So what the doctor prescribed: why medicines are not on the list of vital drugs

After two years, the commission under the Ministry of Health for updating the list of vital and essential drugs (VED) and the list under the program of high-cost nosologies refused to add more than half of the proposed drugs for orphan diseases and oncological diseases to the list. Patients' organizations claim that this is a very serious blow: some of the drugs were modern, highly effective, included in clinical recommendations in Russia, and most importantly - unique in their kind. Izvestia looked into the situation.

Which drugs were not included in the VED list

Irina Borovova, President of the Association of Oncology Patients "Zdravstvuyu!" , told about the situation with the update of the VED list of oncological medicines Irina Borovova in an interview with Rossiyskaya Gazeta. According to her, the interdepartmental commission under the Ministry of Health of the Russian Federation met for the first time in two years and finally updated the VED list, but, unfortunately, less than half of the 16 proposed oncology drugs were included in it.

Among the not accepted drugs, only two were rejected for technical reasons, while the rest are "drugs with great potential for clinical use and high efficacy". Thus, these are several oncohematologic drugs that allow patients to survive until the operation for bone marrow transplantation. Another three drugs are intended for the treatment of severe lung cancer, which significantly prolongs survival; an innovative drug for prostate cancer, which has no alternative; and the drug trastuzumab deruxtecan, which caused a real sensation in the medical world and "shows outstanding results" in women with advanced HER2-positive breast cancer, in which patients even with visceral metastases and brain metastases continue to live an active life.

Irina Myasnikova, the chairman of the board of the All-Russian Society for Orphan Diseases (VOOZ), told Izvestia that the update of the list of VEDs was insufficient from the point of view of the needs of patients with rare diseases.

-Of the 47 drugs submitted, only 23 were approved by the commission, but they have not yet been included in the list, which requires government approval, " she said. - For example, drugs for patients with cystic fibrosis and hemophilia were not included in the list. Moreover, the most popular drug, which is suitable for a large number of cystic fibrosis mutations, was not included.

What is the danger of not including a drug in the VED list?

Irina Myasnikova emphasizes that due to the inclusion of the drug in the list, drugs receive regulated prices, get into other preferential lists, pharmacies and hospitals. And the issue of updating the list is especially acute for graduates of the Circle of Goodness Foundation - adult patients in the regions, says the chairman of the board of the OIE.

- Medicines become unavailable to them due to high cost, if the drug is not included in the list, and the adult patient has no disability. And the condition of many Circle of Kindness graduates is compensated due to therapy, so they may not have such a status," said Irina Myasnikova.

Yury Zhulyov, co-chairman of the All-Russian Patients' Union, emphasizes that drugs outside the list of VEDs are purchased "very sparingly" under the state guarantee program.

- Everything is decided on an individual basis according to the results of medical commissions. It is a long way for a patient to receive therapy," he told Izvestia. - Especially since the decision of the medical commission is not always the basis for purchasing drugs due to budget constraints.

Irina Borovova emphasizes that a number of proposed drugs are the only technology designed to save human life.

- "If such a technology has come, we should be inclined to give it a way," she told Izvestia. - We need to give innovation the opportunity to save a person's life. For example, a drug for lung cancer is really a breakthrough, it prolongs the life of a person with this most serious disease for two years, during which another drug can be developed. Or a drug for women with HER2-positive breast cancer - they are doomed if they don't get this drug.

Why the drugs were not included in the list

Yuri Zhulyov emphasizes that the patient community does not understand what criteria the commission is now using to make decisions.

-Most of the drugs that did not get the required number of votes of the commission did not carry the risk of increased funding, but had documented efficacy, safety and for many patients are literally life-saving,- he emphasized.

Experts note that some drugs could even save the budget due to increased interval between injections or simply because of the duration of action. One of the proposed drugs was even less expensive than a regular non-long-acting drug.

-It is unclear why in some cases drugs with absolute pharmacoeconomic benefits for the state were not included in the list, " says Irina Borovova. - The same drug for patients with HER2-positive breast cancer will still come to us, it will still be purchased, because it is the only line to prolong the life of patients. It is registered in the country, through the court we can get the patient to be provided with it. But what a long way it is!

The head of the "Hello!" association notes that budget issues are of direct importance when considering the expansion of the VED list.

-Without any doubt, there is a certain budget basket, because of which we can't introduce certain technologies, " she said. - It is clear that the state, providing guarantees, should minimize the risks of inability to provide them. Everything must be backed up by finances. But several drugs were cheaper than those already available, and the decision was not understood by experts. For example, a representative of the Federal Antimonopoly Service of Russia spoke very brightly at the commission. He said that he did not understand why a drug was denied inclusion in the list, if the manufacturer gives a price twice lower than in the rest of the world and than what is currently sold in our country. This is a more than strange situation.

Communications Director of the Union of Professional Pharmaceutical Organizations Olesya Polyanskaya stressed that everyone wants the list to expand and give patients access to modern medicines.

- This is the social side of the issue, but there is also an economic side: what budget can withstand such a load? - she told Izvestia. - The nosologies you mention are usually expensive. The list cannot grow all the time.

The Ministry of Health explained to Izvestia that the commission considers the results of a comprehensive evaluation of drugs, including information on the comparative clinical effectiveness and safety of the drug, and assesses the economic consequences of its use. The situation with the supply of the drug in Russia is also taken into account. If the commission refuses to include a drug in the VED list, a new application can be submitted six months later. Now there are 820 medicines on the list.

Whether the system needs to be reformed

Irina Borovova notes that in a number of other countries there are no barriers between a drug being included in clinical recommendations and actually providing it to patients - it happens directly.

- But here we need to talk in general about the gross product spent on healthcare," she said. - After all, the 6-8% of the gross domestic product is not comparable to our 3% (3.7% of GDP in 2024, according to the head of the Ministry of Health. - Ed.). We cannot say unequivocally that we are able to treat our patients according to clinical recommendations. Unfortunately, for the time being, controlling organizations may lean not towards the doctor's decision and clinical guidelines that offer innovative treatment, but towards the standard, which does not include a particular drug.

Irina Myasnikova notes that clinical guidelines themselves need to be updated: doctors who manage specific nosologies should be involved in their updating and inclusion of the drugs included in them in the VED list, she says.

Another problem that the patient community fears to encounter is the extension of the "second extra" rule from the 44-FZ to the VED list. Itis proposed to give a price advantage to medicines from this list that are produced on a full cycle in the EAEU. Yury Zhulyov believes that this rule leads to artificial monopolization of the market, complete dependence of all customers on one manufacturer.

-Both patients and doctors may be jeopardized if for some reason the only domestic manufacturer is unable to meet demand," he told Izvestia. - After some time there may be no manufacturers left on the market, because pharmaceutical companies may stop supplying alternative drugs to the market due to the systematic exclusion of drugs from trading. In our opinion, the rule should not apply to drugs from the VED list.

Irina Borovova also spoke against the "second superfluous" rule, and called for a review of the entire 44-FZ, which is used for the procurement of drugs, as it "does not meet modern requirements" and very often becomes "a barrier to the passage of this or that innovative technology.

Irina Myasnikova emphasized that she welcomed the stimulation of production of domestic drugs, but noted that so far orphan drugs are mainly produced by foreign manufacturers. For Russian pharma this is "a large untapped layer of work", and if efforts are directed at it, a huge sales market will emerge.