At the last meeting of the spring session on 28 July, the Federation Council approved the bill on amendments to the Federal law №323 “On the fundamentals of protection of health of citizens of the Russian Federation” according to which the list of high-cost nosologies program (VZN) added five new diseases.
We are talking about hemolytic uremic syndrome, juvenile arthritis with systemic onset and mucopolysaccharidosis I, II and VI types. Now the informal name of the program “Seven nosologies” is not true. Diseases twelve. According to the calculations of senators, namely the Federation Council in the Duma introduced the relevant amendments, for the treatment of patients with these diseases need to purchase eight drugs in the amount of 10 billion virtually any per year.
As of June 25, 2018 in the Federal register of life-threatening and chronic progressive rare diseases the five diseases included 2130 patients, of which 1583 were children.
In the accompanying documentation States that for patients with hemolytic-uremic syndrome must be purchased eculizumab, the cost of treatment per patient per year is to 10.43 million RUB For patients with mucopolysaccharidosis type I plan to put laronidase, the cost of the annual course on the patient – 2.14 million RUB, mucopolysaccharidosis type II – elaprase value of virtually any 12.25 million per year per person, with mucopolysaccharidosis type VI – naglazyme value of 13.98 million RUB per year per person.
Patients with juvenile arthritis with systemic beginning will be purchased a few preparations – tocilizumab, adalimumab, canakinumab, etanercept. The average course cost for one patient is virtually any of 2.21 million. the Most expensive drug, canakinumab, annual course costs to 7.4 million virtually any., the budget tocilizumab, the annual costs per patient are 223,65 thousand RUB
However, first, all of these medications should be recommended by the Commission of the Ministry of health on the formation of lists of medicines for inclusion in the list of drugs procured under the program WNV, and then approved by the government.
A miracle happened
The theme of the financing of the purchase of drugs for patients with orphan diseases at the Federal level actively discussed the last few years. In September 2017, when discussing the draft Federal budget for 2018 in the state Duma the Minister of health Veronika Skvortsova told deputies that regions will be offered a way to alleviate the burden of drug provision of patients with orphan diseases than the transfer of procurement at the Federal level. “Assistance to regions in this regard can be provided through subsidies. It is planned that this mechanism will be operational from 2019 on the transition to centralized purchasing, it does not go”, – said the Minister.
However, in October 2017, seven deputies, including party leader “Fair Russia” Sergei Mironov, as well as a member of the party Fedot Tumusov, introduced a bill to expand the “Seven nosologies” for six diseases. There are listed almost all made now in WNV disease (hemolytic-uremic syndrome, and mucopolysaccharidosis I, II and VI types), with the exception of juvenile arthritis with systemic onset, in addition to the list was requested of paroxysmal night hemoglobinuria, and idiopathic thrombocytopenic purpura. According to the feasibility study, the additive in the form of six diseases could cost the budget an additional 12 to 22 billion virtually any. per year. And this against the background of statements of the Ministry of health that because the number of patients is necessary to increase funding for the already existing seven nosologies.
In mid-June 2018, the state Duma rejected the bill. As has declared then the Chairman of the Duma Committee on health Dmitry Morozov, it is incorrect to allocate about four hundred orphan diseases six or seven nosologies.
The MP also stated that he supports the federalization of funding rare diseases in the future, as currently the subjects of the Russian Federation is very difficult to fulfil its mandate on the funding of such diseases: “the Topic is extremely thin, like all health care. And if we select some nosologies of all orphan diseases, it can occur that the groups of regions to which such financing will not apply. Because they have no patients with these diseases, and there are others.”
The future is now pretty soon. The Federation Council in the Duma introduced a bill on additions to the list of five WNV disease July 16, 2017 On the following day, the speaker of the Federation Council Valentina Matvienko said that the law will be adopted during the spring session. Then it was hard to believe. However, on 26 July, the state Duma adopted the law in the third reading. Now after the approval of the senators left to do is wait until the law is signed by the President.