Seven plus five

The most successful program lambasruchei 7 high-cost nosologies (7 WNV) will be expanded by almost half. But that entails additional risks, experts warn. Already, more than half of program participants are experiencing problems with obtaining drugs for major diseases. And with the inclusion in the Federal programme of second-line drugs, the vast budget deficit of the program will be felt increasingly.

The current list of high-cost nosologies looks like: hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissue, multiple sclerosis, and also after transplantation of organs or tissues. From next year, according to the changes made this summer to the Federal law About bases of health protection of citizens in the Russian Federation, the list of high-cost nosologies will add another 5 diseases: hemolytic uremic syndrome, juvenile arthritis with systemic onset, mucopolysaccharidosis type I, mucopolysaccharidosis type II, mucopolysaccharidosis type VI.

A program that saves lives

Results and prospects of the Federal program was devoted to a forum 10 years the program of 7 nosologies, held Friday at the initiative of the Russian Union of patient associations. Ten years ago, the Russian authorities have taken a very important step by launching the Federal program 7 WNV, during this time was a unique experience for the entire national health care system for Central maintenance treatment of severe groups of patients. The program saves the lives of hundreds of thousands of people. If not for her, some of the audience simply would not exist. Over the years, increased the quality of life of patients with haemophilia 46% of them work, this figure has increased twice since 2008, said co-chair of the all-Russian Union of patients, President of the national society of a hemophilia Yury Zhulev.

On the other hand, experts noted that in the world there are drugs second line of innovation, and the possibilities of pathogenetic treatment (when a drug eliminates some of pathogenesis of hereditary diseases) diseases not included in the program.

The inclusion of the five additional diseases in 7 WNV will allow you to purchase medicines for their treatment at the expense of the Federal budget, but not at the expense of the regions. We are talking about the sum about 7 billion rubles annually. And it is very good for patients: according to official data, the execution of the Federal program is 98%, while the average supply patients programme entrusted to the shoulders of subjects of the Russian Federation, is much lower and varies greatly depending on the region.

We expected to see a more favorable picture

However, not everything went smoothly and with Federal beneficiaries.The Forum presented the results of a study of quality of life and economy of program 7 WNV. As the analysis of 956 patients questionnaires of program participants, 52% of them experience problems with obtaining medication, even for major diseases. 67% of respondents had to change the drug for the treatment of the disease from two to ten times. Among other problems, the patients described the availability of innovative products, maintaining treatment regimens, the possibility of social rehabilitation and the problems with obtaining drugs in hospitals. Let us speak frankly: patients taking the bags right drug for the purpose of being assisted in the hospital, saviliev.

In addition to different groups of patients differs, and the availability of drugs. According to Goleva starting the study, the authors expected to see a more favorable picture. But, apparently, contributed one or two of CHF patients that experience the greatest financial difficulties associated with purchasing of drugs. In particular, such difficulties were reported by 85% of patients with multiple sclerosis.

The abuse on the ground

Diskreditiert program and abuse in the field, in particular, the facts of the irrational distribution of drugs. This was stated by the Director of the Department of drug supply and regulation of medical devices circulation, Russian Ministry of health Elena Maksimkina. As an example, she cited the Ministry of health of the Kaliningrad region, to apply for one of the most expensive drugs (lenalidomide) for 20 patients. 12 of them were not residents of the region. And in St. Petersburg Roszdravnadzor found 104 unclaimed packages of the drug worth more than 50 million rubles. While many patients in different regions have a much smaller number of packages of drugs than necessary, or not receive them at all. This is the question about how effectively we spend even the resources that we have – said Maksimkina.

But, in any case, the program 7 WNV has proved its efficiency by centralizing and competent management. Especially because for 10 years, the number of patients in the Federal registers increased by 10 times (by increasing the number of people in need of 8-16% per year and rising life expectancy), and the financing grows almost exclusively on the level of inflation. In 2011, this program was allocated to 38.2 billion rubles, in 2014 40.5 billion rubles in 2018 43,6 billion rubles.

Additional risks

Meanwhile, according to Maksimkina this year in the Federal program included an unprecedented number of second-line drugs. This means that the vast budget deficit of the program will be felt increasingly. Additional risks are created by the expansion of the program 7 WNV. According to the co-chair of the all-Russian Union of patients, President of the all-Russian public organization of disabled patients with multiple sclerosis, Yana Vlasova, in the current year the underfunding of the program has already amounted to 7 billion rubles. Next year the shortfall the program will reach 10.7 billion roubles, and in 2020, 15 billion rubles. And there was the treatment by patients in the courts.

Of those who remain behind program 7ВЗН, i.e. patients that fall under the action of 24 rare diseases, reminded the Commissioner under the RF President on the rights of the child Anna Kuznetsova. According to her, the medication of children with orphan diseases, the responsibility for which lies on the subjects of the Russian Federation and the cause of many complaints from the regions. And it’s not fair, expensive drugs for children with all rare diseases should be purchased centrally, according to the Ombudsman. She suggested that the officials and members of patient communities to submit their initiatives for consideration by the Expert Council under the Commissioner, the meeting will be held on November 22.

The authorities intend to solve this problem through import substitution. To date, 40% of drugs in high cost nosologies program of domestic production, said Deputy Minister of industry and trade Sergey Tsyb. At the time of the start of the program 7ВЗН in Russia was carried out only one such drug.Now in the program of the 27 international nonproprietary titles, 19 have come in Russia, the production of a full cycle. According Tsyba, it gave 7 billion of savings over 5 years allowed to increase the number of medicines provided to the patients. In particular, we are talking about innovative monoclonal antibodies. Orphan diseases have given impetus to the technological development of the pharmaceutical industry, otmetilis. We will continue to develop competence with the new five diseases for which a number of products are already under clinical trials.

Irina Reznik