Pharmacoeconomic Guidelines: Poland
Country/Region: Poland
Submission Guidelines
Submission Guidelines Source:
Poland Agency for Health Technology Assessment
http://www.aotm.gov.pl/
http://www.aotm.gov.pl/
Additional Information:
Health Technology Assessment Guidelines Version 3.0 (2016) PDF in Polish
Information current as of Tuesday, August 23, 2022
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | Submission Guidelines |
| Title and year of the document | Health Technology Assessment Guidelines Version 3.0 (2016) |
| Affiliation of authors | AHTAPol, universities, authors of HTA analysis |
| Purpose of the document | Provide methodological and reporting guidelines for HTA evaluations of medical technologies (drugs, devices, procedures) |
| Standard reporting format included | Yes |
| Disclosure | Yes |
| Target audience of funding/ author's interests | Decision makers, researchers, pharmaceutical companies |
| Perspective | The perspective of the economic analysis should be the public payer's perspective, i.e. one of the entity financing health care services from public funds and the joint perspective of public payer and beneficiaries. It is possible to use only public payer's perspective if no or negligible co-payment exists. In justified cases additional perspectives should be used, i.e. social, provider's or public finance perspective. The perspective of budget impact analysis should be public payer's perspective and, in case of co-payment, joint perspective of public payer and the patients. |
| Indication | Approved indication |
| Target population | Relevant groups or sub-groups need to be defined with their estimated size. |
| Subgroup analysis | Yes |
| Choice of comparator | Comparator must be the current medical practice which would be probably replaced by the assessed technology. It is advised that the comparator is the cheapest, most effective, in line with current guidelines and clinical practice. Comparators should be consistent between the clinical and economic analyses. |
| Time horizon | Time horizon of the economic analysis should be long enough to allow proper assessment of differences between results and cost of the assessed health technology and the comparators. |
| Assumptions required | Yes |
| Preferred analytical technique | A regular economic analysis should involve cost-utility analysis or cost-effectiveness analysis. Performing both at the same time: cost-utility and cost-effectiveness is recommended. In case of lack of data for cost-utility analysis cost-effectiveness analysis should be performed; in case of clinical equivalence/no clinically significant differences between compared health technologies cost-minimization must be performed; if cost-utility, cost-effectiveness and cost-minimization analysis is not possible cost-consequence analysis should be performed. If cost-utility, cost-effectiveness and cost-minimization analyses are not possible, it is allowed to perform only the cost-consequence analysis. Cost-benefit analysis is not recommended. |
| Costs to be included | a) direct medical costs; b) direct non-medical costs; c) indirect costs |
| Source of costs | The identification, measurement and valuation of costs should be consistent with the perspective of the Polish health care payer. The cost data should reflect the actual cost associated with the use of the assessed intervention and the comparators, taking into consideration Risk Sharing Schemes, if possible. The following methods of assessing the monetary value of used resources can be implemented: list of standard costs; formerly published research, local scales of charges or service tariffs for specific procedures, direct calculation, data from tenders (inpatient procurements). It is recommended to use the friction costs method for the loss of productivity caused by disease or premature death. The unit cost of lost productivity associated with paid work should be determined on the basis of the gross domestic product (GDP) per one employed person, adjusted to marginal productivity. |
| Modeling | Yes, based on data from trials comparing the study medication and the comparator, observational databases and literature. It is important that the compared alternative technology corresponds to Polish conditions. The model structure should be simple and transparent, corresponding with defined decision problem and be developed with commonly available tools enabling its technical verification except for justified cases. Assumptions should be clear, well justified and tested in sensitivity analyses. |
| Systematic review of evidences | The data collected in the course of clinical analysis should be searched and selected in systematic review, including unpublished studies and studies with negative results, based on detailed protocol. The search strategy should be reproducible and selection criteria and procedures clearly presented. |
| Preference for effectiveness over efficacy | Yes |
| Preferred outcome measure | Yes -QALY |
| Preferred method to derive utility | Utility may be measured using indirect methods, direct methods or questionnaire mapping. It is advised to use indirect methods, preferably through EQ-5D questionnaire. |
| Equity issues stated | Yes, the following issues should be considered: which groups of patients, if any, could be favored or discriminated as a result of the assumptions adopted in the economic analysis? Is the access to the medical technology guaranteed to be equal, when the needs are equal? Is a narrow group of persons expected to receive a big benefit, or the benefit is small but of general character? Does the technology constitute a response for the persons with significant health needs, who are not offered any available treatment method at the moment or whose access to treatment is limited? It should be considered, whether a decision to finance the assessed technology could lead to any social problems, including: an impact on the level of patient satisfaction with the received medical care, a threat of rejection of the procedure by particular patients, can it result in or change patient stigmatization. It should be determined whether the use of the technology imposes special requirements related to the patients/caregiver, the need to ensure the patient's right to dignity and privacy, and confidentiality of his/her information, the need to take into account individual preferences, after providing the patient/caregiver with information as required by law. It should also be analyzed, whether the decision concerning the technology in question has an impact on the rights of a patient or on human rights. |
| Discounting costs | The assumed rate of discount is equal to: 5% – in the basic analysis; 0% – in sensitivity analyses. |
| Discounting outcomes | The assumed rate of discount is equal to: 3.5% – in the basic analysis; 0% – in sensitivity analyses. |
| Sensitivity analysis-parameters and range | The scope of parameter variability should be determined on the basis of a review of publications, experts' opinions or, if data is upset, on the basis of adopted arbitrary dispersion range in order to investigate the effect of changing the value of a given parameter on the results of the analysis. The sensitivity analysis should: identify uncertain parameters, define an justify the scope of variability of uncertain parameters and calculate the main results of the analysis (health outcomes and their difference, total costs and their difference, ICER/ICUR, CER/CUR, assuming specific variability of uncertain parameters. |
| Sensitivity analysis-methods | Yes. In economic analysis at least one-way sensitivity analysis and probabilistic analysis should be conducted (decision of non-conducting probability analysis should be justified) |
| Presenting results | The results of enocomic analysis shoud be presented as: 1) total health outcomes considered in the economic analysis and, separately, total costs of the compared technologies, various categories of costs, the difference in total costs and health outcomes, the difference in the individual cost categories. The results should be presented as the mean value with dispersion measures (from the probabilistic analysis) 2) incremental (ICER/ICUR and absolute CER/CUR ratios of costs to health outcomes, if their presentation is justified. |
| Incremental analysis | Yes |
| Total costs vs effectiveness (cost/effectiveness ratio) | Yes |
| Portability of results (Generalizability) | Health outcomes included in the economic analysis for the intervention and comparators should be based on the clinical analysis. Choice of comparators for the economic analysis should be consistent with the decision problem analysis and the clinical analysis. 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 - see the whole point 5 of he Guidelines. The budget impact analysis determines the financial consequences of the introduction of the assessed health technology in the Polish health care system. |
| Mandatory or recommended or voluntary | For reimbursement process of drugs it is mandatory to enclose 3 types of HTA analysis: clinical effectiveness analysis, economic analysis and budget impact analysis; methodology of these analysis (described in AHTAPol guidelines) is recommended |
Acknowledgement: