WHO-Led Study: Hepatitis C Treatment Unaffordable Globally, Threatens Health Systems

According to a new study by experts at the World Health Organization, prices of hepatitis C treatments are unaffordable globally and put a major strain on national health systems. Hepatitis C can cause liver cirrhosis and cancer, and with an estimated 80 million people affected in the world, if untreated, the sickness could lead to 700,000 deaths per year worldwide, the study said, suggesting that governments and industry stakeholders should develop and implement fair pricing frameworks.

New hepatitis C virus medicines have “markedly improved treatment efficacy and regimen tolerability. However their high prices have limited access, prompting wide debate about fair and affordable prices,” the study [pdf] said. The study was published open access on PLOS.

The authors of the study are: Swathi Iyengar, Kiu Tay-Teo, Sabine Vogler, Peter Beyer, Stefan Wiktor, Kees de Joncheere, and Suzanne Hill. All are listed as officials at the WHO except Vogler, who is at the WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Health Economics Department, Gesundheit Österreich GmbH, Vienna, Austria.

The study compares the price and affordability of sofosbuvir, and ledipasvir/sofosbuvir across 30 countries, assessing affordability to health systems and patients.

Sofosbuvir belongs to Gilead Sciences.

The authors found that “the median nominal ex-factory price of a 12-week course of sofosbuvir across 26 OECD countries was US$42,017, ranging from US$37,729 in Japan to US$64,680 in the US [United States.]” The initial published list price in the US for a 12 week course of treatment with sofosbuvir andledipasvir/sofosbuvir were US$84,000 and US$94,500, respectively.

According to the study, “The manufacturer claimed the new regimen was equal to or less expensive than prior standard of care regimens because the new regimen had much higher cure rates and would reduce the total treatment costs of HCV, including the costs of medications, side effects, complications, and additional health services required.”

Another recent study estimated the cost of production of sofosbuvir to be US$68-US$136 for a 12 week course of treatment, “based on the same manufacturing methods used in the large-scale generic production of HIV/AIDS medicines,” the authors said, adding that the findings of this study have not been challenged.

The study underlines that tiered pricing agreements have been negotiated with some low- and middle-income countries, and voluntary licensing agreements established with 11 India-based generic pharmaceutical manufacturers to produce and distribute sofosbuvir in 101 countries. However, the licence does not cover 39 middle-income countries, including Brazil, China, Mexico and Turkey, the report says, while it is suggested that 73 percent of people with chronic hepatitis live in middle-income countries.

In their research, the authors said they found no observable relationship between the purchasing power parity (PPP)-adjusted price and potential market size.

For example, according to the study, Nordic countries had fewer people requiring treatment and had higher GDP per capita than countries such as Japan, Italy and Spain, but the PPP-adjusted prices of both medicines were much lower. “Although the GDP per capita in Turkey was only about $3,000 higher than in Brazil, the PPP-adjusted price of sofosbuvir in Turkey (PPP $70,331) was 7.2-fold higher than in Brazil (PPP $9,708).”

For countries, the budget impact estimates vary from PPP US$100.9 million (in Luxembourg) to PPP US$166.6 billion in the United States. Those numbers do not include the costs of diagnostic testing, other medicines, or other associated health service costs, the authors said.

For individuals having to pay out of pocket, the medicines would be virtually impossible to buy, they said, as the PPP-adjusted price of a full course of sofosbuvir would be equivalent to at least one year of the PPP-adjusted average earnings for individuals in 12 of the 30 countries analysed.

The report notes that some patients in high-income countries have been reported to import sofosbuvir at lower prices or even devise plan to receive treatment in India.