Patent Profits and the Global Burden of Curing Hep-C

Sofosbuvir, a single drug to treat hepatitis C viremia, has been hailed as a "milestone" because of its efficacy. But as two charts show, what could be the point if its cost is prohibitive?

Just some pills. Credit: naturegeak/Flickr, CC BY 2.0

Credit: naturegeak/Flickr, CC BY 2.0

Modern medicines are ubiquitously judged by two attributes: their efficacy and their prices. By the former measure alone, more people can live longer today than most people ever did. However, the cost can be punishing, putting lifesaving medication out of the hands of those who could most use it.

A case in point: 64-103 million people around the world are afflicted by hepatitis C viremia (HCV), a condition where the hepatitis C virus has entered the bloodstream and is able to infect the rest of the body. Some 700,000 deaths occur every year on its account. According to a March 2014 study, 85% of the 150 million people with chronic HCV live in low- and middle-income countries. A recent development on this front was of the drug sofosbuvir, approved for sale in the US in late 2013. Its significance is simply understood. Before sofosbuvir, HCV patients were recommended a 24-48 week course of pegylated interferons (a combination of three drugs) and ribavirin. On the other hand, a 12-week course of orally ingested sofosbuvir, once daily, has the same effect. On the downside, a 12-week course costs $84,000 in the US.

A study published in the journal PLOS Medicine on May 31, 2016, puts these numbers in perspective.

In India, only generic forms of sofosbuvir are sold, and their prices have been negotiated with its manufacturer, Gilead, down to market prices of Rs.10,000-20,000 per 28 tablets or Rs.38,000 for a 12-week course. The authors of the PLOS Medicine study explain their assumption of a 50% rebate: “There are confidential agreements between manufacturers and insurance agencies/reimbursement organisations, leading to the published prices being higher than the actual prices. We applied a 23% price reduction to estimate the impact of this uncertainty and undertook a sensitivity analysis using a 50% price reduction.”

Such costs have raised eyebrows because, as Médecins Sans Frontières estimated in May 2015, 50 middle-income countries are still excluded from Gilead’s voluntary license to sell sofosbuvir at a lower cost (even if 91 countries are within the license’s coverage). Moreover, some researchers have estimated that sofosbuvir prices could have been marked up by 61,000% – a number that has gone uncontested, and is sure to kick up dust in countries where the total cost of curing HCV in the entire (affected) population is at par with the respective current national pharmaceutical budget, or even exceeds it in some cases.