes a policy to set medicine prices based on price data of the same medicine in other countries. The aim of this chapter is to present how EPR was implemented in the framework of pharmaceutical pricing in European countries and on a global scale. It provides an analysis of similarities and differences in the d...

The aim of this chapter is to provide an overview of available medicine price studies in different regions of the world. The presentation of the studies is clustered as follows: (1) generic and biosimilar medicines, (2) high-priced medicines including orphan medicinal products, (3) medicines for specific indications (e.g., HIV/AIDS, Hepatitis C), (...

Medicine Price Surveys, Analyses and Comparisons establishes guidelines for the study and implementation of pharmaceutical price surveys, analyses, and comparisons. Its contributors evaluate price survey literature, discuss the accessibility and reliability of data sources, and provide a checklist and training kit on conducting price surveys, analy...

Key messages • Policy-makers and purchasers increasingly face very high price tags for new medicines, and some worry that these prices challenge the financial sustainability of solidarity- based, publicly funded health care systems. • EU Member States use a mix of policy instruments to regulate the prices and determine the reimbursement of medicine...

This report reviews and analyses different reimbursement policies for medicines applied by countries in the WHO European region. The study used a mixed methods approach including primary data collection through a questionnaire addressing the competent authorities included in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network,...

This chapter deals with challenges and possible solutions to ensure affordable patient access to high-cost medicines in Europe. In recent years, even high-income countries have been struggling to provide affordable access to new, high-cost medicines. Less affluent countries and small markets have been suffering from delayed launch and, in some case...

Background: Despite potentially considerable implications for public health, the environment and public funds, medicine waste is an under-researched topic. This study aims to analyse medicines drawn from household garbage in Vienna (Austria) and to assess possible financial implications for public payers. Methods: Four pharmaceutical waste sampl...

https://www.barmer.de/blob/125228/3c5d541966251406905d1b5914008b69/data/dl-5-vogler.pdf

Introduction/Study objective: This paper aims to survey the policies implemented by European countries for pricing and promoting the use of biosimilar medicines and to explore similarities and differences with policies for generic medicines. Methods: A literature review was supplemented by primary data collection with policymakers. Members of the P...

Objectives To study the impact of tendering for off-patent outpatient medicines in terms of savings for payers and availability of medicines, to explore stakeholder perceptions and to elaborate prerequisites for a successful implementation of the policy. Methods We selected three case studies (Belgium, Denmark and the Netherlands). Information wa...

Affordable patient access to medicines, particularly to new premium-priced medicines, is an issue, even in high-income countries. The pharmaceutical industry has argued in favour of price discrimination amongst countries based on confidential discounts as a solution to ensuring affordability and availability in less-resourced countries. In this edi...

Objectives: The aim of this study is to conduct an analysis on the regulation and application of managed entry agreements (MEA) for oncology drugs across different European countries. Methods: Literature search and document analysis were performed between September 2015 and June 2016 to collect information on the regulatory framework and practice o...

Managed-Entry Agreements (MEA) kommen immer häufiger auch in Österreich zum Einsatz. Unter MEA werden verschiedene Formen von vertraulichen Abkommen zwischen Pharmaherstellern und Zahlern (Krankenanstaltenträgern, Sozialversicherungen) subsummiert, die vor allem dort ausverhandelt werden, wo über den Nutzen der Medikamente Unsicherheit besteht, abe...