The purpose of this report was to investigate the situation regarding access to drugs treating the hepatitis C virus (HCV) in Russia. To this end, Treatment Preparedness Coalition made an overview of the applicable legislation, and likewise analyzed the data relating to governmental drug procurements, statistics on the prevalence and incidence of hepatitis C in various territories of the Russian Federation, and data regarding the financing of HCV treatment programs.
- Background information
- The HCV epidemic and financial measures for fighting the epidemic in RF territories
- Procurement of pegylated interferons
- Antiviral drug procurements
- Patient community action
- Conclusions and recommendations
Data analysis shows that in conditions of a large-scale HCV epidemic in the RF — which even according to official data amounts to hundreds of thousands of people, but according to estimates by Russian and foreign experts is several million — access to medicines for treating HCV and providing patients with drugs remains at an extremely low level. At best, approximately 4000 patients could be provided treatment with budgetary funds from various levels in 2013, according to the results of the analysis that was conducted. The volume of the allocated budget has remained at a level of more than 1.5 billion roubles, or 47 mln USD. If all the drugs for treating HCV were purchased at the minimum price, fixed by the monitoring results (6 091 roubles, approximately 175 USD), then it would be potentially possible to save almost 600 million roubles (over 17 mln USD), and with this money provide treatment to almost 2 000 additional patients.
However, even the price of 6 091 roubles per vial is extremely high. In a number of countries (India, Thailand, Ukraine, Georgia, and Vietnam), the cost of a vial of pegylated interferon costs approximately 1,500 to 3,500 roubles. Moreover, in these countries bidding terms often allow for competition between various pegylated interferon manufacturers, in as much as the meta-analysis of random clinical trials has demonstrated the interchangeability of the pegylated interferons alpha-2a and 2b . When biosimilar versions of these peginterferons and the drugs cepeginterfon alpha-2a and peginterferon lambda enter the market, competition between manufacturers, if it is encouraged, should lead to a decrease in pricing and to improved access.
In circumstances where increasing the budget is problematic, the only viable way to significantly increase the number of patients in treatment programs is a sharp decrease in prices for registered drugs and drugs in the process of being registered.
Another necessary measure is introducing into the federal budget a separate line for financing the procurement of drugs, testing and preventative services to counteract the HCV epidemic. To allocate target funds to combat hepatitis C a special governmental program is needed, similar to ones adopted in Egypt, Thailand, Ukraine and a number of other countries.
To determine the extent of need, it is necessary to implement a centralized system of registering patients with HCV (patient register), similar to that which already exists in many RF territories. Тhe current documents governing the process of providing medical care to patients with HCV require urgent and regular review in order to take into account the appearance of new drugs and new data on efficacy and safety.