Parents of children with neuroblastoma have appealed to Prime Minister Mikhail Mishustin demanding the purchase of the necessary drug for immunotherapy. The purchase should be carried out by the Circle of Kindness Foundation, which receives funds from the high-income tax. It is unclear when the foundation will begin purchasing the drug.
Neuroblastoma is a malignant tumor that forms from immature cells and affects a child’s nervous system. One of the main treatment options for high-risk neuroblastoma is immunotherapy. Parents complain about the lack of dinutuximab beta, an immunotherapy drug. “In European countries and the USA, this type of therapy is included in the standard treatment. In Russia, the drug is not yet registered and is used on the basis of individual indications,” the parents’ appeal says.
One of the problems with these tumors, says Anastasia Zakharova, co-founder of the ENBY Neuroblastoma Parents Organization, is that they “disguise themselves and become invisible to the human immune system. “Dinutuximab beta represents specific antibodies that attach to a specific protein on the surface of neuroblastoma cells and “act as a beacon for the immune system – making the tumor visible. “And then the immune system itself begins to do what it should do – suppress the abnormal cells,” says Zakharova.
Until now, dinutuximab beta has been purchased mainly with funds raised by families of sick children or charitable organizations. In rare cases, as the authors of the letter point out, regional health ministries have done so, often only after parents have gone to court. In the spring of 2021, the Circle of Kindness Fund for Children with Serious and Rare Diseases added neuroblastoma to the list of diseases whose carriers can count on its support. The fund intends to purchase dinutuximab beta for children with this diagnosis. However, it is unclear when exactly this will happen.
Vladimir Putin announced the creation of the “Circle of Good” fund, which will help children with rare diseases, in January 2021. According to Russian authorities, the organization will be created with funds from an increase in income tax for Russians earning more than 5 million rubles a year. It is expected that in this way the entire annual income from the growth of personal income tax (NDFL) will come into the fund – that is, 60 billion rubles. The majority of this amount – 47 billion rubles – will be used to purchase expensive medicines for children with rare and serious diseases, said Deputy Prime Minister Tatyana Golikova. In total, about 30 diseases have been identified for which the “Circle of Kindness” will provide assistance in the provision of medicines.
ENBI has contacted the Ministry of Health and the Circle of Kindness charity fund, but “they are evasive on the issue of deadlines,” Zakharova says. According to her, the Ministry of Health did not respond to the latest request. In the response of the Circle of Good Fund (a copy of which was obtained by the BBC), it is confirmed that in May 2021 the Board of Trustees of the Fund included dinutuximab beta in the procurement list, but the document does not provide information about possible delivery dates.
Parents of children with neuroblastoma ask the Russian government to ensure the purchase of the necessary medicines by the Ministry of Health as soon as possible, until the work of the “Circle of Kindness” is established. “Some of the children have already missed the starting date of the therapy: “Every day of delay means the lives of our children that could have been saved,” the parents write in their appeal. According to the ENBI organization, about 40 children are currently in need of urgent treatment. “These are those who already have a medical consultation with a prescription and have received permission from the Ministry of Health of Russia to import an unregistered drug into the country. On average, the annual need for the drug can be estimated at 140-150 children,” says co-founder of the organization Zakharova.
There is no Russian analog of dinutuximab beta that could temporarily replace it, she clarifies.