A New Reimbursement System for Innovative Pharmaceuticals Combining Value-Based and Free Market Pricing (original) (raw)
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Reimbursement of pharmaceuticals: reference pricing versus health technology assessment
The European Journal of Health Economics, 2011
Reference pricing and health technology assessment are policies commonly applied in order to obtain more value for money from pharmaceuticals. This study focussed on decisions about the initial price and reimbursement status of innovative drugs and discussed the consequences for market access and cost. Four countries were studied: Germany, The Netherlands, Sweden and the United Kingdom. These countries have operated one, or both, of the two policies at certain points in time, sometimes in parallel. Drugs in four groups were considered: cholesterol-lowering agents, insulin analogues, biologic drugs for rheumatoid arthritis and ''atypical'' drugs for schizophrenia. Compared with HTA, reference pricing is a relatively blunt instrument for obtaining value for money from pharmaceuticals. Thus, its role in making reimbursement decisions should be limited to drugs which are therapeutically equivalent. HTA is a superior strategy for obtaining value for money because it addresses not only price but also the appropriate indications for the use of the drug and the relation between additional value and additional costs. However, given the relatively higher costs of conducting HTAs, the most efficient approach might be a combination of both policies.
Journal of Pharmaceutical Policy and Practice, 2021
Background Advanced therapy medicinal products (ATMPs) represent an important cornerstone for innovation in healthcare. However, uncertainty on the value, the high average cost per patient and their one-shot nature has raised a debate on their assessment and appraisal process for pricing and reimbursement (P&R) purposes. This debate led experts providing for recommendations on this topic. Our primary objective is to investigate the ATMPs P&R process in the main five European countries and to understand if this process is consistent with published P&R expert recommendations. We also investigated the current ATMP pipelines to understand if future ATMPs will create challenges for their P&R process. Methods P&R framework for ATMPs in the European Major five (EU5) countries was investigated through a literature search on PubMed, institutional websites of National Health Authorities and grey literature. The ATMPs pipeline database was populated from a clinical trial database (clinicaltria...
The costs and benefits of regulations for reimbursement of new drugs
Health Policy, 2006
Introduction: An increasing regulation for pricing and reimbursement decisions is associated with both costs and benefits. One potential cost is a delayed introduction of drugs on the market. The objective of this study was to discuss and analyse the time lag between drug authorisation and reimbursement for new chemical entities (NCEs) in Sweden and Finland. Materials and methods: The study was based on a sample of 242 NCE drugs, authorised by the regulatory authorities in Sweden or Finland between January 1995 and April 2003. Data on authorisation dates, reimbursement dates, capacity of manufacturing companies, requirements for economic evaluations by reimbursement authorities, anatomic therapeutic classification, therapeutic value and sale statistics were collected for the drugs. A hypothesis, saying that the lag is affected by the increasing regulation associated with the introduction of formal requirements for cost-effectiveness information for pricing and reimbursement decisions, was tested. Results: One hundred and thirty-eight of the 242 drugs included in the analyses were reimbursed in Sweden and 104 in Finland. The total mean lag time was 175 days, and the mean lag times in Sweden and Finland were 114 and 256 days, respectively. Regression analysis demonstrated that drugs with low sale and drugs from companies with large capacity of introducing new drugs were associated with a longer and shorter lag times, respectively. The results also demonstrated that authorisation during first year after introduction of requirement for cost-effectiveness information was associated with an increased lag time. Discussion: The results demonstrated that there are considerable time lags between authorisation and reimbursement of new drugs, both in Sweden and Finland. The results further indicated that an increased regulation for reimbursement by introducing requirements for cost-effectiveness information is associated with an increased time lag, at least for drugs authorised early after introduction of the new requirements. It is therefore important to further discuss the costs and benefits of an increased regulation for reimbursement, in order to find the optimal regulatory requirements.
Fair Pricing of Innovative Medicines: An EHA Position Paper
HemaSphere, 2020
High prices keep innovative medicines out of reach for many patients across Europe, resulting in growing inequalities in accessibility and standards of care. Budgetary pressures compel payers and insurers to make increasingly difficult choices, at the expense of patients and investment in innovation. Costly new therapies become available only for the lucky few-or for no one in those countries that lack the purchasing power or are left out of manufacturers' marketing strategies altogether. With expensive combination therapies adding to the problem, the potential of scientific and medical innovation remains underused, not least in hematology. By severely limiting the uptake of novel gene and cell therapies, high prices are undercutting efforts to increase, personalize and optimize treatment options for patients suffering from blood disorders. 1 Causes High prices result from a complex set of interrelated factors. Causes can roughly be divided into three categories: Business models Manufacturers are primarily driven by the need to recoup the costs of research and development-of products that eventually make it onto the market and of those that don't-and by a desire to offer substantial return on investment to investors. In a system that rewards patent rights with market exclusivity and which obscures R&D costs, price-setting and profit levels, bringing a profitable drug to market continues to be the main incentive, not the patient and public interest. Market access The authorization of drugs for the European market is based exclusively on criteria of safety and efficacy. As long as these are not supplemented by affordability, added-value and quality-of-life criteria, profit-driven development will prevail over models that put the patient and public interest first. Pricing and reimbursement Decision-making by public payers and insurers is done at the national level, based on different models and methodologies, rather than at the European level in a harmonized, concerted manner. Similarly, price negotiations with pharmaceutical companies are conducted by national governments and in secrecy, instead of collectively and transparently. This fragmentation has negative consequences for overall price levels, (widely disparate) accessibility for patients, value for (taxpayers') money and the sustainability of health systems. The challenge The overall picture is one of imbalance between public and private interests all along the research-to-market development chain. 2 Too often, rewarding (commercial) innovation and investors prevails over the need to ensure access and affordability for patients and health systems.
Health research policy and systems / BioMed Central, 2015
Coverage decisions determining the benefit baskets of health systems have been increasingly relying on evidence regarding patient benefit and costs. Relevant structures, methodologies, and processes have especially been established for pharmaceuticals but approaches differ. The objective of this work was thus to identify institutions in a broad range of European countries (n = 36) in charge of determining the value of pharmaceuticals for pricing and reimbursement purposes and to map their decision-making process; to examine the different approaches and consider national and supranational possibilities for best practice. Institutions were identified through websites of international networks, ministries, and published literature. Details on institutional practices were supplemented with information from institution websites and linked online sources. The type and extent of information available varied considerably across countries. Different types of public regulatory bodies are invo...
European prices of newly launched reimbursable pharmaceuticals – a pilot study
Health Policy, 2005
High prices of new pharmaceuticals play an important part in rapidly rising pharmaceutical costs. Many countries try to curb these rising costs through control of the price of reimbursable medicines. There is, however, little internationally comparable information on prices. This study aimed to examine the prices of new, reimbursable pharmaceuticals in the EU member states. Price data were collected from eight products authorised by the EC in 2000. The prices of these products varied considerably. Wholesale prices were highest in those countries where manufacturers are free to set the prices of their products. Pharmacy margins and taxes, however, change the ranking of the most expensive or the cheapest countries.
Economic Evaluation for Pricing and Reimbursement of New Drugs in Spain: Fable or Desideratum?
Value in Health, 2020
Background: The economic evaluation of healthcare technologies has become in many countries a basic tool for reimbursement, pricing and purchasing decisions. Objective: The objective of this article is to examine the institutional, legal, and political factors that have impeded the application of economic evaluation and the criterion of efficiency in the process of pricing and reimbursement of new medicines in Spain. Methods: Narrative description of the current institutional framework for the use of economic evaluation in pricing and reimbursement in Spain, legal and policy framework in the field of evaluation of new medicines, and stakeholder initiatives and policies related to the use of economic evaluation outside of the pricing and reimbursement process. Results: Spain has an institutional framework created and established over the last years that could have facilitated a formal use of economic evaluation in the process of pricing and reimbursement. Nevertheless, the real use of economic evaluation at the central or regional level is still unknown, although application of the efficiency criterion, linking to cost-effectiveness, has been clearly required by Spanish laws and regulations at the national level. We highlight a certain degree of moral hazard from the central government that is not directly responsible for the budget impact of reimbursement and pricing decisions. There are currently a number of ongoing initiatives in the field of economic evaluation by various agents, but they remain uncoordinated. Conclusions: Poor governance at the highest level of decision making is the main reason for the lack of interest in economic evaluation. A profound political change, supported by transparency and accountability, is required before the criterion of efficiency can be fully considered in the process of pricing and reimbursement of new medicines in Spain.
Journal of Pharmaceutical Policy and Practice, 2019
methodological design in EPR [13]. As long as no concrete or welldefined solution to the medicines access challenge is implemented, a well-designed mix of existing and further developed policies is the next best option. These policies need to be tailored to the different types of medicines and to the country context. Despite their limitations, adequate pricing and reimbursement policies offer value in promoting equitable access to affordable medicines. Advanced methodologies and new evidence, including work presented at the 2019 PPRI Conference, should be considered. Pharmaceutical systems research at the interface of diagnosis and action In this respect, pharmaceutical systems research (PSR) can make a valuable contribution. PSR is a new discipline that derives from health systems research. Through descriptive case studies, it addresses topics such as the organisation and funding of pharmaceutical systems, policies (e.g. related to pricing, reimbursement, distribution and rational use of medicines), actors (e.g. authorities, stakeholders) and implementation procedures. Comparative crosscountry studies, either descriptive or analytic, help improve the pharmaceutical systems of different settings, in terms of affordability, efficiency and quality [14]. Finally, impact evaluations study the effects of policy implementation; using a pharmaceutical system lens can augment the policy relevance of these evaluations. In fact, PSR is a policy-supporting area of science that can support to work on solutions or, at least, improvements in the pharmaceutical policy framework of individual countries and globally. Fixing the future Is it sufficient to have debates, policy papers, scientific evaluation, methodology advancement, crosscountry best practices learnings and exchange experiences to improve pricing and reimbursement policies in Europe and other regions? Each of these pathways taken by policy-makers, payers, researchers and/or stakeholders offers value. Nonetheless, we need a combination of all to arrive from a thorough diagnosis to sustainable impact: we need wise and transparent policy-making, robust and multidisciplinary science, critical assessment of existing policies and tools as well as frank and indepth discussions. The 2019 PPRI Conference makes a significant contribution to providing a platform for these activities that are critical to promote equitable access to affordable medicines.
Background: The launch of hepatitis C (HCV) drugs such as sofosbuvir or ledipasvir has fostered the question of affordability of novel high budget impact therapies even in countries with high domestic product. European countries have developed a variety of mechanisms to improve affordability of such therapies, including 'affordability thresholds', price volume agreements or caps on individual product sales, and special budgets for innovative drugs. While some of these mechanisms may help limit budget impact, there are still significant progresses to be made in the definition and implementation of approaches to ensure affordability, especially in health systems where the growth potential in drug spending and/or in the patient contribution to health insurance are limited. Objectives: In this article, we will review how seven countries in western Europe are approaching the question of affordability of novel therapies and are developing approaches to continue to reward new sciences while limiting budget impact. We will also discuss the question of affordability of cost-effective but hugely expensive therapies and the implications for payers and for the pharmaceutical industry. Results: There is clearly not one solution that is used consistently across countries but rather a number of 'tools' that are combined differently in each country. This illustrates the difficulty of managing affordability within different legal frameworks and within different health care system architectures.