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Seven plus five
The program "7 high-cost nosologies" will be almost doubled. But there are additional risks associated with this, experts warn. Already, more than half of the program participants experience problems with getting medicines for their main disease. And with the inclusion of second-line drugs in the federal program, the absolute budget deficit of the program will be felt more and more.
The most successful drug supply program “7 High Cost Nosologies” (7 VZN) will be expanded almost twice. But there are additional risks associated with this, experts warn. Already, more than half of the program participants are experiencing problems with getting medicines for their main disease. And with the inclusion of second-line drugs in the federal program, the absolute budget deficit of the program will be felt more and more.
The existing list of high-cost nosologies looks like this: hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, as well as helping people after organ or tissue transplantation. From next year, according to the changes introduced this summer to the federal law "On the basics of public health protection in the Russian Federation", the list of high-cost nosologies will be supplemented by 5 more diseases: hemolytic uremic syndrome, juvenile arthritis with systemic onset, mucopolysaccharidosis type I, mucopolysaccharidosis type II, mucopolysaccharidosis type VI.
The results and prospects of the federal program were devoted to the forum "10 years of the program of 7 nosologies", held on Friday at the initiative of the All-Russian Union of Public Associations of Patients. Ten years ago, the Russian authorities took a very important step by launching the federal program "7 VZN", during this time a unique experience was accumulated for the entire national health care system in the centralized support of the treatment of severe groups of patients. “The program saves the lives of hundreds of thousands of people. If not for her, some of those present in the hall simply would not have been. Over the years, the quality of life of patients with hemophilia has improved - 46% of them are working, this figure has doubled since 2008,”said Yuri Zhulev, co-chairman of the All-Russian Union of Patients, President of the All-Russian Society of Hemophilia.
On the other hand, the experts noted, drugs of the second, innovative line have appeared in the world, as well as the possibilities of pathogenetic treatment (when a drug eliminates some link in the pathogenesis of hereditary diseases) of diseases that are not included in the program
The inclusion of five additional diseases in the "7 VZN" program will allow purchasing drugs for their treatment at the expense of the federal budget, and not at the expense of the regions. We are talking about the amount of about 7 billion rubles annually. And this is very good for patients: according to official data, the implementation of the federal program is 98%, while the average provision of patients under the programs entrusted to the shoulders of the constituent entities of the Russian Federation is much lower and varies greatly depending on the region.
We expected to see a better picture
However, not everything is smooth with federal beneficiaries either. The results of the study of the quality of life and economics of the "7 VZN" program were presented at the Forum. Analysis of 956 questionnaires of patients participating in the program has shown that 52% of them experience problems with obtaining medication even for the underlying disease. 67% of respondents had to change the drug to treat the underlying disease from two to ten times. Among other problems, patients named the availability of innovative drugs, the preservation of treatment regimens, the possibility of social rehabilitation and problems with obtaining drugs in hospitals. “Let's speak frankly: patients carry the necessary medication in their bags so that they can receive help in the hospital,” Zhulev said.
In addition, the level of availability of drugs differs in different groups of patients. According to Zhulev, starting the study, its authors expected to see a better picture. But, apparently, one or two nosologies made their contribution, patients with which experience the greatest material difficulties associated with the acquisition of drugs. In particular, 85% of patients with multiple sclerosis reported such difficulties.
Abuses on the ground
The program is also discredited by “local abuse”, in particular, the facts of irrational distribution of drugs. Elena Maksimkina, Director of the Department of Drug Supply and Regulation of the Circulation of Medical Devices of the Ministry of Health of Russia, spoke about this. As an example, she cited the Ministry of Health of the Kaliningrad Region, which submitted an application for one of the most expensive drugs (lenalidomide) for 20 patients. Moreover, 12 of them were not residents of the region. And in St. Petersburg, Roszdravnadzor discovered 104 unclaimed packages of the drug worth more than 50 million rubles. And at the same time, many patients in different regions receive significantly fewer packages of drugs than they need, or do not receive them at all. “This is to the question of how efficiently we spend even the resources that we have,” Maksimkina said.
But, in any case, the 7 VZN program has proven its effectiveness - due to centralization and competent management. Moreover, over 10 years the number of patients in federal registries has grown 10 times (due to an increase in the number of those in need - by 8-16% per year and an increase in their life expectancy), and funding is growing almost only at the inflation level. So, in 2011, 38.2 billion rubles were allocated for this program, in 2014 - 40.5 billion rubles, in 2018 - 43.6 billion rubles.
Meanwhile, according to Maksimkina, this year an unprecedented large number of second-line drugs were included in the federal program. This means that the absolute budget deficit of the program will be felt more and more. The expansion of the 7 VZN program also creates additional risks. According to the co-chairman of the All-Russian Union of Patients, President of the All-Russian Public Organization of People with Disabilities with Multiple Sclerosis, Yan Vlasov, this year the program has already been underfunded by 7 billion rubles. Next year, the deficit of program funds will reach 10.7 billion rubles, and in 2020 - 15 billion rubles. And there have already been appeals from patients to courts.
Anna Kuznetsova, Plenipotentiary under the President of the Russian Federation for the Rights of the Child, reminded of those who remain "overboard" of the "7VZN" program, that is, patients who fall under the "24 Rare Diseases" programs. According to her, the provision of medicines to children with orphan diseases, the responsibility for which lies with the constituent entities of the Russian Federation, is the reason for many complaints from the regions. And this is not fair, expensive medicines for children with all rare diseases should be purchased centrally, the Ombudsman believes. She invited officials and members of patient communities to submit their initiatives to the Expert Council under the Ombudsman, which will meet on November 22.
The authorities themselves intend to solve this problem through import substitution.… Today, 40% of drugs in the program of high-cost nosologies are of domestic production, said the deputy. Minister of Industry and Trade Sergei Tsyb. At the time of the start of the 7VZN program, only one such drug was produced in Russia. Now in the program of 27 international non-proprietary names 19 are already produced in Russia at a full-cycle production. According to Tsyb, this gave 7 billion rubles in savings over 5 years, and made it possible to increase the number of patients provided with drugs. Including, we are talking about innovative monoclonal antibodies. “Orphan diseases gave an impetus to the technological development of the pharmaceutical industry, - said Tsyb. “We will continue to develop competencies, taking into account the new five nosologies, for which a number of products are already at the stage of clinical trials.”