RECENT UPDATE TO RUSSIA'S ESSENTIAL DRUGS LIST AND SEVEN NOSOLOGIES- CLINICAL DIFFERENTIATION AND LOCAL MANUFACTURING IMPLICATIONS FOR NEW DRUG INCLUSION

OBJECTIVES: The objective of this study was to assess implications of the recent update to Russia’s Essential Drugs List (EDL) and Seven Nosologies (VZN) on the access of the local pharmaceutical market in the context of various economic pressures. METHODS: This study was based on the review of current and past iterations of the EDL and VZN, various policy changes, as well as economic and health outcome indicators. In addition, a pragmatic literature review was undertaken to assess the impact of the EDL and VZN updates on the current market access environment in Russia. RESULTS: The 2015 EDL, which was previously updated in 2012, includes an additional 50 therapies, some of which are reimbursed through the VZN. Five new molecules were included within the VZN, including treatments for hemophilia, a cure for Gaucher’s disease, and a second-line therapy for multiple myeloma, bringing the total to 23 therapies since its implementation in 2008. The 2013 decision to delegate the financial responsibilities (tenders) and implementation of the VZN to regional authorities by January 2015 to alleviate federal burden, did not materialize as expected, mainly due to cost concerns. 67% of 608 EDL therapies are manufactured domestically, which is a reflection of their evolving pharmaceutical access policy due to economic pressure; in addition, only 35% of the 20,000 INNs marketed in Russia are reimbursed at the federal or state level while the rest are paid out-of-pocket. CONCLUSIONS: The expansion of the EDL and VZN have made some innovative therapies available to certain populations that were previously unable to access these high-cost treatments. In addition, due to economic uncertainties, laws have been enacted to restrict the admission of foreign drugs to state procurement if equivalent INNs are available through local manufacturers.