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

Abstract

IntroductionNew 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 FindingsPublished 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.ConclusionsCurrent prices of these medicines are variable and unafford...

The perverse impact of external reference pricing (ERP): a comparison of orphan drugs affordability in 12 European countries. A call for policy change

“…The same sales trend was seen in 2005 and in 2014 indicating a persistent trend [22]. In the field of infectious disease, in 2016 Iyengar S. et al [23] assessed the affordability of the innovative Hepatitis C treatments sofosbuvir and ledspavir in 30 countries. Results show that central and eastern European countries had higher PPP-adjusted prices, indicating that low to median income countries may be paying relatively higher costs than economically stronger countries [23].…”

“…In the field of infectious disease, in 2016 Iyengar S. et al [23] assessed the affordability of the innovative Hepatitis C treatments sofosbuvir and ledspavir in 30 countries. Results show that central and eastern European countries had higher PPP-adjusted prices, indicating that low to median income countries may be paying relatively higher costs than economically stronger countries [23]. On the contrary, countries with high purchasing power had lower PPP-adjusted prices rendering higher affordability and better access to innovative treatments [23].…”

“…Results show that central and eastern European countries had higher PPP-adjusted prices, indicating that low to median income countries may be paying relatively higher costs than economically stronger countries [23]. On the contrary, countries with high purchasing power had lower PPP-adjusted prices rendering higher affordability and better access to innovative treatments [23]. In 2012, Carone et al noted in their report that drug prices adjusted using GDP per capita were higher in Poland, Romania, and Bulgaria as compared to Germany, Denmark, and Italy [25].…”

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

“…In particular, the proliferation of high-priced medicines has pushed the issue of access to new medicines high on the policy agenda of all European countries, including in high-income economies [1][2][3][4]. At the same time, pharmaceutical spending is rising again, boosted in 2014 by the entry of new hepatitis C treatments [5]. Apart from prices, payers are increasingly concerned that some of these high-priced medicines only deliver limited therapeutic added benefits to patients [6][7][8].…”

Approaches to manage ‘affordability’ of high budget impact medicines in key EU countries

“…Despite a cure rate greater than 95% and despite the therapy being accepted as cost-effective [4], several European health systems were forced to limit budget impact through prescription delays, limits on target patients or caps on revenues. The World Health Organization recently presented a detailed analysis of budget impact of treating patients with hepatitis C with sofosbuvir or ledipasvir/sofosbuvir [5]. Treating just 20% of hepatitis C patients would consume about 20% of annual drug expenditure in Italy and Spain, 6% in England, and 4% in Germany and France.…”