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Access to hepatitis C medicines Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV).

There is a global epidemic of hepatitis C, with approximately 185 million people estimated to be infected in 20051 and 350 000 500 000 deaths estimated annually.2 Over 80% of those affected by the disease live in low and middle income countries, especially in central, north and west Africa.3,4 Several middle income countries such as Egypt, Nigeria and Pakistan have a high burden of hepatitis C. HCV is most often spread when infected blood enters the body. High risk populations include intravenous drug users and recipients of blood transfusions in poorly controlled environments;2 but the virus is also found in the general population. There are six genotypes of HCV, with distributions varying by region. It is possible for a person to be infected with multiple genotypes; 55 85% of people will develop chronic infection and about one third of these, if not treated, will eventually develop liver cirrhosis or hepatocellular carcinoma.2 Approximately 80% of newly infected people are asymptomatic, which makes it difficult to diagnose and treat those who go on to develop chronic infection.2 Newly available drugs have revolutionized treatment.5 Previous treatments were poorly tolerated and had limited success. In contrast, the new treatments are easier to administer with shorter course durations and higher cure rates.5 There are significant similarities between the hepatitis C epidemic and the human immunodeficiency virus (HIV) crisis of the late 1990s. Both involve global spread of underdiagnosed disease that can carry significant stigma and cause life long illness and death. In both cases, there are new, effective products that can curb the global epidemic, held back by issues of affordability. The HIV crisis in South Africa resulted in a clash between civil society, government and the pharmaceutical industry,6 which led to the development of new ways of working, most notably with generic medicine manufacturers via licensing arrangements, creating a blueprint for access to medicine strategies for years to come. However, there are also critical differences between the two epidemics that influence how pharmaceutical companies design access strategies. With HIV, the greatest disease burden is situated in lower income countries and concentrated in sub Saharan Africa.7 These countries were not viewed, in the earlier days of the epidemic, as representing market potential. In contrast, HCV is prevalent in some middle income countries.4 Middle income countries, though home to most of the world's poor,8 have growing middle classes,9 representing economic opportunities for pharmaceutical companies. As a result, companies have an incentive to maintain exclusivity and charge higher prices in these markets. This may discourage donor, insurer and government investment in expensive new treatments,10 potentially slowing the adoption of new medicines. Here we identify marketed products, product pipelines and access to medicine strategies of companies that make HCV medicines. We describe companies' plans and activities to support greater access to HCV treatment and set out the criticisms, limitations and opportunities of these approaches. Finally, we present recommendations for companies to consider when developing access to medicine strategies for HCV infected people. We used data from the Access to Medicine Index 201411 and other publicly available sources such as company, patients' organization and nongovernmental organization websites. The access to medicine index is created by the Access to Medicine Foundation, an independent initiative funded by the Bill Melinda Gates Foundation, the Dutch Ministry of Foreign Affairs, the United Kingdom Department for International Development, and the Dutch National Postcode Lottery. The Access to Medicine Foundation engages directly with 20 of the world's largest pharmaceutical companies, requesting data biennially on selected activities via a detailed online questionnaire.12 The data are used to rank the companies in a biennial index. This index uses a set of 95 indicators to assess companies' comparative performance in facilitating access to medicines in poor populations. A limitation of the data is that they are largely self reported by companies. However, the data are reviewed by an external research partner (for the 2014 index, this partner was Sustainalytics, Amsterdam, Netherlands) and the foundation's research team, clarified with companies and verified in some areas with external data sources. The World Health Organization (WHO) released new treatment guidelines for hepatitis C infection in April 2014.1 Given that most patients will not realize they are infected, screening is recommended for high risk groups. In countries with high prevalence and low infection control, screening is recommended for the whole population, if resources allow this.1 However, coach store sale diagnostic capacity is limited in many low and middle income countries.10 The size of the population requiring treatment for hepatitis C is difficult to gauge. As noted, not all of the 185 million people estimated to be infected will progress to coach outlet kentucky chronic infection, and there are no conclusive predictors of disease progression.13 There is currently no vaccine against HCV.1 In higher income countries where treatment is available, all persons diagnosed with chronic HCV infection are typically considered suitable for treatment. In countries where treatment availability is constrained, treatment is prioritized for patients in more advanced stages of the disease. Different treatment regimens are advised depending upon HCV genotype.1 Older HCV treatments comprised combination antiviral therapy with pegylated interferon (weekly injections) and ribavirin (tablet, capsules, or oral solution). Pegylated interferon, which remains on patent in most countries, was added to WHO's essential medicines list in 2013. Ribavirin is off patent and generic versions exist. Two companies (Merck Co, Kenilworth, United States of America (USA) and Roche, Basel, Switzerland) included in the access to medicines index manufacture interferon; one also manufactures ribavirin (Roche). This treatment regime is not widely available, can be poorly tolerated and has undesirable side effects. In Egypt, a 48 week course of peginterferon/ribavirin costs 2000 United States dollars (US$).1 Only 30 50% of people are cured, partly because many patients don't finish treatment.1,2 New antiviral drugs for HCV infection, known as oral directly acting antiviral agent therapies, are now available on the market. They are more effective, safer and better tolerated than existing therapies: 90% of people are cured.14 The therapies are orally administered and have shorter treatment courses (12 24 weeks depending on regimen and genotype),1 which decreases monitoring requirements.5 Five currently marketed therapies were added to WHO's essential medicines list in 2015 (Table 1).15 Table 1. Currently marketed hepatitis C medicines from pharmaceutical companies, 2015html, 6kb Of the 20 companies evaluated in the access to medicines index, six are active in HCV medicine development (AbbVie, Chicago, USA; Bristol Myers Squibb, New York City, USA; Gilead, Foster City, USA; Johnson Johnson, New Brunswick, USA, Merck Co., Roche). All have products on the market and in development. In the US market Merck Co. and Vertex recently discontinued boceprevir and telaprevir respectively, with Merck Co. citing "advancement in treatment practices".16 Boehringer Ingelheim (Ingelheim am Rhein, Germany) ceased engagement in research and development for HCV in June 2014, in view of "multiple drug approvals expected from alternative manufacturers".17 One company that is not included in the access to medicines index (Achillion, New Haven, USA) was identified as active in HCV drug development; Genentech (San Francisco, USA), Kadmon and Medivir AB (Stockholm, Sweden) are also involved in marketing HCV products.18 Table 1 and Fig. 1 show, respectively, currently marketed HCV products (FDA and EMA registrations only) and an overview of products in research and development, up to date at the time of this paper's submission. Table 1 indicates the presence of several new products on the market. Fig. 1 summarizes the progress in development of HCV medicines, with many products in phase III of clinical trials. Future competition may play an important role in enhancing affordability, contingent on the relative efficacy of competitors and how broadly companies choose to register them. Fig. 1. Clinical trial stage of 32 hepatitis C medicines, 2015 For the 2014 access to medicine index, companies were asked to disclose plans for making HCV products available in low and middle income countries. We refer to these as company access strategies. Companies shared information about equitable pricing strategies (which take affordability into account for poor populations), voluntary licensing agreements, donations of products and capacity building initiatives. Johnson Johnson and AbbVie disclosed no coach outlet coupons 20% for 2013 access to medicine strategies. Several new HCV products and access strategies were launched after the period of analysis ended. A summary of the access strategies identified is provided in Table 2. Table 2. Access strategies for hepatitis C medicines, 2015html, 4kb Disclosure of access to medicine strategies for products that were still under development was limited across in house and collaborative projects. This may reflect intense competition in HCV medicines. Only Gilead disclosed access strategies for products under development, having agreed licensing conditions for two products before registration. Access strategies are in place for two newly marketed products: sofosbuvir and ledipasvir (Gilead) and were also in place for boceprevir (Merck Co, now discontinued). Three companies are active in pricing strategies (Gilead, Merck Co. and Roche). Only Gilead is currently actively licensing HCV products. In late 2014, Bristol Myers Squibb announced an intention to engage in both licensing for HCV products and tiered pricing (in which different price points are set depending on the market in which the product is sold).19We have highlighted two key points of entry for pharmaceutical companies to help to address access to HCV medicines. First, affordability: the high prices attached to new medicines may be deterring donors (international or bilateral), health insurers and governments from committing sufficient funds to curbing the epidemic.10 Where drugs are paid for out of pocket, ensuring affordability is also critical. Second, generic manufacturers can scale up and distribute new medicines. Generating sufficient competition among generic manufacturers will place downward pressure on prices. Manufacturers of new HCV medicines will benefit from market exclusivity until around 2025.10 For Gilead, this monopoly has been magnified by the dominance of sofosbuvir. However, this lead will be increasingly challenged as other new entrants compete for market share. This effect is already being seen as prices for sofosbuvir in the United States are being increasingly discounted in the face of competition.20 Companies should develop, with governments, mechanisms for significant price discounting based on rigorous, well researched, transparent assessments of affordability in low and middle income countries, clearly taking account of the needs and abilities of payers and the presence or absence of subsidies. Separate pricing policies within countries can make sound business sense and improve access.21 In middle income country markets with greater economic value to companies, private and public systems can be offered different brands and prices. This is known as market segmentation. Proposed strategies from Gilead for enforcing market segmentation of sofosbuvir requiring patient identification and limited dispensing were criticized for risking confidentiality and adherence.22 For poorer populations, high volume, low cost approaches may prove more profitable: in the United States, Gilead appears to be shifting to a higher volume/lower price model as competition from AbbVie intensifies.23 Gilead initially charged US$ 84 000 for a course of sofosbuvir in the United States. The lowest identified price for that treatment in a developing country was US$ 900 in Egypt.24 These prices are much higher than the drug's production cost, which is US$ 68 to US$ 136 for a 12 week course.25 We were not able to estimate the research and development costs for this drug, and Gilead states publicly that they do not track this expenditure per product.26 High prices may be deterring bilateral, international and national funders from allocating funding at the scale required for the widespread rollout of new HCV treatments. The lessons from scaling up HIV/AIDS medicines have shown that the capacity of generic medicine manufacturers to produce high quality medicines and their knowledge of local regulatory requirements are important for manufacture, distribution and treatment. Equally important is the impact of sufficient competition from generic medicine manufacturers on prices: the average price of a first line adult antiretroviral regimen dropped from US$ 414 per person per year in 2003 to US$ 74 coach outlet handbags and free shipping in 2008.27 Licensing can also make business sense. For example, efficiencies may exist in engagement with generic manufacturers who understand local regulatory requirements well, have an existing network of contacts with developing country governments and regulators and can rapidly scale up production. Manufacturers may derive income from the application of royalties to licence agreements, for example 7% royalties were attached to the licences agreed by Gilead for sofusbuvir.28 To date, Gilead is the only manufacturer of new HCV medicines to have completed agreements with generic medicine manufacturers. The number of manufacturers12 is, arguably sufficient to engender competition and the full agreements have been publicly disclosed.29 Although the scope of the licences appears broad, they do not include key middle income country markets with high HCV burdens, such as Brazil, China, Georgia, Mexico, Thailand and Ukraine.30 Further, it is not yet clear on what scale generic manufacturers will enter the market, nor what discounts will be realized, though NATCO, Hyderabad, India, has disclosed a price of 19 900 Indian rupees for 28 400 mg tablets in Nepal.

31 On a 12 week course of treatment, this equates to approximately US$ 900. So, although Gilead's licensing activities represent leading practice among the companies included in the access to medicine index, this approach has limitations in geographic scope and improvements in affordability are not yet clear. Bristol Myers Squibb has also announced its intention to engage with generic medicine manufacturers, detailing the geographic scope of future licences.


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