Treatment Preparedness Coalition. Access to Drugs for Treating Hepatitis C in Russia in 2013. St. Petersburg, 2014. The current version is available at: http://itpcru.org/. Please send any comments to: firstname.lastname@example.org.
Analyzing auctions for the procurement of HCV drugs in RF territories in 2013 showed that the main sources of procurement financing are:
- Inter-budgetary transfers within the framework of Resolution No. 1438, for procuring drugs to meet the needs of specific categories of people, including those with HIV.
- Funds for procuring drugs to meet the needs of specific categories of people in accordance with Law No. 178-F3.
- Funds for target-oriented programs of RF territories, dedicated to combating socially significant diseases, including HCV.
Government Resolution No. 1438 as amended on 1 March 2014 describes regulations for funding procurements of testing materials and drugs for treating HIV, HBV, and HCV at the expense of the federal budget. Among other things, this resolution contains a list of medicines subject to purchase. As a rule, for inclusion in Resolution No. 1438, the drug must be on the EML.
In accordance with Federal Law No. 349-F3 from 2 December 2013 “On the Federal Budget for 2014 and for the Planning Period 2015 and 2016″, the total amount allocated for procuring drugs treating HIV, HBV, and HCV is a little more than 14 billion roubles, or approximately USD 400 000 000 (14 061 597 600). This corresponds exactly with the sum allocated in 2013. There are no guidelines as to how to allocate these funds to specific diseases. This means that it is impossible to say exactly what sum from the federal budget will be dedicated specifically to procuring HCV drugs. This sum can only be determined after completing all bidding and executing the contracts.
At present, the list of medicines from Resolution No. 1438 includes five drugs that are used in treating HCV. This list (using the international non-proprietary names, INN) is shown below: interferon alpha-2a, interferon alpha-2b, peginterferon alpha-2a, peginterferon alpha-2b, and ribavirin10. All of these drugs are including in the EML list, regulating the maximum selling price.
As has already been mentioned in previous publications11, unifying procurement funding for drugs treating HIV and hepatitis B and C within the framework of one resolution in practice results in the fact that in most cases, procuring drugs for treating HCV within the framework of Resolution No. 1438 takes place on the “leftover” principle. In other words, antiretroviral drugs for treating HIV are purchased first, and only thereafter are auctions announced for procuring drugs that treat hepatitis C, based on the amount of the remaining funds.
It is important to note that within the regional target-oriented programs, health-care administrators can often purchase HCV drugs that are not included in Resolution No.1438 or the EML, including the recently registered protease inhibitors for treating HCV: boceprevir12, telaprevir13, and simeprevir14, as well as cepeginterferon alpha-2b.
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