WHO Guidelines May Help With Price Reductions For Hepatitis C Drugs 09/04/2014 by Julia Fraser for Intellectual Property Watch 1 Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)Guidelines for the treatment of hepatitis C released by the World Health Organization today recommend revolutionary new drugs for the virus. However, the exorbitant price of these drugs means they will remain out of reach for most of the millions infected. The WHO guidelines themselves offer limited recommendation for reducing prices, but may help in creating the conditions for price reduction by accruing demand and giving countries official backing in price negotiations. “WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection” were presented at a press conference at the United Nations in Geneva on 8 April. Presenting were Stefan Wiktor, team lead for the WHO’s Global Hepatitis Programme, Peter Beyer, senior advisor for the WHO’s Department for Essential Medicines and Health Products, and Andrew Ball, senior advisor for policy, strategy and equity in WHO’s Department of HIV/AIDS. The full text of the guidelines is available here. Some 130-150 million people are infected globally with the hepatitis C virus (HCV), which often causes related liver diseases including liver cancer and cirrhosis, from which 350,000 to 500,00 people die every year. The guidelines provide recommendations on screening for HCV infection, mitigating liver damage, care of people infected with the virus, treatment and prevention. “They are intended for policy-makers, government officials, and others working in low- and middle-income countries who are developing programmes for the screening, care and treatment of persons with HCV infection,” it says. The virus can be cured with antiviral treatment with a success rate ranging from 50 percent of persons treated with older treatments, to 90% treated using the newest drugs on the market. The most affected regions, according to the WHO, are Central and East Asia and North Africa. Egypt has the highest prevalence of the virus, explained Wiktor, following a past campaign to eradicate schistosomiasis in the country that spread the virus through inadequate sterilization of syringes and needles. Treatment Possibilities, but Access Hindered by Prices Two new drugs for HCV have recently been approved for the virus. The latest one, sofosbuvir, was only approved in December 2013 in the US, and in January 2014 by the European approval authorities. This drug, made by Gilead, is strongly recommended by the guidelines, but “without taking resource into consideration, as pricing information was not available.” Other medicines are currently being developed in the pipeline for release in the next few years. “The recent registration of new, safer and more effective oral hepatitis medicines is a game-changer in hepatitis C treatment,” said the WHO. “Much needs to be done to ensure that these advances lead to greater access to treatment globally.” Older treatments involved a 48-week programme of injections with toxic side effects. This has now been reduced to a 12-week programme, some without the need for injections, and is much safer. Despite this progress, “most people are not receiving treatment,” said Wiktor. Only about 2-3 percent of people who need to be treated get treatment in high-income countries. France has the highest level of treatment at only 6 percent due to a national programme. The data is not known for lower- and middle-income countries, but he said it is “much lower… it’s nothing.” Wiktor puts this down to lack of awareness about the virus, in both civil society and among health workers, expensive laboratory testing and an absence of adequate equipment, among others. Often the infection remains undiagnosed, meaning that a major part of the reason that so few people are treated is because they are unaware that they are infected. But another significant factor is the cost of the medicines on offer. Beyer pointed to page 22 of the guidelines to the section titled “price of medicines.” The current price of sofosbuvir, currently set at $84,000 in the US for a 12-week treatment course, means that “these treatments will remain unaffordable for most persons,” according to the guidelines. According to a statement released by Médecins Sans Frontières (MSF, Doctors without Borders) today, “a study by researchers at Liverpool University however has found that a twelve-week course of sofosbuvir could cost as low as $68-$136.” When asked how companies can justify the high prices, Beyer said, “different perspectives depending on where you come from can define price levels.” Companies, for example, may compare the price of treatment with the even higher price of a liver transplant, or may take into account research costs. Beyer compared the situation to that of HIV/AIDS in 2000, where the prices of drugs on the market were very high, while production costs where very low. Since then there has been a dramatic decrease in price and now 10 million people with HIV are on treatment. “Competition with generic producers, mainly situated in India, were driving price down towards marginal production costs plus benefit. And also the market size really increased” creating huge economies of scale, he said. “With patent barriers on new oral drugs to treat hepatitis C in developing countries, the high price of new treatment could squander the opportunity governments now have to scale up diagnosis and treatment for the disease,” warned MSF. “At these prices, access in middle-income countries – where 75% of the world’s poor actually live – is likely to be extremely limited.” Hope for Price Reductions “Hepatitis C treatment is currently unaffordable to most patients in need. The challenge now is to ensure that everyone who needs these drugs can access them,” said Beyer. “Experience has shown that a multi-pronged strategy is required to improve access to treatment, including creating demand for treatment.” The hepatitis treatment guidelines, he said, “are the first piece of the puzzle.” Ball added that a major role of the guidelines is that it “gives WHO’s clear approval and advocates for countries to actually start treating people.” It also plays a part in stimulating demand. “Greater awareness on the risks associated with hepatitis C should lead to a demand for services and expansion of laboratory capacity and clinical services so that more people can be tested, treated and cured,” said Ball. Beyer also added that the WHO will provide support to countries wanting to introduce the new treatments. At the beginning of the year, the WHO spoke with the national hepatitis task force in Egypt about “how to treat patients, how to scale up treatment and how also to make this new drug, sofosbuvir, affordable.” The Egyptian minister of health recently announced that it has managed to negotiate prices down to $900 for the 12-week course, “a huge difference to the US price.” Egypt has now treated over 300,00 people, which is a “huge amount in a country with very limited resources” said Ball. “If Egypt can do it, we need to learn from that experience…. This is what we’re aiming for: giving guidance which is appropriate for those settings where resources are severely limited and looking at treatment at a large scale.” Ball said the guidelines will help countries develop policies. The WHO will look at putting drugs such as sofosbuvir on the essential medicines list, which often plays a big part when countries negotiate prices with pharmaceutical companies. The guidelines will also help in increasing demand as “unless guidelines are out there, countries won’t take up very expensive treatments.” Beyer predicts that alternative treatments currently in the pipeline will generate further competition when they come to the market, reducing prices. The “multi-pronged” approach recommended by the guidelines also includes the use of both voluntary and compulsory licencing. Beyer emphasised that the compulsory licence is a right that countries have anyway under the World Trade Organization agreements that has been used to access HIV and cancer drugs. Whether public health emergency is a requirement to use such a licence depends on national law, and is not a requirement under the WTO rules, he said. He also added that the guidelines could be used to provide countries with better arguments when defending their right to issue compulsory licences for these select drugs when they face political pressure. Leena Menghaney, India manager for MSF’s Access Campaign said in a statement, “Already, civil society groups have filed patent oppositions in India to ensure affordability and generic production; with 12 million people estimated to be infected with chronic hepatitis C in India, there’s a lot at stake.” The guidelines recommend a collaborative approach between all stakeholders – governments and pharmaceutical companies included – to help ensure that the treatments are affordable and accessible to all those infected. The official launch of the guidelines is taking place at the International Liver Congress in London, tomorrow, 10 April. Julia Fraser is an intern at Intellectual Property Watch. She is currently training to be a solicitor and will start work at an international law firm in London in 2015. She has a BSc Honours in Biology from Edinburgh University where she developed an interest in public health related intellectual property issues. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related Julia Fraser may be reached at email@example.com."WHO Guidelines May Help With Price Reductions For Hepatitis C Drugs" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.