The process and methodologies for submitting and evaluating Health Technology Assessments (HTAs) in Poland – a short note
VRB Analytics Pvt Ltd
Health Economics & Outcome Research services, Real World Evidence, Market Access
Central agencies in the process include AHTAPol, also known as AOTMiT, responsible for conducting the Health Technology Assessment (HTA) and offering recommendations. The Ministry of Health (MoH) serves as the ultimate decision-maker, receiving and considering the assessments from AHTAPol. Following MoH approval, the National Health Fund (NFZ) takes charge of financing the approved health technologies.
Types of submissions categories:
1.????? A- General list
2.????? B- Drug programme
3.????? C- Chemotherapy catalogue
General procedure:
The manufacturer initiates the regulatory pathway by submitting the Health Technology Assessment (HTA) to the Ministry of Health (MoH). The MoH, in its role as the initial evaluator, conducts a formal assessment and then transmits the dossier to the Health Technology Assessment and Policy Analysis (AHTAPol), an entity established in 2005 for this purpose. AHTAPol meticulously undertakes a verification analysis before presenting the evaluation to the Transparency Committee (TC) for their expert opinion. The TC assesses the HTA and conveys its findings to the AHTAPol President. Subsequently, the AHTAPol President communicates the conclusive recommendation to the Economic Committee, initiating negotiations. Following this intricate process, the Economic Committee finalizes decisions, which are communicated back to the MoH. The MoH, as the final authority, issues decisions and updates the reimbursement list in adherence to the comprehensive evaluation. This entire procedure spans approximately 180-240 days. Notably, during this period, decisions from Health Technology Assessments in other EU countries are taken into account. Furthermore, considerations include the determination of Min/Max prices, as well as factoring in rebates and discounts from EU/EFTA countries. Out of the pocket payments are generally up to 30%. (Note: - The analysis of previous submissions shows that the most common reason for nCP/nPR is failure to prove cost-effectiveness).
Types of decisions: Final decision of taken by Minister of Health (MOH). Based on the Council Position and President Recommendation, the decision can be classified as:
Reason for the negative decisions:
1.????? OS – lack of results or no statistically significant improvement in overall survival (OS) has been proven, little benefit was demonstrated,
2.????? QoL – lack of results or no statistically significant improvement in quality of life (QoL) has been proven,
3.????? Efficacy – the results (not referring directly to OS or QoL) included in the clinical analysis were subject to high uncertainty,
4.????? Safety profile – the therapy’s uncertain or unfavourable safety profile,
领英推荐
5.????? Cost-effectiveness – lack of demonstrated cost-effectiveness of the therapy,
6.????? Economic analysis – incorrectly conducted economic analysis or economic analysis associated with high uncertainty,
7.????? Population – the evidence did not match the population indicated in the reimbursement application,
8.????? Methodology – the studies included in the analysis were characterised by poor quality or the wrong methodology of clinical analysis was used,
9.????? Other.
Reasons for conditional recommendation:
1.????? Price – regarding the condition of reducing the price per se or "reducing the cost of therapy to the level of cost-effectiveness",
2.????? RSS (risk-sharing agreements) – when the condition consists in the development of a risk-sharing instrument or when the RSS proposed by the MAH has not been accepted. The following are the general RSS proposed by the manufacturer:
3.????? Change of stipulations – in particular when those changes concern stipulations of a drug programme (e.g. population reduction),
4.????? Other – e.g., in the case a decision limited in time and subject to conditions is issued, after the laps of which a reassessment will take place or in the case of which reimbursement will be granted under the condition of joining the existing drug programme.
Previous HTAs decisions (orders), Public Information Bulletin (BIP) website:
TLK list - Drug technologies of high clinical value: https://bipold.aotm.gov.pl/index.php/wykaz-tlk
List of opinions on active substances for off-label indications: https://bipold.aotm.gov.pl/index.php/rada-przejrzystosci/5084-wykaz-obowiazujacych-opinii