Profitability is in their blood

The share of failed auctions for government purchases of human albumin, a drug made from blood plasma used in emergency medical care, increased to 87% in the third quarter. Distributors are in no hurry to take part in tenders due to the low marginal price, which makes supplies unprofitable, especially for foreign companies. During 2023, manufacturers raised prices several times, citing the risk of albumin shortages. Now regulators are developing a new approach to pricing blood products.

Seven manufacturers of human albumin in October 2023 increased the maximum prices for the drug at a dosage of 20% by 11–59%, Kommersant found in the materials of the Federal Antimonopoly Service (FAS). This became possible due to the risks of human albumin deficiency identified by Roszdravnadzor in August.

Human albumin based on blood plasma is used, among other things, to replenish blood loss during operations and shock conditions. In the Russian Federation, 19 manufacturers have registered the drug. According to Headway Company, in January-September government customers purchased this product for 2.7 billion rubles. At the same time, auctions for the distribution of contracts worth 5.5 billion rubles did not take place. In total, in the third quarter of 2023, according to Headway Company estimates, the share of such trades increased to 87% from 64–65% in the first and second quarters. And in 16 regions not a single auction took place.

The Ministry of Health claims that in 2023, 773.1 thousand packages of human albumin were put into circulation – this corresponds to the indicators of previous years; Of these, almost 300 thousand were purchased at auction. State medical institutions are provided with 685 thousand packages, which is enough for eight months, the ministry adds.

Suppliers are in no hurry to go to auctions due to the low maximum price for the drug. So, for this reason, the Italian Kedrion will not supply its Uman Albumin product at a dosage of 20% in 2023, the company reported. They add that the current maximum selling prices for the drug “have led to a complete loss of commercial viability for supplies to the Russian market.” The Russian office of the German Biotest reported that they had reduced the supply of albumin due to unprofitability.

Biotest and Kedrion factories are located in Europe, and costs for albumin production are denominated in euros, the companies say. Against the backdrop of the 2019–2020 pandemic, the cost of human blood plasma, the raw material for albumin, increased, and there was a shortage of it in the world. It is this component that makes up a significant share of the cost of the drug, Biotest explains.

Albumin prices in Russia changed not only in October of this year, but also in April, according to FAS materials. On average, in 2023, the maximum prices for this drug will be increased by approximately 40%, the Ministry of Health told Kommersant.

The FAS believes that prices for albumins have now been set to the extent necessary to maintain their production and supply to Russia. Kedrion indicates that thanks to the re-registration of prices, supplies of the drug to the Russian Federation will be resumed, but probably not earlier than 2024. At the same time, Biotest considers even re-registered prices unprofitable.

Takeda and the Ivanovo Regional Blood Transfusion Station say they will keep supplies in 2023 at last year’s levels. Microgen promises to increase albumin production by 39% year-on-year by the end of this year, but the main increase is planned for the fourth quarter, reported Nacimbio, which includes Microgen. They consider albumin production profitable.

At the same time, the FAS and the Ministry of Health have developed amendments when calculating maximum prices for blood products from the list of vitally important products, similar to vaccines, the service reported. Russian manufacturers of blood products have made such a proposal, the Ministry of Health adds.

In the latest version of the draft government decree on state regulation of prices for drugs from the list of vital and essential drugs, a clause has appeared on the registration of prices for drugs from blood and blood plasma according to the requirements for reference drugs. According to Alexey Fedorov, an expert at the All-Russian Patients’ Union, this will allow holders of regulatory certificates not to apply reduction factors (biosimilars should be cheaper than original drugs) and raise prices up to the level of the maximum registered. The resolution is expected to come into force on April 1, 2024.

Polina Gritsenko