Pharmacoeconomic Guidelines: Slovak Republic
Country/Region: Slovak Republic
PE Guidelines
Guidelines for Economic Evaluation of Health Care Interventions (August 2022) https://www.slov-lex.sk/pravne-predpisy/SK/ZZ/2011/422/
PE Guidelines Source:
Ministry of Health of the Slovak Republic
http://www.health.gov.sk/?farmako-ekonomicky-rozbor-lieku
http://www.health.gov.sk/?farmako-ekonomicky-rozbor-lieku
Information current as of Tuesday, August 16, 2022
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | PE Guidelines |
| Title and year of the document | Guidelines for Economic Evaluation of Health Care Interventions (August 2022) |
| Affiliation of authors | MoH, ISPOR |
| Purpose of the document | Provide methodological and reporting guidelines for PE evaluations and evaluation of medical devices. |
| Standard reporting format included | Yes |
| Disclosure | Yes |
| Target audience of funding/ author's interests | Decision makers, researchers, pharmaceutical companies |
| Perspective | Costs: Health care payer; Outcomes: society (for health-related quality of life: health state descriptions by patients, valuations from general public). |
| Indication | Approved indication |
| Target population | Relevant groups or sub-groups need to be defined. |
| Subgroup analysis | Yes |
| Choice of comparator | The most relevant alternative treatment which is either the the treatment that is most likely to be replaced by the new treatment or, in case of add-on treatments, the current treatment without the add-on product. |
| Time horizon | Lifetime (chronic conditions or acute conditions with long term sequelae), duration of the treatment or disease and its consequences (acute conditions without long term effects) or 5 years. |
| Assumptions required | Yes |
| Preferred analytical technique | Cost-utility analysis (CUA) if the treatment has an impact on health-related QoL that is significant to the patient or if there are multiple patient-relevant clinical outcome parameters expressed in different units. |
| Costs to be included | Direct health care costs should be included. These encompass costs directly related to the treatment of the disease as well as direct health care costs related to the disease in life years gained. |
| Source of costs | The identification, measurement and valuation of costs should be consistent with the perspective of the Slovak health care payer. Relevant sources should be used for unit costs. |
| Modeling | Yes, based on observational data from trials comparing the study medication and the comparator, observational databases and literature. |
| Systematic review of evidences | Yes, systematic review of the existing clinical and economic studies on the intervention, 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 | Yes |
| Preferred outcome measure | Final outcome parameters: life years gained (CEA) or QALYs gained (CUA) for chronic conditions or other relevant outcome variable, as in the clinical file, for acute conditions. |
| Preferred method to derive utility | TTO or SG (VAS). |
| Equity issues stated | A QALY is a QALY, no matter to whom it accrues. |
| Discounting costs | Future costs should be discounted at a rate of 5 %. |
| Discounting outcomes | Future benefits should be discounted at a rate of 5 %. |
| Sensitivity analysis-parameters and range | Interval estimates should be presented for each parameter in the economic evaluation. All different aspects of uncertainty in the evaluation should be addressed. Confidence interval around the ICER; Cost-effectiveness plane; cost-effectiveness acceptability curve; Tornado diagrams. |
| Sensitivity analysis-methods | Probabilistic sensitivity analyses should be performed on all uncertain parameters in a model. |
| Presenting results | Results should be presented in a defined form, it should contain the discounted costs, outcomes, incremental costs and incremental outcomes in a disaggregated form and separately for the study intervention and the comparator. |
| Incremental analysis | Yes |
| Total costs vs effectiveness (cost/effectiveness ratio) | Yes |
| Portability of results (Generalizability) | The patient population to which the pharmaco-economic evaluation applies should be consistent with the patient population defined in the clinical part of the reimbursement request submission. |
| Financial impact analysis | It is required for 5 years period under different scenarios. |
| Mandatory or recommended or voluntary | Mandatory |
Acknowledgement: