Pharmaceutical Pricing Policies Research Articles

Achieving dynamic efficiency in pharmaceutical innovation: Identifying the optimal share of value and payments required.

It has been argued that cost-effectiveness analysis of branded pharmaceuticals only considers static efficiency, neglects dynamic effects and undermines incentives for socially valuable innovation. We present a framework for designing pharmaceutical pricing policy to achieve dynamic efficiency. We develop a coherent framework that identifies the long-term static and dynamic benefits and costs of offering manufacturers different levels of reward. The share of value that would maximise long-term population health depends on how the quantity and quality of innovation responds to payment. Using evidence of the response of innovation to payment, the optimal share of value of new pharmaceuticals to offer to manufacturers is roughly 20% (range: 6%-51%). Reanalysis of a sample of NICE technology appraisals suggests that, in most cases, the share of value offered to manufacturers and the price premium paid by the English NHS were too high. In the UK, application of optimal shares would offer considerable benefits under both a public health objective and a broader view of social welfare. We illustrate how an optimal share of value can be delivered through a range of payment mechanisms including indirect price regulation via the use of different approval norms by an HTA body.

Balancing medical innovation and affordability in the new healthcare ecosystem in China: Review of pharmaceutical pricing and reimbursement policies

AbstractThe China Basic Medical Insurance Program was created in 1999 with three objectives: equal accessibility, affordability, and quality. Today, it has become the biggest medical insurance program in the world, covering 95% of China's population. Since 2015, China's healthcare ecosystem has been reshaped by increasing innovation, which has in turn been driven by regulatory reform, enhancement of research and development capability, and capital market development. There has also been improved regulatory efficiency to reduce lags in launching drugs. In 2022, nearly 20% of novel active substances launched globally were from China. China has also risen to become the second biggest contributor to innovation in terms of pipelines. Using a “fast‐follow” strategy, many locally developed innovative drugs can compete with products from multinational companies in their quality and pricing. However, China's pharmaceutical and biotechnology industry will continue to face challenges in pricing and reimbursement, as well as a shortened product lifecycle with rapid price erosion. The government has already accelerated the timeline for updating the drug reimbursement list and is willing to create a high‐quality medical insurance program. However, some obstacles are hard to overcome, including reimbursement for advanced therapies, limited funding and an increasing burden of disease due to an aging population. This article reviews the trajectory of medical innovation in China, including the challenges. Looking forward, balancing affordability and innovation will be critical for China to continue the trajectory of growth. The article also offers some suggestions for future policy reform, including optimizing reimbursement efficiency with a focus on high‐quality solutions, enhancing the value assessment framework, payer repositioning from “value buyer” to “strategic buyer”, and developing alternative market access pathways for innovative drugs.

Pharmaceutical Pricing and Reimbursement Policies: lessons learnt and perspectives for Brazil

The special series “Pharmaceutical Pricing and Reimbursement Policies” published throughout 2022, was organised by invitation of the Brazilian Journal of Hospital Pharmacy and Health Services, to characterise medicines pricing and reimbursement in Brazil and other countries and discuss implementation, effects, gaps and opportunities for improvement. The series included an editorial, a perspective on the Pharmaceutical Pricing and Reimbursement Policies (PPRI) network and eight country case studies, namely Austria, Brazil, Greece, Canada, Italy, United Kingdom, Portugal and the United States. In closing the series, an overview is presented, as well as a critical appraisal of how aspects such as innovation, access, health litigation, the importance of international cooperation and networking are producing advances or setbacks for country pharmaceutical regulation, pricing and reimbursement, and in-place health technology assessment. This article also highlights the scenario in Brazil, with recent developments in pharmaceutical policies approaching medicines pricing, incorporation (reimbursement), access, and expenditure, at the same time introducing arguments that show how these same issues may intertwine with planning and budgets, straining sustainability and threatening the concept of comprehensiveness adopted by the Unified Health System. New perspectives for strengthening of pharmaceutical regulation, pricing and reimbursement policies with a life-cycle approach, aiming for improving access to essential medicines, stimulating innovation and ensuring sustainability of the health system are needed. Experiences in the series´ case studies are examples of benchmarking and best practices, opportunities for increasing collaboration and sources of inspiration.

Assessing US Pharmaceutical Policy and Pricing Reform Legislation in Light of European Price and Cost Control Strategies.

This article compares the pharmaceutical pricing policies employed by public and private insurers in the United States with seven price and spending control strategies employed in the United Kingdom, France, and Germany. Differences between American and European policies explain why American pharmaceutical prices and per capita spending are higher than in European nations. The article then analyzes two recent bills as examples of significant American reform ideas-H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (introduced in 2019) and the Build Back Better Act (BBBA, introduced in 2021)-and compares them with European cost control strategies. Key drug price provisions of the BBBA were incorporated into the recently enacted Inflation Reduction Act (IRA). H.R. 3 would have used an international (mostly European) price index to cap U.S. prices; the BBBA would cap Medicare prices at a discount from average U.S. market prices. Neither bill would employ the key cost control strategies that European nations do. Both bills would have significantly less impact on prices than legislation that employs European-style cost controls. This article proposes steps that Congress could take in line with European strategies to lower purchase prices and costs for patients. These measures would have to overcome political obstacles that currently stymie reform.

Improving medicines access in Brazil through collaboration in the PPRI network

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 medicines, and this helps improve access to affordable medicines. Information-sharing is done, among others, through network queries, country reports, meetings and webinars. Contributing to the PPRI network activities, Brazil can benefit from the policy experience of the other countries.

A critical review of methodologies used in pharmaceutical pricing policy analyses

Robust evidence from health policy research has the potential to inform policy-making, but studies have suggested that methodological shortcomings are abundant. We aimed to identify common methodological weaknesses in pharmaceutical pricing policy analyses. A systematic review (SR) of studies examining pharmaceutical pricing policies served as basis for the present analysis. We selected all studies that were included in the SR (n = 56), and those that were excluded from the SR due to ineligible study designs only (n = 101). Risk of bias was assessed and specific study design issues were recorded to identify recurrent methodological issues. Sixty-one percent of studies with a study design eligible for the SR presented with a high risk of bias in at least one domain. Potential interference of co-interventions was a source of possible bias in 53% of interrupted time series studies. Failing to consider potential confounders was the primary cause for potential bias in difference-in-differences, regression, and panel data analyses. In 101 studies with a study design not eligible for the SR, 32% were uncontrolled before-after studies and 23% were studies without pre-intervention data. Some of the methodological issues encountered may be resolved during the design of a study. Awareness among researchers on methodological issues will help improve the rigor of health policy research in general.

Financing Strategies to Facilitate Access to High-Cost Anticancer Drugs: A Systematic Review of the Literature.

Each country manages access to anticancer drugs differently due to variations in the structure and financing of the health system, but a summary of the various strategies used is absent. This study aimed to review and summarize financing strategies implemented across countries to facilitate access to high-cost anticancer drugs. We conducted a systematic review of articles referenced in PubMed, Embase, and Web of Science through May 12, 2021. Articles published in the English language from 2000 that describe strategies implemented in different countries to facilitate access to high-cost anticancer drugs were included. Letters, news articles, and proposed strategies were excluded. Quality assessment was not performed as we aimed to summarize the strategies. Data were analyzed by thematic analysis. A review protocol was registered at PROSPERO (CRD42018068616). The review included 204 studies from 176 countries. Three themes of financing strategies were identified: (1) Basic pharmaceutical reimbursement and pricing policies, (2) Alternative funding strategies specific to high-cost drugs, and (3) Financial assistance for individual patients. Access in most countries depends mainly on basic pharmaceutical reimbursement policies (165 of 176 countries). Apart from that, high-income countries (HICs) tended to use funding strategies targeting high-cost drugs (72% of HICs vs 0%-24% of the rest), such as managed entry agreements (MEAs) or dedicated funds for high-cost drugs. In contrast, lower-income countries tended to implement financial assistance programs for cancer patients as a tool to increase access (32% of HICs vs 62%-79% of the rest). Many countries have implemented a combination of strategies to increase access to high-cost anticancer drugs. Most low- and middle-income countries utilized placement of anticancer drugs on a national list of essential medicines and patient assistance programs (PAPs) to facilitate access, while many HICs implemented a broader range of strategies.

Impact of price control on pharmaceutical sector with reference to India

In India, drug prices are controlled and are commonly known as Drug Price Control Orders (DPCO) issued under the Indian Essential Commodities Act of 1955. It is governed by the National Pharmaceutical Pricing Policy (NPPP) and accordingly, a National List for Essential Medicines (NLEM) was formulated. DPCO is useful for controlling the prices of life-saving drugs that are essential in the current scenario of healthcare and diseases. All the essential drugs are included under DPCO and a ceiling price is formulated. Drug prices cannot exceed the limit stipulated by DPCO. We have studied DPCO and discussed its impact on the pharmaceutical sector. The paper encompasses the brief history of DPCO, its contents, objectives, etc. Effects of DPCO on foreign trade is also analysed in this paper. We have attempted to find the effects of drug price control and its implications on the industry as a whole. We have also attempted to gaze future prospects for the pharmaceutical industry.

Impact of price control on pharmaceutical sector with reference to India

In India, drug prices are controlled and are commonly known as Drug Price Control Orders (DPCO) issued under the Indian Essential Commodities Act of 1955. It is governed by the National Pharmaceutical Pricing Policy (NPPP) and accordingly, a National List for Essential Medicines (NLEM) was formulated. DPCO is useful for controlling the prices of life-saving drugs that are essential in the current scenario of healthcare and diseases. All the essential drugs are included under DPCO and a ceiling price is formulated. Drug prices cannot exceed the limit stipulated by DPCO. We have studied DPCO and discussed its impact on the pharmaceutical sector. The paper encompasses the brief history of DPCO, its contents, objectives, etc. Effects of DPCO on foreign trade is also analysed in this paper. We have attempted to find the effects of drug price control and its implications on the industry as a whole. We have also attempted to gaze future prospects for the pharmaceutical industry.

PNS163 The Definition of Innovation in Health Technology Assessments (HTA): A Systematic Literature Review

A major goal of current pharmaceutical pricing and reimbursement policies is to maintain affordability and access to medicines, yet at the same time provide incentives for continued innovation. While the term “innovation” is widely used, it often remains undefined or is defined differently depending upon the perspective. Accordingly, establishing a link between the level of innovativeness and price premiums poses a major challenge. In this study, we systematically review current literature and discuss how pharmaceutical innovation is defined in health technology assessments (HTA) of different countries and how it is incentivized and rewarded through pricing and reimbursement schemes. We conducted a systematic literature review using PubMed and the Social Science Citation Index (SSCI) and covering articles published from 2010 to 2019. Our review shows that innovation beyond the added therapeutic value is rarely considered in HTAs. While other elements such as nature of treatment or ease and convenience of administering the drug are occasionally considered, only the added therapeutic value is crucial when it comes to pricing and reimbursement decisions. Regarding changes to the current approaches, our review shows that most studies do not advocate drastic changes to the current methods of capturing innovation in pricing policies. Suggestions focus on how added therapeutic benefits, given they exist, are considered in HTAs rather than how innovation should be defined in the first place. Innovation is a widely but variously used term. Generally, a drug that is considered innovative implies that it has properties that are worthy of recognition and reward and that the product has a unique value. However, notions of value are a matter of perspective and valuing innovation is a complex and difficult task. Since the value of innovation could be derived from more unobvious benefits, changes in the current assessment process may be warranted.

The impact of burnout on nurses' work satisfaction

Abstract Background The public health is a “big” employer, it employs approximately 10 % of all workers in the whole European Union, but it suffers from a lack of workers. Approximately 2,500 nurses are lacking in these days in the CR. If the lack will continue to increase, this reality will threaten the functioning of the whole healthcare system. The increasing of a work satisfaction and motivation becomes one of the important factors of nurses' stabilisation. Nevertheless, work dissatisfaction and low motivation is not the only element which can increase the fluctuation. Psychosocial risks (e.g. burnout) which 40 % of nurses in the CR suffer from, can be a problem as well. Methods A cross-sectional design is used in the survey. A principle of the survey was to find out how the burnout syndrome influences a list of factors of work dissatisfaction and motivation. Two questionnaires were used. The first questionnaire contained the list of factors of work environment, and it was created according to Herzberg motivation theory. The second one was Maslach Burnout Inventory. A survey was conducted in 2018, 462 nurses participated in the survey. Descriptive statistics and non-parametric test and Euclidean distance model was used for data processing. Results The survey revealed that burnout effect affects the subjectively perceived order of factors of work environment. The nurses, who do not suffer from burnout effect, prioritize direct patient care on their ranking of work value system. On the other hand, the nurses, who do suffer from burnout, consider a salary as the most important factor. Conclusions Healthcare providers' management should not only seek to increase work satisfaction or motivation on their own. Work satisfaction and low fluctuation can be achieved only through the comprehensive impact on the entire work environment. Key messages Job satisfaction and motivation are closely related to psychosocial risks. Reducing these risks will ensure job satisfaction. Panelists: Dimitra Panteli Department of Health Care Management, Berlin University of Technology, Berlin, Germany Contact: dimitra.panteli@tu-berlin.de Erin Webb Department of Health Care Management, Berlin University of Technology, Berlin, Germany Contact: e.webb@tu-berlin.de Erica Richardson European Observatory on Health Systems and Policies, London, UK Contact: erica.richardson@lshtm.ac.uk Sabine Vogler WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Vienna, Austria Contact: Sabine.Vogler@goeg.at

Systematic reviews of ten pharmaceutical pricing policies \u2013 a research protocol

BackgroundHigh prices of pharmaceutical products are an increasing challenge in high- and low-income countries. Governments in many countries have implemented pricing policies to ensure affordability of medicines to patients and healthcare systems. The World Health Organization published in 2015 the Guideline on Country Pharmaceutical Pricing Policies, which was based on a series of evidence reviews in the preceding years.As part of the ongoing update of this guideline, we present a protocol for 10 systematic literature reviews on pharmaceutical pricing policies to be covered by the updated guideline.MethodsThe systematic literature reviews will be undertaken according to the principles embodied in the Cochrane Handbook and Centre for Reviews and Dissemination. The interventions studied are pharmaceutical pricing policies implemented by public institutions or a group of purchasing organizations/individuals (e.g. health services). Studies reporting price, volume, availability and/or affordability as the primary outcomes will be eligible for inclusion. Studies in any country or jurisdiction, in any language and in any setting published in 2004 or later are eligible. Eligible study designs are randomized and non-randomized trials, and observational studies including cohort studies, panel data analyses, comparative time series design (including interrupted time-series and repeated measures studies), and controlled before-after studies. A list of 21 databases of peer-reviewed and grey literature will be searched, along with supplementary searches of relevant national and international organizational and governmental websites. Risk of bias will be assessed according to the Cochrane Effective Practice and Organisation of Care (EPOC) guidelines. A summary table according to the EPOC Worksheets for preparing a Summary of Findings table (SoF) using GRADE will be provided.DiscussionThe results of the review will be used as part of the update of the WHO Guideline on Country Pharmaceutical Pricing Policies. The current protocol may serve as an example for performing systematic literature reviews to inform policy makers.

PNS41 THE IMPACT OF PROPOSED US FEDERAL PHARMACEUTICAL PRICING POLICIES ON GLOBAL POPULATION HEALTH

To estimate the potential impact of the enactment of various proposed US federal pharmaceutical pricing policies, such as international reference pricing and binding arbitration, on global population health. The Health Economics Medical Innovation Simulation (THEMIS), a Monte Carlo microsimulation, provided estimates of potential changes in new molecules brought to market and quality-adjusted life expectancy after the implementation of binding arbitration and international reference pricing. Based on the literature, 21%-85% reductions in US prices were modeled, resulting in a 9%-36% decrease in US pharmaceutical revenues. A 3.5 elasticity of innovation was utilized in the model to demonstrate how changes in revenue affect innovation and new therapies coming to market. Thus, a 1% decrease in revenue results in a 3.5% decrease in new drugs coming to market. Societal health and quality of life impacts were estimated based on the change in newly marketed therapies and the modeled impact on common chronic diseases. The value of a statistical life year was estimated to be $200,000. If international reference pricing or binding arbitration are implemented by the federal government, the number of new drugs available to patients would decrease by 37%-42% by 2050. For an individual aged 40 to 45 years-old today, implementing these drug pricing policies in the US would decrease life expectancy by approximately 0.9 to 2.5 years. The associated lifetime welfare reductions in health and quality of life — net of drug and medical spending and appropriately monetized — would total $6 trillion-$16 trillion for patients turning 50 before 2080 in the US and Europe. Current drug pricing proposals neglect scientific advances achieved by research and development and their associated population health gains. International reference pricing and binding arbitration may reduce short-term spending, but decrease the rate of pharmaceutical innovation and reduce population health in the US and Europe.

Pharmaceutical pricing policy in Saudi Arabia: findings and implications

Introduction: Many countries have introduced policies and strategies to limit pharmaceutical expenditures. These include pharmaceutical pricing policies and related strategies to control medicine prices and to ensure appropriate and stable prices. The aim of this study was to provide an overview of the current pharmaceutical pricing policy for medicines in Saudi Arabia and to provide an evaluation of the impact of this policy on medicine prices. Methods: A description of the current pharmaceutical policy is presented by reviewing the current official documents and regulations related to pharmaceutical pricing in Saudi Arabia. A price comparison between the original brand medicines and their generic versions was conducted for the top six selling medicines in Saudi Arabia during the period of 2010–2015. Results: The findings showed that Saudi pharmaceutical pricing policy takes into consideration several factors including an international price benchmark, internal price referencing, and the price of the medicine in the country of origin when determining medicine prices. Based on this policy, there were large differences in the prices of generic medicines compared to original brand medicines. The generic medicine to original brand medicine price ratio was 0.87–0.30. However, the price of the first generic medicine was close to the price of original brand medicine, with the first generic medicine-to-original brand medicine price ratio was 0.87–0.81. In this study, there were large differences in the prices of generic medicines for the same molecule. In fact, price ratio among the generic medicines for the same molecule was between 0.96 and 0.18. However, some generic medicines imported from high income countries were cheaper than the medicines manufactured locally or manufactured in other countries in the Middle East. Conclusion: Medicine prices are strictly controlled through the pharmaceutical pricing policy in Saudi Arabia. Overall, the current policy has resulted in significant price differences among medicines, including medicines of the same molecule. Due to this large difference, the cost savings will depend on the product prescribed or procured by the health organization.

Pharmaceutical pricing policies in Qatar and Lebanon: narrative review and document analysis

Pharmaceutical pricing policies in Qatar and Lebanon: narrative review and document analysis

Pharmaceutical Policy Reforms to Regulate Drug Prices in the Asia Pacific Region: The Case of Australia, China, India, Malaysia, New Zealand, and South Korea

Medicine price directly affects affordability and access to medicines particularly in countries where a major portion of pharmaceutical spending is through out-of-pocket payment, such as in the Asia Pacific region. We have undertaken a detailed appraisal of the pharmaceutical policy reforms to regulate drug prices in 3 developed (Australia, New Zealand, and South Korea) and 3 emerging (China, India, and Malaysia) economies of the Asia Pacific region. Despite continuous efforts by the authorities in adopting a wide range of reformatory pharmaceutical pricing policies to ensure affordability of medicines, these policies may not be optimal where drug prices were not lowered as expected (eg, in Korea). On the contrary, considerable price reductions of various pharmaceuticals have been observed in New Zealand and India because of the reform in pharmaceutical pricing policy. This review of pharmaceutical pricing reforms reinforces the need for constant monitoring by policy makers in Asia Pacific countries to regulate drug prices and to undertake reform in pharmaceutical pricing policies when necessary to ensure affordability and access to medicines.

Estimating the economic effects of pharmaceutical reimbursement scheme reform by microsimulation

Estimating the effects of reforms in advance is an important part of evidence-based and transparent legislative processes. The aim of this study was to describe a microsimulation method created to produce ex ante estimates of pharmaceutical pricing and reimbursement policy reforms. As a case example, the estimates for the 2016 pharmaceutical reimbursement scheme reform, including, e.g., the introduction of a €50 annual deductible, are presented. A static microsimulation model was developed based on the reimbursed purchases of 380,931 individuals drawn at random (10% sample) from the prescription register. The 2016 reform was projected to create savings of €44 million/year for the National Health Insurance (NHI). For patients, the median annual out-of-pocket costs increased from €78 to €96 (by +€18). For 97%, the estimated change was less than €50/year. The majority of patients whose out-of-pocket costs increased had relatively low prior costs. However, >€50/year increases predominantly affected patients entitled to higher reimbursements based on chronic or severe illnesses, among whom older and lower-income individuals were overrepresented. Increases of >€100 were rare (0.003%) and derived from exceptional circumstances. The microsimulation produced prompt but versatile estimates of the effects of legislative reforms by factoring in the entire spectrum of individual situations among affected patients.

A systematic review of pharmaceutical pricing policies in developing countries

Objective A systematic review was conducted to summarize government strategies aimed at controlling pharmaceutical prices in developing countries and their effects on relevant outcomes, and to qualitatively analyse eligible studies of pricing policy and their impact on expenditure and medicine prices. Methods Several databases, grey literature and Google Scholar were systematically searched, and reference lists of relevant studies were screened for full-text studies published in Arabic or English between January 2000 and March 2016. Studies describing government pharmaceutical pricing strategies in developing countries and their effect were considered eligible. Key findings Twenty-one studies were included in the explorative synthesis: sixteen covered Asian countries, three covered African countries and three from Latin and South America. Identified policies covered disease-specific and essential medicines with some countries extending it to all medicine classes. Markup regulation (n = 7) was the most commonly used, followed by external reference pricing (n = 6) and cost-plus (n = 5), promotion of generics use (n = 3), while tax exemptions were the least used policy (n = 2). Six of the twenty-one studies were included in the qualitative synthesis. Markup regulation was similarly predominant in this latter synthesis. Although the implemented policies showed a measure of success, medicine prices appeared to be influenced by poor legislative framework, lack of pre-/post-implementation activities and noncompliance by various stakeholders. Conclusion Various internationally recognized pharmaceutical pricing policies are implemented in developing countries; however, these policies are not optimally adopted. Policymakers should tailor the pharmaceutical pricing policy to the nation taking into consideration macro- and microeconomic factors.

Cost analysis study of price variation among the various brands of antiepileptics available in India

Background: One of the major cost that the patient has to bear during therapy is medication cost Different brands of the same mediations are available leading to considerable price variation. This can affect medication compliance by the patient. The present study was undertaken to evaluate the variation in costs of antiepileptic’s available in India.Methods: Cost of all antiepileptics (tablets/capsules) available in India was obtained from CIMS July to Oct 2016 and from IDR Vol XXII issue No 3, 2016. The percentage cos ratio and percentage variation in cost were calculated and compared.Results: The highest cost ratio and percentage price variation was found with carbamazepine 200mg (1:12 and 1100) followed by acetazolamide 250mg (1:11.38 and 1037.68). Other significant cost variations (>100%) were seen with carbamazepine 100mg, phenobarbital 30mg, divalproex sodium 25mg, lorazepam 1mg, clonazepam 1mg and valproic acid 500mg. Lowest percentage cost variation was seen with oxcarbazepine 450mg (1.09), lacosamide 50mg (2.56), pregabalin 50mg (3.51) and zonisamide 50mg (4.21).Conclusions: The Government of India regulates prices of essential drugs through Drug Price Control Order (DPCO) and this is implemented by National Pharmaceutical Pricing Policy (NPPA). However nearly 80% of medications donot fall into this category. This leads to considerable economic burden on poor patients. There is still considerable price difference among various brands of antiepileptic available in India. The Government of India should take a firm decision and implement them with regard to pricing of medications so as to make them more affordable, especially for diseases which require long term treatment such as epilepsy.

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

This article 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 been 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 hospital and offpatent outpatient sectors has been 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.