OBJECTIVES: The comparative efficacy between riociguat and selexipag in patients with pulmonary arterial hypertension (PAH) has never been described in literature. Our aim was to prepare indirect treatment comparison (ITC) to evaluate the cost-effectiveness of riociguat in Czechia. METHODS: A systematic literature review identified two relevant trials with comparable endpoints to inform a Bucher ITC of relative and absolute effects. Given the comparable efficacy of riociguat and selexipag, a cost-minimization analysis (CMA) was conducted. RESULTS: A Bucher ITC provided evidence for the comparable relative efficacy of riociguat defined as the odds of unimproved functional class III 0.761 (95% CI 0.372 to 1.558; p = 0.455) compared to selexipag and a comparable absolute efficacy defined as a difference in the 6-minute walking distance of 10.560 meters (95% CI -10.692 to 31.812; p = 0.330). The CMA identified riociguat as the cost-saving therapy. CONCLUSIONS: Switching to riociguat represents the cost-saving therapy for PAH patients who were inadequately compensated with the PDE5i+ERA therapy. Consequently, riociguat has been introduced to the list of reimbursed medicines in Czechia from October 2021. Based on two global trials, we prepared the first indirect treatment comparison followed with CMA of these therapies that may improve future decision-making for PAH indications.

• MeSH
• antihypertenziva MeSH
• lidé MeSH
• náklady a analýza nákladů MeSH
• plicní arteriální hypertenze * MeSH
• plicní hypertenze * farmakoterapie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• systematický přehled MeSH

INTRODUCTION: Though cost-effectiveness analyses (CEAs) have evaluated continuous renal replacement therapy (RRTs) and intermittent RRTs in acute kidney injury (AKI) patients; it is yet to establish which RRT technique is most cost-effective. We systematically reviewed the current evidence from CEAs of CRRT versus IRRT in patients with AKI. AREAS COVERED: PubMed, EMBASE, and Cochrane databases searched for CEAs comparing two RRTs. Overall, seven CEAs, two from Brazil and one from US, Canada, Colombia, Belgium, and Argentina were included. Five CEAs used Markov model, three reported following CHEERS, none accounted indirect costs. Time horizon varied from 1-year-lifetime. Marginal QALY gain with CRRT compared to IRRT was reported across CEAs. Older CEAs found CRRT to be costlier and not cost-effective than IRRT (ICER 2019 US$: 152,671$/QALY); latest CEAs (industry-sponsored) reported CRRT to be cost-saving versus IRRT (-117,614$/QALY). Risk of mortality, dialysis dependence, and incidence of renal recovery were the key drivers of cost-effectiveness. EXPERT OPINION: CEAs of RRTs for AKI show conflicting findings with secular trends. Latest CEAs suggested CRRT to be cost-effective versus IRRT with dialysis dependence rate as major driver of cost-effectiveness. Future CEAs, preferably non-industry sponsored, may account for indirect costs to improve the generalizability of CEAs.

• MeSH
• akutní poškození ledvin * terapie   MeSH
• analýza nákladů a výnosů MeSH
• dialýza ledvin MeSH
• intermitentní metody náhrady funkce ledvin * ekonomika   MeSH
• kontinuální metody náhrady funkce ledvin * ekonomika   MeSH
• lidé MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• systematický přehled MeSH

BACKGROUND: Utilities of the general population or expert estimates have been used for all published cost-effectiveness analyses of screening for thyroid disorders in pregnancy. METHODS: A systematic review CRD42019120897 of studies with patient-reported outcomes (PRO) and laboratory evidence of thyroid function/autoimmunity was conducted using PubMed, Cochrane Central, EconLit, SocIndex, DARE, NHS EEDS, Annual Reviews, and CINAHL. Quality was assessed using Joanna Briggs Institute appraisal tool. RESULTS: Of 664 abstracts screened, we analyzed 97 full texts. All studies describing the impact of thyroid disease on the generic QoL excluded pregnant and postpartum women. 21 reports of acceptable quality (321,850 pregnancies) determined depression and anxiety with validated tools and/or reported subjective symptoms. During pregnancy, contradictory conclusions were published on the impact of thyroid disease on PRO. Postpartum, antithyroid antibodies coincide with alexithymia and depression, postpartum thyroiditis negatively impacts mood. No conclusion could be drawn on the impact of thyroid hormonal levels. CONCLUSIONS: The generic QoL in autoimmune thyroid disease during pregnancy has never been described, which represents an obstacle for the construction of economic models. We found contradictory information on the impact of thyroid disease on depression, anxiety, and specific symptoms.

• MeSH
• autoimunitní tyreoiditida * MeSH
• kvalita života * MeSH
• lidé MeSH
• poporodní období MeSH
• těhotenství MeSH
• Check Tag
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• systematický přehled MeSH

Introduction: There are growing concerns among European health authorities regarding increasing prices for new cancer medicines, prices not necessarily linked to health gain and the implications for the sustainability of their healthcare systems.Areas covered: Narrative discussion principally among payers and their advisers regarding potential approaches to the pricing of new cancer medicines.Expert opinion: A number of potential pricing approaches are discussed including minimum effectiveness levels for new cancer medicines, managed entry agreements, multicriteria decision analyses (MCDAs), differential/tiered pricing, fair pricing models, amortization models as well as de-linkage models. We are likely to see a growth in alternative pricing deliberations in view of ongoing challenges. These include the considerable number of new oncology medicines in development including new gene therapies, new oncology medicines being launched with uncertainty regarding their value, and continued high prices coupled with the extent of confidential discounts for reimbursement. However, balanced against the need for new cancer medicines. This will lead to greater scrutiny over the prices of patent oncology medicines as more standard medicines lose their patent, calls for greater transparency as well as new models including amortization models. We will be monitoring these developments.

• MeSH
• dávkové mechanismy ekonomika   MeSH
• ekonomické modely MeSH
• lidé MeSH
• nádory farmakoterapie   ekonomika   MeSH
• náklady a analýza nákladů MeSH
• náklady na léky trendy   MeSH
• patenty jako téma MeSH
• poskytování zdravotní péče ekonomika   MeSH
• protinádorové látky ekonomika   MeSH
• vyvíjení léků MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Evropa MeSH

The Pharmacoeconomics Section of the Pharmaceutical Association of Serbia organised a one day international conference on the value of innovation in decision-making in health care in Central and Eastern Europe. The focus of the conference was on reimbursement decisions for medicines using health technology assessment and the use of managed entry agreements (MEAs). The objectives of this conference were firstly to discuss the challenges and opportunities with the use of MEAs in Central and Eastern European countries; secondly the role of patient registries especially with outcome based schemes, and finally new approaches to improve accessibility to new medicines including better managing their entry.

• MeSH
• dávkové mechanismy MeSH
• ekonomika farmaceutická * MeSH
• hodnocení biomedicínských technologií MeSH
• lidé MeSH
• poskytování zdravotní péče ekonomika   metody   MeSH
• rozhodování * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• kongresy MeSH
• Geografické názvy
• východní Evropa MeSH

AIM: To map health-related quality of life (Qol) with clinical parameters BASFI and ASDAS-CRP measure, and other covariates. METHODS: Our prospective multicenter non-interventional observation study of ankylosing spondylitis (AS) collected data about QoL and clinical outcomes on the initial and four subsequent visits. We employed simple linear regression analysis of a cross-sectional dataset, and fixed effect, random effect and pooled linear regression of a longitudinal dataset. RESULTS: We showed that BASFI and ASDAS-CRP are very strong, robust predictors of EQ-5D utilities in all regression specifications together with sex (female), invalidity, and activity impairment. Additionally, the longitudinal regression analysis showed that a fixed effect model may be a viable alternative to the most commonly used random effect model or pooled linear regression due to the nature of our dataset. CONCLUSION: This is one of the first studies using a fixed effect model in longitudinal patient-level data, although, this method has been widely used in economics.

• MeSH
• ankylózující spondylitida patofyziologie   MeSH
• dospělí MeSH
• kvalita života * MeSH
• lidé středního věku MeSH
• lidé MeSH
• lineární modely MeSH
• longitudinální studie MeSH
• následné studie MeSH
• prospektivní studie MeSH
• sexuální faktory MeSH
• stupeň závažnosti nemoci MeSH
• teoretické modely * MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH

BACKGROUND: This study aims to compare the cost-effectiveness of treatment sequences with available biologics, including adalimumab (ADA), biosimilar infliximab (bsIFX), originator infliximab (IFX) and vedolizumab (VEDO) for luminal Crohn's disease in nine European countries. METHODS: A Markov-model was constructed to simulate five-year medical costs and quality-adjusted life years (QALYs). Data on clinical efficacy were obtained from randomised controlled trials. Country-specific unit costs, discount rates and a third-party payer perspective were applied. RESULTS: The bsIFX versus conventional therapy resulted in the most favourable incremental cost-utility ratios (ICURs) ranging from €34,580 (Hungary) to €77,062/QALY (Sweden). Compared to bsIFX, the bsIFX-ADA sequence was more cost-effective than the bsIFX-VEDO sequence with ICURs varying between €70,277 (France) and €162,069/QALY (Germany). The ICURs of the bsIFX-ADA-VEDO sequence versus the bsIFX-ADA strategy were between €206,266 (The Netherlands) and €363,232/QALY (Spain). CONCLUSION: We are the first to compare cost-effectiveness of multiple biological sequences for luminal Crohn's disease. Based on our findings, bsIFX can be recommended as a first-line treatment in patients unresponsive to conventional treatments. While biological sequences only slightly differ in their associated health gains, their costs vary greatly. The bsIFX-ADA-VEDO seems to be the most cost-effective sequence of the available biologics across Europe.

• MeSH
• adalimumab aplikace a dávkování   ekonomika   terapeutické užití   MeSH
• analýza nákladů a výnosů MeSH
• biosimilární léčivé přípravky aplikace a dávkování   ekonomika   terapeutické užití   MeSH
• Crohnova nemoc farmakoterapie   ekonomika   MeSH
• ekonomické modely MeSH
• gastrointestinální látky aplikace a dávkování   ekonomika   terapeutické užití   MeSH
• humanizované monoklonální protilátky aplikace a dávkování   ekonomika   terapeutické užití   MeSH
• infliximab aplikace a dávkování   ekonomika   terapeutické užití   MeSH
• kombinovaná farmakoterapie MeSH
• kvalitativně upravené roky života MeSH
• lidé MeSH
• Markovovy řetězce MeSH
• randomizované kontrolované studie jako téma MeSH
• rozvrh dávkování léků MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• srovnávací studie MeSH
• Geografické názvy
• Evropa MeSH

Prevention of cytomegalovirus infection using antiviral prophylaxis or the pre-emptive therapy approach is an integral part of management of patients after solid organ transplantation. Regarding renal transplantation, valacyclovir is currently the only antiviral agent recommended for prophylaxis as an alternative to valganciclovir. This review article discusses studies documenting the efficacy and safety of valacyclovir prophylaxis as well as those comparing valacyclovir with other prophylactic regimens or with pre-emptive therapy. Also addressed are the economic aspects supporting the cost-effectiveness of valacyclovir prophylaxis and demonstrating lower costs compared with other cytomegalovirus preventive strategies.

• MeSH
• acyklovir škodlivé účinky   analogy a deriváty   ekonomika   terapeutické užití   MeSH
• analýza nákladů a výnosů MeSH
• antivirové látky škodlivé účinky   ekonomika   terapeutické užití   MeSH
• cytomegalovirové infekce ekonomika   prevence a kontrola   MeSH
• lidé MeSH
• náklady na léky * MeSH
• transplantace orgánů škodlivé účinky   ekonomika   MeSH
• úspory nákladů MeSH
• valin škodlivé účinky   analogy a deriváty   ekonomika   terapeutické užití   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

AIMS: To estimate the direct and indirect costs associated with disability due to multiple sclerosis (MS) in Poland. METHODS: Recently a cost-of-illness study was conducted in the Czech Republic, involving 909 patients with different levels of disability (the COMS study). Data on resource use from this trial was extrapolated to Polish patients and combined with Polish unit costs in 2012. The mean annual costs from societal and payers perspective were calculated for patients according to EDSS. RESULTS: The estimated mean annual cost per patient with MS from a societal perspective ranges from 6970 EUR to 26,791 EUR. Indirect costs (production loss due to early retirement, sick-leave and informal care) cover up to 70% of total costs. CONCLUSIONS: With an estimated 40-60,000 patients with MS in Poland, the disease poses a high economic burden. Indirect costs have a substantial share in these costs. A high-quality prospective study on costs is needed.

• MeSH
• lidé MeSH
• osobní újma zaviněná nemocí * MeSH
• roztroušená skleróza ekonomika   MeSH
• zdravotnické zdroje statistika a číselné údaje   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika MeSH
• Polsko MeSH

A total of 7 years after the addition of Poland, the Czech Republic and Hungary to the EU, the pricing and reimbursement regulations introduced in these countries are still considered to be not fully compliant with Directive 89/105/EEC, commonly referred to as the 'Transparency Directive' (TD). The TD aims to ensure the transparency of the pricing and reimbursement processes for medicinal products established by the member states. Among the most difficult barriers on the way to successful implementation of the TD discussed are meeting the timelines indicated by the TD, the implementation of objective and verifiable criteria for decisions, and the availability of remedies for negative decisions. Health technology assessment (HTA) has been introduced in to the reimbursement systems in Poland, the Czech Republic and Hungary almost simultaneously to their accession to the EU. Even though Central Eastern European (CEE) countries faced similar challenges during the transformation to a democratic system, certain differences in the extent to which HTA principles have been implemented in these countries could be distinguished. Hence, it is thought-provoking to consider the different views of HTA experts on the role of HTA in the adaptation of the TD in the CEE region. The key objective of this article will be to discuss whether the adaptation of HTA principles has supported or only triggered additional challenges in the process of successful implementation of the TD in the CEE region. In particular, the article will discuss whether the introduction of mandatory HTA recommendations or explicit willingness-to-pay threshold would encourage or discourage implementation of the TD. The importance of the independent HTA agency as a condition for successful introduction of the TD will also be debated.

• MeSH
• časové faktory MeSH
• dávkové mechanismy zákonodárství a právo   MeSH
• Evropská unie MeSH
• hodnocení biomedicínských technologií zákonodárství a právo   metody   MeSH
• lidé MeSH
• náklady a analýza nákladů zákonodárství a právo   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika MeSH
• Maďarsko MeSH
• Polsko MeSH