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1. Use of Biologic Therapies in the Treatment of Asthma – A Comparative Real World Data Analysis on Healthcare Resource Utilization and Costs Before and After Therapy Initiation

Author

Hardtstock F, Krieger J, Wilke T, Lukas M, Ultsch B, Welte R, Quinzler R, Maywald U, and Timmermann H

Subjects
biologics, treatment pattern, claims data, real-world evidence, germany, Immunologic diseases. Allergy, RC581-607
Abstract

Fraence Hardtstock,1 Julia Krieger,1 Thomas Wilke,1 Marco Lukas,2 Bernhard Ultsch,2 Robert Welte,2 Renate Quinzler,3 Ulf Maywald,4 Hartmut Timmermann5 1IPAM e.V, Wismar, Germany; 2GlaxoSmithKline GmbH & Co. KG, München, Germany; 3AOK Baden-Württemberg, Stuttgart, Germany; 4AOK PLUS, Dresden, Germany; 5Schwerpunktpraxis Colonnaden, Hamburg, GermanyCorrespondence: Fraence Hardtstock, Email Fraence.hardtstock@ipam-wismar.deBackground: Asthma is one of the most common chronic diseases in Germany. While many patients achieve asthma control under standard therapies, some patients still experience exacerbations and persistent airway obstructions. Thus, further pharmacological treatment is needed, and biologics could fill this gap, as they have shown clinical benefit in patients with severe asthma. Therefore, this real-world study aimed to compare healthcare resource utilization (HCRU) and associated costs before and after biologic therapy initiation.Methods: A retrospective claims data analysis has been conducted on adult asthma patients who initiated a long-term biologic therapy between January 2015 and June 2018. Patients were therapy-naïve to biologics for at least 12 months. HCRU and cost incurred by patients during 12 months before and after therapy initiation were compared.Results: Overall, 571 asthma patients initiated a biologic therapy during the observational period (316 omalizumab, 232 mepolizumab, 16 benralizumab, and 7 reslizumab). Patients had a mean age of 54.86 (62.70% female), and the majority (93.70%) received at least one follow-up prescription of their index-biologic agent within one year. During baseline, patients received on average 2.75 OCS prescriptions compared to 2.17 during follow-up. Most patients received less or the same amount of OCS after therapy initiation. Moreover, hospitalizations and asthma-related sick leave days decreased significantly. The average total costs per patient were € 6618.90 during baseline and € 22,832.33 during follow-up. Biologics mainly drove the increase; however, hospitalization costs were reduced significantly (€ 2443.37 vs € 1941.93; p< 0.001).Conclusion: Our study demonstrates an improved asthma control due to the initiation of a biologic therapy in terms of decreased hospitalization frequency, OCS consumption, and sick leave days. However, biologics are associated with high costs for healthcare providers during the first year after initiation. Therefore, short- and long-term clinical benefits and financial burden must be considered in the overall context of healthcare.Keywords: biologics, treatment pattern, claims data, real-world evidence, Germany

Published
2022

13. Cost impact of prospective HLA-B*5701-screening prior to abacavir/lamivudine fixed dose combination use in Germany

Author

Wolf E, Blankenburg M, Bogner JR, Becker W, Gorriahn D, Mueller MC, Jaeger H, Welte R, Baudewig M, Walli R, and Stoll M

Subjects
HLA-B*5701, pharmacogenomics, abacavir, Medicine
Abstract

Abstract Objective Avoiding abacavir in HIV-infected patients tested positive for HLA-B*5701 reduces the risk of abacavir hypersensitivity reaction (ABC-HSR). Our aim was to assess the costs of clinically suspected HSR and to estimate potential cost savings of implementing prospective HLA-B*5701-screening for HIV-infected patients initiating abacavir/lamivudine fixed-dose combination (ABC/3TC FDC) compared to initiating respective treatment without screening. Methods Employing a decision tree model the expected HSR-related costs of screening vs. no screening were estimated from the societal and healthcare payer perspective (reference year 2007). A retrospective standardized assessment of all clinically suspected ABC-HSR cases without screening at 5 German HIV-centres was performed to measure resource consumption. In- and outpatient care, discarded ABC/3TC FDC and concomitant medication were considered. Direct resource utilization was valued using German fees (EBM, G-DRGs). Indirect costs were measured with the human capital approach. Estimates for the HLA-B*5701-prevalence, HSR-incidence, and hospitalization rate were based on clinical trials and cohorts and it was assumed that screening reduces the incidence of clinically suspected ABC-HSR from 10% to 0.5%. Results Thirty-two ABC-HSR cases were identified from 1998 to 2007. Mean direct and total costs per clinically suspected HSR case were € 1,362 and € 2,235, respectively. Hospital costs contributed 63.3% to direct costs. Potential cost savings when implementing genetic screening were estimated at € 44 and € 127 per screened patient, from a healthcare payer or societal perspective. Conclusion HLA-B*5701 screening prior to ABC/3TC FDC initiation prevents significant HSR-related costs per screened patient and is likely to lead to overall net savings.

Published
2010
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14. A DELPHI study on aspects of study design to overcome knowledge gaps on the burden of disease caused by serogroup B invasive meningococcal disease

Author

Marten, O, Koerber, F, Bloom, D, Bullinger, M, Buysse, Corinne, Christensen, H, De Wals, P, Dohna-Schwake, C, Henneke, P, Kirchner, M, Knuf, M, Lawrenz, B, Monteiro, AL, Sevilla, JP, Velde, N, Welte, R, Wright, C, Greiner, W, Marten, O, Koerber, F, Bloom, D, Bullinger, M, Buysse, Corinne, Christensen, H, De Wals, P, Dohna-Schwake, C, Henneke, P, Kirchner, M, Knuf, M, Lawrenz, B, Monteiro, AL, Sevilla, JP, Velde, N, Welte, R, Wright, C, and Greiner, W

Published
2019

23. Economic evaluations of hepatitis B vaccination strategies - A systematic review of the literature

Author

Wit GA de, Welte R, and CZO

Subjects
literatuuronderzoek, vaccinatie, economic evaluation, prevention, preventie, literature, review, hepatitis b, kosten-effectiviteits-analyse, vaccination, economische evaluatie, cost-effectiveness-analysis
Abstract

National and international economic evaluations of universal vaccination against hepatitis B were systematically selected from the literature. Only the studies meeting the following criteria were selected: (a) original data reported in Dutch, English, French or German; (b) at least one universal vaccination strategy evaluated; (c) a high methodological quality shown and (d) conducting of the study in countries with a hepatitis B epidemiological pattern comparable to the Dutch situation. Sixteen relevant studies were identified out of 1060 publications registered in the databases, COCHRANE LIBRARY, CURRENT CONTENTS, DARE, HEED, INAHTA DATABASE, MEDLINE, NEED, and by applying the system of reference tracking. Despite the strict inclusion criteria, great divergence was seen among assumptions applied to a study, methodologies, outcomes and conclusions. Some studies show universal screening to be cost-saving, while others report unfavourable cost-effectiveness ratios. Studies that investigated similar vaccination strategies reach dissimilar conclusions on the most cost-effective strategy. Several parameters were found to have a usually large impact on the results and conclusions of a study. These are: a) vaccine costs, b) discount rate, c) hepatitis B incidence, d) inclusion of indirect costs and effects, e) percentage of acute infections that lead to chronic hepatitis, f) discounting effects and h) assumed lifelong costs of hepatitis B infection, including long-term consequences such as cirrhosis and liver cancer. Hence, in any further study these important variables should be subject to an extensive sensitivity analysis. Economic evaluations that are intended to assist in local policy-making should take careful account of local circumstances. The 16 selected studies have little practical relevance for Dutch policy-makers.

Published
2012

24. Kosteneffectiviteit van vaccinatie tegen pneumokokken en meningokokken infecties bij kinderen

Author

Bos JM, Rumke HC, Welte R, Postma MJ, Zwanepol E, Jager JC, and CZO

Subjects
vaccinatie, kosteneffectiviteit, kosten, meningokokken, economische evaluatie, pneumokokken
Abstract

Doel: Het vaststellen van de programmakosten, monetaire baten en "quality adjusted" gewonnen levensjaren, verbonden aan volgende vaccinatiestrategieen: vaccinatie van jonge kinderen met een geconjugeerd pneumokokken vaccin en vaccinatie van jonge kinderen met een meningokokken B vaccin. De vaccins die geevalueerd worden zijn een 7-valent geconjugeerd pneumokokken vaccin en een 6-valent meningokokken buitenmembraaneiwit vaccin. Data & Methode: Een epidemiologisch model is ontwikkeld en gekoppeld aan economische data. Alle analyses zijn gedaan vanuit een maatschappelijk perspectief. In de basisanalyse worden alleen directe kosten meegenomen. In de gevoeligheidsanalyse is een berekening van de indirecte kosten gemaakt volgens de frictie-kosten methode. Zowel toekomstige kosten als gezondheidseffecten worden verdisconteerd met 4%. De studies zijn uitgevoerd volgens de richtlijnen voor farmaco-economisch onderzoek van de ziekenfondsraad. Resultaten. Het aantal gewonnen QALY door interventie bedraagt voor het pneumokokken vaccin 229 en voor het meningokokken vaccin 480. Door pneumokokken vaccinatie kan per jaar 8 sterfgevallen en 8 gevallen van ernstig blijvend letsel voorkomen worden. Meningokokken vaccinatie voorkomt per jaar 19 sterfgevallen en 8 gevallen van ernstig blijvend letsel. De kosten van de vaccinatieprogramma's bedragen 12.201.569 euro per jaar voor het pneumokokken vaccin en 9.115.711 euro per jaar voor het meningokokken vaccin. De kosteneffectiviteitratio's bedragen in de basisanalyse 38.440 euro per QALY voor het pneumokokken vaccin en 11.407 euro per QALY voor het meningokokken vaccin Conclusie: Zowel meningokokken als pneumokokken vaccinatie bij jonge kinderen heeft een, in vergelijking met grenswaarden die in internationale publicaties gehanteerd worden, acceptabele kosteneffectiviteitsratio.

Published
2012

29. Cost-effectiveness of partner pharmacotherapy in screening women for asymptomatic infection with Chlamydia Trachomatis

Author

Maarten Postma, Welte, R., Den Hoek, J. A., Doornum, G. J., Jager, H. C., Coutinho, R. A., and Methods in Medicines evaluation & Outcomes research (M2O)

Subjects
Adult, Male, Adolescent, Cost-Benefit Analysis, Decision Trees, Ligase Chain Reaction, Chlamydia trachomatis, Health Care Costs, Azithromycin, Chlamydia Infections, Drug Costs, Infectious Disease Transmission, Vertical, Sexual Partners, Cost of Illness, Pregnancy, Disease Progression, Humans, Mass Screening, Female, Economics, Pharmaceutical, Pregnancy Complications, Infectious, health care economics and organizations, Netherlands
Abstract

OBJECTIVE: To assess the cost-effectiveness of pharmacotherapy for male partners in screening women for asymptomatic infection with Chlamydia trachomatis (CT). METHODS AND DATA: A pharmacoeconomic decision analysis model was constructed for the health outcomes of a CT screening program, such as averted cases of pelvic inflammatory disease and infertility (major outcomes). Reinfection in the absence of partner pharmacotherapy was included in the model. Cost-effectiveness from a societal perspective was estimated for prevalence data from a selective opportunistic screening program in Amsterdam. For diagnosis of asymptomatic CT infection a Ligase Chain Reaction (LCR) test on urine was used; for pharmacotherapy of women and partners azithromycin was used. By linking health outcomes with health care costs and productivity losses, averted costs were estimated. Cost-effectiveness was expressed as net costs per major outcome averted. RESULTS: Partner pharmacotherapy reduces net costs per major outcome averted of the screening program by approximately 50%. Sensitivity analysis indicates significant improvements in cost-effectiveness of the screening program, even when relevant assumptions are varied. Within the broader framework of the screening program, partner pharmacotherapy is a cost-saving activity. CONCLUSIONS: Inclusion of partner pharmacotherpy provides significant improvements in overall cost-effectiveness of the CT screening program among women aged 15 to 29. Partner pharmacotherapy lowers net costs per major outcome averted to the realm where implementation of the screening program should be considered. Considering the cost-saving potential, male partner pharmacotherapy should be pursued within the broader framework of a CT screening program for women. Reinfection should be included in any future pharmacoeconomic model of CT screening. Further work on this type of model should also be directed to linking cost-effectiveness to epidemiological models for the long-term spread of infectious diseases in populations.

Published
2001

30. Screening op asymptomatische infectie met Chlamydia trachomatis in de zwangerschap: gunstige kosteneffectiviteit bij een prevalentie van tenminste 3%

Author

Postma, M. J., Bakker, A., Welte, R., Van Bergen, J.E.A.M., Van den Hoek, J.A.R., De Jong-Van den Berg, L.T.W., and Jager, J.C.

Subjects
Adult, Adolescent, Pregnancy, Cost-Benefit Analysis, Humans, Mass Screening, Chlamydia trachomatis, Female, Prenatal Care, Chlamydia Infections, Pregnancy Complications, Infectious, health care economics and organizations, Netherlands
Abstract

OBJECTIVE: To estimate the cost-effectiveness of antenatal screening for Chlamydia trachomatis. DESIGN: Pharmaco-economic model analysis. METHOD: The risks of C. trachomatis infection during pregnancy and of complications of the infection as well as the cost of screening for complications (pelvic inflammatory disease, chronic pelvic pain, ectopic pregnancy, infertility and neonatal pneumonia) and of treatment were estimated. Assumed were a ligase chain reaction on urine and treatment of identified infected cases with erythromycin or amoxicillin (second choice). Cost-effectiveness was calculated and presented in net direct and indirect costs per major complication averted. RESULTS: For C. trachomatis prevalences in pregnancy above 4% benefits exceed the costs. For prevalences between 2.82% and 4.00% net costs are positive, but a major complication averted costs less than f 1000.-. Considering sensitivity analysis as well, screening for C. trachomatis at prevalences above 3% costs less than f 1000.-per major complication averted and might even save costs. No recent Dutch data on C. trachomatis prevalence in pregnancy are published however. CONCLUSION: Given the current information, antenatal C. trachomatis screening can be recommended from a pharmaco-economic perspective if C. trachomatis prevalence in pregnancy is 3% or more.

Published
2000

33. Cost-effectiveness of screening programs for Chlamydia trachomatis: a population-based dynamic approach.

Author

Welte R, Kretzschmar M, Leidl R, van den Hoek A, Jager JC, Postma MJ, Welte, R, Kretzschmar, M, Leidl, R, van den Hoek, A, Jager, J C, and Postma, M J

Abstract

Background: Models commonly used for the economic assessment of chlamydial screening programs do not consider population effects.Goal: To develop a novel dynamic approach for the economic evaluation of chlamydial prevention measures and to determine the cost-effectiveness of a general practitioner-based screening program.Study Design: The dynamic approach was used to estimate the cost-effectiveness of a screening program for the first 10 years of screening in The Netherlands. Screening involved a ligase chain reaction test on urine followed by standardized therapies and partner referral. Eligible persons were sexually active, 15 to 24 years, visited a general practitioner, and had no symptoms of sexually transmitted diseases. The heterosexual model population, which consisted of persons 15 to 64 years, had a total chlamydial prevalence of 4.1% before screening. Screening effects on chlamydial incidence were computed by using a population-based stochastic simulation model. Incidence data were connected with a decision analysis model to determine the health effects of the program. The net costs of the program were calculated (investment costs minus averted costs, in 1997 US$) from a societal perspective and expressed per major outcome averted (symptomatic pelvic inflammatory disease, chronic pelvic pain, ectopic pregnancy, infertility, neonatal pneumonia).Results: Unlike the standard static approach, our model adequately addresses dynamic processes such as chlamydial transmission and the impact of screening programs on chlamydial incidence in the population. During the first 10 years of screening, the investigated program yields savings of US $492 or US $1,086 per major outcome averted, excluding or including indirect costs, respectively. These results depend on chlamydial prevalence and partner referral.Conclusions: The cost-effectiveness of chlamydial screening programs seems best to be determined by using dynamic modeling on a population basis. In addition to preventing negative health outcomes, the investigated screening program may save costs. [ABSTRACT FROM AUTHOR]

Published
2000
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37. Do costs of varicella justify routine infant vaccination?

Author

Postma, M.J., Bos, J.M., Welte, R., Groot, R. de, Luytjes, W., Rumke, H.C., Beutels, P., Postma, M.J., Bos, J.M., Welte, R., Groot, R. de, Luytjes, W., Rumke, H.C., and Beutels, P.

Abstract

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Published
2003

47. Kosteneffectiviteit van vaccinatie tegen pneumokokken en meningokokken infecties bij kinderen

Author

CZO, Bos JM, Rumke HC, Welte R, Postma MJ, Zwanepol E, Jager JC, CZO, Bos JM, Rumke HC, Welte R, Postma MJ, Zwanepol E, and Jager JC

Abstract

RIVM rapport:Objective: Assessment of the program costs, monetary benefits and quality adjusted life years connected to the following vaccination strategies: vaccination of infants against invasive pneumococcal infections and otitis media and vaccination of infants against meningococcal infections. The vaccines that are evaluated are a 7 valent conjugated pneumococcal vaccine and the 6-valent outer membrane vesicle (OMV) meningococcal vaccine. Data & Methods: A decision analysis model is applied which links an epidemiological model with economic data. Only effects of vaccination on invasive infections were considered in the analysis. The perspective of the society was chosen and costs and effects were discounted at 4%. In the baseline analysis only direct costs were considered. However, indirect costs were included in the sensitivity analysis. The cost-effectiveness analyses correspond to the Dutch guidelines for farmacoeconomic research. The cost-effectiveness ratios are expressed in costs per quality adjusted life years (QALY) gained. Results: Pneumococcal vaccination renders 229 QALY per year. Meningococcal vaccination yields 480 QALY per year. When not corrected for quality of life, pneumococcal vaccination renders 189 life years gained. Meningococcal yields 386 life years gained. Pneumococcal vaccination prevents 8 deaths and 8 cases of severe sequelae per year. Meningococcal vaccination prevents 19 deaths and 8 cases of severe sequelae per year. Program costs of pneumococcal vaccination are 12,201,569 euro. Program costs of meningococcal vaccination are estimated as 9,115,711 euro. The cost-effectiveness ratios are 38,440 euro per QALY gained for pneumococcal vaccination and 11,407 euro per QALY gained for meningococcal vaccination. Conclusions: Both meningococcal and pneumococcal vaccinations of infants are in the favourable category, according to categories set by the Institute of Medicine. Further research is necessary to assess the cost-effectiveness of pneumococcal va, Doel: Het vaststellen van de programmakosten, monetaire baten en "quality adjusted" gewonnen levensjaren, verbonden aan volgende vaccinatiestrategieen: vaccinatie van jonge kinderen met een geconjugeerd pneumokokken vaccin en vaccinatie van jonge kinderen met een meningokokken B vaccin. De vaccins die geevalueerd worden zijn een 7-valent geconjugeerd pneumokokken vaccin en een 6-valent meningokokken buitenmembraaneiwit vaccin. Data & Methode: Een epidemiologisch model is ontwikkeld en gekoppeld aan economische data. Alle analyses zijn gedaan vanuit een maatschappelijk perspectief. In de basisanalyse worden alleen directe kosten meegenomen. In de gevoeligheidsanalyse is een berekening van de indirecte kosten gemaakt volgens de frictie-kosten methode. Zowel toekomstige kosten als gezondheidseffecten worden verdisconteerd met 4%. De studies zijn uitgevoerd volgens de richtlijnen voor farmaco-economisch onderzoek van de ziekenfondsraad. Resultaten. Het aantal gewonnen QALY door interventie bedraagt voor het pneumokokken vaccin 229 en voor het meningokokken vaccin 480. Door pneumokokken vaccinatie kan per jaar 8 sterfgevallen en 8 gevallen van ernstig blijvend letsel voorkomen worden. Meningokokken vaccinatie voorkomt per jaar 19 sterfgevallen en 8 gevallen van ernstig blijvend letsel. De kosten van de vaccinatieprogramma's bedragen 12.201.569 euro per jaar voor het pneumokokken vaccin en 9.115.711 euro per jaar voor het meningokokken vaccin. De kosteneffectiviteitratio's bedragen in de basisanalyse 38.440 euro per QALY voor het pneumokokken vaccin en 11.407 euro per QALY voor het meningokokken vaccin Conclusie: Zowel meningokokken als pneumokokken vaccinatie bij jonge kinderen heeft een, in vergelijking met grenswaarden die in internationale publicaties gehanteerd worden, acceptabele kosteneffectiviteitsratio.

Published
2000

48. Naar een vaccinatieprogramma voor Nederland in de 21ste eeuw

Author

SB1, VTV, LVR, LVO, CZO, Zeijst BAM van der, Dijkman MI, Kramers PGN, Luytjes W, Rumke HC, Welte R, SB1, VTV, LVR, LVO, CZO, Zeijst BAM van der, Dijkman MI, Kramers PGN, Luytjes W, Rumke HC, and Welte R

Abstract

RIVM rapport:A view is presented on the future vaccination policy in the Netherlands. The report addresses the following four subjects. (i) Improvement of the current national vaccination programme (RVP). Maintaining and improving the quality of the RVP requires efforts related to efficacy, safety and adverse effects, vaccination schemes, (re)vaccination of elderly people and the eradication of polio. (ii) Possible inclusion in the RVP of available vaccines or vaccines probably available before 2010. Twelve candidate vaccines were analysed with respect to disease-burden, cost-efectiveness and feasibility of inclusion in the current vaccination programme. The analysis resulted in the identification of vaccines deemed suitable and less suitable for incorporation in the RVP with a number of recommendations for further action. (iii) Vaccines in a stage of early development and possibly available between 2010 and 2020. Some of these vaccines (five) may be relevant for the Dutch public health. Progress in these fields should be monitored. In addition, active participation with respect to combination vaccines and alternative application routes (to parenteral immunisation) is paramount. (iv) Activities important for maintaining a successful RVP were identified., Er wordt een visie gepresenteerd voor een toekomstig vaccinatiebeleid in Nederland. De volgende vier onderwerpen worden komen aan de orde. (i) Verbetering van het huidige rijksvaccinatieprogramma (RVP). Handhaving en verbetering van de kwaliteit van het RVP vergt inspanning m.b.t. effectiviteit, veiligheid en bijwerkingen, vaccinatieschema's, (her)vaccinatie van ouderen en de uitroeiing van polio. (ii) Mogelijke opname in het RVP van nieuwe vaccins of vaccins die waarschijnlijk voor 2010 beschikbaar zijn. Twaalf kandidaat vaccins werden geanalyseerd m.b.t. voorkombare ziektelast, kosteneffectiviteit en haalbaarheid van inpassing in het RVP. Op basis van de analyse werden de vaccins beoordeeld als geschikt of minder geschikt voor opname in het RVP. Daarnaast werden voorstellen voor actie geformuleerd. (iii) Vaccins in een vroeg stadium van ontwikkeling en mogelijk beschikbaar tussen 2010 en 2020. Vijf vaccins uit deze groep lijken relevant voor de Nederlandse volksgezondheid. De voortgang op dit terrein moet gevolgd worden. Actieve participatie m.b.t. combinatievaccins en andere dan parenterale toedieningsvormen is van belang. (iv) Activiteiten van belang voor handhaving van een succesvol RVP.

Published
2000

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