A SYSTEM OF MEDICINE SUBSTITUTION SHOULD TAKE INTO ACCOUNT THE INTERESTS OF EVERYBODY

Drug substitutability, pricing and launching pilot projects on drug substitution are, perhaps the hottest topics that today concern all participants of the pharmaceutical market

Head of FAS Department for Control over Social Sphere and Trade, Timophei Nizhegorodtsev gave short interviews on stage of the XV International Conference – “The Pharmaceutical business in Russia: fulfilling the “Healthcare” National Project”, where he was developing three key themes that are currently in the focus of attention of the pharmaceutical market and the healthcare system in general.

Head of FAS Department for Control over Social Sphere and Trade opened the session with discussing the law on medicinal drug substitutability, adopted in December 2019. He reminded that the key objective of the law is to level the requirements to the quality of registration dossiers of all medicinal drugs circulating on the market.

“In spite of the norms and requirements, according to which generics had to be registered in the same dosage form and strength, as the reference preparations, a different practice formed in the Russian economy, which became a problem for the economy of the healthcare sector as well as for use of drugs in clinical practice”, said Timophei Nizhegorodtsev. “The objective of the new law is to carry out a critical analysis of the circumstances of registering medicinal drugs and ensure that all drugs circulating on the market conform to the common rules. It is necessary in order to eliminate unfair competition and discrimination of some manufacturers against others, as well as to remove any doubts that registered drugs failed to pass any expert examination or are less efficient and, ultimately, are not substitutes”.

Moving to a new pricing technique for medicinal drugs and price re-registration, which has been electrifying the pharmaceutical market for already second year, every time being surrounded by new myths, Head of FAS Department for Control over Social Sphere and Trade pointed out that this method does not differ at all from the one adopted back in 2010 [1].

“The only new thing is that now it must be fulfilled”, emphasized Timophei Nizhegorodtsev. “Today’s price re-registration – is a story with reviewing an array of earlier registered prices and adjusting them to the uniform requirements that have existed since 2010, but in many cases have been ignored by manufacturers”.

He informed that in 2016 FAS made around 1,500 decisions to decrease prices.

“There were some bright moments, in particular, when price plummeted tenfold, but the drugs were not withdrawn from the market. It is essential because FAS does not demand to reduce prices below some minimum thresholds. We demand that the prices in Russia should be at the average European level; and practically all pharmaceutical companies can do it, taking into consideration the scope of the Russian market in comparison with the markets in the reference countries”, informed Head of FAS Department for Control over Social Sphere and Trade.

A list of the reference countries, that earlier comprised 21 countries, was shortened. Nine countries were excluded where prices were either very high or very low. Thus, only the countries with the average price level remain on the reference list.

As for re-registering the ceiling ex-works prices, FAS is already actively involved in this work. So far, FAS has approved 25 ceiling ex-works prices of 6 manufacturers for reference medicinal drugs.

Another important theme covered by the speaker was related to the pilot projects on drug reimbursement.

“A drug reimbursement system should take into account the interests of everybody: manufacturers, patients, the medical community and administrators. It is kind of an ideal world, the utopian “Sun Town”. But when we begin to count and look at the circumstances as to how the “Sun Town” should be built, questions emerge that must be answered”, concluded Timophei Nizhegorodtsev.

The Federal Antimonopoly Service is so far the only body that has analyzed possible drug reimbursement models based on the data of a project for drug supplies to patients suffering from acute cardiovascular diseases. For example, FAS exposed a potential budget shortage due to use of obsolete, “tentatively correct” morbidity data. There are also no clear criteria of efficiency of such projects.

“Although the difference between the programme costs between the three drug supply models of is not significant, the epidemiological consequences for the population are principally different”, explains Head of FAS Department for Control over Social Sphere and Trade. “At the same time, the goal of the drug reimbursement programme is to provide treatment to the maximum number of people under a particular budget, but with much better opportunities for pharmaceutical manufacturers involved in the pilot project. Therefore, the median pricing is the must reasonable in terms of possible economic, epidemiological and administrative effects. It allows to provide medicines, particularly, expensive drugs to patients free-of-charge, enhance a choice of drugs for patients and wholesalers by involving a lot of pharmaceutical companies in the project, and also decreases the risk of inventory shortage”.

Overall, to be able to fulfill the pilot projects on drug reimbursement, the following conditions should be met, in FAS opinion:

- Devise and approve a regulatory framework at the federal and regional levels;

- Give a conservative assessment of patients and relevant budgets (without reduction);

- Devise indices for pilot projects’ efficiency that would be the same for all regions;

- Organize pilot projects in no more than 2-5 regions. (At the same time, the pilot project should fully cover each region rather that its separate districts);

- Participants of the pilot projects must guarantee presence of a developed information system for electronic prescription of drugs and their movement from the consulting physician to the pharmacy and back, availability of the regional budget and also guarantee prompt adoption of a regulatory framework to launch a project in a region.

Reference:

[1] 983U Order of the Ministry of Healthcare of the Russian Federation and the Federal Tariff Service.