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- Björnerstedt, Jonas, et al.
(författare)
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Validation of overall survival extrapolations made by TLV in the assessment of cost-effectiveness of oncology drugs in Sweden : A pilot study comparing extrapolated and observed life-years gained
- 2024
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Ingår i: Journal of Medical Economics. - : Taylor & Francis. - 1369-6998 .- 1941-837X. ; 27:1, s. 193-200
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Tidskriftsartikel (refereegranskat)abstract
- Aim: The aim of the study is to assess the accuracy of overall survival (OS) extrapolations in cost-effectiveness analysis made by the Dental and Pharmaceutical Benefits Agency (TLV) to decide on the reimbursement and use of oncology drugs in Sweden.Material and methods: TLV appraisals for oncology drugs were identified during a 5-year period (2013-2017). To be included each appraisal and health economic model must include a TLV base case extrapolation of OS. Further, Kaplan-Meier (KM) estimates on OS from the original and follow-up clinical trials must be available. Potential follow-up trials on OS were identified in ClinicalTrials.gov and the Lund University Libraries databases, and in the Swedish Medical Products Agency (MPA) and the European Medicines Agency (EMA) databases. In cases where the KM estimates were not available, data points from figures published in TLV's appraisals were extracted using the semi-automated tools Digitizelt and WebPlotDigitizer. The accuracy of survival extrapolations was assessed by comparing extrapolated and observed life-years (LYs), using three different measures: 1) difference in LYs between the treatment and control group; 2) LYs in the treatment group, 3) LYs in the control group.Results: We study TLV's preferred OS extrapolations and show that on average they overestimate the observed mean gain in LYs by 17%, and underestimate observed LYs by 5% and 1% in the treatment and control group, respectively.Conclusions: We conclude that it is feasible to validate OS extrapolations by comparing extrapolated and observed life-years. Even if survival extrapolations are reasonably accurate for the treatment and control group, respectively, this may still imply that extrapolations of LYs gained deviates to a larger extent. Follow-up studies on OS should be carried out to an increased extent to be able to validate, update and improve OS extrapolations in cost-effectiveness analysis of oncology drugs.
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| 5. |
- Burström, Kristina, et al.
(författare)
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Swedish experience-based value sets for EQ-5D health states
- 2014
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Ingår i: Quality of Life Research. - : Springer Science and Business Media LLC. - 1573-2649 .- 0962-9343. ; 23:2, s. 431-442
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Tidskriftsartikel (refereegranskat)abstract
- PurposeTo estimate Swedish experience-based value sets for EQ-5D health states using general population health survey data.MethodsApproximately 45,000 individuals valued their current health status by means of time trade off (TTO) and visual analogue scale (VAS) methods and answered the EQ-5D questionnaire, making it possible to model the association between the experience-based TTO and VAS values and the EQ-5D dimensions and severity levels. The association between TTO and VAS values and the different severity levels of respondents’ answers on a self-rated health (SRH) question was assessed.ResultsAlmost all dimensions (except usual activity) and severity levels had less impact on TTO valuations compared with the UK study based on hypothetical values. Anxiety/depression had the greatest impact on both TTO and VAS values. TTO and VAS values were consistently related to SRH. The inclusion of age, sex, education and socioeconomic group affected the main effect coefficients and the explanatory power modestly.ConclusionsA value set for EQ-5D health states based on Swedish valuations has been lacking. Several authors have recently advocated the normative standpoint of using experience-based values. Guidelines of economic evaluation for reimbursement decisions in Sweden recommend the use of experience-based values for QALY calculations. Our results that anxiety/depression had the greatest impact on both TTO and VAS values underline the importance of mental health for individuals’ overall HRQoL. Using population surveys is in line with recent thinking on valuing health states and could reduce some of the focusing effects potentially appearing in hypothetical valuation studies.
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| 6. |
- Döring, Nora, et al.
(författare)
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Economic evaluation of primrose-a trial-based analysis of an early childhood intervention to prevent obesity
- 2018
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Ingår i: Frontiers in Endocrinology. - : Frontiers Media SA. - 1664-2392. ; 9:MAR
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Tidskriftsartikel (refereegranskat)abstract
- Background: Childhood obesity is a major clinical and economic health concern. Alongside the clinical understanding of obesity, there is a growing interest in designing and implementing interventions that are worth their money given the scarce resources in the health care sector. This study is one of the first efforts to provide evidence by assessing the effects and costs of a population-based primary prevention intervention targeting pre-school children attending child health centers in Sweden. Methods: The economic evaluation is based on the PRIMROSE cluster-randomized controlled trial aiming to establish healthy eating and physical activity among pre-school children (9-48 months of age) through motivational interviewing applied by trained nurses at child health centers. The cost-effectiveness is assessed over the trial period from a societal perspective. The primary outcome was BMI at age 4. Cost data was prospectively collected alongside the trial. Scenario analyses were carried out to identify uncertainty. Results: The estimated additional mean total costs of the PRIMROSE intervention were 342 Euro (95% CI: 334; 348) per child. During pre-school years direct costs mainly consist of training costs and costs for the additional time used by nurses to implement the intervention compared to usual care. Early indirect costs mainly consist of parents' absence from work due to their participation in the intervention. The incremental cost-effectiveness ratio in the base case analysis was 3,109 Euro per 1 BMI unit prevented. Conclusion: We cannot provide evidence that the PRIMROSE intervention is cost-effective, given the uncertainty in the effect measure. Until further evidence is provided, we recommend resources to be spent elsewhere within the field of obesity prevention. Furthermore, to achieve valid and reliable cost-effectiveness results, the economic evaluation of obesity prevention programs in early childhood should incorporate the life time impact to capture all relevant costs and benefits.
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- Ekman, Mattias, et al.
(författare)
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Cost effectiveness of bisoprolol in the treatment of chronic congestive heart failure in Sweden : Analysis using data from the cardiac insufficiency bisoprolol study II trial
- 2001
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Ingår i: PharmacoEconomics. - : Springer. - 1179-2027 .- 1170-7690. ; 19:9, s. 901-916
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Objective: To investigate the cost effectiveness of adding the P-blocker bisoprolol to standard treatment in patients with congestive heart failure (CHF). Design and setting: A cost-effectiveness study was based on the Cardiac Insufficiency Bisoprolol Study II (CIBIS-II), a randomised clinical trial investigating the efficacy of adding bisoprolol to standard therapy of CHF. The cost-effectiveness analysis was carried out from a societal perspective, Methods: Health effects were measured in terms of years of life gained. On the cost side, treatment costs for pharmaceuticals and hospitalisations were included. Data on healthcare resource consumption from CIBIS-II were used and were combined with average Swedish retail prices for medicines, and average costs for hospitalisations based on hospital admissions, in the base case. The costs of added years of life, i.e. consumption net of production during life-years gained were also included. Results: If costs of added years of life were not included, then bisoprolol therapy increased life expectancy at an incremental cost of Swedish kronor (SEK) 13 094 (1999 values) per year of life gained. If costs of added years of life were included, then the incremental cost-effectiveness ratio of bisoprolol therapy was SEK168 858 per year of life gained. Conclusions: For patients with CHF with the characteristics of those in CIBIS-II, the cost effectiveness of bisoprolol therapy compares favourably with that of other cardiovascular therapies.
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| 8. |
- Ekman, Mattias, et al.
(författare)
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Kostnadseffektivt att behandlakronisk hjärtsvikt med bisoprolol [Cost-effectiveness of bisoprolol in chronic heart failure]
- 2002
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Ingår i: Läkartidningen. - 0023-7205 .- 1652-7518. ; 14, s. 646-650
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Kliniska prövningar har visat att betablockerare har gynnsamma effekter på dödlighet och sjuklighet vid kronisk hjärtsvikt.Hjärtsvikt är ett vanligt och allvarligt tillstånd, som dessutom orsakar samhällsekonomiska kostnader på minst 2 miljarder kronor per år.Den kliniska studien CIBIS II, som omfattade 2 647 patienter i funktionsklass III och IV, visade en signifikant minskning av mortaliteten på 32 procent när beta-blockeraren bisoprolol adderades till konventionell hjärtsviktsbehandling.Som ett led i en ekonomisk utvärdering av bisoprolol undersöktes kostnader och hälsoeffekter i samband med behandlingen. Uppgifter om läkemedelsförbrukning och sjukhusinläggningar hämtades från CIBIS II-studien. Uppgifter om patienternas överlevnad är dels hämtade från CIBIS-II-studien, dels baserade på uppgifter från tidigare studier.Den ekonomiska utvärderingen indikerar att behandling av kronisk hjärtsvikt med bisoprolol är ett kostnadseffektivt alternativ.
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| 9. |
- Ellingsen, Tore, et al.
(författare)
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A randomized trial of the effect of testosterone and estrogen on verbal fluency, verbal memory, and spatial ability in healthy postmenopausal women
- 2011
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Ingår i: Fertility and Sterility. - : Elsevier. - 0015-0282 .- 1556-5653. ; 95:1, s. 152-157
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To test the causal relationship between sex hormones and cognitive skills in postmenopausal women. We hypothesized that testosterone would decrease verbal memory and verbal fluency and increase spatial ability compared with a placebo. For estrogen, we conversely hypothesized that the treatment would increase verbal fluency and verbal memory and decrease spatial ability. Design: Randomized, double-blind, placebo-controlled, parallel-group trial. Setting: Women's health clinical research unit at a university hospital. Patient(s): Two-hundred healthy, naturally postmenopausal women aged 50-65 years. Intervention(s): Randomization to 4 weeks' treatment with testosterone (testosterone undecanoate, 40 mg/day), estrogen (oral E2 2 mg/day) or placebo. Main outcome measure(s): Comparisons in verbal fluency, verbal memory, and spatial ability between the three treatment groups. Result(s): We found no significant effects of testosterone or estrogen on verbal fluency, verbal memory, or spatial ability. Conclusion(s): Our results give no support for short-term testosterone or estrogen treatment having any substantial effect on verbal fluency, verbal memory, or spatial ability in healthy postmenopausal women. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
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| 10. |
- Ernstsson, Olivia, et al.
(författare)
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Association between pulse width and health-related quality of life after electroconvulsive therapy in patients with unipolar or bipolar depression : an observational register-based study
- 2024
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Ingår i: Nordic Journal of Psychiatry. - : Taylor & Francis. - 0803-9488 .- 1502-4725. ; 78:2, s. 137-145
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: To examine the association between pulse width and HRQoL measured within one week after electroconvulsive therapy (ECT) and at six-month follow-up in patients with unipolar or bipolar depression.METHODS: This was an observational register study using data from the Swedish National Quality Registry for ECT (2011-2019). Inclusion criteria were: age ≥18 years; index treatment for unipolar/bipolar depression; unilateral electrode placement; information on pulse width; EQ-5D measurements before and after ECT. Multiple linear regressions were performed to investigate the association between pulse width (<0.5 ms; 0.5 ms; >0.5 ms) and HRQoL (EQ-5D-3L index; EQ VAS) one week after ECT (primary outcome) and six months after ECT (secondary outcome).RESULTS: The sample included 5,046 patients with unipolar (82%) or bipolar (18%) depression. At first ECT session, 741 patients (14.7%) had pulse width <0.5 ms, 3,639 (72.1%) had 0.5 ms, and 666 (13.2%) had >0.5 ms. There were no statistically significant associations between pulse width and HRQoL one week after ECT. In the subsample of patients with an EQ-5D index recorded six months after ECT (n = 730), patients receiving 0.5 ms had significantly lower HRQoL (-0.089) compared to <0.5 ms, after adjusting for demographic and clinical characteristics (p = .011). The corresponding analysis for EQ VAS did not show any statistically significant associations.CONCLUSION: No robust associations were observed between pulse width and HRQoL after ECT. On average, significant improvements in HRQoL were observed one week and six months after ECT for patients with unipolar or bipolar disease, independent of the pulse width received.
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