The acting head of the Federal Antimonopoly Service, Timofey Nizhegorodtsev, stated that the expensive “Spinraza” was included in the list of vital and essential drugs (VED) prematurely, although the commission under the Ministry of Health voted in favor of it. The money for this drug was to be taken from the “tax on the rich” initiated by Putin.
The spinal muscular atrophy drug “Spinraza” is one of the most expensive drugs in the world. “The cost of treatment for one year is 42 million rubles. For each subsequent year, it is necessary to reduce the amount by half, and treatment is necessary throughout life,” said Olga Germanenko, director of the “Families with SMA” Foundation, according to the BBC.
If this drug is included in the list of essential drugs, the state will be obliged to provide it free of charge to patients within the framework of state guarantees for compulsory health insurance, if the patient has indications. According to Germanenko, there are about 1000 people with spinal muscular atrophy (SMA) in Russia. The regions buy the drug, but there is not enough for everyone. Only 10% of patients in the country receive treatment, according to Germanenko.
In January and February 2020, three children in Russia died because they did not receive the injections of medication they were waiting for. Regions ask the government to finance the treatment from the federal budget. For example, recently the Duma of the Moscow region sent such a request to the government. In the Moscow region there are 43 children diagnosed with SMA.
On August 3, the commission of the Ministry of Health, consisting of doctors and officials from various departments, recommended that “Spinraza” be included in the list of essential medicines. However, the Federal Antimonopoly Service (FAS) asked to delay the drug’s inclusion in the list for six months.
Update: On November 23, 2020, the Russian government decided to include the drug nusinersen (trade name – “Spinraza”) in the list of essential medicines for 2021.
The Ministry of Health Commission meets every year (sometimes more often) to review new drugs that manufacturers propose for inclusion on this list. Doctors explain the advantages of new drugs over those already on the list and who they can help. The commission also discusses the cost of drugs and the manufacturers’ plans for locating the production of drugs in Russia. The discussion about “Spinraza” took place on August 3 and lasted over an hour. In the end, 11 votes were cast in favor of adding the drug to the list, and nine votes were cast against it.
The issue of the price of the drug stood out the most. According to the representative of the company Biogen (the manufacturer of the drug), for Russia, if included in the list of essential drugs, the lowest price compared to “other countries from the reference basket” is proposed – 5 million rubles. Currently, the average price of this drug in regional government procurement, according to the representative of the company “Farmvestnik”, is 7.5 million rubles.
The representative of the company was asked what prevents selling the drug at a discounted price without including it in the list of vital and essential drugs (ZhNVLP), to which the representative of Biogen replied that when the drug is included in the list, not only the manufacturer’s price is fixed, but also the wholesale mark-up. “Do you mean that a surcharge of 2.5 million rubles will be made now?” clarified the director of the Department of State Regulation of Medicines of the Ministry of Health, Romanov. “I need to confirm this, but it seems so,” she replied.
Deputy Head of the Federal Antimonopoly Service Timofey Nizhegorodtsev suggested to the commission to wait until the fund for financing the treatment of children with rare diseases mentioned by Vladimir Putin is operational in Russia. On August 7, Nizhny Novgorod residents essentially repeated the same thing, telling RIA Novosti that “Spinraza” is “incredibly expensive” and it will take time to decide where to get the money.
In the comments, the BBC emphasized that they proposed to postpone the inclusion of the drug in the list for only six months. “In order to prevent the possibility of increasing deficits of regional budgets allocated for health care, it is very important to correlate the subject parts of the patient registry with these budgets,” he added. Elena Maksimkina, the director of the Ministry of Health’s department of drug supply and medical equipment regulation, supported the proposal at the Nizhgorodtseva Commission.
According to her, the fund announced by Vladimir Putin will primarily pay for drugs that are not included in the lists with state guarantees, such as the High-Cost Nosologies Program (HCP). Inclusion of the drug in the list of essential medicines is only a recommendation of the commission, clarified Elena Maksimkina based on the voting results. The final decision will be made by the government. Moreover, the government’s decisions on this issue have been in line with the Commission’s recommendations.
A state fund for children with rare and serious diseases will be established in Russia. Its creation was approved by Vladimir Putin. In his televised address, he announced that the treatment of rare diseases will be financed with funds from the “wealth tax”, which will be introduced on January 1. Income tax for people earning more than 5 million rubles a year will increase from 13% to 15%. According to the plan, this should bring in 60 billion rubles.
Tatyana Golikova proposed the creation of such a fund in June. She proposed to finance the purchase of drugs for SMA from three sources: regional funds, federal budget funds, and funds from socially oriented companies, which were invited to invest in the creation of a fund to support children suffering from serious diseases. Exactly how the fund will work is unknown. According to the government decree, the funds will be distributed with the participation of charitable organizations. They can also be spent on treatment abroad.
One more question – it concerns adults with SMA. The President mentioned a fund to help children. But when a child grows up, it is unclear whether an adult will be able to rely on medication. If they are on the VED list, they will be given the drugs.