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Russia expands list of vital drugs, including latest drugs from global majors

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Thursday, December 27, 2018

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The Russian government has expanded the list of vital and essential drugs from 699 to 735 items for 2019, according to recent statements by the press-service of Russia's Prime Minister Dmitry Medvedev, reports The Pharma Letter's local correspondent.

The expanded list includes some drugs against orphan diseases, as well a number of antitumor drugs.

One of such drugs is lapatinib, produced by Swiss pharma giant Novartis (NOVN: DE). It is designed for the treatment of breast cancer and will be marketed under the Tyverb brand name in Russia, as it is in Europe while it is Tykerb in the USA.

According to some Russian media reports, earlier the drug was a subject of 1.5 years' trial between Novartis and the Russian Federal Antimonopoly Service (FAS), which accused the company of the establishing a monopoly high price for Tyverb in the Russian pharmaceutical market. As a result of these trials, the parties agreed to set a price for the drug at 122.200 roubles ($1779).

In the meantime, in addition to Tyverb, another anticancer drug, produced from Novartis - ceritinib (Zikadia brand name) was also included in the expanded list. That came about several months later after its official registration in Russia in March 2018.

It is planned the drug will be purchased by the Moscow Department of Health in the last days of the current year, while the total amount of contracts may reach 1.5 million roubles. The volumes of purchases will be significantly increased during the period of 2019-2020.

Finally, taliglucerase alfa, which is a drug designed for the treatment of Gaucher disease, was also included in the list. It is produced under the Elelyso brand name by the US giant Pfizer (NYSE: PFE) and was registered in Russia in August 2017.

According to the Russian Ministry of Health, the inclusion in the list of vital drugs means the authorities will control the cost of these medicines, setting maximum sale prices for it in the domestic market.

Russian government to increase share of interchangeable drugs in domestic market
The Russian government has also announced its plans to increase the share of interchangeable drugs in the domestic market by several times by 2021, according to recent statements of the Russian Minister of Health Veronica Skvortsova and other senior officials from the Russian government.

Ms Skvortsova said implementation of these plans will help to reduce the cost of public procurements for drugs in Russia by more than 20% compared to the current figures.

According to current Ministry data, at present only 16% of drugs, available in the Russian pharmaceutical market can be considered as interchangeable. However, according to state plans, by 2021, their share should grow to 60%–70%.

To date, the Ministry of Health, together with the Federal Antimonopoly Service, have developed a bill that expands the concept of interchangeability of drugs in Russia. The document has already been agreed with the departments and is currently under the consideration of the Russian Prime Minister Dmitry Medvedev.

According to the FAS, the document proposes to establish interchangeability for 80% of drugs by December 31, 2020, and for the remaining 20% by the end of 2021.

Drug supplies are the second largest (after construction) item of state public procurements. According to the Russian Ministry of Economy, in 2017 the government purchased drugs and medical equipment for state needs for the total sum of 600 billion roubles ($8.73 billion).

Source: thepharmaletter
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