FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology

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Vol 7, No 4 (2014)
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Russian Studies

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the article presents the results of analysis of the state procurement of the drugs for rare diseases. The analysis was conducted on the basis of 1499 selected trade procedures on rare disease drugs procurement in 2013. The article evaluates the state of competition in procurement of monopoly and alternative drugs, the level of price reduction as a result of trading, the amount and volume of purchases in the subjects of the Russian Federation. The analysis results show that tender procedures used for the procurement of monopoly drugs are ineffective because of the lack of competition; distributors are not interested in price reduction at noncompetitive procedures. In the procurement of alternative drugs at competitive trade procedures it is possible to reach a high level of price reduction, indicating overpricing of the initial (maximum) contract price of procured drugs.

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the goal of our research was to carry out an analysis of psychotropic drug utilization used for patients with schizophrenia in two (state and municipal) in-patient clinics during 2000 and 2010, using the DDD methodology. As the result, we found out that psychotropic drug utilization increased from 2000 to 2010 in both types of in-patient clinics. Consumption of second-generation antipsychotics increase in state clinic in 2010. And in the state clinic we can observe a favorable trend in the decrease of antidepressants and tranquilizers consumption.

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decision tree and Markov model we used for calculating the anticipated costs when comparing two alternative medical organizational technologies, taking into account the continuing incapacity of the patient: the patient in the treatment of neurological hospital in the treatment of a patient in a neurological hospital with subsequent transfer him to the medical rehabilitation. Under the conditions of this model the expected cost to the patient, taking into account the likelihood of continued disability, using a phased treatment less compared to traditional treatment. Thus, by using the simulation we determined the decision tree after prediction for a particular combination of characteristics and events. The structure of the «cost disease» treatment costs of patients who received combined, staged treatment in a neurological hospital with subsequent transfer to the Department of Rehabilitation was only 6.6%. Results of treatment of patients with neurological disorders in the treatment of a neurological hospital with subsequent transfer to the Department of Rehabilitation characterized: medical effectiveness, satisfaction with social, economic efficiency.

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study goal is to prepare a road map for development of price regulation system and system of drug supply at the expense of funds of the healthcare system of the Russian Federation.

Study methodology. A structured interview was conducted which involved 11 experts - key participants of the drug price regulation process in the Russian Federation in order to identify current problems and proposals on system reformation; there were analyzed manufacturer’s prices limits, prices of public drug supply contracts, prices for 25 drugs for treatment of malignant neoplasms and cardiovascular diseases, included in the list of vital and essential drugs (VED list) at Russian pharmacies; a road map for development of price regulation system and system of drug supply out of funds of the healthcare system of the Russian Federation for 2015-2017 was prepared.

Study results. According to the participants of a structured interview which are the representatives of the Ministry of Health, pharmaceutical companies, distributors and pharmacy organizations,
the existing system of drug price regulation requires significant legislative and structural changes aimed at transition from the system of state regulation of prices on drugs from the VED list to the system of public drug supply (comprehensive drug reimbursement system) and reference pricing. The analysis of prices on drugs from the VED list revealed significant (up to 25-fold) price differences for drugs within a single INN, one pack size and one dosage form based on the review of information from all sources.

Conclusion. According to the prepared road map, the fundamental changes in the existing system of drug price regulation and public drug supply out of funds of the healthcare system of the Russian Federation shall include the following: transition from the price registration according to the trade names to the registration of drug prices according to international nonproprietary names (reference price) and promulgation of this system for all drugs purchased at public expense; negotiated pricing for drugs, which have no analogues; legislative regulation and introduction of co-payment of the population in case of expansion of public financing programs of drug supply. The initial steps in preparation for the reform of the system should be as follows: transition of the pharmaceutical manufacturers to compliance with the requirements of GMP standards; monitoring of quality, efficacy and safety of drugs circulating on the Russian market with further cancellation of drug registration in case of inefficacy; development of the list of interchangeable drugs and the list of drugs financed out of funds of the healthcare system; pilot implementation of reference pricing for drugs under the current drug reimbursement system.

Economic Review

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financing of rare disease drugs remains a serious problem for both foreign countries and our country. A limited budget for treatment of such patients determines significant difficulties for its distribution as part of drug supply to rare disease patients. The introduction of multiple-criteria analysis for identifying priority areas for financing diseases can be considered as one of the approaches to increase objectivity and transparency of decisions in the area of rare diseases. The main advantage of multiple-criteria analysis is the comprehensiveness of decisions: this type of analysis can provide consideration of disease severity and treatment efficacy. In 2014, a pilot study was conducted in the Russian Federation which involved 85 experts in various fields of medicine (clinical medicine, health financing, health management, scientific activity), which demonstrated that, from the point of view of experts, the characteristics of treatment are more important for identification of rare disease funding priority than the characteristics of the disease itself.

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the analysis of foreign pricing and drug supply public funding systems (or a so-called drug reimbursement) shows a substantial variety and presence of national peculiarities; however the majority of the developed foreign countries apply reference pricing. As part of the introduction of reference pricing, internal and external price regulation can be distinguished. External referencing system has been used in Russia for several years already, while national or internal reference pricing system hasn’t been applied until recently. The introduction of the notion of interchangeability of drugs at the legislative level creates the preconditions for a deeper study of advantages and disadvantages of this system, as well as the possibility of its use in the Russian Federation. This article describes various options for the introduction of this system, its advantages and limitations.

ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)