Russia’s Essential Drugs List (перечень жизненно необходимых и важнейших лекарственных препаратов) was created in April 2010, which enabled the federal authorities to more effectively regulate the prices of vital and essential pharmaceutical products in Russia in order to increase access to them for the public and healthcare institutions. Rosminzdrav, or the Russian Ministry of Health, has updated this list several times, most recently in December 2014, which ultimately took effect on March 01, 2015. The most updated list includes 608 products, 67% of which are manufactured domestically, which is viewed as a necessary move given Russia’s currency fluctuating rates.
In 2008, prior to the establishment of the EDL, Russia carved out the Seven Nosologies (VZN) Programme as a method for patients to access high cost treatments for relatively rare diseases. The following disease areas are currently reimbursed by the “Seven Nosologies” programme.
1. Formation of malignant lymphoid haematogenic and related tissues (chronic myeloleukemia, chronic lymphatic leukemia and other oncohaematological illnesses)
2. Cystic fibrosis
4. Pituitary dwarfism
5. Gaucher’s Disease
6. Multiple Sclerosis
7. Organ and tissue transplants
The list initially included 18 therapies, and in 2012, the programme had an estimated budget of 1.8 million USD and had a reach of approximately 91,800 people. In 2011, the therapies provided through the Seven Nosologies were officially incorporated in the EDL, making them subject to price control measures as well. The EDL list that took effect on March 01, 2015, also contains an updated list of therapies covered by the “Seven Nosologies Programme.” Notable additions include:
• lenalidomide (REVLIMIDTM), which is now the second multiple myeloma therapy to be reimbursed through the programme after bortezomib (VELCADE)
• moroctocog alfa (REFACTOTM), which becomes the fifth haemophilia therapy to be reimbursed through the programme
• velaglucerase alfa (VPRIVTM), which becomes the second therapy for Gaucher’s disease to be reimbursed
However, due to budget constraints, many therapies have either been approved only after extensive negotiations, while others have simply been excluded. Lenalidomide (REVLIMIDTM), for instance, took approximately four years to secure inclusion into the Seven Nosologies; according to authorities in Russia, the process was a “great scandal at the federal level and a nightmare.” TASIGNATM, which demonstrated clinical superiority over GLEEVECTM in the treatment of chronic myeloid leukemia, was ultimately not included, along with other products that have been determined to be “life-saving.”