Access barrier to groundbreaking hepatitis C treatments

New medications unveiled in the last two years have revolutionized the treatment of hepatitis C (HCV) drastically improving patients’ chances of a cure. The challenge now is getting these lifesaving medications to those who need them.

Worldwide, 150 million people are chronically infected with hepatitis C and over 700,000 die from HCV-related liver diseases each year, according to the World Hepatitis Alliance. The infection is all too common in people with bleeding disorders. Up to 90 per cent of people with hemophilia who used clotting factor in the 1980s were exposed to HCV through contaminated products. Transmission of the virus remains possible in parts of the world where untreated blood products are still used. Prof. Michael Makris, who leads the European Haemophilia Safety Surveillance (EUHASS) project, reports that hepatitis C has been the leading cause of mortality and adverse events in people with hemophilia across Europe since 2008, when the project began.

Before the first new-generation HCV drug was licensed in late 2013, treatment for hepatitis C was lengthy, riddled with side effects, and had variable success rates – as low as 40 per cent in some cases. Today, with as many as six direct acting antiviral (DAA) products on the market, the vast majority of patients are being cured by interferon-free regimens that take between 12-24 weeks (as opposed to almost 48 weeks), with relatively low side effects. If previously the biggest challenge in HCV was the lack of treatment options, patients today are faced with a very different problem: access. Unfortunately, this is not a new issue for the hemophilia community. As with clotting factor concentrates, the high cost of new HCV medications means the majority of patients cannot access these treatments.

Whereas traditional treatment with a combination of interferon and ribavirin costs somewhere between US$12,000-22,000, new hepatitis C therapies are priced significantly higher at US$65,000-95,000 per course. While no one can argue the cost-effectiveness of the medications, even at these prices, they are still less expensive than paying for the hospitalizations, cancer treatments, liver transplants, and other expenditures that often come with untreated HCV infection. This in turn is still a significant burden for any healthcare system to bear, given the proportion of the population affected by HCV.

As a result, these new medications are simply not available in many countries. In others, access is limited to patients with significant liver disease or end-stage cirrhosis, and in a very select few, treatment is accessible to all HCV patients. “The solution in many European countries has been to prioritize those most in need and then roll out to the other groups,” said Declan Noone of the Irish Haemophilia Society. “With significant competition in the market and price deals being made with the manufacturers, we are now seeing this roll out happen much more quickly than we had anticipated, which is terrific news for patients. Now is the time for patient organizations to work coherently at a national level to advocate for better organization of care and access to treatment.”

The Scottish government made treatment of hepatitis C a priority five years ago and now, they are close to running out of patients to treat. In Canada, all people with hemophilia are entitled to treatment, regardless of their stage of liver disease, under the Hepatitis C settlement agreement. Egypt, which has the highest prevalence rates of hepatitis C in the world, entered into an agreement with one manufacturer to receive their new HCV medication at a discount of 99 per cent of the U.S. price. In turn, over 130,000 patients were treated by 2015. While these cases are not the norm, hemophilia patient organizations can look to these examples as what is possible when advocating for access to these life-saving medications.

What can patient organizations do?

Learn more about the medications that are available, the costs and the challenges related to access.

Gather data about the rate of HCV infection in the bleeding disorder community and their level of access to care.

Set a goal for improving access to treatment and launch an advocacy campaign.

Reach out to hepatitis organizations in your country or region and see if you can work together to reach your common goals.

If patients do have access to new medications, provide education and support to help them prepare for treatment.