On November 24, Russian Prime Minister Mikhail Mishustin signed a decree on the inclusion of the drug "Spinraza", used to treat patients with spinal muscular atrophy, in the list of vital and essential drugs.

Spinal muscular atrophy is a severe, progressive congenital disease that leads to a gradual failure of the muscles; in the last stages, the muscles responsible for swallowing and breathing stop working.

In 2016, the drug Nusinersen (trade name - "Spinraza") appeared in the USA, stopping the course of the disease. 

Now Spinraza is the only medicine for SMA registered in Russia.

This is one of the most expensive drugs in the world - one ampoule costs about 8 million rubles.

Moreover, only in the first year of treatment, the patient should receive six doses of Spinraza, then - three injections per year throughout his life.

After the registration of the drug in the Russian Federation, patients with SMA have the opportunity to receive the drug at the expense of the state.

However, the regional authorities are reluctant to provide treatment.

Even with the conclusion of the medical commission, patients are often forced to knock out "Spinraza" through the courts.

The talks on including Spinraza in the VED list have been going on for the last several months.

In August, the Ministry of Health of the Russian Federation recommended that the government include the drug in the list of vital ones.

What will the inclusion in the VED list give

The inclusion of Spinraza in the list of vital drugs will allow the state to regulate the price of the drug, Olga Germanenko, director of the SMA Family charitable foundation, told RT.

“But it seems to me that one cannot say that after Spinraza is included in the VED list, it will become easy and simple to immediately receive the drug - this is probably an unrealizable expectation.

Nevertheless, this will make it possible to somewhat improve the situation with access to treatment, primarily by fixing the price of Spinraza.

Today it can be sold for at least 10 million, at least 20 - as far as the impudence is enough, sell for as much.

And when the drug is included in the list, it is possible to set the maximum selling price, ”explained Germanenko.

She recalled that in August, when the possibility of adding the drug to the VED list was discussed in the Ministry of Health, the manufacturer of Spinraza expressed its readiness to reduce the price by 25%.

“What does a 25% price reduction mean in practical terms?

Today, the selling price of Spinraza, which we see on the public procurement portal, averages 7.85 million rubles per dose of the drug.

Accordingly, if we are talking about a 25% decline, then this is, conventionally, about 5.5-5.6 million rubles.

It turns out that when the drug is included in the VED, every fourth patient will be treated at the expense of this savings, ”says the interlocutor of RT. 

According to Germanenko, the inclusion of Spinraza in the list of essential drugs will also deprive the regional ministries of health of the ability to refuse patients with SMA to provide an expensive drug under the pretext that the drug is not on the VED list.

“In fact, both medical commissions and regional ministries of health most often use the absence of Spinraza in the VED list as the most important argument when they refuse to provide the patient with the drug.

SMA patients and their parents mention this problem very often, and now it will be solved.

Moreover, on the basis of the list of vital and essential drugs, the so-called territorial programs of medical assistance are formed, which means that the corresponding budget will be immediately laid down.

This is another step to alleviate the situation of SMA patients, ”Germanenko said.

The opinion of patients with SMA

SMA patients consider the inclusion of Spinraza in the list of essential drugs a real victory.

Lada Penkova, a 19-year-old resident of the Krasnodar Territory (diagnosed with type II SMA), hopes that this measure will simplify the procedure for obtaining Spinraza.

“This is great news, we have been striving for this for a long time,” Penkova tells RT.

- I hope that there will be no more problems with obtaining it and patients will not need to call the prosecutor's office, the UK to get treatment for themselves or their child.

I hope that now, for example, when the date of the injection is coming up, two or three weeks before the patient will be called and allowed to pick up the ampoules. "

Muscovite Elina Leontyeva, mother of little Masha with a diagnosis of type I SMA, also considers the inclusion of Spinraza in the list of vital and essential drugs great news.

“I thought this issue would be resolved only in 2021, but it turned out that the drug had already been added to the list, which is great,” the RT interlocutor rejoices.

Elina's one-year-old daughter began receiving Spinraza in April 2020.

At the same time, the family is raising money for an even more expensive medicine - Zolgensma.

Unlike Spinraza, this drug has not yet been registered in Russia, and the family cannot get it for free.

The cost of the medicine is over 150 million rubles, but just one injection can stop the development of the disease forever.

Elina Leontyeva explained to RT that Spinraza and Zolgensma can be used simultaneously, but the second drug can only be used if the child is under two years old.

If the inclusion of "Spinraza" in the list of vital and essential drugs simplifies the process of providing the drug, it will allow patients to gain time, Leontyeva said.

“If the age and weight of the child allows, many collect money for Zolgensma, and if, in parallel, so that the child does not fade away, treatment is provided by Spinraza, it will be just fine. For example, our collection for Zolgensma has been going on for ten months already. At the end of April, Masha began to receive Spinraza, six months after her diagnosis. Doctors say that within a month after Spinraza it is possible to inject Zolgensma, that is, these drugs can be combined, "Elina explained.