National Center for Pharmacoeconomics

Dublin, Ireland

National Center for Pharmacoeconomics

Dublin, Ireland
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de Bruijn W.,University Utrecht | Ibanez C.,Catalan Health Service Servei Catala Of La Salut | Frisk P.,Public Health Services Committee | Alkan A.,Turkish Medicines and Medical Devices Agency | And 37 more authors.
Frontiers in Pharmacology | Year: 2016

Background: Infection with the Hepatitis C Virus (HCV) is a widespread transmittable disease with a diagnosed prevalence of 2.0%. Fortunately, it is now curable in most patients. Sales of medicines to treat HCV infection grew 2.7% per year between 2004 and 2011, enhanced by the launch of the protease inhibitors (PIs) boceprevir (BCV) and telaprevir (TVR) in addition to ribavirin and pegylated interferon (pegIFN). Costs will continue to rise with new treatments including sofosbuvir, which now include interferon free regimens. Objective: Assess the uptake of BCV and TVR across Europe from a health authority perspective to offer future guidance on dealing with new high cost medicines. Methods: Cross-sectional descriptive study of medicines to treat HCV (pegIFN, ribavirin, BCV and TVR) among European countries from 2008 to 2013. Utilization measured in defined daily doses (DDDs)/1000 patients/quarter (DIQs) and expenditure in Euros/DDD. Health authority activities to influence treatments categorized using the 4E methodology (Education, Engineering, Economics and Enforcement). Results: Similar uptake of BCV and TVR among European countries and regions, ranging from 0.5 DIQ in Denmark, Netherlands and Slovenia to 1.5 DIQ in Tayside and Catalonia in 2013. However, different utilization of the new PIs vs. ribavirin indicates differences in dual vs. triple therapy, which is down to factors including physician preference and genotypes. Reimbursed prices for BCV and TVR were comparable across countries. Conclusion: There was reasonable consistency in the utilization of BCV and TVR among European countries in comparison with other high priced medicines. This may reflect the social demand to limit the transmission of HCV. However, the situation is changing with new curative medicines for HCV genotype 1 (GT1) with potentially an appreciable budget impact. These concerns have resulted in different prices across countries, with their impact on budgets and patient outcomes monitored in the future to provide additional guidance. © 2016 de Bruijn, Ibáñez, Frisk, Bak Pedersen, Alkan, Vella Bonanno, Brkicic, Bucsics, Dedet, Eriksen, Fadare, Fürst, Gallego, Godói, Guerra Júnior, Gürsöz, Jan, Jones, Joppi, Kerman, Laius, Madzikwa, Magnússon, Maticic, Markovic-Pekovic, Massele, Ogunleye, O'Leary, Piessnegger, Sermet, Simoens, Tiroyakgosi, Truter, Thyberg, Tomekova, Wladysiuk, Vandoros, Vural, Zara and Godman.


Gold R.,Ruhr University Bochum | Toumi M.,University of Lyon | Meesen B.,Ismar Healthcare | Fogarty E.,National Center for Pharmacoeconomics
Multiple Sclerosis | Year: 2016

Background: In Europe, there exists considerable variability in access to care and treatment for multiple sclerosis (MS). Objectives: To improve this situation, we identified key issues payers should take into account when making decisions on access to care and treatment for MS. We also give an overview of the different dimensions determining total MS burden and discuss why it is key to integrate the patient's perspective in estimating this burden. Results: The total burden of MS relates to three dimensions: clinical, humanistic and economic. Although the clinical burden is extensively studied, crucial information is still missing about MS pathophysiology, how MS-related symptoms will develop during the disease course and which patients will progress more rapidly. With regard to the humanistic burden, information on patient-reported quality of life systematically collected in clinical trials for registration purposes is still scarce. Early engagement between pharmaceutical companies, the European Medicines Agency and health technology agencies to prospectively identify key evidence needs for the regulatory and reimbursement processes is required as a first step towards more equal access to care and treatment in MS in Europe. Patients' expectations regarding treatment outcomes should be better researched and integrated into decision-making and patients should be counselled in this process. © SAGE Publications.


O'Connell K.,Park University | Kelly S.B.,Park University | Fogarty E.,Park University | Fogarty E.,National Center for Pharmacoeconomics | And 5 more authors.
Multiple Sclerosis and Related Disorders | Year: 2014

Background: Multiple sclerosis (MS) commonly affects young adults and can be associated with significant disability resulting in considerable socioeconomic burden for both patient and society. Aims: The aim was to determine the direct and indirect cost of an MS relapse. Methods: This was a prospective audit composed of medical chart review and patient questionnaire. Relapses were stratified into 3 groups: low, moderate and high intensity. Age, gender, MS subtype, disease duration, expanded disability status scale (EDSS) score, disease modifying therapy (DMT) use and employment status were recorded. Direct costs included GP visits, investigations, clinic visit, consultations with medical staff, medication and admission costs. Indirect costs assessed loss of earnings, partner's loss of earnings, childcare, meals and travel costs. Results: Fifty-three patients had a clinically confirmed relapse. Thirteen were of low intensity; 23 moderate intensity and 17 high intensity with mean costs of €503, €1395 and €8862, respectively. Those with high intensity episodes tended to be older with higher baseline EDSS (p<0.003) and change in EDSS (p<0.002). Direct costs were consistent in both low and moderate intensity groups but varied with length of hospital stay in the high intensity group. Loss of earnings was the biggest contributor to indirect costs. A decision to change therapy as a result of the relapse was made in 23% of cases, further adding to annual MS related costs. Conclusions: The cost of an MS relapse is dependent on severity of the episode but even low intensity episodes can have a significant financial impact for the patient in terms of loss of earnings and for society with higher annual MS related costs. © 2014 Elsevier B.V. All rights reserved.


Schmitz S.,Trinity College Dublin | Adams R.,National Center for Pharmacoeconomics | Walsh C.,Trinity College Dublin | Walsh C.,National Center for Pharmacoeconomics
BMC Medical Research Methodology | Year: 2012

Background: Estimates of relative efficacy between alternative treatments are crucial for decision making in health care. When sufficient head to head evidence is not available Bayesian mixed treatment comparison models provide a powerful methodology to obtain such estimates. While models can be fit to a broad range of efficacy measures, this paper illustrates the advantages of using continuous outcome measures compared to binary outcome measures. Methods. Using a case study in rheumatoid arthritis a Bayesian mixed treatment comparison model is fit to estimate the relative efficacy of five anti-TNF agents currently licensed in Europe. The model is fit for the continuous HAQ improvement outcome measure and a binary version thereof as well as for the binary ACR response measure and the underlying continuous effect. Results are compared regarding their power to detect differences between treatments. Results: Sixteen randomized controlled trials were included for the analysis. For both analyses, based on the HAQ improvement as well as based on the ACR response, differences between treatments detected by the binary outcome measures are subsets of the differences detected by the underlying continuous effects. Conclusions: The information lost when transforming continuous data into a binary response measure translates into a loss of power to detect differences between treatments in mixed treatment comparison models. Binary outcome measures are therefore less sensitive to change than continuous measures. Furthermore the choice of cut-off point to construct the binary measure also impacts the relative efficacy estimates. © 2012 Schmitz et al.; licensee BioMed Central Ltd.


Schmitz S.,Trinity College Dublin | Adams R.,National Center for Pharmacoeconomics | Walsh C.,Trinity College Dublin | Walsh C.,National Center for Pharmacoeconomics
Statistics in Medicine | Year: 2013

Estimates of relative efficacy between alternative treatments are crucial for decision making in health care. Bayesian mixed treatment comparison models provide a powerful methodology to obtain such estimates when head-to-head evidence is not available or insufficient. In recent years, this methodology has become widely accepted and applied in economic modelling of healthcare interventions. Most evaluations only consider evidence from randomized controlled trials, while information from other trial designs is ignored. In this paper, we propose three alternative methods of combining data from different trial designs in a mixed treatment comparison model. Naive pooling is the simplest approach and does not differentiate between-trial designs. Utilizing observational data as prior information allows adjusting for bias due to trial design. The most flexible technique is a three-level hierarchical model. Such a model allows for bias adjustment while also accounting for heterogeneity between-trial designs. These techniques are illustrated using an application in rheumatoid arthritis. © 2013 John Wiley & Sons, Ltd.


Fogarty E.,National Center for Pharmacoeconomics | Schmitz S.,Luxembourg Institute of Health | Tubridy N.,St Vincents University Hospital | Walsh C.,University of Limerick | Barry M.,National Center for Pharmacoeconomics
Multiple Sclerosis and Related Disorders | Year: 2016

Introduction Randomised studies have demonstrated efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis (RRMS). However it is unclear how the magnitude of treatment efficacy varies across all currently available therapies. Objective To perform a systematic review and network meta-analysis to evaluate the comparative efficacy of available therapies in reducing relapses and disability progression in RRMS. Methods A systematic review identified 28 randomised, placebo-controlled and direct comparative trials. A network meta-analysis was conducted within a Bayesian framework to estimate comparative annualised relapse rates (ARR) and risks of disability progression (defined by both a 3-month, and 6-month confirmation interval). Potential sources of treatment-effect modification from study-level covariates and baseline risk were evaluated through meta-regression methods. The Surface Under the Cumulative RAnking curve (SUCRA) method was used to provide a ranking of treatments for each outcome. Results The magnitude of ARR reduction varied between 15-36% for all interferon-beta products, glatiramer acetate and teriflunomide, and from 50 to 69% for alemtuzumab, dimethyl fumarate, fingolimod and natalizumab. The risk of disability progression (3-month) was reduced by 19-28% with interferon-beta products, glatiramer acetate, fingolimod and teriflunomide, by 38-45% for pegylated interferon-beta, dimethyl fumarate and natalizumab and by 68% with alemtuzumab. Broadly similar estimates for the risk of disability progression (6-month), with the exception of interferon-beta-1b 250 mcg which was much more efficacious based on this definition. Alemtuzumab and natalizumab had the highest SUCRA scores (97% and 95% respectively) for ARR, while ranking for disability progression varied depending on the definition of the outcome. Interferon-beta-1b 250 mcg ranked among the most efficacious treatments for disability progression confirmed after six months (92%) and among the least efficacious when the outcome was confirmed after three months (30%). No significant modification of relative treatment effects was identified from study-level covariates or baseline risk. Conclusion Compared with placebo, clear reductions in ARR with disease-modifying therapies were accompanied by more uncertain changes in disability progression. The magnitude of the reduction and the uncertainty associated with treatment effects varied between DMTs. While natalizumab and alemtuzumab demonstrated consistently high ranking across outcomes, with older interferon-beta and glatiramer acetate products ranking lowest, variation in disability progression definitions lead to variation in the relative ranking of treatments. Rigorously conducted comparative studies are required to fully evaluate the comparative treatment effects of disease modifying therapies for RRMS. © 2016 Elsevier B.V.


PubMed | National Center for Pharmacoeconomics, Luxembourg Institute of Health, University of Limerick and St Vincents University Hospital
Type: | Journal: Multiple sclerosis and related disorders | Year: 2016

Randomised studies have demonstrated efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis (RRMS). However it is unclear how the magnitude of treatment efficacy varies across all currently available therapies.To perform a systematic review and network meta-analysis to evaluate the comparative efficacy of available therapies in reducing relapses and disability progression in RRMS.A systematic review identified 28 randomised, placebo-controlled and direct comparative trials. A network meta-analysis was conducted within a Bayesian framework to estimate comparative annualised relapse rates (ARR) and risks of disability progression (defined by both a 3-month, and 6-month confirmation interval). Potential sources of treatment-effect modification from study-level covariates and baseline risk were evaluated through meta-regression methods. The Surface Under the Cumulative RAnking curve (SUCRA) method was used to provide a ranking of treatments for each outcome.The magnitude of ARR reduction varied between 15-36% for all interferon-beta products, glatiramer acetate and teriflunomide, and from 50 to 69% for alemtuzumab, dimethyl fumarate, fingolimod and natalizumab. The risk of disability progression (3-month) was reduced by 19-28% with interferon-beta products, glatiramer acetate, fingolimod and teriflunomide, by 38-45% for pegylated interferon-beta, dimethyl fumarate and natalizumab and by 68% with alemtuzumab. Broadly similar estimates for the risk of disability progression (6-month), with the exception of interferon-beta-1b 250mcg which was much more efficacious based on this definition. Alemtuzumab and natalizumab had the highest SUCRA scores (97% and 95% respectively) for ARR, while ranking for disability progression varied depending on the definition of the outcome. Interferon-beta-1b 250mcg ranked among the most efficacious treatments for disability progression confirmed after six months (92%) and among the least efficacious when the outcome was confirmed after three months (30%). No significant modification of relative treatment effects was identified from study-level covariates or baseline risk.Compared with placebo, clear reductions in ARR with disease-modifying therapies were accompanied by more uncertain changes in disability progression. The magnitude of the reduction and the uncertainty associated with treatment effects varied between DMTs. While natalizumab and alemtuzumab demonstrated consistently high ranking across outcomes, with older interferon-beta and glatiramer acetate products ranking lowest, variation in disability progression definitions lead to variation in the relative ranking of treatments. Rigorously conducted comparative studies are required to fully evaluate the comparative treatment effects of disease modifying therapies for RRMS.

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