AIPM Analytics: only one cancer drug per year becomes available to patients in Russia

In 2025, Russia launched a new national project according to which, by 2030, two-thirds of cancer patients will live for five or more years after being diagnosed. However, analysts say that only one new drug is available each year in Russia, compared to four in Europe on average and three in other comparable economies. This makes it difficult to achieve the goal of the national project. The Ministry of Health explains the slow pace of the system by strict conditions for drug selection, which prevent those whose efficacy and economic viability have not been proved from being approved.

In Russia, there is a list of medicines that the state is obliged to purchase and distribute to patients free of charge. This list is called VED — a list of vital and essential medications. The absence of this list makes drugs inaccessible to many patients, even though they may be approved by the Ministry of Health.

The availability of modern medications on this list is particularly critical for cancer patients. From 2021 onwards, antitumor medications outside the VED will be excluded from hospital protocols paid for by compulsory health insurance. According to the Ministry of Heath, these medications have not been proven to be clinically effective or economically feasible. However, manufacturers can continue to attempt to prove their effectiveness. If the special commission does not approve an application, it can be submitted again, but no earlier than six months later.

The gap between the registration of a drug and its actual availability to patients is clearly visible to those who work directly in the clinic. "If a drug is not included in clinical guidelines, is not purchased by the government, and is not covered by insurance, it means that for most patients, there is no treatment available," says Evgeny Ledin, an oncologist and founder of Ledin Clinic. "The cost of modern cancer therapy is so high that most people simply cannot afford to pay for it out of their own pocket."

Therefore, he believes that we should not talk about the registration of a drug, but rather about its actual availability for a specific person. He reminded us that the national project "Long and Active Life" was launched in Russia in January 2025. One of its key objectives in the field of oncology is to increase the proportion of patients who have lived for five years or more since their diagnosis to 67% by 2030 (currently, it is 62.6%). In order to achieve the national project's goals, it is crucial to ensure the availability of modern medications and the speed at which they are processed through the essential medicines system.

To assess how well it meets the national project's ambitions, AIPM analyzed the history of attempts to include foreign drugs in the list over a five-year period, from 2021 to 2025. During this period, foreign pharmaceutical companies submitted 74 applications for the inclusion of new drugs in the list of essential medicines. Taking into account repeated attempts, when the same drug was submitted again after being rejected, the total number of applications submitted was 116. Ultimately, exactly half of the drugs were recommended for inclusion, with 37 out of 74 receiving approval. However, many companies required two, three, or even four attempts to be included in the list.

The situation is particularly bad in oncology, where the need for new drugs is particularly high, as well as in hematology. These two areas accounted for 40 of the 74 drugs and 68 of the 116 attempts. However, only 16 received a positive decision from the Ministry of Health.

If we look not only at the approval rate, but also at the waiting time, we can see that the average time from the registration of a drug in Russia to the Ministry of Health's decision to include it in the list of essential medicines is 41 months in hematology, which is almost three and a half years, and 34 months in oncology, which is slightly less than three years. For comparison, this figure is 28 months for cardiovascular diseases, 22 months for diabetes, and 11 months for orphan diseases.

Is this a lot or a little? To answer this question, the AIPM compared Russian indicators with data from the so-called reference basket, a list of countries approved by the Russian government and used for pricing medicines. This list includes Hungary, Romania, Poland, Greece, the Czech Republic, Slovakia, and Turkey. In these countries, the average time from registration to full availability of an oncological drug is 21 months. In Russia, it is 34 months, which is more than a year longer.

In response to a question about the reasons for Russia's lag behind comparable European countries, the Ministry of Health's press service stated that clinical and pharmacoeconomic advantages of a candidate compared to other medications are considered when making decisions about inclusion in the lists. "In addition, the cost of treating the disease is taken into account in comparison with the cost of treating analogues included in the list of essential medicines," they said. However, according to Larisa Matveeva, the price of any medication in each country of the reference basket is equal to or higher than in Russia throughout the entire life cycle of the medication. It means that the financial argument about whether or not to include the drug in the list of essential medicines does not work in this case, she said.

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The inclusion of a drug in the list of essential medicines does not mean that it will be available immediately. First, it must be included in clinical guidelines, which are the documents that doctors use to prescribe treatment. According to the AIPM, one in four of the 37 drugs that were recommended for inclusion in the list of essential medicines during the analyzed period were not synchronized with clinical guidelines at the time of inclusion.

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After studying the commission's decisions over a five-year period, the AIPM also prepared a list of proposals to increase the availability of innovative medicines and sent it to the Ministry of Health. Firstly, the association called for the creation of a separate accelerated market entry pathway for drugs with the so-called special significance status. These are medicines that demonstrate a fundamentally new mechanism of action or fill a therapeutic niche where there are no alternatives. For these drugs, an early access mechanism is proposed, which involves a simplified inclusion process followed by monitoring of their effectiveness in real clinical practice.

Secondly, it is proposed to automatically include drugs that demonstrate budget savings with equal or greater effectiveness in the list of essential medicines. Currently, the commission looks at the cost of the drug itself relative to direct analogues in the list of essential medicines, and if the price is higher or there is no exact analogue for comparison, it may refuse to include it.

Another point is the introduction of a discount mechanism for exceeding the planned procurement volumes. This will allow the government to expand access to treatment without fear of budget imbalance: as the number of patients increases, the price of the drug decreases proportionally. The Ministry of Health's press service confirmed that they have received the AIPM's proposals, and their evaluation is conducted by the Center for Expertise and Quality Control of Medical Care (CEQMC) of the Ministry of Health.