No developing countries have so far come forward to buy massively discounted hepatitis C drugs to treat their populations. The Global Procurement Fund, created this year to provide discounted medications by the Center for Disease Analysis Foundation (CDAF), Louisville, CO, USA, appealed on this year’s World Hepatitis Day for countries to step up to mark and commit to buying these live-saving drugs.
Some 70 million people worldwide have chronic hepatitis C infection, which if left untreated can cause extensive liver damage, cancer, and death. Since their introduction in 2014, directly acting antiviral (DAA) drugs have transformed the hepatitis C landscape.
A disease which previously needed long-term treatment with interferon-based regimens (with ghastly side effects and no guarantee of cure) can now be cured with a short course of oral DAAs with few or no side effects. However, much of this breakthrough has been overshadowed by the debate around the prices of these therapies.
“It has always been assumed that price was the primary hurdle stopping developing countries accessing these drugs,” says Dr. Homie Razavi, the managing director CDAF. “However, despite us negotiating prices as low as US$50 for a bottle of 28 tablets of Sofosbuvir, no developing country has yet placed an order through the fund.”
High-income countries have a variety of mechanisms in place to pay for DAAs. The cost of these drugs varies depending on the country, for example, the range is $17,000 – $35,000 per patient (depending on the purchasing agency) in the USA and $10,000 – $30,000 per patient (depending on the drug) in the UK. However, competition in low and middle-income countries is significantly lower with only half of the companies producing these new therapies participating in these markets.
Leading manufacturer Gilead and Bristol-Myers Squibb have provided licenses to the generic manufacturers that can provide generic copies of their products in over 100 low and middle-income countries. These countries account for over 60% of HCV infections globally. However, this strategy did not always result in the desired outcome. In several markets, including Pakistan, Gilead was forced to register and launch its own generic copies at a lower price to force its licensees to lower their prices. In addition, small countries like Kiribati, an Island nation in the Pacific Ocean, could not negotiate low prices for the generic drugs due to the small order size.
CDAF launched the Global Procurement Fund launched in April 2017. The foundation, which is funded by private donors, has been working with over 85 countries to help develop national hepatitis plans. Two years ago, it launched the Polaris Observatory, which keeps track of how many individuals are infected with hepatitis C and B and how many are treated and diagnosed. It works with a network of more than 500 experts across the globe to gather up-to-date information.
Costs were an issue for generic companies because they have to apply for registration in each country, which can take a year or more to approve, and most countries require their own labels and packaging. These costs are often the same if the country is going to order enough medicine for 1,000 patients or 100,000 patients. In addition, receiving payments can be an issue with smaller countries and manufacturers don’t know when, if ever, they will get paid. “After meeting with all concerned parties, a key recommendation was to develop a procurement fund that takes orders from multiple countries, so the order size is attractive to generic companies, and guarantees timely payment. In return, they would provide lower negotiated prices,” explains Dr Razavi.
Right now, the fund has been able to negotiate a price of $50 for a bottle of Sofosbuvir and $35 for a bottle of daclatasvir. Combined, the two-drug combination can be used to treat nearly all hepatitis C genotypes for a total cost of less than $260 per patient. This is much less than the cost most developing countries can negotiate on their own.
“A big barrier has been to get over the expectation of donor funded programs. The HIV, tuberculosis, and malaria programs have left many developing countries with the expectation that donors from high-income countries will now pay for the roll-out of the hepatitis programs,” says Dr. Razavi.
He adds: “The big difference between GPRO and previous initiatives is that we expect the national governments to pay for purchases in the public health sector. We are working on lining up funds to help with the upfront financing and currency exchange risk, but at the end of the day, the national governments are expected to pay and this has not been easy for many countries. There is an expectation that if they wait long enough, donors will come forward to support hepatitis programs. While this continues, many thousands of patients with hepatitis C worldwide will progress to more serious liver disease, liver cancer, and death.”
He concludes: “We are trying to make it as easy as possible for low and middle-income countries to provide access to HCV treatment and diagnostics but we need the countries take that first step of signing up and committing funds.”
“Globally, little more than 1% of people have access to life-saving hepatitis C medicines and if things remain the same it will take 100 years to cure everybody,” says Raquel Peck, CEO of the World Hepatitis Alliance, London, UK.
“Pooled procurement mechanisms offer the ability to buy medicines and drugs in much bigger quantities leading to a massive scale up in testing and treatment, whilst driving down prices. It’s a win-win.”