Pawel Kawalec

Pawel Kawalec
Jagiellonian University | UJ · Institute of Public Health

PhD, MD

About

191
Publications
28,050
Reads
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1,674
Citations
Citations since 2016
107 Research Items
1486 Citations
2016201720182019202020212022050100150200250300
2016201720182019202020212022050100150200250300
2016201720182019202020212022050100150200250300
2016201720182019202020212022050100150200250300
Additional affiliations
October 2002 - present
Jagiellonian University
Position
  • Professor (Assistant)
October 2002 - present
Instytut Zdrowia Publicznego
Position
  • Professor (Assistant)
October 2002 - present
Institute of Public Health
Position
  • Professor (Assistant)

Publications

Publications (191)
Article
Full-text available
Background There is a high variability of out-of-packet patient costs of inflammatory bowel diseases (IBDs), but the issue is not widely recognised. Therefore, we compared patient costs of IBDs between 12 European countries. Methods A questionnaire-based study was conducted among adult patients with IBD. Data on patient characteristics and out-of-...
Research
Full-text available
A rise in the incidence of infections with severe acute respiratory syndrome coronavirus 2 has sparked the search for protective strategies against the new pathogen. It is known that individual food components can interact with different immune cells, modulating the immune response of the body. The aim of this study was to develop an index assessin...
Article
Introduction: Major depressive disorder remains a prevalent world-wide health problem. Currently available antidepressant medications take weeks of dosing, do not produce antidepressant response in all patients, and have undesirable ancillary effects. Areas covered: The present opinion piece focuses on the major inroads to the creation of new an...
Article
Background: National studies report a high variability of indirect costs of inflammatory bowel disease (IBD). In this study, selected aspects of the societal burden of IBDs were compared between 12 European countries. Methods: A questionnaire-based study among adult patients with IBD was performed. Data on patient characteristics, productivity l...
Article
Full-text available
Introduction: The expansion of orphan drug treatment at increasing prices, together with uncertainties regarding their (cost-)effectiveness raises difficulties for decision-makers to assess these drugs for reimbursement. The present qualitative study aims to gain better insight into current value assessment and appraisal frameworks for orphan drugs...
Article
Aim: To assess the clinical efficacy and safety profile of opicapone (25 and 50 mg once daily) versus placebo. Patients: Levodopa-treated adults with Parkinson’s disease. Material & methods: A systematic review and meta-analysis were conducted. Results: Opicapone provided a greater reduction in the absolute OFF-time, increased the chances of ≥1-h r...
Article
Objective: This study aimed to compare the safety profile of high-efficacy disease-modifying therapies (DMTs) natalizumab, fingolimod, alemtuzumab, cladribine, ocrelizumab, ofatumumab, ozanimod, as well as a potentially high-efficacy DMT, ponesimod, in adult patients with relapsing-remitting multiple sclerosis (RRMS). Methods: A systematic revie...
Preprint
Full-text available
Introduction Clinical evidence on effectiveness and safety for orphan drugs is limited. We aimed to assess the correlation between clinical robustness of studies on orphan drugs and the status assigned by the European Medicines Agency (EMA). Methods We assessed all medicines with an orphan designation included in the EMA website as of June 1, 2020....
Article
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Background: The aim of this study was to investigate the impact of selected legislative initiatives and their implementation for off-patent medicinal products in Slovakia compared with the rest of the Visegrád Group (V4 countries). Methods: We analyzed the development of applications for the reimbursement of generic and biosimilar drugs. Particular...
Article
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The purpose of this study was to compare the sensitivity and specificity of computed tomography (CT) scans of the chests of patients with the reference reverse-transcription real-time polymerase chain reaction (RT-PCR) in early diagnosis of COVID-19. A systematic review with meta-analysis for numerical outcomes was performed, including 10 studies (...
Article
Full-text available
Background: It is essential to provide safe healthcare in complex, difficult, and quickly changing conditions. The quality of healthcare services directly influences the safety of both the patients and staff. Understanding healthcare staff attitudes toward safety in the healthcare delivery context is foundational for building a culture of safety....
Article
Full-text available
Introduction Recently, a considerable attention has been paid to glutamatergic conception of mood disorders. The development of new treatment strategies targeted at glutamate provides new opportunities for the treatment of mood disorders. It is expected that these novel therapeutic options will provide a fast and sustained antidepressant effect and...
Article
Full-text available
Background: The reimbursement of orphan drugs (OD) is an increasingly important for country policymakers, and still insufficiently understood, especially in Central and Eastern Europe. The aim of this research was to provide a comprehensive description of country-specific health technology assessment (HTA) policies as well as evaluate the percenta...
Article
Full-text available
Objectives: To analyse the market shares of biosimilars in Slovakia and to calculate the potential cost-savings from the use of biosimilars in Slovakia based on two different data sources. Methods: National reimbursement lists from the Czech Republic, Hungary, Poland and Slovakia were used for analyzing the availability of biosimilars with public f...
Article
Full-text available
Introduction Depression remains a major cause of morbidity worldwide; consequently, there is a need in neuropsychiatry for new antidepressants with a rapid onset of action. Intranasal administration of antidepressants is an attractive and promising approach to the treatment of mental disorders, as this route is noninvasive, offers a fast onset of a...
Article
Objectives: To assess the productivity losses among the parents of children with inflammatory bowel diseases (IBDs) in Poland and their relationship with disease activity and the patient's quality of life. Methods: A questionnaire-based self-reported Internet survey was conducted among the parents of patients (0-17 years old) with a diagnosis of...
Article
Full-text available
Background: Due to unmet clinical needs for efficient drugs with a rapid onset of antidepressant effects, we aimed to evaluate the efficacy of single-dose ketamine in different subgroups of patients with major depression and establish whether repeated ketamine administration could be a viable strategy to maintain treatment gains. Methods: Electr...
Article
Evidence regarding the influence of coffee drinking on colorectal cancer (CRC) is limited, and it remains unclear whether coffee consumption is associated with the risk of the disease. To clarify this association, a comprehensive meta-analysis was performed. The risk of CRC was compared between the categories of coffee consumption, and a dose-respo...
Preprint
Full-text available
Objective: To review the reimbursement recommendations issued by selected European health technology assessment agencies for orphan drugs and the reimbursement status of these drugs; to assess the relationship between the type of recommendation and reimbursement status. Methods: The list of orphan drugs to be included in the analysis was obtained f...
Preprint
Full-text available
Objective: To review the reimbursement recommendations issued by selected European health technology assessment agencies for orphan drugs and the reimbursement status of these drugs; to assess the relationship between the type of recommendation and reimbursement status. Methods: The list of orphan drugs to be included in the analysis was obtained f...
Article
Introduction: In March 2019, intranasal esketamine was approved by the Food and Drug Administration (FDA) for the treatment of treatment-resistant depression (TRD) in adults. This review presents the results of clinical trials underlying the FDA approval of intranasal esketamine. Areas covered: Esketamine’s efficacy and safety in TRD were assessed...
Article
Full-text available
Objectives The aim of this study was to review legislative provisions for the reimbursement of biosimilars, assess the impact of the implemented regulations on access to biosimilars, and to calculate the lost opportunity for savings due to the limited availability of biosimilars in Slovakia. Methods The Slovak legislation concerning the reimbursem...
Article
Full-text available
Background Reimbursement policies influence access of patients to orphan drugs in the European countries. Objectives To provide a comprehensive description of orphan drug reimbursement policies and to assess reimbursement decision-making process in the EU-CEE countries as well as the impact of the type of approval and disease on reimbursement deci...
Article
Full-text available
Baricitinib is an innovative small-molecule drug that reversibly inhibits continuous activation of JAK/STAT pathway, thus reducing joint inflammation. The drug was approved for use as monotherapy or in combination with methotrexate (MTX) in the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The aim of this paper w...
Article
Full-text available
Objective: To assess shares of reimbursed orphan drugs and agreement in reimbursement decision-making in different European Union member states as well as to define odds for reimbursement influenced by the presence of conditional approval or exceptional circumstances granted by the European Medicines Agency (EMA) or by type of the disease. Methods:...
Article
Full-text available
Background Funding of orphan medicinal products (OMPs) is an increasing challenge in the European Union (EU). Objectives To identify the different methods for public funding of OMPs in order to map the availability for rare disease patients, as well as to compare the public expenditures on OMPs in 8 EU member states. Methods Information on the re...
Article
Full-text available
Introduction Clinical studies have revealed that fixed-dose combinations (FDCs) of drugs can have a better effect on blood pressure than free-equivalent combinations (FECs). Our objectives were to perform an up-to-date assessment of the effectiveness of FDCs and FECs in antihypertensive therapy, to provide more accurate results by using a stratifie...
Article
Full-text available
Objectives: The aim of the study was to compare the access of patients with rare diseases (RDs) to biotechnological drugs in several Central and Eastern European countries (CEECs). We focused on the legislative pricing and reimbursement requirements, availability of biotechnological orphan medicinal products (BOMPs) for RDs, and reimbursement expen...
Article
Full-text available
Background. There is conflicting evidence on the impact of biologic treatment on the rate of complications and surgeries in Crohn’s disease (CD). We aimed to assess real-world consequences of biologic treatment of CD. Methods. All adult patients with CD treated with infliximab and adalimumab in the years 2012–2014 were identified from the database...
Article
Full-text available
Objective The aim was to evaluate the cost-effectiveness of Crohn’s disease (CD) treatment with vedolizumab and ustekinumab after failure of therapy with tumor necrosis factor-a antagonists (anti-TNFs). Methods The Markov model incorporated the lifetime horizon, synthesis-based estimates of biologics’ efficacy in relation to anti-TNF exposure, an...
Article
Full-text available
To assess the comparative effectiveness and safety of novel biologic therapies in psoriatic arthritis (PsA) and to establish the position of the non-anti-tumor necrosis factor α (TNF-α) biologic drugs in the treatment regimen of the disease. A systematic review and network meta-analysis (NMA) was conducted according to the preferred reporting items...
Article
Full-text available
Introduction Ulcerative colitis (UC) is an idiopathic inflammatory bowel disorder, which requires lifelong treatment. It generates substantial direct and indirect costs, and significantly affects the quality of life, especially in the active state of the disease. Aim To evaluate the direct and indirect costs of UC as well as to assess disease acti...
Article
Full-text available
Background Ulcerative colitis (UC) is a chronic autoimmune inflammation of the colon. The condition significantly decreases quality of life and generates a substantial economic burden for healthcare payers, patients and the society in which they live. Some patients require chronic pharmacotherapy, and access to novel biologic drugs might be crucial...
Article
Full-text available
Objectives: The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries. Methods: A questionnaire-based survey was performed in the period from November 2016 to March 2017 among experts involved in reimbursement matters from CEE coun...
Article
Background: Inflammatory bowel diseases (IBDs) such as ulcerative colitis (UC) and Crohn's disease (CD) are chronic autoimmune disorders that constitute a major societal and economic burden for individual patients, their families and the society. The aim of this study was to assess the current prevalence and treatment patterns of IBD in Poland. P...
Article
Full-text available
Paweł Kawalec,1 Katarzyna Śladowska,2 Iwona Malinowska-Lipień,3 Tomasz Brzostek,3 Maria Kózka4 1Drug Management Department, Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, 2Department of Experimental Hematology, Institute of Zoology and Biomedical Research, Faculty of Biology and Earth Sciences, Jagi...
Article
Aim: An indirect comparison of ustekinumab versus vedolizumab in patients with active moderate-to-severe Crohn's disease who were nonresponsive or intolerant to previous TNF-antagonist therapy. Methods: A systematic review was performed in Medline via PubMed, Embase, Cochrane Library, until 30 April 2017. Inclusion criteria were: randomized cont...
Article
Objectives: Novel oral treatments (including biologics) of inflammatory bowel disease (IBD) are emerging. Apart from improvement of health, treatment convenience may be of value to patients. This 'process utility' can be estimated under the quality-of-life framework. We investigated the process utility associated with subcutaneous and intravenous...
Conference Paper
OBJECTIVES: Inflammatory bowel disease (IBD) constitute a significant burden for both patients and the society. The aim of our study was to assess the total direct costs of IBD in Poland. METHODS: Information on drugs, dietary supplements, medical devices, outpatient and inpatient services utilized by 60,472 IBD patients from Poland for the years 2...
Article
Objective: To assess changes in the involvement of advisory bodies in the reimbursement decision-making process in Poland, and to evaluate variables that influenced HTA recommendations in the years 2013-2015. Research design and methods: Two independent contributors reviewed the statements of the TC, recommendations issued by the president of th...
Article
Full-text available
Bulgaria has a mixed public-private healthcare financing system. Health care is financed mainly by compulsory health insurance contributions and out-of-pocket payments. Out-of-pocket payments constitute a large share of the total healthcare expenditure (44.14%in 2014). The share of drugs expenditure for outpatient treatment was 42.3% of the total h...
Article
We presented a general overview of the health care system as well as the pricing and reimbursement environment in Poland. Poland aims to ensure proper access to safe and effective medicines while reducing patients' share in treatment costs. Nevertheless, the co-payment for pharmacotherapy is still high (more than 60%). The key policymaker and regul...
Article
Aim: The aim of the systematic review and meta-analysis was to assess the efficacy and safety of ustekinumab in the induction therapy of anti-TNF-α failure patients with Crohn's disease. Methods: A systematic literature search was conducted in Medline (PubMed), EMBASE, Cochrane Library until 30 December 2016. We included randomized controlled tr...
Article
Full-text available
Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries. Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among...
Article
Full-text available
The aim of this systematic review was to collect and summarise all current data on the cost-effectiveness of biological treatment in ulcerative colitis. A literature search was conducted using the Medline, Embase, Centre for Reviews and Dissemination databases and included all cost-effectiveness analyses comparing biological treatment with any comp...
Article
Full-text available
Introduction Ulcerative colitis (UC) require expensive, lifelong treatment, which generates huge direct costs and has a significant impact on the quality of life, especially in the active state of the disease. Aim To assess the indirect costs, health-related quality of life, and clinical characteristics of patients with UC in Poland. Additionally,...