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Sovaldi, Harvoni unaffordable in various countries

A global economic analysis of pricing of a 12-week duration of treatment with Sovaldi or Harvoni in 30 countries indicated prices varied according to country wealth and both treatments were unaffordable in many countries, according to new data published in PLoS Medicine.

“In order for countries to increase investment and minimize the burden of hepatitis C, governments and industry stakeholders will need to jointly develop and implement fairer pricing frameworks that deliver lower and more affordable prices,” Swathi Iyengar, of the WHO, Switzerland, and colleagues wrote.

The researchers obtained 2015 pricing for Sovaldi (sofosbuvir, Gilead Sciences) from 26 countries in the Organization for Economic Co-operation and Development (OECD) and four low- to middle-income countries that included Brazil, India, Egypt and Mongolia. Harvoni (sofosbuvir/ledipasvir, Gilead Sciences) prices were obtained from 21 of the 26 OECD countries as well as India, Egypt and Mongolia. All prices were converted from their national currencies to U.S. dollars while adjusting for purchasing power parity. Prices were analyzed and compared with national economic performance and estimated market size, the cost of the drugs and how they related to the countries’ annual total pharmaceutical expenditure and how long a patient would need to work to pay out-of-pocket for treatment with either regimen.

Average annual wages of the OECD from 2014 were combined with International Labor Organization median wage data to determine patient affordability. For the base case analysis, a 23% discount was applied to the prices reported from each country, except counties that had generic licensing agreements or separate pricing arrangements (ie, Brazil, India, Egypt and Mongolia).

Assuming the 23% discount, the median nominal price of sofosbuvir was $42,017 for 12 weeks for all countries in the OECD. The price ranged from $37,729 in Japan and $64,680 in the U.S.

The nominal prices of sofosbuvir were $6,875 in Brazil, $932 in Egypt, $900 in Mongolia and $539 in India.

In countries with stronger purchasing power, purchasing power parity adjustment resulted in lower prices, whereas countries with weaker purchasing power had a significant increase in price with purchasing power parity adjustment. Countries in Central and Eastern Europe had higher purchasing power parity adjustment compared with other countries. For example, sofosbuvir cost $101,063 in Poland and $70,331 in Turkey, and sofosbuvir/ledipasvir cost $118,754 in Poland — these prices were at least 1.09 and 1.63 times higher compared with the U.S. ($64,680 for sofosbuvir, $72,765 for sofosbuvir/ledipasvir).

Treating every person with HCV with either regimen at the adjusted prices with the 23% discount would total at least one-tenth of the current annual total pharmaceutical expenditure across all countries analyzed — 10.5% of total pharmaceutical expenditure in the Netherlands and 190.5% of total pharmaceutical expenditure in Poland.

The price of one duration of treatment with sofosbuvir was the same as 1 year or more of the average wage of individuals in 12 countries — 0.21 in Egypt and 5.28 in Turkey.

These data suggest that in countries where both the prices of the drugs and HCV burden is high, the total cost for treating all patients would be greater than the cost of all other medicines combined.

“These prices threaten the sustainability of health systems in many countries and prevent large-scale provision of treatment,” the researchers wrote.

The researchers acknowledged the study data are limited by the following factors: pricing could be inaccurate as a result of confidentiality agreements between manufacturers and purchasers, the exact number of people with HCV is unknown and other costs associated with treatment for HCV are unknown.

Lower prices would ease countries’ budgets and speed up access to patients, but the budget impact might not be as severe as Iyengar and colleagues suggest, Elliot Marseille, DrPH, MPP, of Health Strategies International, Oakland, Calif., and James G. Khan, MD, MPH, of the Philip R. Lee Institute for health Policy Studies at University of California at San Francisco, state in an accompanying editorial.

“Once the backlog of prevalent cases [of HCV] is treated, the budgetary impact drops dramatically, as only the relatively few incident cases need be treated. Thus, while fiscally disruptive of all HCV-infected persons were immediately put on treatment, that disruption would last only 1 year. … Treating everyone is year 1 is implausible. The process of identifying cases, limits to health system capacity and patient preferences all suggest a multi-year catch-up process [therefore] the fiscal burden expressed as a percent of [total pharmaceutical expenditure] or as a portion of the average annual wage would be much less than the maximum burden as presented in [the] article.”

Iyengar and colleagues concluded: “Without lower prices, countries are unlikely to be able to increase investment to minimize the burden of hepatitis C.” – by Melinda Stevens

Disclosure: Iyengar reports no relevant financial disclosures. Please see the study for all other researchers’ relevant financial disclosures. Marseille and Kahn report no relevant financial disclosures.