RISK-SHARING IN RUSSIAN HEALTHCARE SYSTEM – THE IMMEDIATE FUTURE OR A DISTANT PROSPECT?

In FAS opinion, implementing such programme in Russia is possible only subject to several conditions

An obvious advantage of a risk-sharing system* is accelerating access of patients to innovative drugs. The international practice shows, however, that such contracts also have shortcomings, affecting patients, medical facilities and payers.

As noticeable from open sources, patients associate a serious risk of employing this system with being involved in the programme without drugs giving the expected effect. It is also probable that upon completing the pilot projects access of patients to the drug that proved its efficacy will be limited.

“When we discussed possibility to launch pilot risk-sharing projects, a lot of regions rejected the idea since it incurs particular financial obligations that they cannot fulfill due to absence of such items in the budget”, explained Head of FAS Department for Control Over Social Sphere and Trade, Timophei Nizhegorodtsev, at theVI International Conference on “Health Technology Assessment: Innovations in the National Healthcare System. Personalized Medicine”. “It means that money are available to perform experiments but not available to support ongoing system-wide performance”.

Medical facilities, in their turn, emphasize high costs and administrative barriers associated with implementation of such agreements. They also stress the difficulties related to data computerization and patient control as well as managing several contracts simultaneously. Payers face obstacles in view of the complexity of identifying efficacy indicators that can be measured accurately.

“Therefore, the question which effects from drug use we can register and how they can be measured is in the focus of ongoing discussions”, pointed out Head of FAS Department.

There is no integrated information system enabling to accumulate data at the regional and national levels.

“Our healthcare system is not ready institutionally for risk-sharing. The system of pharmaceutical control is currently under development; there is no proper control over relations between medical practitioners and pharmaceutical companies. Furthermore, the risk-sharing proposals submitted to FAS do not comply with the provisions of the Law on contractual system. Therefore, the programme cannot be fulfilled so far in our legal environment”, underlined Timophei Nizhegorodtsev.

In FAS opinion, a risk-sharing programme can be used in Russia only subject to the following conditions:

• Drugs should be innovative (reference drugs) and patent-protected;

• There should be no registered therapeutic analogues and the need to use a drug should be determined by impossibility to use other medications and aimed at protecting the rights of the population for access to innovative drugs in life-threatening conditions;

• Drugs should not be on the list of vital and essential medicines;

• Ex-works drug prices should not exceed the price in the reference countries;

• Projects should be aimed at assessment of drug economic efficiency subject to 100 % compensation of the costs of budgetary spending by the drug suppliers in case of a negative outcome of the pilot project;

• The results should be determined through clear, measurable efficacy indicators;

• Patients that get medicinal drugs in the projects must be insured under the Law on drugs circulation and have guarantees for continuation of financing if an agreement is no longer valid, subject to established efficacy with regard to a particular patient;

• The agreements should be executed under the common rules and requirements, sample documents, drafted and approved by the Ministry of Healthcare of the Russian Federation.

“If we’d like to discuss result-oriented execution of such contracts, we must focus on developing a system of reimbursement for medicines since risk-sharing is a private case of developing this system. When a medicine reimbursement system is implemented, such contracts will not contradict the Law on the contractual system and the institutional environment for drug procurement”, concluded Timophei Nizhegorodtsev.

Background:

*Risk-sharing system means that the state pays manufacturers for use of only those innovative drugs that proved to be efficient. I.e., no results – no payment. It seems to be an ideal model of reimbursement for medicines, when most risks fall on manufacturers, with whom payers, for example, medical facilities, enter into contracts.