Nazarkina V. Theoretical and applied substantiation of the socio-economic system of pricing of medicines on the basis of health technologies assessment

Українська версія

Thesis for the degree of Doctor of Science (DSc)

State registration number

0521U101281

Applicant for

Specialization

  • 15.00.01 - Технологія ліків, організація фармацевтичної справи та судова фармація

06-05-2021

Specialized Academic Board

Д 64.605.02

National University of Pharmacy

Essay

The dissertation is devoted to the development and substantiation of theoretical, methodological, scientific and applied principles of improving the pricing system for medicines on the basis of health technology assessment (HTA). Based on the results of the structure and content of the legislative and regulatory framework governing the pricing of drugs, the systematization of regulations by hierarchy, objects and directions and рroposed their codification. Тhe priority directions of state regulation of drug prices are determined: regulation of surcharges; tax benefits / discounts; use of reference pricing; orientation of the health care system on the predominant use of generic drugs; tenders and negotiations, joint procurement, value-based pricing and HTA. An analysis of the effectiveness of the current system of state regulation of drug prices in Ukraine was conducted. The priority areas for its improvement in terms of increasing the affordability of medicines have been identified. The basic methodological bases of application of reference pricing in different countries are generalized. Methods of calculating the cost of production in domestic and foreign practice were generalized and systematized. A scientific and methodological substantiation of the socio-economic feasibility of implementing and evaluating the effectiveness of pilot projects and government programs on state price regulation and the introduction of reference pricing for drugs. The priority directions of implementation of pilot projects on state regulation of prices and reference pricing of drugs by the most common nosologies are substantiated. According to the results of the survey of medical and pharmaceutical workers, an assessment of the current state and problems of pharmaceutical supply of CVD patients was carried out according to the government's reimbursement program. A generalized model of reference pricing for insulin drugs was developed. The proposed model provides a rationale for the choice of reference countries, criteria for the distribution of insulin drugs into reference groups, the algorithm for calculating the wholesale and reference price (reimbursement prices) for insulin drugs. Тhe business process of forming the register of reference price (reimbursement prices) and standard operating procedures (SOP) pricing for insulin drugs is proposed. According to the results of a survey of administrative and production staff of pharmacies that have licenses to manufacture drugs, the problems of extemporaneous formulation were investigated. Methodical recommendations on formation of prime cost of drugs of serial production in the conditions of drugstores were developed. Theoretical and methodological bases of the organization of НТА are developed, on the basis of which for the first time recommendations to creation of the branch standard of carrying out НTA are developed, its structure and the maintenance, in particular the basic components concerning pricing and reimbursement of drugs are substantiated. The materials of the research in the preparation of the draft Resolution of the Cabinet of Ministers of Ukraine "On approval of the Procedure for state assessment of medical technologies", in particular, comparative note and regulatory impact analysis. Methodical approaches to price and pharmacoeconomic evaluation of new and existing health technologies in pharmacotherapy of socially dangerous diseases (cardiovascular diseases, type I and II diabetes mellitus, etc.) are substantiated. The analysis of drug availability for CVD treatment using HTA methodology (in particular, clinical and economic analysis, ABC-VEN analysis, frequency analysis of drug prescriptions) was performed, as well as calculations and analysis of drug price indices, availability, liquidity and solvency adequacy. An analysis of the state and features of the organization of public procurement in health care as a tool to ensure the affordability of drugs was conducted. Theoretical and applied approaches to the development of a pricing model for essential drugs in the context of the introduction of HTA were substantiated. For the first time, the international experience of training specialists in НТА in the historical aspect was analyzed and systematized. A basic program for conducting information seminars on the problems of HTA implementation in Ukraine was developed. According to the results of the survey of health professionals, the state, problems and prospects of HTA implementation at the current stage of reforming the industry were studied. The qualification characteristic of the expert on HTA was developed. For the first time, the main competencies of the specialist, the structure and content of the educational program "Health technologies assessment" were substantiated.

Files

Similar theses