“A vital step”: the head of the Fund “SMA Families” on increasing personal income tax and allocating funds for the treatment of seriously ill children

In an address to the Russians on June 23, President Vladimir Putin proposed starting January 1, 2021, to change the tax rate on personal income from 13 to 15% for those who earn over 5 million rubles a year. The higher rate will be taxed on the portion of income exceeding this amount. According to the head of state, as a result, the budget will receive an additional about 60 billion rubles.

“I propose, as experts say, to“ color ”these funds, protect them from any other use, and purposefully direct them to treat children with serious, rare diseases, to purchase expensive medicines, equipment and rehabilitation tools, and to carry out high-tech operations,” Vladimir said Putin

The President emphasized that all existing programs for the treatment of rare diseases of children should be preserved, and the proceeds will complement those resources that are already allocated from the budget for high-tech care and drug provision. He added that it is necessary to create a mechanism that excludes bureaucracy in the distribution of funds for these purposes.

Spinal muscular atrophy, some forms of which lead to a loss of ability to move and then breathe, is considered one of the most “expensive” diseases in the world. For example, the treatment so far the only Spinrase drug registered in Russia costs about 45 million rubles for the first course and about 20 million rubles each subsequent year (the therapy is carried out for life). Another drug, Zolgensma, is sufficient to be administered only once, but an injection costs from $ 2.1 million to $ 2.5 million.

Director of the SMA Families Foundation Olga Germanenko told how additional financing can affect the lives of patients with spinal muscular atrophy.

“Behind us the lives of children”

- Did you know about the upcoming changes?

- We very much hoped that some decision would be made in the near future, especially after the issue of drug provision for patients with SMA was discussed at a meeting with the president on June 8. Then Vladimir Putin said that the problem must be solved, and now the discussion, which began several years ago, reached the highest level. For us, this step is not just important, it is vital.

Spinal muscular atrophy, like 29 other diseases, is not included on any list today. I cannot say that this group suffers more than others from the lack of mechanisms for treating rare diseases, but we are by far the most numerous category among these nosologies.

The president’s decision answered the main question that always arises in any discussion: “Where will we get the money?” But I would like to emphasize that now the ball is on the side of the executive branch. It is they who must make sure that the money reaches the patients in the right time.

The new tax system is introduced from January 1, 2021. This means that taxes will only go to the treasury in 2022, and that is not at the very beginning. However, for patients who suffer without medication, it is important that the problem be resolved today. It is clear that in a large clumsy state system this is not always possible to do quickly, and any step forward is already a step, but it is all the more important to understand what we should do at what stage.

The year 2022 is a very long time, patients will not survive. I would like to know that our children will be treated before this date, and, what would be optimal, from the federal, not the regional budget. Then the mothers of our patients will be able to come to their children, kiss them and say: “Finally, I can be your mother again, and not a lawyer, psychologist, doctor, lawyer. Mom can stop this endless struggle for the right to treat you. ”

- To whom did the foundation turn to draw attention to the fees for treatment of SMA?

- Of course, the decision on an increased personal income tax rate and allocation of funds to patients with SMA was not made overnight. This is the result of a lot of work, to which many completely different people have joined. Whom we just saw in the allies - the State Duma, the Federation Council, the Ministry of Health, regional legislative assemblies. Weekly deputies and officials contacted us in the fund with a request to help a particular patient.

We know that there is huge competition in politics, but we interacted with different parties and saw how they join forces to solve a common problem. It is amazing how our children and adult patients are able to unite hearts!

But the decision made on June 23 is a merit not only of officials, but, of course, of the patients themselves. Since 2014, when the fund started to work, we managed to create a real “network family”. Each family fought for its child, and when it turned out or did not work out, it joined the common struggle for all of our patients. And people did not give up, they realized that no matter how hard it was, we had to move forward, because we have no other option. Behind us is the life and health of our children and adults.

“Adult patients are worried”

- How many patients with SMA are on the registry now?

- 779 children and 210 adults, a total of 989 patients. An important point is worth mentioning here: in his address, the president spoke about the problem of treating children with rare diseases. And adult patients with SMA worry that their decision will not affect them, although they make up 20% of patients with this disease. How the 17-year-old patient differs from the 18-year-old is not very clear to us. Therefore, I would very much like that the decisions that will be made concern generally rare diseases, not only children, but also adults.

- The treatment of rare serious illnesses is often incredibly expensive. Is 60 billion enough to cover all patients?

- If we are only talking about the treatment of SMA, then this amount is not something that will cover the needs of patients - it will cover them. Based on the fact that we still have one registered drug in our country, and if it is decided to include Spinrazu in Vital and Essential Drugs (a list of vital and most important drugs), the total amount for treatment of all patients will decrease by 25-30%. In addition, there are some patients who have already started therapy; less funds are needed to continue it.

If earlier it was a question of an amount of 40 billion rubles, now it is 25–35 billion rubles maximum to solve the problems of all patients with SMA in Russia.

- What other steps need to be taken, in addition to directly allocating additional funds?

- First of all, the accelerated registration procedure for other drugs. For example, there is a medicine called Riddiplam; it, like Spinrase, is used for life, only the patient is not injected into the spinal cord, but is allowed to swallow the syrup. In March, manufacturers submitted documents for its registration in Russia, a free pre-registration access program is running, about 30 people are already receiving therapy. The appearance of other drugs on the market will give a choice of several types of therapy: the doctor will be able to decide which patient in which condition this or that treatment will bring the greatest benefit.

In addition, I would very much like to include SMA in the program of high-cost nosologies, which would allow now, and not in 2022, to treat patients at the expense of the federal budget and reduce the burden on the regions.

Of course, treatment of SMA is not limited to drug provision alone. Patients also need rehabilitation, technical equipment, respiratory equipment and so on.

But we understand that the problem with medicines is now the most acute, and if it is solved, then it will be easier to deal with the rest, including through charity.

- And what is the situation with patients with SMA? How did a coronavirus pandemic affect them?

- If we are talking exclusively about the scope of drug provision, it could be worse. There were several patients, for example, in St. Petersburg and Astrakhan, who had to delay the start of therapy due to coronavirus, but in the vast majority of regions the treatment was not delayed and was carried out with all precautions. On the other hand, we have a very small sample - still only a few have been able to achieve treatment so far.

As for patients who collected charity funds and went for treatment abroad, one family encountered certain problems regarding a trip to the USA, but they were resolved. I also want to note that the training of Russian clinics on the use of the gene therapy drug was timely organized. The final stage of training, however, had to be carried out online because of the pandemic, but everything went well and now patients can receive this drug from charity funds in three clinics without having to go abroad.