THE POLICY CHALLENGES OF RARE DISEASES IN THE RUSSIAN FEDERATION
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1 THE POLICY CHALLENGES OF RARE DISEASES IN THE RUSSIAN FEDERATION Maria Avxentyeva Russian Academy of National Economy and Public Administration, Moscow, Russia Rare diseases in Russia: short history The problem of limited access to medical care for rare diseases patients was raised by medical community approximately 10 years ago The definition of rare (orphan) disease was included into the federal law in 2011, and the bodies responsible for drug supply were found There is still no definition for orphan drug 1
2 The discussion about financing of rare diseases treatment still continues The is not fair to spend millions for the only patient when we can t provide cheap necessary care to everybody in need All people have equal rights for health! We can t choose the disease to suffer from! Rare diseases in Russia: current legislation Rare (orphan) disease should have prevalence rate no more than 10 cases per 100,000 population The Ministry of Health makes the list of rare (orphan) diseases on the basis of statistical data; this list should be available in the official Internet-site of the Ministry The Government approves the list of life-threatening chronic progressing rare (orphan) diseases that decrease life expectancy and cause disability Federal Law on the Foundation of Health Protection in Russia, 323-FZ from Nov 21,
3 Medical care and drug supply for rare diseases patients: current legislation Medical care for rare diseases is a part of the health protection Regional authorities are responsible for drug supply of patients with life-threatening chronic progressing rare (orphan) diseases that decrease life expectancy and cause disability Federal Law on the Foundation of Health Protection in Russia, 323-FZ from Nov 21, 2011 DRUF SUPPLY PROGRAMS FEDERAL BUDGET REGIONAL BUDGET Essential drugs supply program 7 expensive diseases program Regional drug supply 3.8 million people million people 4.6 million people 24 rare diseases drug supply 796 million 1,035 million 798 million 14.6 per prescription 1019 per prescription 15.4 per prescription 3
4 Drug supply for rare diseases in patients 4,43 billion rubles (85 million Euro) The most prevalent: disorders of aromatic amino acids metabolism (31% of patients) The most costly for the health care system: the paroxysmal nocturnal hemoglobinuria (19% of all expenditures) The most cost per patient: mucopolysaccharidosis type II (177 thousand Euro per patient) 10 most prevalent rare diseases Disease Number of patients in 2013 Disorders of aromatic amino acids metabolism Idiopathic thrombocytopenic purpura Juvenile arthritis with systemic onset Aplastic anemia, unspecified 652 Wilson s disease 520 Osteogenesis imperfecta 485 Central precocious puberty 484 Primary pulmonary hypertension 356 Galactosemia 221 4
5 Yakutia Oryol Chelyabinsk Adygea Bashkortostan Magadan Kalmykia Chechnya St Petersbourgh Vladimir Buryatia Altay Republik Perm Leningrad obl. Yamalo-Nenetsky Penza Krasnodar Kaluga Tver Sverdlovsk obl. Stavropol Kostroma Orenburg Novosibirsk Kaliningrad Sakhalin Tambov Voronezh Karelia Ryazan Khabarovsk Kursk Moscow Krasnoyarsk Rostov Ulyanovsk Belgorod Kurgan Tyumen Kabardibo-Balkaria Kirov Khanty-Manssijsk Lipetsk Omsk Novgorod Altay Pskov Tomsk Ivanovo Tyva Khakasia Yaroslavl Amur Saratov Zabaykalsky Judish Autonomous obl. Tula Tatarstan Kemerovo N. Novgorod Kamchatka Karachaevo-Cherkesskaya Arkhangelsk Smolensk Vologda Astrakhan Udmurtia Marij El Chukotka Bryansk North Osetia Samara Volgorad Chuvash Primorsky Moscow St Petersbourgh Sverdlovsk obl. Tatarstan N. Novgorod Krasnodar Samara Saratov Bashkortostan Kemerovo Novosibirsk Tula Orenburg Perm Khanty-Manssijsk Stavropol Chelyabinsk Krasnoyarsk Rostov Volgorad Leningrad obl. Omsk Vologda Altay Voronezh Primorsky Ryazan Tomsk Ulyanovsk Khabarovsk Kurgan North Osetia Arkhangelsk Sakhalin Yaroslavl Tyumen Bryansk Penza Tver Zabaykalsky Kursk Belgorod Udmurtia Vladimir Ivanovo Tambov Kirov Buryatia Chuvash Pskov Karelia Chechnya Amur Kaluga Yakutia Marij El Kaliningrad Karachaevo-Cherkesskaya Smolensk Kabardibo-Balkaria Astrakhan Kostroma Novgorod Khakasia Yamalo-Nenetsky Lipetsk Adygea Kamchatka Tyva Oryol Altay Republik Judish Autonomous obl. Magadan Kalmykia Chukotka Number of rare disease patients in 76 regions of Russia (2013) 1,400 1,200 1, in Moscow in Chukotka 0 Patients Population, x10,000 Variability in expenditures for rare diseases drugs per patient between Russian regions (2013) thousands in Yakutia and Oryol in Primorsky region 0 5
6 Expected need for financing: 15 billion rubles (302 million Euro) Calculated on the basis of standards of medical care REGIONAL BUDGET The amendment to the Federal Law on Foundation of Health Protection proposed to make a special federal program for rare diseases It was declined by State Duma Regional drug supply 707,7 million (2012) 24 rare diseases drug supply 302 million? Main challenges Treatment of rare diseases is the great burden for the regions with very different abilities of financing health care. The access to drugs depends on the personal activities of the patients and there families Some drugs are not included into Essential Drug List and their price is not registered There are no clear indications for drugs prescription All discussion about rare diseases is mostly concentrated around expensive drugs 6
7 Proposals The list of orphan drugs should be made, assessment of their therapeutic value is necessary Most expensive drugs should be supplied through federal program The clear diagnostic criteria for rare diseases and indications for drug prescription must be developed 7
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