Introduction: The significant therapeutic potential of the advanced therapies (ATs) has predetermined the increased interests in their development mainly in the context of rare diseases most of which are genetically determined. However, there are still many challenges in front of the health insurance funds related to the cost-effectiveness and budget impact issues of these therapies. Our aim was to review and analyze the potential of low- and middle-income countries for health technology assessment (HTA) of advanced therapies focusing on Bulgaria, Romania and Poland as reference countries. A literature review of the existing good practices related to HTA of advanced therapies across the world and comparison with the national reality were performed. A list of challenges and issues from the point of view of the payer institution of all analyzed countries was performed. Pilot recommendations on how to overcome the barriers were created based on the existing practices and the potential of the national system.Discussion: 15 out of 80 articles identified in PubMed were found as applicable to the study scope as most of them were published in the period 2019–2021. Undoubtedly, the main challenges correspond to the high treatment costs, the uncertainty in clinical effectiveness, and poor HTA methodological approaches applicable for ATs worldwide. The issues identified for low and middle-income countries are similar having as well the lack of enough qualified health economists for the purposes of assessment and appraisal of HTA dossiers of the advanced therapies, lack of adequate existing separate financial programs for those therapies, and not preparedness of the health system and the society as a whole for such therapies.Conclusions: Despite the difficulties and challenges, the advanced therapies can be defined as a futuristic therapy for which great discoveries are yet to come. Therefore, each country should consider the implementation of reliable and nationally oriented programs for HTA and adequate financial coverage of these therapies.
Heart failure has becoming an increasing medical, economic, and social problem globally. The prevalence of this syndrome is rising, and despite unequivocal positive effects of modern therapy, reduction of mortality has been achieved at the cost of more frequent hospitalisations. Unlike in many European countries, in Poland heart failure is usually recognised later, at a more advanced stage of the disease, leaving less time for ambulatory treatment and resulting in a high number of hospitalisations. The current paper presents the most important data regarding morbidity and mortality due to heart failure in Poland. The experts in the field focus on the key source of high costs of therapy and highlight several critical organisational deficits present in the Polish health care system. This background information builds a basis for a concept of coordinated care for patients with heart failure. The paper discusses the fundamental elements of the system of coordinated care for patients with heart failure necessary to enhance the diagnosis, improve therapeutic effects, and reduce medical, economic, and social costs.
Chronic obstructive pulmonary disease (COPD) is currently the third most common cause of death worldwide and the total number of people affected reaches over 200 million. It is estimated that approximately 50 % of persons having COPD are not aware of it. In the EU, it is estimated that the total annual costs of COPD exceed €140 billion, and the expected increase in the number of cases and deaths due to COPD would further enhance economic and social costs of the disease. In this article we present the results of cost analysis of health care benefits associated with the treatment of COPD and with the disease-related incapacity for work. The analysis is based on the data of the National Health Fund and the Social Insurance Institutions, public payers of health benefits in Poland. The annual 2012 expenditures incurred for COPD treatment was €40 million, and the benefits associated with incapacity for work reached more than €55 million. The extent of these expenditures indicates that it is necessary to optimize the functioning system, including the allocation of resources for prevention, social awareness, and detection of COPD at early stages when treatment costs are relatively low.
Migraine is a common primary headache disease, which reduces quality of life. About 8% of migraineurs suffer from chronic migraine (CM), which is the most severe and troublesome type. It has been proven that onabotulinumtoxinA (ONA-BoNT/A) significantly improves CM, presumably inhibiting the release of calcitonin gene-related peptide (CGRP) and other neurotransmitters from c-fibres endings, and thus decreasing activation of nociceptive pathways and transmission of pain. The aim of this position paper was to assess the place of ONA-BoNT/A for the prophylaxis of CM in adults. The authors have compared the efficacy, safety and tolerance of the toxin to those of classical oral preventive therapies as well as to recently introduced anti-CGRP-pathway monoclonal antibodies. The results of randomised controlled studies of ONA-BoNT/A have been compared to open label (real world practice) trials.
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