TIMOPHEI NIZHEGORODTSEV: WE PERCEIVE ASSESSMENT OF HEALTHCARE TECHNOLOGIES AS A FORM OF COMPETITIVE INTERACTION

French-Russian Round Table “Partnership in the name of health. Improving solutions and provision in healthcare” was organized in Moscow.  The event focused on assessment of healthcare technologies, development of electronic healthcare and access to innovations.

“We perceive assessment of technologies in healthcare, first of all, as a form of competitive interaction between pharmaceutical companies”, started his speech Timophei Nizhegorodtsev, Head of FAS Department for Control over Social Sphere and Trade. “That is why we consider that it is essential for competition authorities to participate in all processes related to technologies assessment to prevent discrimination of particular companies on the market”.

Speaking at the Round Table, he highlighted the main FAS requirements to the mechanisms for evaluating healthcare technologies: an objective approach to fixing therapeutic effects, possibility to determine the value of therapeutic effects for the healthcare system, as well as new approaches to determining the equivalence of medicines.

Discussing substitutability, Timophei Nizhegorodtsev pointed out at the archaic nature of the approaches to defining substitutability and equivalence of medicinal medicine that currently are available in Russia: “Typically we shut ourselves to the single international non-proprietary name (INN) and don’t even think that two medicine with different active agents can be equivalent in a particular clinical practice”.

As an example he gave a decision of Italy’s Competition Authority (ICA) regarding “Roche” and “Novartis”. The pharmaceutics manufacturers formed a cartel to maintaining the sales volumes of a more expensive medicine – “Lucentis” and concealed the therapeutic equivalence of “Avastin”, which costs several times cheaper.

According to the speaker, equivalence of medicine with different INN is especially important nowadays due to an increasing role of the use of biological medicine in clinical practice.

“Proteins of such medicines can act in a similar manner and generate the same therapeutic effect, but at the same time the medicines may cost significantly less”, stated Timophei Nizhegorodtsev, Head of FAS Department for Control over Social Sphere and Trade.

Another important line of the discussion concerned regulation of medicine prices. Nadezhda Sharavskaya, Deputy Head of FAS Department for Control over Social Sphere and Trade, said that “in Russia registration of medicine prices is based on two mechanisms: first, manufacturers’ prices are registered at the level no higher than prices for medicine in the references countries; and second, when medicine are included in the government programmes for providing medicine for the population, manufacturers can reduce the price even more, which will impact clinical-and-economic assessment of the medicine”.

Darya Starykh, Head of the Medicine Price Regulation Unit, FAS Department for Control over Social Sphere and Trade, discussed the new method for registering prices. Since autumn 2018, Russia applies an indicative method of price registration that is used efficiently in many countries.

The Round Table also discussed possibility to implement the “risk-sharing” system in the Russian healthcare system.

“Such projects are possible in Russia and it is under discussion”, said Nadezhda Sharavskaya. “The key thing, however, is how they will be executed and for what particular medicine”.

The speaker outlined the necessary criteria for such medicines and added that “absence of infrastructure and transparent mechanisms for evaluating efficiency prevent current use of the “risk-sharing” system”.