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.
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.
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.
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.
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.
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.
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.
Tough decisions on essential medicines in 2015 Magrini, Nicola; Robertson, Jane; Forte, Gilles ...
Bulletin of the World Health Organization,
04/2015, Letnik:
93, Številka:
4
Journal Article
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Odprti dostop
In 1977, the World Health Organization (WHO) published its first Model List of Essential Medicines. This year, the Expert Committee for the Selection and Use of Medicines will consider requests to ...include high-cost medicines for cancer, hepatitis C, multidrug-resistant tuberculosis and new oral anticoagulants on the model list. Previous expert committees have recognized the message that comes with identifying a medicine as essential. In 2013, the expert committee defined public health relevance to encompass overall incidence and prevalence of diseases as well as diseases that are specific to certain regions and diseases that are uncommon but for which there are effective medicines. Two novel agents against tuberculosis, bedaquiline and delamanid, achieved regulatory approval based on promising, though limited, data from clinical trials. The model list uses a classification of core and complementary medicines. This does not imply that only core medicines should be procured by the public system, while complementary medicines are optional.
Barbui and Purgato have critiqued the processes used to select WHO's list of essential medicines and provided suggestions on how it could be improved. 1 As mentioned, reforms in 2001 substantially ...changed the way that the expert committee reviews submissions, introducing systematic evidence synthesis and appraisal as a requirement, along with an assessment of comparative cost and cost effectiveness.
Abstract Background Previous studies have suggested that medicines prices in Europe converge over time as a result of policy measures such as external price referencing. Objective To explore whether ...ex-factory prices of on-patented medicines in Western European countries have converged over a recent period of time. Methods Prices of ten on-patent medicines in five years (2007, 2008, 2010, 2011, 2012) of 15 European countries were analyzed. The unit of analysis was the ex-factory price in Euro per defined daily dose (exchange rate indexed to 2007). A score (deviation from the average price) per country as well as the ranges were calculated for all medicines. Results The prices between countries and selected products varied to a great extent from as low as an average price of € 1.3/DDD for sitagliptin in 2010–2012 to an average of € 221.5/DDD for alemtuzumab in 2011. Between 2008 and 2012, a price divergence was seen which was fully driven by two countries, Germany (up to 27% more expensive than the average) and Greece (up to 32% cheaper than the average). All other countries had stable prices and centered around the country average. Prices of less expensive as well as expensive medicines remained relatively stable or decreased over time, while only the price of sirolimus relatively increased. Conclusions Our study period included the time of the recession and several pricing policy measures may have affected the prices of medicines. Instead of the expected price convergence we observed a price divergence driven by price changes in only two of the 15 countries. All other European countries remained stable around the country average. Further research is needed to expand the study to a bigger sample size, and include prescribing data and Eastern European countries.
Cost-effectiveness thresholds: pros and cons Bertram, Melanie Y; Lauer, Jeremy A; De Joncheere, Kees ...
Bulletin of the World Health Organization,
12/2016, Letnik:
94, Številka:
12
Journal Article
Recenzirano
Odprti dostop
Cost-effectiveness analysis is used to compare the costs and outcomes of alternative policy options. Each resulting cost-effectiveness ratio represents the magnitude of additional health gained per ...additional unit of resources spent. Cost-effectiveness thresholds allow cost-effectiveness ratios that represent good or very good value for money to be identified. In 2001, the World Health Organization's Commission on Macroeconomics in Health suggested cost-effectiveness thresholds based on multiples of a country's per-capita gross domestic product (GDP). In some contexts, in choosing which health interventions to fund and which not to fund, these thresholds have been used as decision rules. However, experience with the use of such GDP-based thresholds in decision-making processes at country level shows them to lack country specificity and this - in addition to uncertainty in the modelled cost-effectiveness ratios - can lead to the wrong decision on how to spend health-care resources. Cost-effectiveness information should be used alongside other considerations - e.g. budget impact and feasibility considerations - in a transparent decision-making process, rather than in isolation based on a single threshold value. Although cost-effectiveness ratios are undoubtedly informative in assessing value for money, countries should be encouraged to develop a context-specific process for decision-making that is supported by legislation, has stakeholder buy-in, for example the involvement of civil society organizations and patient groups, and is transparent, consistent and fair.
Highlights • Over 550 pharmaceutical measures were surveyed in 32 European countries (2010–2015). • Most frequent measures were price reductions and changes in co-payments. • Countries strongly hit ...by the crisis tended to make more policy changes. • Less than a quarter of the pharmaceutical policies were pure austerity measures. • The international experience supports policy-makers in their choices of policy options.
Access to medicines is key to achieving universal health coverage (UHC); however, such access can be hindered by unaffordable prices. A good example of improvement in access to medicines is treatment ...for human immunodeficiency virus (HIV) infection. Global coverage was very low in 2000, with only 611 000 people receiving treatment; however, in 2017, 21.7 million people were on treatment. This increase was partly due to access to affordable, quality-assured generic HIV medicines in low- and middle-income countries.One way to achieve better access to new medicines is patent pools, which allow third parties to acquire nonexclusive licences for the intellectual property needed to develop products. While patent pools have existed for several decades in other fields of technology, such as in digital technologies, they are a relatively new concept in public health, where they have been applied to address some of the access challenges in low- and middle-income countries.To improve access to antiretroviral treatment in low- and middle-income countries, Unitaid established the Medicines Patent Pool in 2010 as the first public health patent pool.
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.
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