HTA Consulting

Kraków, Poland

HTA Consulting

Kraków, Poland
SEARCH FILTERS
Time filter
Source Type

Truxima™ est approuvé dans l’UE pour le traitement des personnes atteintes de lymphome non hodgkinien (LNH), de leucémie lymphoïde chronique (LLC) , d’arthrite rhumatoïde (AR), de granulomatose avec polyangéite et polyangéite microscopique.1 Cette approbation est basée sur la totalité des preuves soumises à l’Agence européenne des médicaments, qui font apparaître une similitude probante entre Truxima™ et le rituximab de référence en termes d’efficacité, d’innocuité, d’immunogénicité, de pharmacodynamique (PD) et de pharmacocinétique (PK), chez les patients atteints d’AR et de lymphome folliculaire à un stade avancé, qui est un type de LNH.2 2 Lesdits essais ont été effectués chez plus de 600 patients et englobent des données sur 104 semaines.1 Dr Bertrand Coiffier, principal investigateur mondial de l’étude sur le lymphome folliculaire à un stade avancé, responsable du Département d’Hématologie aux Hospices civils de Lyon et professeur à l’Université Claude Bernard, Lyon, France, a déclaré : « Le biosimilaire du rituximab a indiqué avoir une efficacité et une innocuité comparables au rituximab de référence au cours d’un vaste programme d’essais qui a fourni des preuves convaincantes de la similarité des deux produits. Ces constatations ont été reconnues par les autorités réglementaires et nous espérons qu’elles ouvriront la voie à d’autres innovations dans ce domaine ». « En supposant que le prix du biosimilaire du rituximab est 70 % en comparaison avec le rituximab de référence, et que la part de marché du biosimilaire du rituximab est 30 % (première année), 40 % (deuxième année) et 50 % (troisième année), au cours de cette période de trois ans, les économies budgétaires dans les 28 pays de l’UE se chiffreraient à environ 570 millions EUR », a fait savoir le Prof. László Gulácsi, directeur du Département de l’Économie de la santé, Université Corvinus de Budapest; HTA Consulting Budapest, Hongrie. « Cela équivaut à 49 000 nouveaux patients atteints d’AR, de LNH et de LLC qui pourraient recevoir un traitement changeant leur vie, qui est clairement un énorme gain global en matière de santé, à la fois au niveau national et au niveau de l’UE. » Les cancers hématologiques prennent naissance dans les tissus hématopoïétiques ou les cellules du système immunitaire. Il existe trois types fréquents de cancers hématologiques : le lymphome, la leucémie et le myélome. Il existe de nombreux types de LNH, le groupe le plus fréquent étant les lymphomes des cellules B, parmi lesquels le lymphome folliculaire et le lymphome diffus à grandes cellules B sont les plus répandus. La LLC est un type de leucémie et elle se caractérise par l’accumulation de cellules B monoclonales (type de globule blanc). En Europe, plus de 2,9 millions de personnes souffrent d’AR, et plusieurs d’entre elles sont en âge de travailler. En moyenne, une personne sur trois qui souffre d’AR devient handicapée, et jusqu’à 40 % cessent entièrement de travailler dans les cinq ans qui suivent le diagnostic.4 Bien qu’il n’existe aucun traitement pour guérir l’AR, il est possible de limiter l’inflammation et soulager la douleur. Tout comme pour toutes les maladies rhumatismales, il est essentiel de diagnostiquer et d’intervenir rapidement. Les données cliniques de la Phase 1 ont montré que le PK de Truxima™ et du rituximab de référence étaient statistiquement équivalents pendant une durée de 24 semaines après une série unique de traitement, et que son efficacité, PD, immunogénicité et innocuité étaient similaires pendant deux séries de traitement (une durée allant jusqu’à 72 semaines). 2 Celltrion Healthcare se charge de la commercialisation, la vente et la distribution de médicaments biologiques mis au point par Celltrion, Inc. à travers un réseau mondial couvrant plus de 120 pays. Les produits de Celltrion Healthcare sont fabriqués dans des installations de pointe destinées à la culture de cellules de mammifères et conformes aux normes de bonnes pratiques de fabrication de la FDA américaine et de l’UE. Pour de plus amples renseignements, visitez le site : http://www.celltrionhealthcare.com/


News Article | February 22, 2017
Site: www.businesswire.com

„ Wir freuen uns, den ersten Biosimilar-mAb in der Onkologie anbieten zu können. Wir arbeiten mit unseren Partnern überall in der Welt daran, Truxima™ den zahlreichen Patienten zugänglich zu machen, die von dieser Behandlung profitieren können“, erklärte Jung-Jin Seo, Vorsitzender der Celltrion Group, auf einer Konferenz der europäischen Partner des Konzerns in Paris. „ Damit sind wir in der Lage, dem durch hohe Kosten für Onkologietherapien belasteten Gesundheitswesen eine Option zu bieten, die einerseits erhebliche Einsparungen ermöglicht und andererseits sicherstellt, dass Patienten weiterhin Zugang zu hochwertigen und effektiven Therapien haben.“ Dr. Bertrand Coiffier, globaler Leiter der erweiterten Studie über das follikuläre Lymphom, Leiter des Department of Hematology am Hospices Civils de Lyon und Professor an der Claude Bernard-Universität in Lyon, Frankreich, erklärt: „ Im Hinblick auf Wirksamkeit und Sicherheit weist Biosimilar Rituximab in einer umfassenden Studienreihe vergleichbare Werte wie das Referenz-Rituximab auf. Damit ist der eindeutige Beweis für die Ähnlichkeit der beiden Produkte erbracht. Diese Tatsache wurde von den Zulassungsbehörden anerkannt und ebnet hoffentlich den Weg für weitere Innovationen in diesem Bereich.“ „ Angenommen, der Preis von Biosimilar Rituximab betrüge nur 70 % des Referenz-Rituximab und der Marktanteil von Biosimilar Rituximab läge bei 30 % (im ersten Jahr), 40 % (im zweiten Jahr) und 50 % (im dritten Jahr); dann beliefen sich die Kosteneinsparungen in den 28 Ländern der EU über diesen Zeitraum auf ca. 570 Mio. Euro“, erklärte Prof. László Gulácsi, Leiter der Abteilung für Gesundheitsökonomie an der Corvinus University of Budapest; HTA Consulting Budapest, Ungarn. „ Das würde bedeuten, dass 49.000 neue Patienten mit RA, NHL und CLL landes- und europaweit von dieser Behandlung gesundheitlich profitieren und somit eine deutlich höhere Lebensqualität genießen könnten.“ Hämatologische Krebserkrankungen beginnen im blutbildenden Gewebe oder in Zellen des Immunsystems. Drei Arten hämatologischer Krebserkrankungen sind verbreitet: Lymphom, Leukämie und Myelom. NHL tritt in verschiedenen Ausprägungen auf; die häufigste Form ist die Gruppe der B-Zellen-Lymphome. In dieser Gruppe sind follikuläre Lymphome und diffuse, großzellige B-Zellen-Lymphome am stärksten vertreten. CLL, eine Form der Leukämie, ist durch die Anhäufung monoklonaler B-Zellen (eine Art weißer Blutzellen) charakterisiert. 2 European Commission. What you need to know about biosimilar medicinal products. Available at ec.europa.eu/DocsRoom/documents/8242. [Letzter Zugriff Februar 2017]. 3 World Health Organisation. Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy. 2014. WHA67.21. Verfügbar unter: apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R21-en.pdf. [Letzter Zugriff Februar 2017].


News Article | February 22, 2017
Site: www.businesswire.com

INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today announced that the European Commission has approved Truxima™ (biosimilar rituximab) for all indications of reference rituximab in the European Union (EU). Truxima™ is the first biosimilar monoclonal antibody (mAb) approved in an oncology indication worldwide. The approval of Truxima™ builds on Celltrion Healthcare’s strong global clinical biosimilar programme. “ We are excited to offer the first biosimilar mAb in oncology. With our partners across Europe, we will work together to ensure that Truxima is available to the many patients who can benefit from this treatment”, said Jung-Jin Seo, Chairman of Celltrion Group, speaking at a meeting of their European partners in Paris. “ For healthcare systems burdened with high cost oncology treatments, we are pleased to provide an option that has the potential to offer significant savings whilst ensuring patients retain access to high-quality and effective treatments”. Truxima™ is approved in the EU for the treatment of people with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.1 This approval is based on the totality of evidence submitted to the European Medicines Agency showing compelling similarity between Truxima™ and reference rituximab in terms of efficacy, safety, immunogenicity, pharmacodynamics (PD) and pharmacokinetics (PK) in patients with RA and advanced follicular lymphoma, a type of NHL.2 These trials were conducted in over 600 patients and include data up to 104 weeks.1 Dr Bertrand Coiffier, the global principle investigator of the advanced follicular lymphoma study, Head of the Department of Hematology at Hospices Civils de Lyon and Professor at the University Claude Bernard, Lyon, France said, “ Biosimilar rituximab has been shown to have comparable efficacy and safety to reference rituximab in a large program of trials providing convincing evidence for the similarity of the two products. This has been recognised by the regulatory authorities, and hopefully this will pave the way for further innovation in this area”. Biosimilars have the potential to offer cost savings for healthcare systems and therefore the potential to increase patient access to biological therapies.2,3 “ Assuming the price of biosimilar rituximab is 70% compared to reference rituximab, and the market share of biosimilar rituximab is 30% (first year), 40% (second year) and 50% (third year), over this three-year time period the budget savings across the 28 countries of the EU would be around €570 million”, said Prof. László Gulácsi, Head of Department of Health Economics, Corvinus University of Budapest; HTA Consulting Budapest, Hungary. “ This equates to 49,000 new RA, NHL and CLL patients who could be receiving life-changing treatment which is clearly a huge aggregate health-gain at both a national and EU level”. Hematological cancers begin in blood-forming tissue or cells of the immune system. There are three common types of hematological cancers: lymphoma, leukaemia and myeloma. There are many types of NHL, the most common group is B cell lymphomas, of which follicular lymphoma and diffuse large B cell lymphoma are the most common. CLL is a type of leukaemia and is characterised by accumulation of monoclonal B cells (a type of white blood cell). In Europe more than 2.9 million people have RA, many of whom are of working age. On average, every third person with RA becomes work disabled and up to 40 per cent leave work completely within 5 years of diagnosis.4 Although there is no cure for RA, there are many treatments that can reduce inflammation and ease pain. As with all rheumatic diseases early diagnosis and intervention is key. Truxima™ is a mAb that targets CD20, a protein found on the surface of most B cells. Overactive B cells can stimulate attack of healthy cells in immune-related diseases such as RA. B cells are also implicated in some types of hematological cancer including NHL and CLL. B cells express CD20 at many stages of their development making the protein a good target for treatments. Truxima™ is approved in the EU for the treatment of people with NHL, CLL, RA, granulomatosis with polyangiitis and microscopic polyangiitis. Further details of the approved indications and safety information for Truxima™ are available in the summary of product characteristics (SmPC).1 Phase 1 clinical data demonstrated the PK of Truxima™ and reference rituximab were statistically equivalent over 24 weeks after a single course of treatment, and that their efficacy, PD, immunogenicity and safety were similar up to 2 courses of treatments (up to 72 weeks).2 A phase 1 open label extension study showed that switching to Truxima™ from reference rituximab was similarly effective with comparable safety to continuing Truxima™ for two years.2 Three phase 3 studies in patients with RA, advanced follicular lymphoma and low-tumor-burden follicular lymphoma (LTBFL) are ongoing: Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/ 2 European Commission. What you need to know about biosimilar medicinal products. Available at ec.europa.eu/DocsRoom/documents/8242. [Last accessed February 2017]. 3 World Health Organisation. Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy. 2014. WHA67.21. Available at: apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R21-en.pdf. [Last accessed February 2017]. 4 NRAS, European Fit for Work Report. Available at www.nras.org.uk/european-fit-for-work-report. [Last accessed February 2017].


Flisiak R.,Medical University of Bialystok | Halota W.,CMUMK Bydgoszcz | Tomasiewicz K.,Medical University of Lublin | Kostrzewska K.,HTA Consulting | And 2 more authors.
European Journal of Gastroenterology and Hepatology | Year: 2015

Background and aims: Chronic hepatitis C virus infection is prevalent among 200 000 individuals in Poland; however, few are aware of their condition (30 000 diagnosed) and even fewer are treated (2490 in 2014). This analysis projected future disease burden and developed two treatment scenarios to control or eliminate hepatitis C virus-related disease in Poland. Methods: Using a modeling approach, the infected population and future disease progression were quantified. Baseline variables included viremic prevalence, age and sex, diagnosis rate, treatment rate, disease progression, and sustained virologic response rates. Data were collected from the literature and through expert interviews. Results: The number of prevalent hepatitis C virus infections is projected to decrease (5%) by 2030. However, the numbers of individuals with compensated and decompensated cirrhosis, and hepatocellular carcinoma are estimated to increase by 40, 55, and 60%, respectively. By increasing sustained virologic response rates to 95% from 2015 onward, and the number of treated cases (from 2490 to 5000), the number of individuals with cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma is projected to remain constant until 2030. A strategy to eliminate chronic hepatitis C virus infection was also considered. To reduce total infections by 90% and mortality by 80%, treatment was increased to 15 000 patients annually. This scenario required the diagnosis of 15 000 new cases (compared with 3000 today). Conclusion: A marked reduction in hepatitis C virus-related disease burden is possible, with increased diagnosis and treatment. The results could inform the development of effective disease management in Poland. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Szmurlo D.,HTA Consulting | Schubert A.,Novo Nordisk AS | Kostrzewska K.,HTA Consulting | Rys P.,HTA Consulting | Skrzekowska-Baran I.,Novo Nordisk AS
Polskie Archiwum Medycyny Wewnetrznej | Year: 2011

INTRODUCTION: Diabetes Poland has recently published guidelines for the treatment of type 2 diabetes. Treatment according to these guidelines is more expensive and requires more involvement of the patient than is the case in current clinical practice. OBJECTIVES: The aim of the study was to assess to what extent the cost of type 2 diabetes treatment according to the Diabetes Poland guidelines may be increased when compared with the cost of the current treatment, so that the introduction of the guidelines remains cost-effective in the Polish setting. PATIENT S AND METHODS: Two hypothetical patients were defined, John and Peter, representing the population of newly diagnosed type 2 diabetic patients. The disease progression was simulated assuming that John is treated according to the current practice and Peter is treated to achieve and maintain the goals defined by Diabetes Poland. The simulation was performed using the CORE model, which has been constructed based on the published scientific evidence and includes more than a dozen of diabetes complications. The model has been widely validated by numerous studies and is broadly used; it enables a reliable estimation of costs and clinical effects associated with diabetes. The parameters of the model were adapted to the Polish conditions. The analysis was conducted in a life-long perspective, discounting of costs/effects was included, and the acceptability threshold was set at 25,511 EUR per quality-adjusted life-year (QALY). RESULTS: The quality-adjusted life expectancy of John will be 0.3 QALY lower than the life expectancy of Peter. The treatment of diabetic complications will be 400 EUR more expensive in the case of John compared with that of Peter. Assuming the willingness to pay at the level of 7500 EUR/QALY, the cost of diabetes treatment of Peter may be 250 EUR higher than that of John's treatment. For the threshold level of 15,000 EUR/QALY, the difference in cost may be 450 EUR, and for the threshold level of 25,000 EUR/QALY - 725 EUR per year. CONCLUSIONS: Treatment according to the guidelines of Diabetes Poland may be cost-effective provided that the additional costs associated with intensification of therapy will not exceed 725 EUR per year. Copyright by Medycyna Praktyczna, Kraków 2011.


Wladysiuk M.,HTA Consulting | Araszkiewicz A.,Medical Academy | Godman B.,Mario Negri Institute for Pharmacological Research | Godman B.,University of Liverpool | And 4 more authors.
Applied Health Economics and Health Policy | Year: 2011

Introduction: Despite recent concerns over the effectiveness and safety of atypical antipsychotics compared with first-generation antipsychotics, prescribing of atypical antipsychotics continues to increase. The use of generic atypical antipsychotics is one way to address cost concerns, especially if there are no major differences in outcomes between generic and originator formulations. Market forces do appear to help lower prices if patients have to cover any difference between higher priced generics and originators and the current reference-priced products themselves, which they try to avoid, and if companies strive to gain market share. However, this approach may compromise individualizing atypical choice if reference classes consist of several atypicals between which there are significant co-payment differences. Objectives: First, to assess whether differences in patient co-payment levels between the various atypical antipsychotic formulations alter the atypical formulation prescribed and/or dispensed in practice in Poland. Second, to assess whether market forces in Poland help drive down generic prices in reality as successive generics are launched. Third, to assess the impact of the reduction in reference prices on the overall expenditure on atypicals by the National Health Fund in Poland. Methods: Prescription and reimbursed expenditure data for olanzapine and risperidone were provided by the National Health Fund from 2002 to 2006, although no individual patient data were available. Reimbursement limits for the various presentations of olanzapine and risperidone were based on regulations from the Ministry of Health. Results: Analysis of the data showed that the level of patient co-payment appeared to impact on the atypical antipsychotic dispensed, with utilization of olanzapine growing once its co-payment was reduced when generic olanzapine became available. The reverse was seen with risperidone, with only limited growth in utilization when co-payment levels increased. Market forces resulted in a 40% reduction in the reimbursed reference price (based on the defined daily dose) of olanzapine and a 77% reduction for risperidone from 2002 to July 2008. These price reductions helped moderate the growth in atypical expenditure in Poland despite appreciably increased utilization, especially for olanzapine. Continued moderation (or even a reduction) in the growth of expenditure on atypicals is envisaged, despite increasing utilization, as more generic formulations are launched, with further reductions in the reference price for both olanzapine and risperidone. Conclusions: Market forces appear to drive down the prices of generics and originators as more atypical formulations are launched. However, alternative approaches may be needed if significant co-payment differences compromise individualized care. © 2011 Adis Data Information BV. All rights reserved.


Wojciechowski P.,HTA Consulting | Rys P.,HTA Consulting | Lipowska A.,Emory University | Lipowska A.,Jagiellonian University | And 3 more authors.
Polskie Archiwum Medycyny Wewnetrznej | Year: 2011

INTRODUCTION: Self-monitoring of blood glucose (SMBG) is a crucial element of clinical care in type 1 diabetes, but it may not provide adequate glucose control. A newer alternative approach is continuous glucose monitoring (CGM) system, which allows a more thorough metabolic control. However, the results of trials comparing CGM with SMBG are inconsistent. OBJECTIVES: Based on a systematic review and meta-analysis, we aimed to assess the efficacy and safety of various CGM systems compared with SMBG. METHODS: We searched major medical databases up to June 2011 for randomized controlled trials comparing CGM and SMBG in type 1 diabetes. Studies of at least 12-week duration were included. Weighted mean difference (WMD) or standardized mean difference (SMD) was calculated for continuous measures and dichotomous data were expressed as odds ratio (OR) or risk ratio. RESULTS: We identified 14 relevant trials including a total of 1268 type 1 diabetic patients, of whom 670 were randomized to the CGM group and 598 to the SMBG group. Patients using CGM had a greater decrease in hemoglobin A 1c (HbA 1c) from baseline compared with those using SMBG (WMD -0.26% [-0.34; -0.19]). We found that the magnitude of the effect was similar in the subset of children and adolescents (WMD -0.25% [-0.43; -0.08]) to that in adults (WMD -0.33% [-0.46; -0.2]). Only real-time devices for CGM improved glycemic control (WMD -0.27% [-0.34; -0.19]). The percentage of patients achieving target HbA 1c was higher in the CGM group (OR 2.14 [1.41; 3.26]). Pooled results from 4 studies revealed a reduction in hypoglycemic events in the CGM group (SMD -0.32 [-0.52; -0.13]). CONCLUSIONS: CGM, partcicularly its real?time system, has a favorable effect on glycemic control and decreases the incidence of hypoglycemic episodes in both adult and pediatric patients with type 1 diabetes. Copyright by Medycyna Praktyczna, Kraków 2011.


Rys P.,HTA Consulting | Wojciechowski P.,HTA Consulting | Rogoz-Sitek A.,HTA Consulting | Niesyczynski G.,HTA Consulting | And 4 more authors.
Acta Diabetologica | Year: 2015

Aims: A variety of basal insulin preparations are used to treat patients with type 2 diabetes mellitus (T2DM). We aimed to summarize scientific evidence on relative efficacy and safety of insulin glargine (IGlar) and other insulins in T2DM. Methods: A systematic review was carried out in major medical databases up to December 2012. Relevant studies compared efficacy and safety of IGlar, added to oral drugs (OAD) or/and in combination with bolus insulin, with protamine insulin (NPH) or premixed insulin (MIX) in the same regimen, as well as with insulin detemir (IDet), in T2DM. Target HbA1c level without hypoglycemic events was considered the primary endpoint. Results: Twenty eight RCTs involving 12,669 T2DM patients followed for 12–52 weeks were included in quantitative analysis. IGlar + OAD use was associated with higher probability of reaching target HbA1c level without hypoglycemia as compared to NPH + OAD (RR = 1.32 [1.09, 1.59]) or MIX without OAD (RR = 1.61 [1.22, 2.13]) and similar effect as IDet + OAD (RR = 1.07 [0.87, 1.33]) and MIX + OAD (RR = 1.09 [0.86, 1.38]). IGlar + OAD demonstrated significantly lower risk of symptomatic hypoglycemia as compared to NPH + OAD (RR = 0.89 [0.83, 0.96]), MIX + OAD (RR = 0.75 [0.68, 0.83]) and MIX without OAD(RR = 0.75 [0.68, 0.83]), but not with IDet + OAD (RR = 0.99 [0.90, 1.08]). In basal-bolus regimens, IGlar demonstrated similar proportion of T2DM patients achieving target HbA1c as compared to NPH (RR = 1.14 [0.91, 1.44]) but higher than MIX (RR = 1.26 [1.12, 1.42) or IDet (RR = 1.38 [1.11, 1.72]). The risk of severe hypoglycemia was lower in IGlar than in NPH (RR = 0.77 [0.63, 0.94]), with no differences in comparison with MIX (RR = 0.74 [0.46, 1.20]) and IDet (RR = 1.10 [0.54, 2.25]). IGlar + OAD has comparable safety profile to NPH, with less frequent adverse events leading to treatment discontinuation than MIX + OAD (RR = 0.41 [0.22, 0.76]) and IDet + OAD (RR = 0.40 [0.24, 0.69]). Also severe adverse reactions were less common for IGlar + OAD when compared to MIX + OAD (RR = 0.71 [0.52; 0.98]). Conclusion: For the majority of examined efficacy and safety outcomes, IGlar use in T2DM patients was superior or non-inferior to the alternative insulin treatment options. © 2015, The Author(s).


PubMed | Jagiellonian University and HTA Consulting
Type: Journal Article | Journal: Ortopedia, traumatologia, rehabilitacja | Year: 2015

The increasing incidence of osteoporotic fractures is becoming a growing burden on the health service. Due to the high cost of treatment, these fractures require a broader look at the underlying problem. The aim of the study was to assess the 10-year probability of hip fracture or any other major osteoporotic fracture at which the treatment becomes cost-effective.This was a retrospective study of a group of 1,024 patients. The cost-effectiveness of pharmacological low-energy fracture prevention was analyzed by means of the medication defined as the reimbursement limit basis in the reimbursement limit group 147.0. (medications used in bone diseases) in July 2013 (Alendrogen 70 mg). 3- and 5-year therapies were analysed. The outcome was compared with the results of FRAX (of the Polish and British population) in every patient.The model for calculating cost-effectiveness showed that treatment after the age of 50 until the age of 60-65 years is cost-effective at a similar level of 10-year major fracture probability (regardless of treatment duration). After the age of 65, there is a clear decline in the profitability of the therapy. The results indicate that, for the population of women aged >50 years, the treatment is cost-effective when the 10-year major fracture probability equals 5.1% and 6% for a 3- and 5-year therapy, respectively.1. The study showed pharmacological treatment to be cost-effective in a large group of patients forming the study population. 2. The analysis also revealed a strong correlation between study results and the specific tool employed to define fracture probability.


INCHEON, Zuid-Korea--(BUSINESS WIRE)--Celltrion Healthcare heeft vandaag bekendgemaakt dat de Europese Commissie Truxima™ (biosimilair rituximab) heeft goedgekeurd voor alle indicaties van referentie-rituximab in de Europese Unie (EU). Truxima™ is wereldwijd het eerste biosimilaire monoklonale antilichaam (mAb) dat in een oncologie-indicatie wordt goedgekeurd. De goedkeuring van Truxima™ is het gevolg van het sterke wereldwijde klinische biosimilaire programma van Celltrion Healthcare. " We zijn verheugd het eerste biosimilaire mAb in de oncologie aan te bieden. Samen met onze partners in Europa willen we ervoor zorgen dat Truxima beschikbaar is voor de vele patiënten die baat kunnen hebben bij deze behandeling", zei Jung-Jin Seo, voorzitter van Celltrion Group, op een vergadering van de Europese partners in Parijs. " Voor de gezondheidszorgstelsels die gebukt gaan onder de hoge kosten van oncologiebehandelingen zijn we tevreden dat we een kans bieden op aanzienlijke besparingen terwijl de toegang van patiënten tot hoogwaardige en doeltreffende behandelingen behouden blijft." Truxima™ is in de EU goedgekeurd voor de behandeling van mensen met non-Hodgkin lymfoom (NHL), chronische lymfocytaire leukemie (CLL), reumatoïde artritis (RA), granulomatose met polyangiitis en microscopische polyangiitis.1 Deze goedkeuring is gebaseerd op het volledige pakket bewijsmateriaal dat is ingediend bij het Europees Geneesmiddelenbureau, waaruit een opmerkelijke gelijkenis bleek tussen Truxima™ en referentie-rituximab wat betreft doeltreffendheid, veiligheid, immunogeniciteit, farmacodynamica (PD) en farmacokinetica (PK) bij patiënten met RA en gevorderd folliculair lymfoom, een soort van NHL.2 Deze onderzoeken zijn bij meer dan 600 patiënten uitgevoerd en bevatten gegevens van maximaal 104 weken.1 Dr. Bertrand Coiffier, de toponderzoeker van wereldniveau in het onderzoek naar gevorderd folliculair lymfoom, hoofd van het departement hematologie in Hospices Civils de Lyon en professor aan de universiteit Claude Bernard, Lyon, Frankrijk, zei: " Er is aangetoond dat biosimilair rituximab een vergelijkbare doeltreffendheid en veiligheid heeft als referentie-rituximab in een omvangrijk testprogramma dat tot overtuigend bewijs heeft geleid voor de gelijkenis tussen de twee producten. De regelgevingsautoriteiten erkennen dit en hopelijk leidt deze stap tot verdere innovatie op dit gebied." " Als we aannemen dat de prijs van biosimilair rituximab 70% bedraagt van referentie-rituximab en het marktaandeel van biosimilair rituximab het eerste jaar 30%, het tweede jaar 40% en het derde jaar 50% bedraagt, zou de besparing op de begroting in de 28 EU-lidstaten voor deze drie jaar ongeveer € 570 miljoen bedragen", verklaarde professor László Gulácsi, hoofd van het departement gezondheidseconomie, Corvinus-universiteit Boedapest; HTA Consulting Boedapest, Hongarije. " Dit stemt overeen met 49.000 nieuwe patiënten met RA, NHL en CLL die een levensnoodzakelijke behandeling kunnen krijgen en dat is een enorm succes voor de gezondheidszorg op zowel nationaal als EU-niveau." Hematologische kankers ontstaan in het bloedvormingsweefsel of cellen van het immuunsysteem. Er zijn drie veelvoorkomende soorten: lymfoom, leukemie en myeloom. Er zijn veel soorten NHL: de meest voorkomende groep is B-cellymfomen en daarvan komen folliculair lymfoom en diffuus grootcellig B-lymfoom het vaakst voor. CLL is een soort leukemie en wordt gekenmerkt door de accumulatie van monoklonale B-cellen (een soort witte bloedcel). Truxima™ is een mAb dat zich richt op CD20, een proteïne die op het oppervlak van de meeste B-cellen wordt gevonden. Overactieve B-cellen kunnen aanleiding geven tot een aanval van gezonde cellen in immuunziekten zoals RA. B-cellen zijn ook betrokken bij sommige soorten hematologische kankers, waaronder NHL en CLL. CD20 is aanwezig op B-cellen in veel van hun ontwikkelingsfasen, wat de proteïne een goed doelwit maakt voor behandelingen. Truxima™ is in de EU goedgekeurd voor de behandeling van mensen met NHL, CLL, RA en granulomatose met polyangiitis en microscopische polyangiitis. Nadere gegevens over de goedgekeurde indicaties en veiligheidsinformatie voor Truxima™ zijn beschikbaar in de samenvatting van de productkenmerken (SmPC).1 Celltrion Healthcare verzorgt de wereldwijde marketing, verkoop en distributie van biologische geneesmiddelen die door Celltrion, Inc. zijn ontwikkeld via een omvangrijk wereldwijd netwerk dat meer dan 120 landen omvat. De producten van Celltrion Healthcare worden vervaardigd in geavanceerde faciliteiten voor zoogdiercelstructuren die zo zijn ontworpen en gebouwd dat ze voldoen aan de cGMP-richtsnoeren van de Amerikaanse Food and Drug Administration (FDA) en de GMP-richtsnoeren van de EU. Zie voor meer informatie: http://www.celltrionhealthcare.com/ Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.

Loading HTA Consulting collaborators
Loading HTA Consulting collaborators