In the Federal budget for 2017-2019 should be provided funds for a pilot project for the return of money for ineffective treatment. This follows from the orders of first Deputy Prime Minister Igor Shuvalov, the Ministry of Finance, the Ministry of health and Ministry of economic development dated November 21, 2016. A copy is available . The authenticity of the document was confirmed by the representative Shuvalov.
We are talking about risk-sharing (risk sharing, or the agreement on risk sharing). It is a model in which the state buys drugs from pharmaceutical companies on certain conditions: if treatment is ineffective, the companies return the money to the authorities. There is a second variant of risk-sharing when the payment is made only upon successful treatment.
Budget money will be spent on the establishment and operation of a special organization that will implement in Russia the model of risk-sharing, to the letter the first Deputy Minister of healthcare Igor Kagramanyan to the government dated 13 October (a copy is in). The document notes that the new Agency will need to evaluate the effectiveness of treatment. How it will be assessed, the health Ministry said. The Agency has estimated the cost of such an organization in 20 mln signed in behalf of the Deputy Prime Minister, is unknown: neither the press service Shuvalov, nor to the relevant ministries are unable to answer this question.
Application of the model, providing return of money for ineffective treatment, common in Europe. From 1993 to 2013 in the European Union was signed 148 of such agreements. 71% of all agreements have in Italy, UK, Netherlands and Sweden. In other key markets such as Germany, France and Spain, the risk-sharing is not so widespread — about 2-3% of all agreements.
In the pilot project will involve drugs, particularly against cancer, hepatitis C, multiple sclerosis and rheumatoid arthritis. August 23, 2016, the health Ministry has sent to the regions information about the 14 drugs of the applicant, which produce nine international pharmaceutical companies: Bayer, BioMarin, Bristol-Myers Squibb, Novartis, Johnson & Johnson, MSD, Sanofi Genzyme, Roche, and Takeda.
The cost of drugs from the list — from 12 thousand to 331 thousand. (data provided by the analytical company DSM Group).
Examination of applications received from pharmaceutical companies by the Center for examination and quality control of medical care, Ministry of health, also said in the letter. Only institution on 8 December 2016 received approximately 25 applications from pharmaceutical companies for participation in risk-sharing, said the General Director of the center Vitaly Omel’yanovskiy.
The company applications describe the efficacy and indications for your drug prices. Data must be complete and correspond to reality, said Omel’yanovskii. While none of the applications was not consistent. The experts of the companies soon plan to ask the companies for clarifications and additional information, he explained.
In addition to properly made requests an additional requirement to the drugs-one applicants — registration in Russia, said Omel’yanovskii. The final decision to work with the medicine within the framework of the pilot or not accept the Ministry of health.
The legal framework for the application of the model of reimbursement for ineffective drugs yet to be established, said Omel’yanovskii. Its development involved the Ministry of health, Ministry of economic development and other interested agencies.
While in the pilot project are interested in three regions: Moscow, Moscow and Kaluga region, told Omel’yanovskii. This information is confirmed by the letter of Kagramanyan. In a press-service of relevant departments of the three regions did not respond to requests .
In the Moscow region planned to introduce a program for reimbursement for drugs against hepatitis C, said in July the chief hepatologist of the Ministry of health of the Moscow region Pavel Bogomolov in an interview with the online edition of “the suburbs today.” “This year in the Moscow region, risk-sharing will be launched with a high probability. Already has the consent of several major players in the pharmaceutical market,” said Bogomolov.
Negotiations about perspectives of implementation of the pilot project for the reimbursement of the costs of ineffective treatment with a number of regions leads MSD, told in its press-service. In addition to the already mentioned three regions of MSD advises Saint Petersburg, Tatarstan and Krasnodar. “The preparatory work of clarifying the terms of the treaties in the context of the current legislation”, — explained the press service of the manufacturer. On the negotiations with the regions is also stated in the press service of Bayer.