| 1. |
- Sangskär, Heléne, 1980, et al.
(author)
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Safety, effectiveness, women's experience, and economic costs of outpatient induction in women with uncomplicated pregnancies: A systematic review and meta-analyses.
- 2022
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In: International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. - : Wiley. - 1879-3479. ; 161:2, s. 343-55
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Research review (peer-reviewed)abstract
- Induction of labor is increasing worldwide, and some countries have started to introduce outpatient induction in low-risk women.To assess current knowledge concerning the safety, efficacy, women's experience, and economic costs of outpatient induction compared with inpatient induction.Multiple databases were last searched on October 19, 2021. Studies were selected according to our pre-specified inclusion, selection, and exclusion criteria.PICO; P-women with low-risk pregnancy planned for induction of labor. I-Outpatient induction C-Inpatient induction O-Outcomes according to the core outcome set for induction of labor (COSIOL).Pooled in meta-analyses. The certainty of evidence was assessed using the GRADE system.The 20 included studies, including 7956 women, showed an overall low incidence of adverse events and indicated comparable results for inpatient and outpatient induction, but the studies were underpowered for safety-related outcomes. Women's experiences of outpatient induction were mostly positive. Based on three studies, the economic costs consequence is inconclusive.Due to early randomization, heterogenic study design, and underpowered studies regarding safety outcome, the certainty of evidence is very low. It is uncertain whether outpatient induction affects the risk for neonatal and maternal complications.
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| 2. |
- Abuloha, Sumaya, et al.
(author)
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A Review of the Cost-Effectiveness Evidence for FDA-Approved Cell and Gene Therapies.
- 2024
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In: Human gene therapy. - 1557-7422.
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Journal article (peer-reviewed)abstract
- Cell and gene therapy innovations have provided several significant breakthroughs in recent years. However, cell and gene therapies often come with a high upfront cost, raising questions about patient access, affordability, and long-term value. This study reviewed cost-effectiveness analysis studies that have attempted to assess the long-term value of FDA-approved cell and gene therapies. Two reviewers independently searched the Tufts Medical Center Cost-Effectiveness Analysis Registry to identify all studies for FDA-approved cell and gene therapies per January 2023. A data extraction template was used to summarize the evidence in terms of the incremental cost-effectiveness ratio expressed as the cost per Quality-Adjusted Life-Year (QALY) and essential modeling assumptions, combined with a template to extract the adherence to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. The review identified 26 CEA studies for seven cell and gene therapies. Around half of the base-case cost-effectiveness results indicated that the cost per QALY was below $100,000-$150,000, often used as a threshold for reasonable cost-effectiveness in the US. However, the results varied substantially across studies for the same treatment, ranging from being considered very cost-effective to far from cost-effective. Most models were based on data from single-arm trials with relatively short follow-ups, and different long-term extrapolations between studies caused large differences in the modeled cost-effectiveness results. In sum, this review showed that despite the high upfront costs, many cell and gene therapies have cost-effectiveness evidence that can support long-term value. Nonetheless, substantial uncertainty regarding long-term value exists because so much of the modeling results are driven by uncertain extrapolations beyond the clinical trial data.
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| 3. |
- Alkmark, Mårten, 1973, et al.
(author)
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Induction of labour at 41weeks of gestation versus expectant management and induction of labour at 42weeks of gestation: a cost-effectiveness analysis
- 2022
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In: BJOG: An International Journal of Obstetrics and Gynaecology. - : Wiley. - 1470-0328 .- 1471-0528. ; 129:13, s. 2157-2165
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Journal article (peer-reviewed)abstract
- Objective: To assess the cost-effectiveness of induction of labour (IOL) at 41weeks of gestation compared with expectant management until 42weeks of gestation. Design: A cost-effectiveness analysis alongside the Swedish Post-term Induction Study (SWEPIS), a multicentre, randomised controlled superiority trial. Setting: Fourteen Swedish hospitals during 2016–2018. Population: Women with an uncomplicated singleton pregnancy with a fetus in cephalic position were randomised at 41weeks of gestation to IOL or to expectant management and induction at 42weeks of gestation. Methods: Health benefits were measured in life years and quality-adjusted life years (QALYs) for mother and child. Total cost per birth was calculated, including healthcare costs from randomisation to discharge after delivery, for mother and child. Incremental cost-effectiveness ratios (ICERs) were calculated by dividing the difference in mean cost between the trial arms by the difference in life years and QALYs, respectively. Sampling uncertainty was evaluated using non-parametric bootstrapping. Main outcome measures: The cost per gained life year and per gained QALY. Results: The differences in life years and QALYs gained were driven by the difference in perinatal mortality alone. The absolute risk reduction in mortality was 0.004 (from 6/1373 to 0/1373). Based on Swedish life tables, this gives a mean gain in discounted life years and QALYs of 0.14 and 0.12 per birth, respectively. The mean cost per birth was €4108 in the IOL group (n=1373) and €4037 in the expectant management group (n=1373), with a mean difference of €71 (95%CI −€232 to €379). The ICER for IOL compared with expectant management was €545 per life year gained and €623 per QALY gained. Confidence intervals were relatively wide and included the possibility that IOL had both lower costs and better health outcomes. Conclusions: Induction of labour at 41weeks of gestation results in a better health outcome and no significant difference in costs. IOL is cost-effective compared with expectant management until 42weeks of gestation using standard threshold values for acceptable cost per life year/QALY. Tweetable abstract: Induction of labour at 41weeks of gestation is cost-effective compared with expectant management until 42weeks of gestation.
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| 4. |
- Andersson, Helen, 1968, et al.
(author)
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The cost-effectiveness of a two-step blood pressure screening programme in a dental health-care setting
- 2021
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In: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 16:5
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Journal article (peer-reviewed)abstract
- Background Hypertension is one of the largest contributors to the disease burden and a major economic challenge for health-care systems. Early detection of persons with high blood pressure can be achieved through screening and has the potential to reduce morbidity and mortality. We evaluate the cost-effectiveness of an opportunistic hypertension screening programme in a dental-care facility for individuals aged 40-75 in comparison to care as usual (the no-screening baseline scenario). Methods A cost-effectiveness analysis (CEA) was carried out from the payer and societal perspectives, and the short-term (from screening until diagnosis has been established) cost per identified case of hypertension and long-term (20 years) cost per quality-adjusted life year (QALY) were reported. Data on the short-term cost were based on a real-world screening programme in which 2025 healthy individuals were screened for hypertension. Data on the long-term cost were based on the short-term outcomes combined with modelling in a Markov cohort model. Deterministic and probabilistic sensitivity analyses were carried out to assess uncertainty. Results The short-term analysis showed an additional cost of 4,800 SEK (470) per identified case of hypertension from the payer perspective and from the societal perspective 12,800 SEK (1,240). The long-term analysis showed a payer cost per QALY of 2.2 million SEK (210,000) and from the societal perspective 2.8 million SEK per QALY (270,000). Conclusion The long-term model results showed that the screening model is unlikely to be cost-effective in a country with a well-developed health-care system and a relatively low prevalence of hypertension.
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| 5. |
- Balogun, F. M., et al.
(author)
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Stated preferences for human papillomavirus vaccination for adolescents in selected communities in Ibadan, Southwest Nigeria: A discrete choice experiment
- 2022
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In: Human Vaccines & Immunotherapeutics. - : Informa UK Limited. - 2164-5515 .- 2164-554X. ; 18:6
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Journal article (peer-reviewed)abstract
- Administration of the human papillomavirus (HPV) vaccine in early adolescence is effective in preventing cervical cancer, a common cancer in sub-Saharan Africa. Nigeria is in the pre-introduction era of the HPV vaccine. Understanding the preferences of the population for the vaccine can help design the HPV immunization program to ensure high uptake of the vaccine. This study explored the preferences for the HPV vaccine among stakeholders in selected communities in Ibadan, Nigeria. A discrete choice experiment survey based on six attributes of the HPV vaccine (which were the number of doses, the efficacy of the vaccine, cost of the vaccine, location of the service point, other benefits of the vaccine apart from prevention of cervical cancer and the odds of a side effect from the vaccine) was carried out in five communities. Data were analyzed using conditional and mixed logit models. Seven hundred community members were recruited, 144 (20.7%) were adolescents and 248 (35.4%) were males. In line with expectations, respondents preferred vaccines with higher efficacy, less severe side effects and lower costs. Preference heterogeneity was identified for adolescents that were less price-sensitive and other community members who were less likely to prefer using schools as the service point. The high socioeconomic class preferred a vaccine that also prevents genital warts. There were variabilities in the preferences for the attributes of the HPV vaccine in the study communities. These variabilities need to be considered in the introduction of the HPV vaccine to ensure high uptake of the vaccine.
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| 6. |
- Bonander, Carl, 1988-, et al.
(author)
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Model-based economic evaluation of ice cleat distribution programmes for the prevention of outdoor falls among adults from a Swedish societal perspective
- 2021
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In: Injury Prevention. - : BMJ Publishing Group Ltd. - 1353-8047 .- 1475-5785.
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Journal article (peer-reviewed)abstract
- Background: Slipping on snow or ice poses a significant health risk among older adults in Sweden. To combat this problem, about 80 Swedish municipalities have distributed ice cleats to older citizens (65+ years old) over the last decade. This paper details a cost-benefit analysis of such programmes. Materials and methods: We developed a decision-analytical model to estimate the costs and benefits of ice cleat programmes in Swedish municipalities compared with a business-as-usual scenario. The modelled benefits of the programme were based on effect estimates from previous research, data from population and healthcare registers and a survey of attitudes to and actual ice cleat use. The modelled costs of the programme were based on resource use data collected from 34 municipalities with existing ice cleat programmes. We assessed heterogeneity in the potential impact and benefit-to-cost ratios across all Swedish municipalities as a function of the average number of days with snow cover per year. Uncertainty in the cost-benefit results was assessed using deterministic and probabilistic sensitivity analyses. Results: The average benefit-to-cost ratio was 87, ranging from about 40 in low-risk municipalities to 140 in high-risk municipalities, implying that the potential benefits of ice cleat programmes greatly outweigh their costs. Probabilistic and deterministic sensitivity analyses support the robustness of this conclusion to parameter uncertainty and large changes in assumptions about the magnitude of the impact on ice cleat use and injuries. Conclusion: The benefits of distributing ice cleats to older adults appear to outweigh the costs from a Swedish societal perspective.
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| 7. |
- Bonander, Carl, et al.
(author)
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Using causal forests to assess heterogeneity in cost-effectiveness analysis
- 2021
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In: Health Economics (United Kingdom). - : Wiley. - 1057-9230 .- 1099-1050. ; 30:8, s. 1818-1832
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Journal article (peer-reviewed)abstract
- We develop a method for data-driven estimation and analysis of heterogeneity in cost-effectiveness analyses (CEA) with experimental or observational individual-level data. Our implementation uses causal forests and cross-fitted augmented inverse probability weighted learning to estimate heterogeneity in incremental outcomes, costs and net monetary benefits, as well as other parameters relevant to CEA. We also show how the results can be visualized in relevant ways for the analysis of heterogeneity in CEA, such as using individual-level cost effectiveness planes. Using a simulated dataset and an R package implementing our methods, we show how the approach can be used to estimate the average cost-effectiveness in the entire sample or in subpopulations, explore and analyze the heterogeneity in incremental outcomes, costs and net monetary benefits (and their determinants), and learn policy rules from the data.
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| 8. |
- Chauca Strand, Gabriella, 1995, et al.
(author)
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Assessment of the clinical and cost-effectiveness evidence in the reimbursement decisions of new cancer drugs
- 2022
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In: ESMO Open. - : Elsevier. - 2059-7029. ; 7:5
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Journal article (peer-reviewed)abstract
- Background: This study aimed to describe the clinical and cost-effectiveness evidence supporting reimbursementdecisions of new cancer drugs and analyze the influence of trial characteristics and the cost per quality-adjusted lifeyears (QALYs) on the likelihood of reimbursement in Sweden.Patients and methods: Data were extracted from all appraisal dossiers for new cancer drugs seeking reimbursement inSweden and claiming added therapeutical value between the years 2010 and 2020. The data were analyzed usingdescriptive statistics, and logistic regression models were also used with the cost per QALY, study design,comparator, and evidence on final outcomes in the clinical trials as predictors of reimbursement.Results: All 60 included appraisals were based on trial evidence that assessed at least one final outcome (overallsurvival [OS] or quality of life [QoL]), although rarely as a primary outcome. Of the appraisals with a final decision(n ¼ 58), 79% were approved for reimbursement. Among the reimbursed drugs, only half had trial evidencedemonstrating improved OS or QoL. Only one drug had trial evidence supporting improvements in both OS andQoL. The average cost per QALY for reimbursed cancer drugs was estimated to be 748 560 SEK (V73 583). A highercost per QALY was found to decrease the likelihood of reimbursement by 9.4% for every 100 000 SEK (V9830)higher cost per QALY (P ¼ 0.03). For cost-effectiveness models without direct evidence of improvements in finaloutcomes, a larger QALY gain was observed compared with those with evidence mainly relying on intermediate andsurrogate outcomes.Conclusions: There are substantial uncertainties in the clinical and cost-effectiveness evidence underlyingreimbursement decisions of new cancer drugs. Decision makers should be cautious of the limited evidence onpatient-centered outcomes and the implications of allocating resources to expensive treatments with uncertainvalue for money.
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| 9. |
- Chauca Strand, Gabriella, 1995, et al.
(author)
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Cancer Drugs Reimbursed with Limited Evidence on Overall Survival and Quality of Life : Do Follow-Up Studies Confirm Patient Benefits?
- 2023
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In: Clinical drug investigation. - : Springer. - 1173-2563 .- 1179-1918. ; 43:8, s. 621-633
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Journal article (peer-reviewed)abstract
- Background and ObjectiveCancer drug costs have increased considerably within healthcare systems, but many drugs lack quality-of-life (QoL) and overall survival (OS) data at the time of reimbursement approval. This study aimed to review the extent of subsequent literature documenting improvements in OS and QoL for cancer drug indications where no such evidence existed at the time of reimbursement approval.MethodsDrug indications with claims of added therapeutical value but a lack of evidence on OS and QoL that were reimbursed between 2010 and 2020 in Sweden were included for review. Searches were conducted in PubMed and ClinicalTrial.gov for randomized controlled trials examining OS and QoL.ResultsOf the 22 included drug indications, seven were found to have at least one trial with conclusive evidence of improvements in OS or QoL after a mean follow-up of 6.6 years. The remaining 15 drug indications either lacked subsequent randomized controlled trial data on OS or QoL (n = 6) or showed no statistically significant improvements (n = 9). Only one drug demonstrated evidence of improvement in both OS and QoL for its indication.ConclusionsA considerable share of reimbursed cancer drug indications continue to lack evidence of improvement in both OS and QoL. With limited healthcare resources and an increasing cancer burden, third-party payers have strong incentives to require additional post-reimbursement data to confirm any improvements in OS and QoL.
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| 10. |
- Djerf, Henrik, et al.
(author)
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Absence of Long-Term Benefit of Revascularization in Patients with Intermittent Claudication: Five-Year Results from the IRONIC Randomized Controlled Trial
- 2020
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In: Circulation: Cardiovascular Interventions. - 1941-7640 .- 1941-7632. ; 13:1
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Journal article (peer-reviewed)abstract
- © 2020 Lippincott Williams and Wilkins. All rights reserved. Background: The long-term benefit of revascularization for intermittent claudication is poorly understood. The aim of this study was to investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach. Methods: The IRONIC trial (Invasive Revascularization or Not in Intermittent Claudication) randomized patients with mild-to-severe intermittent claudication to either revascularization + best medical therapy + structured exercise therapy (the revascularization group) or best medical therapy + structured exercise therapy (the nonrevascularization group). The health-related quality of life short form 36 questionnaire was primary outcome and disease-specific health-related quality of life (vascular quality of life questionnaire) and treadmill walking distances were secondary end points. Health-related quality of life has previously been reported superior in the revascularization group at 1- and 2-year follow-up. In this study, the 5-year results were determined. The cost-effectiveness of the treatment options was analyzed from a payer/healthcare standpoint. Results: Altogether, 158 patients were randomized in a 1:1 ratio. Regarding the primary end point, no intergroup differences were observed for the short form 36 sum or domain scores from baseline to 5 years, except for the short form 36 role emotional domain score, with greater improvement in the nonrevascularization group (n=116, P=0.007). No intergroup differences were observed in the vascular quality of life questionnaire total and domain scores (n=116, NS) or in treadmill walking distances (n=91, NS). A revascularization strategy resulted in almost twice the cost per patient compared with a noninvasive treatment approach ($13 098 versus $6965, P=0.02). Conclusions: After 5 years of follow-up, a revascularization strategy had lost its early benefit and did not result in any long-term improvement in health-related quality of life or walking capacity compared to a noninvasive treatment strategy. Revascularization was not a cost-effective treatment option from a payer/healthcare point of view. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01219842.
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