Deputy Prime Minister Tatiana Golikova, Kommersant found out, instructed the Russian Ministry of Health to conduct “explanatory work” with chief freelance specialists on possible replacements of drugs “not produced in Russia and friendly countries.” Following the order, the NMIC of Radiology of the Ministry of Health has prepared a list of 39 names of anticancer drugs that are likely to be in short supply. According to experts, the proposed replacements discard medicine 20 years ago, and not all of them are equivalent even in terms of indications. Foreign pharmaceutical companies have assured Kommersant that supplies of medicines, including those mentioned in the document, continue in full. The Ministry of Health explains that the letter was sent “for information purposes”: “So that the regions in case of, for example, logistics violations, know in advance how best to make a temporary replacement.” At the same time, in the long run, the need to replace some of these international non-proprietary names (INNs) in public procurement may be due to rising prices for imported drugs.
According to Kommersant’s letter to the Ministry of Health, Kommersant Tatiana Golikova instructed the ministry to organize work to clarify the possibility of replacing drugs not produced in Russia and friendly foreign countries at risk of shortages. similar “. The letter also mentions the need for healthcare professionals to “explain” to patients about the “possibility” of such a replacement. The list of recipients includes 94 chief freelance specialists of the Ministry of Health (including children) – from the chief freelance first aid specialist to a plastic surgeon and a specialist in men’s reproductive health.
Kommersant was able to get acquainted with a letter from the NMIC of Radiology of the Ministry of Health, which, on behalf of Tatiana Golikova, was addressed to the heads of executive bodies in the field of health care of the Central Federal District, PFD, North-Central Federal District, and chief freelance oncologists and chief oncologists NMIC sends information to colleagues about possible substitutions of foreign drugs for “similar”.
The letter lists 39 international non-proprietary names. They are used to treat including the most common types of oncology: melanoma, breast cancer, bronchial cancer, lung and prostate cancer.
According to Nikolai Zhukov, an oncologist and member of the board of the Russian Society of Clinical Oncology (RUSSCO), the NMIC letter mentions the most expensive and most innovative drugs – “the backbone of modern anticancer therapy.” According to Headway Company estimates, the cost of these INNs in 2021 accounted for 62% of all spending on chemotherapy drugs in public procurement in Russia. The total amount of expenditures for these purposes last year amounted to just over 226 billion rubles, and the cost of purchasing these INNs – just over 140 billion rubles. 90% of the proposed Russian drugs, says Nikolai Zhukov, are not equivalent to foreign substitutes: “This is a return to therapy 20-30 years ago, somewhere with the preservation of similar lines of treatment, but only at the initial stage.” However, the risks are indicated in the letter. For example, the antitumor solution ipilimumab (trade name “Euro”, US manufacturer), which is used in colorectal cancer, melanoma, lung cancer, renal cell carcinoma, is proposed to be replaced by Russian drugs, including those of the domestic company “Biokad”, with a reservation that for high-risk groups this treatment option is “less effective”.
It should be noted that according to the statistical collection of the Ministry of Health of the Russian Federation, in 2020 556,036 malignant neoplasms were registered in Russia. In 2019, the agency claimed 640.4 thousand. new patients, and in total, according to official data, there are more than 3.7 million cancer patients in Russia.
Representatives of foreign pharmaceutical companies (Roche, Merck, MSD, Ferring, Boehringer Ingelheim, AstraZeneca) told Kommersant that supplies of medicines, including those mentioned in the NMIC letter, continue in full.
For example, Roche (four of their products are listed in the letter) assured that they are “making every effort” to ensure continuous deliveries “as far as possible.” There are three possible shortages of Pfizer drugs on the list. The company said that all of them are available in sufficient quantities in a warehouse in the Russian Federation “for the uninterrupted and timely provision of the needs of cancer patients.” Lilly stated that three of their drugs listed in the letter are available in stock at Russian distributors and are available for sale in Russia.
Bahodur Kamolov, President of the Together Against Cancer Foundation, believes that if there is an acute shortage of modern imported oncological drugs, the letter “will not solve the problem”: “We will have to reconsider all clinical recommendations drug therapy, but also radiation therapy, diagnostics “. Mr. Kamolov led expert groups of public organizations in creating clinical guidelines in 2019-2021. According to him, the specialists then “did everything to ensure that Russian patients received care in accordance with European and American clinical protocols.” “In any case, it is important to create conditions for full-fledged import substitution, so that in any situation, patient replacements are proportionate,” said Bahodur Kamolov.
At the request of the Together Against Cancer Foundation, Biokad, a key Russian manufacturer of anticancer drugs, confirmed that due to the restrictions, there are difficulties with the purchase and supply of equipment, components, consumables and raw materials from the United States and Europe. However, the company emphasizes that Biocad is currently working in accordance with the production plan for 2022.
“These days we are answering calls from doctors from the regions, explaining that the letter refers exclusively to the situation of shortage of these drugs,” said Polina Gabay, a lawyer and vice president of the Together Against Cancer Foundation. edition of clinical guidelines, and any substitutions must be not only medically but also legally justified. ” According to her, such letters are often accepted as a direct guide to action, so “it is important that they are accompanied by clearer emphasis and adequate explanations.” She also reminds that the state guarantee program has been formed and patients should have the right to receive expensive therapy: “First of all, the program is formed at the expense of MHI funds, and this is mainly at the expense of taxpayers. The tax burden has not been reduced, so reducing guarantees, especially in the absence of supply problems, is unacceptable. “
Kommersant has found out that a list of possible replacements, similar to those set out in the letter from the NMIC of Radiology, is being prepared by other specialists.
In particular, the Center for Palliative Care in Moscow is working on a list of Russian analogues of palliative care drugs. This was reported to Kommersant by the Vera hospice. The HIV community is aware of the letter, but claims that it has not yet been received by the chief physicians of the AIDS centers.
“It is extremely important that regions, in the case of, for example, logistics violations, know in advance how best to temporarily replace certain drugs, taking into account the priority of the patient’s interests and minimize risks. The letter was sent precisely for the purpose of such information, ”the Russian Ministry of Health explained to Kommersant. The agency stressed that all pharmaceutical manufacturers continue to work in the Russian market, deliveries are on schedule: “We are in constant contact with manufacturers and see no reason for a shortage of certain groups of drugs.”
At the same time, in the long run, the need to replace any part of the INN in public procurement may be due to rising prices for imported drugs. As Kommersant previously reported, the Ministry of Health has updated the mechanism for re-registering prices for drugs from the ZHNVLP list, including to allow foreign manufacturers to compensate for rising prices for finished drugs and pharmaceuticals (see Kommersant, March 22).