Pharmacoeconomic Guidelines: Ukraine
Country/Region: Ukraine
Submission Guidelines
| State Health Technology Assessment for medicines |
Submission Guidelines Source:
Information current as of Tuesday, January 9, 2024
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | Submission Guidelines |
| Title and year of the document | State Health Technology Assessment for medicines (2023 Ukrainian Version) |
| Affiliation of authors | Ministry of Health of Ukraine, State Enterprise "State Expert Center of the Ministry of Health of Ukraine" (Department of Health Technology Assessment and Rational Pharmacotherapy) |
| Purpose of the document | This guideline defines methodological recommendations for stakeholders for conducting HTA of medicines in Ukraine, including development of dossier submissions, their expertise by the HTA body, abbreviated HTA upon the Ministry of Health (MoH) requests for the inclusion of medicines on regulatory lists (National list of essential medicines, the nomenclature) and the use of HTA recommendations for decision-making and in real clinical practice. |
| Standard reporting format included | Yes |
| Disclosure | Yes |
| Target audience of funding/ author's interests | HTA experts, manufacturers, health providers, decision makers, purchasers of health care services, academics. |
| Perspective | The analysis should be carried out taking into account the capabilities of the purchaser to finance medical technologies and services from the state and local budgets, as well as the capacity of the health care institution, which is obliged to finance medical services from the state and local budgets taking into account the availability of mechanisms for co-payment for medical services (common perspective of the state budget and patients). If the co-payment of patients is absent or insignificant in comparison with the expenses of the state and local budgets, only the perspective of the state and local budgets can be used. |
| Indication | Approved indication. In case if unregistered medicine is being evaluated - the indication has to be approved in countries with strict regulatory system (such as USA, Europe, Canada, Japan, Australia etc.). |
| Target population | Relevant groups or sub-groups need to be defined. |
| Subgroup analysis | Yes |
| Choice of comparator | The comparator should be a medicine or other medical technology, which is the current practice of treatment in Ukraine and which is the most prescribed therapy in Ukraine, widely used in clinical practice (incl. which is included in the healthcare industry standards, and registered in Ukraine for the relevant indication and line of treatment). |
| Time horizon | Time horizon of the economic analysis should be long enough to allow proper assessment of differences in health outcomes and costs between the assessed health technology and the comparators. The chosen length of the time horizon should be appropriate to the nature of the disease (acute or chronic) and record changes in the patient's health for a period of time sufficient to assess such changes in full. The time horizon shorter than the patient's life expectancy could be used if there is no difference in mortality between technologies compared, and the differences between outcomes and costs occur over a short period. In the case of a cost-minimizing analysis, the time horizon could be one year, provided that the costs of technologies compared are constant over time. |
| Assumptions required | Yes |
| Preferred analytical technique | The pharmacoeconomic method of analysis is always chosen according to the identified and measured health outcome. Pharmacoeconomic analysis should include cost-utility or cost-effectiveness analysis. In the absence of relevant quality of life data to perform a cost-utility analysis, a cost-effectiveness analysis is performed, which includes, among other indicators, data on life years gained (LYG). A standard economic analysis may include: a) cost-minimization analysis; b) cost-effectiveness analysis; c) cost-utility analysis; d) cost-benefit analysis |
| Costs to be included | Pharmacoeconomic analysis should include the cost of resources used in Ukraine, when using medical technology in daily clinical practice. Identification of cost categories and determination of the method of pharmacoeconomic analysis should correspond to the perspective and time horizon of such analysis. A pharmacoeconomic model should include direct medical costs. Costs of other sectors of society, such as indirect costs, might be presented as an additional scenario if appropriate. |
| Source of costs | The identification, measurement and valuation of costs should be consistent with the payer perspective in the local settings. The recommended sources of costs should be used as follows: 1) a list of tariffs for medical services; 2) published studies provided the cost of medical services; 3) the cost of medical services at individual healthcare facilities; 4) electronic public procurement system; 5) register of wholesale prices for medicines; 6) orders of the MoH on the distribution of medicines under budget programs; 7) market research analytical systems. |
| Modeling | Yes, modeling is used when available data are insufficient to determine cost-effectiveness and to extrapolate and predict disease rates beyond the time horizon of a clinical trial. The structure of the model and the modeling method should correspond to the question posed in the study. It is recommended that the model be as simple and transparent as possible. However, it must maintain the level of detail required to correctly determine the cost-effectiveness of comparable medical technologies. |
| Systematic review of evidences | Yes, systematic review of the existing clinical and economic studies on the technology, including unpublished studies and studies with negative results. The search strategy should be reproducible and selection criteria and procedures clearly presented. |
| Preference for effectiveness over efficacy | Efficacy and effectiveness are assessed. Real-world data, if available, can be provided by the applicant as additional information for making decisions on financing and reimbursement of medical technology. Real-world data complement and refine the efficacy data obtained as the "gold standard" from randomised clinical trials. |
| Preferred outcome measure | Yes. Preference is given to presenting clinically significant endpoints (eg death, survival, number of cases, morbidity rates, functional efficiency, etc.). If the surrogate endpoint is used (a variable that indirectly determines the outcome of treatment, for example lowering blood pressure, changing the level of low-density lipoprotein cholesterol etc.) the applicant has to provide justification for its use and the related supporting information with the search result. |
| Preferred method to derive utility | Preference is given to data collected from patients involved in the same trial that is used as evidence of the clinical efficacy of the technologies compared. The tool for measuring the quality of life of adults is preferably the EQ-5D questionnaire (version EQ-5D-3L or EQ-5D-5L). |
| Equity issues stated | Yes |
| Discounting costs | The recommended discount rate in the baseline pharmacoeconomic analysis is 3% for treatment costs and outcomes (according to WHO recommendations) |
| Discounting outcomes | The recommended discount rate in the baseline pharmacoeconomic analysis is 3% for treatment costs and outcomes (according to WHO recommendations) |
| Sensitivity analysis-parameters and range | Sensitivity analysis should focus on the inputs that have the highest impact on the result (ICER). The sensitivity analysis aims to identify the most influential parameters, determine and argue the scope of variability of uncertain parameters, calculate the main results of the analysis (treatment results and their differences, total costs and their differences, ICER), assuming specific variability of inaccurate parameters (variability limits). Values from the ranges of input variability and assumptions should be chosen to estimate the minimum and maximum additional cost changes. The results of the sensitivity analysis should be presented in a table and graphically ("tornado diagram"). |
| Sensitivity analysis-methods | Yes. In the pharmacoeconomic analysis, at least one-way sensitivity analysis must be performed. It is recommended to conduct a probabilistic sensitivity analysis as a complement. |
| Presenting results | It is recommended to present the results of pharmacoeconomic analysis using the algorithm of the standard of consolidated reporting on pharmacoeconomic analysis - CHEERS (The consolidated Health Economics evaluation Reporting Standards), developed by ISPOR. As for the budget impact analysis - for each year during the period under review, both total and additional budget impact should be provided. Resource consumption and costs should be presented in separate tables to show changes in costs each year within the time horizon. |
| Incremental analysis | Yes |
| Total costs vs effectiveness (cost/effectiveness ratio) | Yes |
| Portability of results (Generalizability) | The patient population to which the economic evaluation applies should be consistent with the patient population defined in the clinical part of the reimbursement request submission. |
| Financial impact analysis | Yes. Budget impact analysis allows to comprehensively assess the consequences of the decision to finance medical technology with public funds. It determines the financial consequences of the introduction or withdrawal from the procurement / financing / reimbursement programs of the evaluated medical technology in the health care system in Ukraine, which may be supplemented by an analysis of the legal and organizational consequences of the decision to finance the evaluated medical technology at public expense. |
| Mandatory or recommended or voluntary | Recommended. All mandatory points are presented in the Decree of Cabinet of Ministers of Ukraine №1300 “On the approval of the state health technology assessment procedure” dated on 23 December, 2020. Compliance with the provisions of the Guideline by stakeholders facilitates planning and conducting HTA in a systematic way and optimizes the assessment of dossier submissions, as well as improves patients' access to publicly funded medicines in Ukraine. |
Acknowledgement:
| Oresta Piniazhko, PhD, Director of HTA Department of SEC of Ministry of Health of Ukraine; Alona Masheiko, PhD and Valeriia Serediuk, HTA Department of SEC of Ministry of Health of Ukraine, and the ISPOR Ukraine Chapter highly contributed to the key feature form. |