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Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study).
Aznar-Lou, I, Zabaleta-Del-Olmo, E, Casajuana-Closas, M, Sánchez-Viñas, A, Parody-Rúa, E, Bolíbar, B, Iracheta-Todó, M, Bulilete, O, López-Jiménez, T, Pombo-Ramos, H, et al
The international journal of behavioral nutrition and physical activity. 2021;(1):88
Abstract
BACKGROUND Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. METHODS An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. RESULTS The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. CONCLUSION The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. TRIAL REGISTRATION Clinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.
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Costs of cancer attributable to excess body weight in the Brazilian public health system in 2018.
Corrêa Ferreira da Silva, R, Bahia, LR, Machado da Rosa, MQ, Malhão, TA, Mendonça, EP, Rosa, RDS, Araújo, DV, Maya Moreira, LG, Schilithz, AOC, Diogenes Melo, MEL
PloS one. 2021;(3):e0247983
Abstract
OBJECTIVES The prevalence of excess body weight (EBW) has increased over the last decades in Brazil, where 55.4% of the adult population was overweight in 2019. EBW is a well-known risk factor for several types of cancer. We estimated the federal cost of EBW-related cancers in adults, considering the medical expenditures in the Brazilian Public Health System. METHODS We calculated the costs related to 11 types of cancer considering the procedures performed in 2018 by all organizations that provide cancer care in the public health system. We obtained data from the Hospital and Ambulatory Information Systems of the Brazilian Public Health System. We calculated the fractions of cancer attributable to EBW using the relative risks from the literature and prevalence from a nationally representative survey. We converted the monetary values in Reais (R$) to international dollars (Int$), considering the purchasing power parity (PPP) of 2018. RESULTS In Brazil, the 2018 federal cost for all types of cancers combined was Int$ 1.73 billion, of which nearly Int$ 710 million was spent on EBW-related cancer care and Int$ 30 million was attributable to EBW. Outpatient and inpatient expenditures reached Int$ 20.41 million (of which 80% was for chemotherapy) and Int$ 10.06 million (of which 82% was for surgery), respectively. Approximately 80% of EBW-attributable costs were due to breast, endometrial and colorectal cancers. CONCLUSION A total of 1.76% of all federal cancer-related costs could be associated with EBW, representing a substantial economic burden for the public health system. We highlight the need for integrated policies for excess body weight control and cancer prevention.
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Reducing the cost of managing patients with atrial fibrillation undergoing percutaneous coronary intervention with stenting.
Mehran, R, Vogel, B, Levy, P
Journal of cardiology. 2021;(1):93-99
Abstract
Patients undergoing percutaneous coronary intervention (PCI) have an increased risk of both ischemic events and bleeding complications resulting from antithrombotic therapy. These events are particularly common in patients with a concomitant indication for oral anticoagulation, such as those with atrial fibrillation, and are associated with a substantial healthcare resource burden. Advances in procedural aspects of PCI have led to marked improvements in outcomes and a consequent reduction in the costs resulting from PCI-associated complications. Furthermore, recent randomized clinical trials have investigated the optimal antithrombotic strategy in the specific case of patients with atrial fibrillation undergoing PCI, leading to a shift toward the tailoring of antithrombotic therapy according to the patient's individual stroke and bleeding risks. Here we review these recent advances, with a particular focus on the improvements in antithrombotic strategies offered by the non-vitamin K antagonist oral anticoagulants.
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Cost-Effectiveness of First-Line Versus Second-Line Use of Daratumumab in Older, Transplant-Ineligible Patients With Multiple Myeloma.
Patel, KK, Giri, S, Parker, TL, Bar, N, Neparidze, N, Huntington, SF
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021;(10):1119-1128
Abstract
PURPOSE The MAIA trial found that addition of daratumumab to lenalidomide and dexamethasone (DRd) significantly prolonged progression-free survival in transplant-ineligible patients with newly diagnosed multiple myeloma, compared with lenalidomide and dexamethasone alone (Rd). However, daratumumab is a costly treatment and is administered indefinitely until disease progression. Therefore, it is unclear whether it is cost-effective to use daratumumab in the first-line setting compared with reserving its use until later lines of therapy. METHODS We created a Markov model to compare healthcare costs and clinical outcomes of transplant-ineligible patients treated with daratumumab in the first-line setting compared with a strategy of reserving daratumumab until the second-line. We estimated transition probabilities from randomized trials using parametric survival modeling. Lifetime direct healthcare costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated for first-line daratumumab versus second-line daratumumab from a US payer perspective. RESULTS First-line daratumumab was associated with an improvement of 0.52 QALYs and 0.66 discounted life-years compared with second-line daratumumab. While both treatment strategies were associated with considerable lifetime expenditures ($1,434,937 v $1,112,101 in US dollars), an incremental cost of $322,836 for first-line daratumumab led to an ICER of $618,018 per QALY. The cost of daratumumab would need to be decreased by 67% for first-line daratumumab to be cost-effective at a willingness-to-pay threshold of $150,000 per QALY. CONCLUSION Using daratumumab in the first-line setting for transplant-ineligible patients may not be cost-effective under current pricing. Delaying daratumumab until subsequent lines of therapy may be a reasonable strategy to limit healthcare costs without significantly compromising clinical outcomes. Mature overall survival data are necessary to more fully evaluate cost-effectiveness in this setting.
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[Effects and costs of The Healthy Primary School of the Future].
van Schayck, CP, Willeboordse, M, Oosterhof, M, Bartelink, N, van Assema, P, Kremers, S, Winkens, B, Savelberg, H, Jansen, M, Joore, M, et al
Nederlands tijdschrift voor geneeskunde. 2021
Abstract
OBJECTIVE To study school lifestyle interventions for elementary school children (The Healthy Primary School of the Future). RESEARCH QUESTION What are the effects of the introduction of increased physical activity with or without healthy nutrition on health behaviour and BMI of young children and what are the costs of this program? DESIGN Prospective controlled non-randomized study with nearly 1700 children in Parkstad (South-East Netherlands). RESULTS Preliminary results after two years show that the combination of increased physical activity and healthy nutrition result in a decreased BMIz-score (-0.036), increased physical activity alone in hardly any change (-0.10) while in the control group the BMIz-score increased (0.052). The net societal costs of the combination of physical activity and health nutrition costs were 1 euro per child per day. CONCLUSION The study contributes to the increasing amount of evidence proving that lifestyle interventions are effective in reducing the obesity epidemic. Future studies will show whether a weight reduction in children will result in the prevention of chronic disease later on in life and what the cost reduction related to this result will be.
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Associations of Intensive Lifestyle Intervention in Type 2 Diabetes With Health Care Use, Spending, and Disability: An Ancillary Study of the Look AHEAD Study.
Huckfeldt, PJ, Frenier, C, Pajewski, NM, Espeland, M, Peters, A, Casanova, R, Pi-Sunyer, X, Cheskin, L, Goldman, DP
JAMA network open. 2020;(11):e2025488
Abstract
IMPORTANCE Intensive lifestyle interventions focused on diet and exercise can reduce weight and improve diabetes management. However, the long-term effects on health care use and spending are unclear, especially for public payers. OBJECTIVE To estimate the association of effective intensive lifestyle intervention for weight loss with long-term health care use and Medicare spending. DESIGN, SETTING, AND PARTICIPANTS This ancillary study used data from the Look AHEAD randomized clinical trial, which randomized participants with type 2 diabetes to an intensive lifestyle intervention or control group (ie, diabetes support and education), provided ongoing intervention from 2001 to 2012, and demonstrated improved diabetes management and reduced health care costs during the intervention. This study compared Medicare data between study arms from 2012 to 2015 to determine whether the intervention was associated with persistent reductions in health care spending. EXPOSURE Starting in 2001, Look AHEAD's intervention group participated in sessions with lifestyle counselors, dieticians, exercise specialists, and behavioral therapists with the goal of reducing weight 7% in the first year. Sessions occurred weekly in the first 6 months of the intervention and decreased over the intervention period. The controls participated in periodic group education sessions that occurred 3 times per year in the first year and decreased to 1 time per year later in the trial. MAIN OUTCOMES AND MEASURES Outcomes included total Medicare spending, Part D prescription drug costs, Part A and Part B Medicare spending, hospital admissions, emergency department visits, and disability-related Medicare eligibility. RESULTS This study matched Medicare administrative records for 2796 Look AHEAD study participants (54% of 5145 participants initially randomized and 86% of 3246 participants consenting to linkages). Linked intervention and control participants were of a similar age (mean [SD] age, 59.6 [5.4] years vs 59.6 [5.5] years at randomization) and sex (818 [58.1%] women vs 822 [59.3%] women). There was no statistically significant difference in total Medicare spending between groups (difference, -$133 [95% CI, -$1946 to $1681]; P = .89). In the intervention group, compared with the control group, there was statistically significantly higher Part B spending (difference, $513 [95% CI, $70 to $955]; P = .02) but lower prescription drug costs (difference, -$803 [95% CI, -$1522 to -$83]; P = .03). CONCLUSIONS AND RELEVANCE This ancillary study of a randomized clinical trial found that reductions in health care use and spending associated with an intensive lifestyle intervention for type 2 diabetes diminished as participants aged. Intensive lifestyle interventions may need to be sustained to reduce long-term health care spending. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03952728.
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Real-World Assessment of Health Care Costs for Patients with Metastatic Pancreatic Cancer Following Initiation of First-Line Chemotherapy.
Bullock, A, Rowan, CG, Oestreicher, N, Yeganegi, H, Chiorean, EG
Journal of managed care & specialty pharmacy. 2020;(7):872-878
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Abstract
BACKGROUND Management of metastatic pancreatic ductal adenocarcinoma (mPDA) places a significant financial burden on the U.S. health care system because of such factors as treatment with multidrug chemotherapy regimens, management of chemotherapy-related adverse events, and disease- or treatment-related hospitalizations. Depending on functional status, first-line chemotherapy regimens that are guideline recommended include nab-paclitaxel with gemcitabine (AG) and FOLFIRINOX (FFX), the combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin. However, few previous studies have examined overall health care costs associated with mPDA management. OBJECTIVE To describe health care costs following initiation of first-line treatment with AG or FFX among patients with mPDA. METHODS Retrospective cohorts of first-line AG and FFX initiators were constructed from the MarketScan database (2014-2017). The index date was the date of first-line AG or FFX initiation. Included patients had insurance enrollment for 6 months before the index date. Total cumulative health care costs and costs from outpatient services, inpatient admissions, emergency department visits, chemotherapy administrations, and pharmacy dispensing were assessed within 12 months after the index date (i.e., 0-1, 0-2, …, 0-12 months). Patient-level cost data began accruing from the first paid claim and continued accruing until the censoring date. RESULTS A total of 2,199 patients with mPDA initiated first-line AG (n = 1,352) or FFX (n = 847). Compared with AG initiators, FFX patients were younger (mean age 59 vs. 63 years) and had better baseline health status, with fewer having diabetes (43% vs. 57%) or coronary artery disease (12% vs. 22%). Median follow-up was 5.4 and 7.2 months for AG and FFX, respectively. Median first-line treatment duration was 2.1 months with AG and 2.3 months with FFX. Six months following first-line treatment initiation, total cumulative health care costs (median) were $85,714 (95% CI = $79,683-$91,788) and $114,116 (95% CI = $105,816-$119,591) for AG and FFX initiators, respectively. Outpatient services contributed the largest fractional cost for both groups. CONCLUSIONS Total health care costs for patients with mPDA who initiated FFX or AG are driven mostly by outpatient rather than inpatient costs. Further research, using comparative methodology, is warranted to fully understand cost drivers and whether higher costs for FFX patients relate primarily to use of FFX or higher underlying use of outpatient care among FFX patients. DISCLOSURES This study was funded by Halozyme Therapeutics. Oestreicher and Yeganegi were employees of Halozyme Therapeutics at the time of the study and were involved in study design, data interpretation, and the decision to submit the data for publication. Bullock reports advisory board fees from Eisai, Exelixis, Bayer, and Taiho and consulting fees from Halozyme Therapeutics, outside the submitted work. Rowan reports consulting fees from Halozyme Therapeutics, during the conduct of the study. Chiorean reports grants and consulting fees from Celgene and Halozyme Therapeutics; grants from Lilly, Stemline, Ignyta, Roche, Merck, Boehringer-Ingelheim, Bristol Meyer Squibb, Incyte, Macrogenics, Rafael, and AADi; and consulting fees from Astra Zeneca, Array, Eisai, Ipsen, Five Prime Therapeutics, Seattle Genetics, Vicus, and Legend, outside the submitted work.
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Cost-effectiveness and Clinical Outcomes of Early Anti-Tumor Necrosis Factor-α Intervention in Pediatric Crohn's Disease.
Bashir, NS, Walters, TD, Griffiths, AM, Ito, S, Ungar, WJ
Inflammatory bowel diseases. 2020;(8):1239-1250
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BACKGROUND Anti-tumor necrosis factor-α (anti-TNF-α) treatments are increasingly used to treat pediatric Crohn's disease, even without a prior trial of immunomodulators, but the cost-effectiveness of such treatment algorithms has not been formally examined. Drug plan decision-makers require evidence of cost-effectiveness to inform funding decisions. The objective was to assess the incremental cost-effectiveness of early intervention with anti-TNF-α treatment vs a conventional step-up strategy per steroid-free remission-week gained from public health care and societal payer perspectives over 3 years. METHODS A probabilistic microsimulation model was constructed for children with newly diagnosed moderate to severe Crohn's disease receiving anti-TNF-α treatment and concomitant treatments within the first 3 months of diagnosis compared with children receiving standard care consisting of steroids and/or immunomodulators with the possibility of anti-TNF-α treatment after 3 months of diagnosis. A North American multicenter observational study with 360 patients provided input into clinical outcomes and health care resource use. RESULTS Early intervention with anti-TNF-α treatment was more costly, with an incremental cost of CAD$31,112 (95% confidence interval [CI], $2939-$91,715), and more effective, with 11.3 more weeks in steroid-free remission (95% CI, 10.6-11.6) compared with standard care, resulting in an incremental cost per steroid-free remission-week gained of CAD$2756 from an Ontario public health care perspective and CAD$2968 from a societal perspective. The incremental cost-effectiveness ratio was sensitive to the price of infliximab. CONCLUSIONS The results suggest that although early anti-TNF-α was not cost-effective, it was clinically beneficial. These findings, along with other randomized controlled trial evidence, may inform formulary decision-making.
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Cost-effectiveness of a lifestyle intervention in high-risk individuals for diabetes in a low- and middle-income setting: Trial-based analysis of the Kerala Diabetes Prevention Program.
Sathish, T, Oldenburg, B, Thankappan, KR, Absetz, P, Shaw, JE, Tapp, RJ, Zimmet, PZ, Balachandran, S, Shetty, SS, Aziz, Z, et al
BMC medicine. 2020;(1):251
Abstract
BACKGROUND Data on the cost-effectiveness of lifestyle-based diabetes prevention programs are mostly from high-income countries, which cannot be extrapolated to low- and middle-income countries. We performed a trial-based cost-effectiveness analysis of a lifestyle intervention targeted at preventing diabetes in India. METHODS The Kerala Diabetes Prevention Program was a cluster-randomized controlled trial of 1007 individuals conducted in 60 polling areas (electoral divisions) in Kerala state. Participants (30-60 years) were those with a high diabetes risk score and without diabetes on an oral glucose tolerance test. The intervention group received a 12-month peer-support lifestyle intervention involving 15 group sessions delivered in community settings by trained lay peer leaders. There were also linked community activities to sustain behavior change. The control group received a booklet on lifestyle change. Costs were estimated from the health system and societal perspectives, with 2018 as the reference year. Effectiveness was measured in terms of the number of diabetes cases prevented and quality-adjusted life years (QALYs). Three times India's gross domestic product per capita (US$6108) was used as the cost-effectiveness threshold. The analyses were conducted with a 2-year time horizon. Costs and effects were discounted at 3% per annum. One-way and multi-way sensitivity analyses were performed. RESULTS Baseline characteristics were similar in the two study groups. Over 2 years, the intervention resulted in an incremental health system cost of US$2.0 (intervention group: US$303.6; control group: US$301.6), incremental societal cost of US$6.2 (intervention group: US$367.8; control group: US$361.5), absolute risk reduction of 2.1%, and incremental QALYs of 0.04 per person. From a health system perspective, the cost per diabetes case prevented was US$95.2, and the cost per QALY gained was US$50.0. From a societal perspective, the corresponding figures were US$295.1 and US$155.0. For the number of diabetes cases prevented, the probability for the intervention to be cost-effective was 84.0% and 83.1% from the health system and societal perspectives, respectively. The corresponding figures for QALY gained were 99.1% and 97.8%. The results were robust to discounting and sensitivity analyses. CONCLUSIONS A community-based peer-support lifestyle intervention was cost-effective in individuals at high risk of developing diabetes in India over 2 years. TRIAL REGISTRATION The trial was registered with Australia and New Zealand Clinical Trials Registry ( ACTRN12611000262909 ). Registered 10 March 2011.
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Lenvatinib versus sorafenib for unresectable hepatocellular carcinoma: a cost-effectiveness analysis.
Cai, H, Zhang, L, Li, N, Zheng, B, Liu, M
Journal of comparative effectiveness research. 2020;(8):553-562
Abstract
Aim: To investigate the cost-effectiveness of lenvatinib and sorafenib in the treatment of patients with nonresected hepatocellular carcinoma in China. Materials & methods: Markov model was used to simulate the direct medical cost and quality-adjusted life years (QALY) of patients with hepatocellular carcinoma. Clinical data were derived from the Phase 3 randomized clinical trial in a Chinese population. Results: Sorafenib treatment resulted in 1.794 QALYs at a cost of $43,780.73. Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively. Conclusion: According to WHO's triple GDP per capita, the use of lenvatinib by providing drugs is a cost-effective strategy.