Pharmacoeconomic Guidelines: Hungary
Country/Region: Hungary
Published PE Recommendations
'Az Emberi Erőforrások Minisztériuma egészségügyi szakmai irányelve az egészség-gazdaságtani elemzések készítéséhez és értékeléséhez
(The Technical Guideline on Conducting and Assessment of Health-Economic Analyses by the Ministry of Human Resources) Egészségügyi Közlöny 2021/21. 2178-2200.
Published PE Recommendations Source:
Additional Information:
Further considerations regarding the technology assessments related to reimbursement procedures can be found here.
Information current as of Wednesday, January 19, 2022
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | Published PE Recommendations |
| Title and year of the document | Az Emberi Erőforrások Minisztériuma szakmai irányelve az egészség-gazdaságtani elemzések készítéséhez és értékeléséhez. The Technical Guideline on Conducting and Assessment of Health-Economic Analyses by the Ministry of Human Resources) Egészségügyi Közlöny (2021) |
| Affiliation of authors | ISPOR Hungary Chapter / Hungarian Health Economics Association (META), National Institute of Pharmacy and Nutrition - Department of Health Technology Assessment (OGYÉI-TéF), Experts from the public sector and academia. Feedback of experts from the private sector were collected via stakeholder consultation. |
| Purpose of the document | To support all decision-making processes with sound cost/effectiveness data and high quality economic assessments. |
| Standard reporting format included | No complete reporting format is defined in the Guideline, however it includes several exemplary tables that can be used to report certain parts (e.g. clinical studies, cost elements, Budget impact) of the analysis in a transparent and clear way. The guidance also provides a recommended structure for the analyses. |
| Disclosure | It is necessary to provide the disclose of the authorship, sponsorship and the results of the health economic analysis for the end user. |
| Target audience of funding/ author's interests | Manufacturers, sponsors, health technology assessors, health providers, policy makers, and purchasers of health care services. |
| Perspective | The perspective of the analysis must be the national healthcare system’s perspective as the base case. If a significant part of benefits and costs manifest outside of the healthcare system, it is appropriate to provide a supplementary analysis with societal perspective as well. |
| Indication | The indication used in the analysis must be precisely described. In the case of reimbursement, the claimed indication may only target the patient population for which the licenced therapeutic indication and contraindications together allow it. |
| Target population | The target population of the analysis must be described. |
| Subgroup analysis | Possible. For budget impact analysis if necessary, it is also recommended to define subgroups that are medically sound and supported by clinical and cost-effectiveness evidence. Selected subgroups should be defined and identified on the basis of clear criteria, based on pre-defined, biologically, or clinically justified conditions. |
| Choice of comparator | The comparator must be the routinely used therapy for that population examined in the health economic analysis / claimed for reimbursement, that could be replaced by the new health technology. |
| Time horizon | The time horizon should be long enough to cover all significant clinical and cost consequences that are directly related to the intervention, however the life expectancy of the Hungarian population at the given age and disease specific mortality should be taken into account. If the time horizon is several decades long, results should be presented on shorter proportionally relevant time horizons as well, in sensitivity analyses. |
| Assumptions required | The assumptions used in the analysis must be presented as part of the analysis, and ideally, its impact on the cost-effectiveness conclusion should be evaluated. |
| Preferred analytical technique | The preferred method is cost-utility analysis (CUA), which can be supplemented with a cost-effectiveness analysis (CEA). If properly justified, cost-minimization analysis (CMA), cost-consequences analysis (CCA) or cost-benefit analysis (CBA) can also be chosen. |
| Costs to be included | In health economic analyses conducted from the local healthcare system's perspective, only direct costs should be included. In analyses conducted from the societal perspective, indirect costs should also be included. |
| Source of costs | The source of costs should be clearly stated in the analysis. If the study is conducted from the perspective of the healthcare system, the publicly available costs of health technologies and services should be used in the analysis. |
| Modeling | Modeling should be used to analyze costs and outcomes. The model used for the economic analysis must be presented and submitted (although this is set out by law, not by the current guidance). |
| Systematic review of evidences | Clinical results used in economic analysis have to be searched, assessed and presented according to the rules evidence-based medicine and the internationally accepted methodologies for systematic reviews. |
| Preference for effectiveness over efficacy | The health economic analysis seek to quantify health gains using routine, long-term evidence (when available) in addition to the results of randomized, controlled trials. |
| Preferred outcome measure | As cost-utility analysis (CUA) is the preferred type of analysis, the final outcomes should be presented in Quality-Adjusted Life Years (QALYs). |
| Preferred method to derive utility | It is preferred to use Hungarian health-related quality of life (HRQoL) data gathered by using validated versions of questionnaires. If such data is not available, HRQoL data gathered from other countries can be accepted. |
| Equity issues stated | It is recommended to present the other aspects (e.g. patient and society related aspects) of the health technology assessment in question. |
| Discounting costs | Base-case: 3.7% |
| Discounting outcomes | Base-case: 3.7% |
| Sensitivity analysis-parameters and range | Sensitivity analyses should be conducted on all uncertain parameters. The range applied in the case of each parameter should be described properly. Ranges should be selected to be meaningful from a real-life perspective. |
| Sensitivity analysis-methods | Deterministic (DSA) and probabilistic (PSA) sensitivity analyses can be used with proper documentation of the methodology. The results of the sensitivity analyses should be described properly. The results of the DSA must be explained and presented on a tornado diagram. |
| Presenting results | Results must be presented in detail and should be compared to the threshold described. |
| Incremental analysis | In addition to the incremental cost-effectiveness rates, results directly related to the effectiveness, efficacy, and cost of the technology are required to be presented. |
| Total costs vs effectiveness (cost/effectiveness ratio) | In the case of cost-utility analysis the incremental cost effectiveness ratio must be presented which is quotient of the difference in the cost of the technologies to be compared and the difference in their health benefits expressed in QALYs. |
| Portability of results (Generalizability) | The generalizability of the results should be assessed if the claimed indication is different from the indication assessed in the analysis. |
| Financial impact analysis | Budget impact over the next 4-year period should be estimated. |
| Mandatory or recommended or voluntary | It is mandatory to conduct analyses according to the guideline. |
Acknowledgement: