Purchasing medicines for the public sector: Evaluation of the performance of centralised procurement in Portugal.

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 and regional health administrations), patient associations and pharmaceutical industry were held in Portugal in Q1/2020. RESULTS: CPM has contributed to improved transparency in processes and governance, to increased equity in access to medicines across the country and to lower workload for some users. The findings of the impact on medicine prices and availability are mixed. The benefits of CPM are undermined by some gaps: Lengthy, bureaucratic processes have resulted in delayed availability of medicines at the beginning of a year and in coping strategies of hospitals such as parallel individual procurements. The list of active ingredients under CPM has not been updated since 2016. The procurement agency does not routinely perform market consultations. Key performance indicators for CPM are lacking. CONCLUSIONS: Portuguese policy-makers are urged to develop an updated procurement strategy to provide guidance and clarity on the objectives of CPM, the role of the procurement agency and further authorities and key performance indicators.

European collaborations on medicine and vaccine procurement.

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 when it became increasingly difficult to ensure access to high-priced medicines, even in high-income countries. Two European country collaborations (the Nordic Pharmaceutical Forum and the Baltic Procurement Initiative) have successfully concluded at least one joint tender process for medicines and vaccines and the Beneluxa Initiative has concluded its first successful joint price negotiation. This article describes the experiences of these country collaborations. Challenges observed included: legal barriers; institutional and organizational differences between health-care systems in member countries; and the risk that suppliers will be reluctant to cooperate with country collaborations. Although these collaborations helped improve access to medicines and vaccines for the countries involved, in situations such as a global health crisis, larger-scale, more-inclusive initiatives are needed. In the current coronavirus disease 2019 (COVID-19) pandemic, COVID-19 Vaccines Global Access (COVAX) initiative established a global procurement mechanism to ensure the equitable distribution of COVID-19 vaccines globally. Despite differences in organization and scale, the European country collaborations and COVAX have some similarities: (i) their success depends on the increased purchasing power associated with pooled order volumes; (ii) expert knowledge and previous procurement experience is pooled; (iii) they perform other collaborative activities that go beyond procurement alone; and (iv) they actively involve external partners and stakeholders.

Depuis des décennies, certaines régions du monde ont uni leurs efforts pour s'organiser, négocier et effectuer des achats groupés de grandes quantités afin d'assurer un accès équitable aux médicaments et vaccins. Des mécanismes d'acquisition supranationaux ont fait de même à l'échelle planétaire. En Europe, des États ont récemment commencé à collaborer en matière d'achat et de négociation lorsqu'il est devenu de plus en plus difficile de garantir l'accès à des médicaments coûteux, y compris dans les pays à haut revenu. Deux collaborations entre pays européens (le Forum pharmaceutique nordique et l'Initiative d'acquisition de la Baltique) ont mené à bien au moins un processus d'offre conjoint pour des médicaments et vaccins, tandis que l'Initiative Beneluxa a conclu sa première négociation tarifaire conjointe. Cet article décrit les expériences liées à ces collaborations entre nations. Plusieurs défis se sont posés, notamment des obstacles juridiques; des différences institutionnelles et organisationnelles entre les systèmes de santé des États membres; et enfin, le risque que les fournisseurs soient peu enclins à accepter ces collaborations entre pays. Bien que ces collaborations aient amélioré l'accès aux médicaments et vaccins pour les pays impliqués, des initiatives plus globales et à plus grande échelle sont nécessaires dans des situations telles qu'une crise sanitaire mondiale. Durant l'actuelle pandémie de maladie à coronavirus 2019 (COVID-19), l'initiative COVAX (COVID-19 Vaccines Global Access) a abouti à un dispositif d'approvisionnement mondial pour veiller à distribuer équitablement des vaccins contre la COVID-19 dans le monde. Malgré des variations d'organisation et d'échelle, les collaborations entre États européens partagent des similitudes avec le COVAX: (i) le succès de ces deux démarches dépend d'un accroissement du pouvoir d'achat combiné à des volumes de commande groupés; (ii) elles mettent en commun les connaissances approfondies et expériences passées; (iii) elles mènent d'autres activités collectives qui dépassent le simple cadre de l'acquisition; et enfin, (iv) elles impliquent activement une série d'intervenants et de partenaires externes.

Para garantizar un acceso equitativo a los medicamentos y las vacunas, los esfuerzos organizativos y los volúmenes de compra se han unido en adquisiciones y negociaciones conjuntas durante décadas en algunas regiones del mundo, así como a nivel mundial a través de mecanismos de adquisición supranacionales. En Europa, los países empezaron a colaborar en las adquisiciones y negociaciones recientemente, cuando se hizo cada vez más difícil garantizar el acceso a los medicamentos con precios altos, incluso en los países de renta alta. Dos colaboraciones de países europeos (el Foro Farmacéutico Nórdico y la Iniciativa de Adquisición del Báltico) han concluido con éxito al menos un proceso de licitación conjunta de medicamentos y vacunas, y la Iniciativa Beneluxa ha concluido con éxito su primera negociación conjunta de precios. Este artículo describe las experiencias de estas colaboraciones entre países. Entre los retos observados se encuentran: las barreras legales, las diferencias institucionales y organizativas entre los sistemas sanitarios de los países miembros y el riesgo de que los proveedores se muestren reacios a cooperar con las colaboraciones entre países. Aunque estas colaboraciones ayudaron a mejorar el acceso a los medicamentos y las vacunas para los países implicados, en situaciones como una crisis sanitaria mundial, se necesitan iniciativas a mayor escala y más inclusivas. En la actual pandemia de la enfermedad por coronavirus (COVID-19), la iniciativa Acceso global a las vacunas de la COVID-19 (COVAX, por sus siglas en inglés) estableció un mecanismo de adquisición mundial para garantizar la distribución equitativa de las vacunas contra la COVID-19 en todo el mundo. A pesar de las diferencias de organización y escala, las colaboraciones de los países europeos y COVAX tienen algunas similitudes: i) su éxito depende del mayor poder adquisitivo asociado a los volúmenes de pedidos mancomunados; ii) se ponen en común los conocimientos de los expertos y la experiencia previa en materia de adquisiciones; iii) realizan otras actividades de colaboración que van más allá de la mera adquisición; e iv) implican activamente a socios y partes interesadas externas.

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

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 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 (where applicable), 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 were run over 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: In most scenarios, after 10 years, medicine prices in all or most surveyed countries were-sometimes considerably-lower than in the base case scenario. But in a few scenarios medicine prices increased in some countries. 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 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 by taking appropriate methodological choices in the EPR design.

The impact of managed entry agreements on pharmaceutical prices.

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 discount. Using a theoretical model, we show that, under most price setting regimes, the introduction of an MEA leads to a higher list price. This is confirmed by our empirical analysis of a sample of 156 medicines in six countries, providing a conservative estimate of the increase in price due to the MEA of 5.9%. A relevant policy implication is that payers may overestimate the financial gains that can be achieved through this  tool.

Affordable and equitable access to subsidised outpatient medicines? Analysis of co-payments under the Additional Drug Package in Kyrgyzstan.

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 explore the extent of co-payments for ADP-listed medicines and to explain the reasons for developments. METHODS: A descriptive statistical analysis was performed on prices and volumes of prescribed ADP-listed medicines dispensed in pharmacies during 2013-2015 (1,041,777 prescriptions claimed, data provided by the Mandatory Health Insurance Fund). Additionally, data on the value and volume of imported medicines in 2013-2015 (obtained from the National Medicines Regulatory Agency) were analysed. RESULTS: In 2013-2015, co-payments for medicines dispensed under the ADP grew, on average, by 22.8%. Co-payments for ADP-listed medicines amounted to around 50% of a reimbursed baseline price, but as pharmacy retail prices were not regulated, co-payments tended to be higher in practice. The increase in co-payments coincided with a reduction in the number of prescriptions dispensed (by 14%) and an increase in average amounts reimbursed per prescription in nearly all therapeutic groups (by 22%) in the study period. While the decrease in prescriptions suggests possible underuse, as patients might forego filling prescriptions due to financial restraints, the growth in average amounts reimbursed could be an indication of inefficiencies in public funding. Variation between the regions suggests regional inequity. Devaluation of the national currency was observed, and the value of imported medicines increased by nearly 20%, whereas volumes of imports remained at around the same level in 2013-2015. Thus, patients and public procurers had to pay more for the same amount of medicines. CONCLUSIONS: The findings suggest an increase in pharmacy retail prices as the major driver for higher co-payments. The national currency devaluation contributed to the price increases, and the absence of medicine price regulation aggravated the effects of the depreciation. It is recommended that Kyrgyzstan should introduce medicine price regulation and exemptions for low-income people from co-payments to ensure a more affordable and equitable access to medicines.

Assessing Data Sources for Medicine Price Studies.

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 relevant for medicine price comparisons and practical experience of the authors in medicine price studies informed the conceptional work of the framework development. A draft version of the framework was reviewed by peer pricing experts. The feasibility of the framework was tested in case studies. RESULTS: According to the developed framework (called Re-ADAPT), a medicine price data source should meet the following criteria: reliability and sustainability; accessibility at a cost that users can afford; provision of medicine price information at the date(s) required; information for the defined geographic area, or at least in a representative way; coverage of the pharmaceuticals and at the price type(s) required. Easy handling and provision of additional information were defined as supportive assets of candidate data sources (secondary criteria). The case studies confirmed the feasibility of the Re-ADAPT framework. In some cases, however, it can be difficult to disentangle assessment criteria (particularly geographic area, scope of pharmaceuticals and price types) for separate consideration, given their interlinkage. CONCLUSIONS: While selection of the most appropriate data sources will remain a challenge, the Re-ADAPT framework aims to provide practical guidance and thus contribute to a more careful, balanced, and evidence-based selection of data sources for medicine price studies.

Economic Evaluation of Hospital and Community Pharmacy Services.

OBJECTIVE: To review the international body of literature from 2010 to 2015 concerning methods of economic evaluations used in hospital- and community-based studies of pharmacy services in publicly funded health systems worldwide, their clinical outcomes, and economic effectiveness. DATA SOURCES: The literature search was undertaken between May 2, 2015, and September 4, 2015. Keywords included "health economics" and "evaluation" "assessment" or "appraisal," "methods," "hospital" or "community" or "residential care," "pharmacy" or "pharmacy services" and "cost minimisation analysis" or "cost utility analysis" or "cost effectiveness analysis" or "cost benefit analysis." The databases searched included MEDLINE, PubMed, Google Scholar, Science Direct, Springer Links, and Scopus, and journals searched included PLoS One, PLoS Medicine, Nature, Health Policy, Pharmacoeconomics, The European Journal of Health Economics, Expert Review of Pharmacoeconomics and Outcomes Research, and Journal of Health Economics. STUDY SELECTION AND DATA EXTRACTION: Studies were selected on the basis of study inclusion criteria. These criteria included full-text original research articles undertaking an economic evaluation of hospital- or community-based pharmacy services in peer-reviewed scientific journals and in English, in countries with a publicly funded health system published between 2010 and 2015. DATA SYNTHESIS: 14 articles were included in this review. Cost-utility analysis (CUA) was the most utilized measure. Cost-minimization analysis (CMA) was not used by any studies. The limited use of cost-benefit analyses (CBAs) is likely a result of technical challenges in quantifying the cost of clinical benefits, risks, and outcomes. Hospital pharmacy services provided clinical benefits including improvements in patient health outcomes and reductions in adverse medication use, and all studies were considered cost-effective due to meeting a cost-utility (per quality-adjusted life year) threshold or were cost saving. Community pharmacy services were considered cost-effective in 8 of 10 studies. CONCLUSIONS: Economic evaluations of hospital and community pharmacy services are becoming increasingly commonplace to enable an understanding of which health care services provide value for money and to inform policy makers as to which services will be cost-effective in light of limited health care resources.

Cancer drugs in 16 European countries, Australia, and New Zealand: a cross-country price comparison study.

BACKGROUND: Cancer drugs challenge health-care systems because of their high prices. No cross-country price comparison of cancer drugs for a large number of countries has been published. We aimed to survey the prices of cancer drugs in high-income countries (Europe, Australia, and New Zealand). METHODS: Based on comparability in terms of the economic situation and of the pharmaceutical system, we surveyed official list prices per unit at ex-factory price level of 31 originator cancer drugs in 16 European countries, Australia, and New Zealand as of June, 2013. Drug price data for the European countries were provided by the Pharma Price Information (PPI) service; Australian and New Zealand drug price data were retrieved from the respective pharmaceutical schedules. FINDINGS: In Austria, Denmark, Finland, Germany, Italy, Norway, Sweden, and the UK, price information was available for all or all but one drug surveyed whereas the availability of price data was restricted for some drugs in other countries, especially in New Zealand and Portugal. The difference of a drug price between the highest priced country and the lowest priced country varied between 28% and 388%. A few drugs had lower outliers, especially Greek and UK prices, and upper outliers (particularly prices in Switzerland, Germany, and Sweden). Overall, Greek prices ranked at a low level, whereas Sweden, Switzerland, and Germany showed price data in similarly high ranges. INTERPRETATION: Our results showed variations in ex-factory prices of originator cancer drugs in the 18 surveyed countries. However, the surveyed prices do not include discounts negotiated by funding organisations because these discounts are confidential. Because pricing authorities can also only use these official undiscounted prices when they set prices through the common policy of external price referencing, they risk overpaying. Our findings provide an evidence base for policy makers to decide whether further policy measures related to drug prices are needed. FUNDING: None.

Prices, Costs, and Affordability of New Medicines for Hepatitis C in 30 Countries: An Economic Analysis.

INTRODUCTION: New hepatitis C virus (HCV) medicines have markedly improved treatment efficacy and regimen tolerability. However, their high prices have limited access, prompting wide debate about fair and affordable prices. This study systematically compared the price and affordability of sofosbuvir and ledipasvir/sofosbuvir across 30 countries to assess affordability to health systems and patients. METHODS AND FINDINGS: Published 2015 ex-factory prices for a 12-wk course of treatment were provided by the Pharma Price Information (PPI) service of the Austrian public health institute Gesundheit Österreich GmbH or were obtained from national government or drug reimbursement authorities and recent press releases, where necessary. Prices in Organisation for Economic Co-operation and Development (OECD) member countries and select low- and middle-income countries were converted to US dollars using period average exchange rates and were adjusted for purchasing power parity (PPP). We analysed prices compared to national economic performance and estimated market size and the cost of these drugs in terms of countries' annual total pharmaceutical expenditure (TPE) and in terms of the duration of time an individual would need to work to pay for treatment out of pocket. Patient affordability was calculated using 2014 OECD average annual wages, supplemented with International Labour Organization median wage data where necessary. All data were compiled between 17 July 2015 and 25 January 2016. For the base case analysis, we assumed a 23% rebate/discount on the published price in all countries, except for countries with special pricing arrangements or generic licensing agreements. The median nominal ex-factory price of a 12-wk course of sofosbuvir across 26 OECD countries was US$42,017, ranging from US$37,729 in Japan to US$64,680 in the US. Central and Eastern European countries had higher PPP-adjusted prices than other countries: prices of sofosbuvir in Poland and Turkey (PPP$101,063 and PPP$70,331) and of ledipasvir/sofosbuvir in Poland (PPP$118,754) were at least 1.09 and 1.63 times higher, respectively than in the US (PPP$64,680 and PPP$72,765). Based on PPP-adjusted TPE and without the cost of ribavirin and other treatment costs, treating the entire HCV viraemic population with these regimens at the PPP-adjusted prices with a 23% price reduction would amount to at least one-tenth of current TPE across the countries included in this study, ranging from 10.5% of TPE in the Netherlands to 190.5% of TPE in Poland. In 12 countries, the price of a course of sofosbuvir without other costs was equivalent to 1 y or more of the average annual wage of individuals, ranging from 0.21 y in Egypt to 5.28 y in Turkey. This analysis relies on the accuracy of price information and infection prevalence estimates. It does not include the costs of diagnostic testing, supplementary treatments, treatment for patients with reinfection or cirrhosis, or associated health service costs. CONCLUSIONS: Current prices of these medicines are variable and unaffordable globally. These prices threaten the sustainability of health systems in many countries and prevent large-scale provision of treatment. Stakeholders should implement a fairer pricing framework to deliver lower prices that take account of affordability. Without lower prices, countries are unlikely to be able to increase investment to minimise the burden of hepatitis C.

Analysis of Medicine Prices in New Zealand and 16 European Countries.

OBJECTIVE: To compare prices of medicines, both originators and generics, in New Zealand and 16 European countries. METHODS: Ex-factory price data as of December 2012 from New Zealand and 16 European countries were compared for a basket of 14 medicines, most of which were at least partially funded by the state in the 17 countries. Five medicines had, at least in some countries, generic versions on the market whose prices were also analyzed. Medicine price data for the 16 European countries were provided by the Pharma Price Information service. New Zealand medicine prices were retrieved from the New Zealand Pharmaceutical Schedule. Unit prices converted into euro were compared at the ex-factory price level. RESULTS: For the 14 medicines surveyed, considerable price differences at the ex-factory price level were identified. Within the European countries, prices in Greece, Portugal, the United Kingdom, and Spain ranked at the lower end, whereas prices in Switzerland, Germany, Denmark, and Sweden were at the upper end. The results for New Zealand compared with Europe were variable. New Zealand prices were found in the lowest quartile for five medicines and in the highest quartile for seven other products. Price differences between the originator products and generic versions ranged from 0% to 90% depending on the medicine and the country. CONCLUSIONS: Medicine prices varied considerably between European countries and New Zealand as well as among the European countries. These differences are likely to result from national pricing and reimbursement policies.

Inequalities in medicine use in Central Eastern Europe: an empirical investigation of socioeconomic determinants in eight countries.

BACKGROUND: Equitable access to essential medicines is a major challenge for policy-makers world-wide, including Central and Eastern European countries. Member States of the European Union situated in Central and Eastern Europe have publicly funded pharmaceutical reimbursement systems that should promote accessibility and affordability of, at least essential medicines. However, there is no knowledge whether socioeconomic inequalities exist in these countries. Against this backdrop, this study analyses whether socioeconomic determinants influence the use of prescribed and non-prescribed medicines in eight Central and Eastern European countries (Bulgaria, Czech Republic, Hungary, Latvia, Poland, Romania, Slovenia, Slovakia). Further, the study discusses observed (in)equalities in medicine use in the context of the pharmaceutical policy framework and the implementation in these countries. METHODS: The study is based on cross-sectional data from the first wave of the European Health Interview Survey (2007-2009). Multivariate logistic regression analyses were carried out to determine the association between socioeconomic status (measured by employment status, education, income; controlled for age, gender, health status) and medicine use (prescribed and non-prescribed medicines). This was supplemented by a pharmaceutical policy analysis based on indicators in four policy dimensions (sustainable funding, affordability, availability and accessibility, and rational selection and use of medicines). RESULTS: Overall, the analysis showed a gradient favouring individuals from higher socioeconomic groups in the consumption of non-prescribed medicines in the eight surveyed countries, and for prescribed medicines in three countries (Latvia, Poland, Romania). The pharmaceutical systems in the eight countries were, to varying degrees, characterized by a lack of (public) funding, thus resulting in high and growing shares of private financing (including co-payments for prescribed medicines), inefficiencies in the selection of medicines into reimbursement and limitations in medicines availability. CONCLUSION: Pharmaceutical policies aiming at reducing inequalities in medicine use require not only a consideration of the role of co-payments and other private expenditure but also adequate investment in medicines and transparent and clear processes regarding the inclusion of medicines into reimbursement.

Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries.

OBJECTIVE: To identify pharmaceutical policy changes during the economic recession in eight European countries and to determine whether policy measures resulted in lower sales of, and less expenditure on, pharmaceuticals. METHODS: Information on pharmaceutical policy changes between 2008 and 2011 in eight European countries was obtained from publications and pharmaceutical policy databases. Data on the volume and value of the quarterly sales of products between 2006 and 2011 in the 10 highest-selling therapeutic classes in each country were obtained from a pharmaceutical market research database. We compared these indicators in economically stable countries; Austria, Estonia and Finland, to those in economically less stable countries, Greece, Ireland, Portugal, Slovakia and Spain. FINDINGS: Economically stable countries implemented two to seven policy changes each, whereas less stable countries implemented 10 to 22 each. Of the 88 policy changes identified, 33 occurred in 2010 and 40 in 2011. They involved changing out-of-pocket payments for patients in 16 cases, price mark-up schemes in 13 and price cuts in 11. Sales volumes increased moderately in all countries except Greece and Portugal, which experienced slight declines after 2009. Sales values decreased in both groups of countries, but fell more in less stable countries. CONCLUSION: Less economically stable countries implemented more pharmaceutical policy changes during the recession than economically stable countries. Unexpectedly, pharmaceutical sales volumes increased in almost all countries, whereas sales values declined, especially in less stable countries.

Impact of pharmaceutical policy interventions on utilization of antipsychotic medicines in Finland and Portugal in times of economic recession: interrupted time series analyses.

OBJECTIVES: To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession--a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal - on utilization of, as a proxy for access to, antipsychotic medicines. METHODOLOGY: We obtained monthly IMS Health sales data in standard units of antipsychotic medicines in Portugal and Finland for the period January 2007 to December 2011. We used an interrupted time series design to estimate changes in overall use and generic market shares by comparing pre-policy and post-policy levels and trends. RESULTS: Both countries' policy approaches were associated with slight, likely unintended, decreases in overall use of antipsychotic medicines and with increases in generic market shares of major antipsychotic products. In Finland, quetiapine and risperidone generic market shares increased substantially (estimates one year post-policy compared to before, quetiapine: 6.80% [3.92%, 9.68%]; risperidone: 11.13% [6.79%, 15.48%]. The policy interventions in Portugal resulted in a substantially increased generic market share for amisulpride (estimate one year post-policy compared to before: 22.95% [21.01%, 24.90%]; generic risperidone already dominated the market prior to the policy interventions. CONCLUSIONS: Different policy approaches to contain pharmaceutical expenditures in times of the economic recession in Finland and Portugal had intended--increased use of generics--and likely unintended--slightly decreased overall sales, possibly consistent with decreased access to needed medicines--impacts. These findings highlight the importance of monitoring and evaluating the effects of pharmaceutical policy interventions on use of medicines and health outcomes.

Tackling medicine shortages during and after the COVID-19 pandemic: Compilation of governmental policy measures and developments in 38 countries.

In response to increasing shortages of medicines, governments have implemented legislative and non-legislative policy measures. This study aimed to map these policies across high-income countries in Europe and beyond as of 2023 and to analyse developments in governmental approaches since the beginning of the pandemic. Information was collated from 38 countries (33 European countries, Australia, Brazil, Canada, Israel and Saudi Arabia) based on a survey conducted with public authorities involved in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network in 2023. 34 countries requested pharmaceutical companies to notify national registers of upcoming shortages and 20 countries obliged manufacturers and/or wholesalers to stock supply reserves of critically needed medicines. Further common measures included export bans for defined medicines (18 countries), regulatory measures to facilitate import and use of alternative medicines (35 countries) and multi-stakeholder coordination (28 countries). While the legislation of 26 countries allows imposing sanctions, particularly for non-compliance to reporting requirements, fines were rather rarely imposed. Since 2022, at least 18 countries provided financial incentives, usually in the form of price increases of some off-patent medicines. Overall, several policies to address medicine shortages were taken in recent years, in some countries as part of a comprehensive package (e.g., Australia, Germany). Further initiatives to secure medicine supply in a sustainable manner were being prepared or discussed.

Pricing, Procurement and Reimbursement Policies for Incentivizing Market Entry of Novel Antibiotics and Diagnostics: Learnings from 10 Countries Globally.

BACKGROUND: 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 pull incentives in pricing, procurement and reimbursement policies (e.g., additions to, modifications of, and exemptions from standard policies) for novel antibiotics, diagnostics and health products with a similar profile in 10 study countries. It also explores whether incentives for non-AMR health products could be transferred to AMR health products. METHODS: This research included a review of policies in 10 G20 countries based on literature and unpublished documents, and the production of country fact sheets that were validated by country experts. Initial research was conducted in 2020 and updated in 2023. RESULTS: Identified pull incentives in pricing policies include free pricing, higher prices at launch and price increases over time, managed-entry agreements, and waiving or reducing mandatory discounts. Incentives in procurement comprise value-based procurement, pooled procurement and models that delink prices from volumes (subscription-based schemes), whereas incentives in reimbursement include lower evidence requirements for inclusion in the reimbursement scheme, accelerated reimbursement processes, separate budgets that offer add-on funding, and adapted prescribing conditions. CONCLUSIONS: While a few pull incentives have been piloted or implemented for antibiotics in recent years, these mechanisms have been mainly used to incentivize launch of certain non-AMR health products, such as orphan medicines. Given similarities in their product characteristics, transferability of some of these pull incentives appears to be possible; however, it would be essential to conduct impact assessments of these incentives. Trade-offs between incentives to foster market entry and thus potentially improve access and the financial sustainability for payers need to be addressed.

Innovations in pharmaceutical policies and learnings for sustainable access to affordable medicines.

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 policy options, which are able to address current and future challenges. The Conference invites a broad audience of stakeholders, including researchers, policymakers, payers, patients, industry and health professionals. The conference topics are organised in three strands: Strand 1 on 'Local challenges, global learnings' aims to contribute to lively discussions on the implementation of pharmaceutical policies across the globe. Best-practice examples will be presented, supplemented by case studies of less effective policies which can offer rich learnings. Strand 2 on 'Strengthening the evidence base' is the place for presentations and discussions on topics such as health technology assessments, managed entry agreements and real-world data. Strand 3 'Futureproofing pharmaceutical policies' is particularly dedicated to explore innovation in policymaking to achieve sustainable access to affordable medicines.

The role of discounts and loss leaders in medicine procurement in Austrian hospitals - a primary survey of official and actual medicine prices.

BACKGROUND: Knowledge about the prices of medicines used in hospitals, particularly the actually achieved ones, is scant. There are indications of large discounts and the provision of medicines cost-free to Austrian hospitals. The study aims to survey the official and actual prices of medicines procured by Austrian hospitals and to compare them to the out-patient prices. METHODS: Primary price collection of the official hospital list prices and the actually achieved prices for 12 active ingredients as of the end of September 2009 in five general hospitals in Austria and analysis of the 15 most commonly used presentations. RESULTS: The official hospital list prices per unit differed considerably (from 1,500 Euro for an oncology medicine to 0.20 Euro for a generic cardiovascular medicine). For eight on-patent medicines (indications: oncology, anti-inflammatory, neurology-multiple sclerosis and blood) actual hospital medicine prices equaled the list prices (seven medicines) or were lower (one medicine) in four hospitals, whereas one hospital always reported higher actual prices due to the application of a wholesale mark-up. The actual hospital prices of seven medicines (cardiology and immunomodulation) were below the official hospital prices in all hospitals; of these all cardiovascular medicines were provided free-of-charge. Hospital prices were always lower than out-patient prices (pharmacy retail price net and reimbursement price). CONCLUSION: The results suggest little headroom for hospitals to negotiate price reductions for "monopoly products", i.e. medicines with no therapeutic alternative. Discounts and cost-free provision (loss leaders) appear to be granted for products of strategic importance for suppliers, e.g. cardiovascular medicines, whose treatment tends to be continued in primary care after discharge of the patient.

Interface management of pharmacotherapy. Joint hospital and primary care drug recommendations.

PURPOSE: In September 2012 an interactive course on the "Interface Management of Pharmacotherapy" was organized by the Stockholm Drug and Therapeutics Committee in cooperation with Department of Clinical Pharmacology at Karolinska Institutet and at Karolinska University Hospital in Stockholm, Sweden, in collaboration with the WHO. The basis for the course was the "Stockholm model" for the rational use of medicines but also contained presentations about successful models in interface management of pharmacotherapy in other European countries. METHODS: The "Stockholm model" consists of 8 components: 1) Independent Drug and Therapeutics Committee with key role for respected drug experts with policy for "interest of conflicts", 2) The "Wise List", recommendations of medicines jointly for primary and hospital care, 3) Communication strategy with continuous medical education, 4) Systematic introduction of new expensive medicines, 5) E-pharmacological support at "point of care", 6) Methods and tools for follow-up of medicines use, 7) Medicines policy strategy and 8) Operative resources. RESULTS: The course highlighted the importance of efficient and targeted communication of drug recommendations building on trust among prescribers and patients for the guidelines to achieve high adherence. Trust is achieved by independent Drug and Therapeutics Committees with a key role for respected experts and a strict policy for "conflicts of interest". Representations of GPs are also crucial for successful implementation, being the link between evidence based medicine and practice. CONCLUSION: The successful models in Scotland and in Stockholm as well as the ongoing work in Catalonia were considered as examples of multifaceted approaches to improve the quality of medicine use across primary and hospital care.

Shortages of Medicines to Treat COVID-19 Symptoms during the First Wave and Fourth Wave: Analysis of Notifications Reported to Registers in Austria, Italy, and Spain.

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 wave of the pandemic), and, in comparison, in November 2021 (fourth wave). Publicly accessible shortage registers managed by the national regulatory authorities were consulted. For 48 active substances, a shortage was notified for at least one of the study months, mostly March and April 2020. Out of these 48 active substances, 30 had been explicitly recommended as COVID-19 therapy options. A total of 71% of the active substances with notified shortage concerned medicines labeled as essential by the World Health Organization. During the first wave, Spain and Italy had higher numbers of shortage notifications for the product sample, in terms of active substances as well as medicine presentations, than Austria. In November 2021, the number of shortage notifications for the studied substances reached lower levels in Austria and Spain. The study showed an increase in shortage notifications for COVID-19-relevant medicines in the first months of the pandemic.