In Russia, there is a shortage of the drug for treating breast cancer, Ixempra.

In Russia, there is a shortage of the unique oncological drug for the treatment of breast cancer, Ixempra, based on ixabepilone. Over the past two years, the drug’s copyright holder, the American subsidiary R-Pharma, has introduced only one series of the drug into circulation in the country, purchased annually for about 300 million rubles. The company explains that due to a change in the distributor of the substance, the drug has become more expensive and is counting on raising the maximum price in order to resume supplies. Experts say the drug is not essential, but note a negative trend toward fewer treatment options.

In 2023, 78% of announced auctions for the purchase of the oncological drug Ixempra, based on ixabepilone, used in the treatment of breast cancer, did not take place, Headway Company calculated for Kommersant. In the third and fourth quarters of last year, the share of failed trades, according to analysts, reached 98% and 94%, respectively. It is impossible to find the drug in pharmacies, Kommersant was convinced based on data from the AptekaMos help desk and the services Megapteka, Uteka, Apteka.ru.

Ixabepilone is indicated as monotherapy or in combination with capecitabine for the treatment of metastatic or locally advanced breast cancer. Ixempra is sold by the American subsidiary of R-Pharma, R-Pharm US, which bought the rights to the drug from Bristol-Myers Squibb (BMS) in 2015. There are no analogues of Ixempra in Russia.

According to Headway Company, in 2021, government customers purchased the drug for almost 318 million rubles, in 2022 – for 269.3 million rubles, and in 2023 – for an amount 4.2 times less. According to RNC Pharma, if in 2021 R-Pharm US put into circulation almost 24 thousand packages of the drug, then in 2022-2023 only one batch of 2.7 thousand packages was delivered.

The Ministry of Health confirmed a shortage of the drug in 2023 due to pricing, R-Pharma told Kommersant.

They indicate that thanks to this, the company has the right to demand a recalculation of the selling price. On January 15, FAS Russia agreed to increase the maximum price for Ixempra by 35% to almost 25 thousand rubles. for the most popular dosage of 15 mg, as follows from the service materials.

At R-Pharma, the need to increase prices is associated with a change in the supplier of the substance and, accordingly, with an increase in purchase prices for raw materials, which is why the cost of the drug has increased. The company allows the resumption of Ixempra’s introduction into circulation in 2024 if the price is brought into line. The drug is produced at the facilities of the German Baxter, secondary packaging is also produced at the Russian plant of the R-Pharm group.

Ixabepilone is not indispensable, but it is one of almost one and a half dozen effective drugs for the treatment of breast cancer, and its disappearance will be noticeable, says Evgeniy Ledin, chief specialist in the profile of antitumor drug therapy at Medsi Group.

He calls this event “a negative trend that ultimately leads to a reduction in patient treatment options.”

There are cases when pharmaceutical companies refused to supply drugs due to rising costs and the inability to increase the maximum price, but they are rather local in nature, says Nikolai Bespalov, development director at RNC Pharma. According to him, several dozen such situations can be found on the entire market. But the very fact that there is a procedure for increasing the maximum price in Russia suggests that regulators understand this need, Bespalov emphasizes. Although this procedure, of course, according to him, needs improvement and development. In 2022, due to the low marginal price, there were difficulties with the availability of drugs prescribed to patients with Parkinson’s disease and with the procurement of foreign vaccines (“Kommersant” dated May 23, 2022).

At the time Ixempra was purchased from BMS, the drug was approved for use in the United States and 18 other countries. In the USA, R-Pharm was also going to sell olokizumab (Artlegia), used for rheumatoid arthritis and the “cytokine storm” of COVID-19. The drug was also studied in the USA. But after the start of the Russian-Ukrainian conflict, R-Pharma said that they would work in the markets of unfriendly countries through partners.

Polina Gritsenko