REVISION OF THE DRUG LISTS FOR 2019

Publication date: 19 september 2018

In September of this year, a number of meetings were held the Ministry of Health where the change in the composition of the drug lists was discussed. Altogether, the designated MoH Committee reviewed around 120 new applications.

It should be noted that this time the number of applications to withdraw a drug from the List of Vital and Essential Medicines (EDL) and other lists has grown.

The pharmaceutical companies submitted six applications for drug exclusion, of which only three were approved by the Committee (Mometasone, Betamethasone and Lornoxicam).

In the near future, Aston Health is going to present the detailed analysis of the changes to the drug lists effective as of 2019. The report will comment on the modified criteria for drug inclusion/exclusion, feature the most prominent cases, and provide the feedback from the experts and industry stakeholders.

Link to online stream recordings of the meetings:

- September 4; second part of the meeting from September 4

- September 5

- September 6

- September 7

Kirill Bukharov

Senior Consultant, Strategic Consulting Department, Aston Health

"The EDL was the first drug list adopted in Russia following the Order of the Russian Government # 2199-p dated December 7, 2011 to introduce the mechanism of price regulation for essential medicines and improve patient access to these medications.

It was put together using ATC criteria (ATC — Anatomical Therapeutic Chemical Classification System) with pharmaceuticals being recorded under INN names. The listed drugs are available to patients free of charge in the inpatient and emergency settings though the Government Guarantees Program of Free Medical Care. Also, EDL is used as the benchmark for the regional drug lists and formularies in the hospital segment.

Since 2013, the List has been revised each year. The procedure was developed and put in place for filing a drug application. All applications are examined by the expert panel using the established criteria (clinical effectiveness and economic value of treatment, price and the degree of production localization).

The Department of Drug Supply and Regulation of Medical Device Circulation headed by the Director, Elena Maximkina holds annual meetings to review the inclusion/exclusion applications for EDL drugs, which involve the Chief Specialists in various therapeutic areas, the representatives of FAC (Federal Antimonopoly Committee), the Ministry of Industry and Trade and patient organizations.

These annual September meetings are certainly the defining event for the pharmaceutical companies operating in the public sector in terms of shaping the appropriate strategy for the local market."