scholarly journals Predicting Cost-Effectiveness of Generic Versus Brand Dabigatran Using Pharmacometric Estimates among Patients with Atrial Fibrillation in the United States

2019 ◽  
Author(s):  
Ching-Yu Wang ◽  
Phuong N. Pham ◽  
Sarah Kim ◽  
Karthik Lingineni ◽  
Stephan Schmidt ◽  
...  

ABSTRACTGeneric entry of newer anticoagulants is expected to decrease the costs of atrial fibrillation management. However, when making switches between brand and generic medications, bioequivalence failures are possible. The objectives of this study were to predict and compare the lifetime cost-effectiveness of brand dabigatran with hypothetical future generics. Markov micro-simulations were modified to predict the lifetime costs and quality-adjusted life years of patients on either brand or generic dabigatran from a U.S. private payer perspective. Event rates for generics were predicted using previously developed pharmacokinetic-pharmacodynamic models. The analyses showed that generic dabigatran with lower-than-brand systemic exposure was dominant. Meanwhile, generic dabigatran with extremely high systemic exposure was not cost-effective compared to the brand reference. Cost-effectiveness of generic medications cannot always be assumed as shown in this example. Combined use of pharmacometric and pharmacoeconomic models can assist in decision making between brand and generic pharmacotherapies.

Cancers ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 931
Author(s):  
Chi-Leung Chiang ◽  
Sik-Kwan Chan ◽  
Shing-Fung Lee ◽  
Horace Cheuk-Wai Choi

Background: The IMbrave 150 trial revealed that atezolizumab plus bevacizumab (atezo–bev) improves survival in patients with unresectable hepatocellular carcinoma (HCC) (1 year survival rate: 67.2% vs. 54.6%). We assessed the cost-effectiveness of atezo–bev vs. sorafenib as first-line therapy in patients with unresectable HCC from the US payer perspective. Methods: Using data from the IMbrave 150, we developed a Markov model to compare the lifetime cost and efficacy of atezo–bev as first-line systemic therapy in HCC with those of sorafenib. The main outcomes were life-years, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratio (ICER). Results: Atezo–bev demonstrated a gain of 0.44 QALYs, with an additional cost of USD 79,074. The ICER of atezo–bev was USD 179,729 per QALY when compared with sorafenib. The model was most sensitive to the overall survival hazard ratio and body weight. If we assumed that all patients at the end of the IMbrave 150 trial were cured of HCC, atezo–bev was cost-effective (ICER USD 53,854 per QALY). However, if all patients followed the Surveillance, Epidemiology, and End Results data, the ICER of atezo–bev was USD 385,857 per QALY. Reducing the price of atezo–bev by 20% and 29% would satisfy the USD 150,000/QALY and 100,000/QALY willingness-to-pay threshold. Moreover, capping the duration of therapy to ≤12 months or reducing the dosage of bev to ≤10 mg/kg would render atezo–bev cost-effective. Conclusions: The long-term effectiveness of atezo–bev is a critical but uncertain determinant of its cost-effectiveness. Price reduction would favorably influence cost-effectiveness, even if long-term clinical outcomes were modest. Further studies to optimize the duration and dosage of therapy are warranted.


Author(s):  
Brendan L Limone ◽  
William L Baker ◽  
Craig I Coleman

Background: A number of new anticoagulants for stroke prevention in atrial fibrillation (SPAF) have gained regulatory approval or are in late-stage development. We sought to conduct a systematic review of economic models of dabigatran, rivaroxaban and apixaban for SPAF. Methods: We searched the Medline, Embase, National Health Service Economic Evaluation Database and Health Technology Assessment database along with the Tuft’s Registry through October 10, 2012. Included models assessed the cost-effectiveness of dabigatran (150mg, 110mg, sequential), rivaroxaban or apixaban for SPAF using a Markov model or discrete event simulation and were published in English. Results: Eighteen models were identified. All models utilized a lone randomized trial (or an indirect comparison utilizing a single study for any given direct comparison), and these trials were clinically and methodologically heterogeneous. Dabigatran 150mg was assessed in 9 of models, dabigatran 110mg in 8, sequential dabigatran in 9, rivaroxaban in 4 and apixaban in 4. Adjusted-dose warfarin (either trial-like, real-world prescribing or genotype-dosed) was a potential first-line therapy in 94% of models. Models were conducted from the perspective of the United States (44%), European countries (39%) and Canada (17%). In base-case analyses, patients typically were at moderate-risk of ischemic stroke, initiated anticoagulation between 65 and 73 years of age, and were followed for or near a lifetime. All models reported cost/quality-adjusted life-year (QALY) gained, and while 22% of models reported using a societal perspective, no model included costs of lost productivity. Four models reported an incremental cost-effectiveness ratio (ICER) for a newer anticoagulant (dabigatran 110mg (n=4)/150mg (n=2); rivaroxaban (n=1)) vs. warfarin above commonly reported willingness-to-pay thresholds. ICERs (in 2012US$) vs. warfarin ranged from $3,547-$86,000 for dabigatran 150mg, $20,713-$150,000 for dabigatran 110mg, $4,084-$21,466 for sequentially-dosed dabigatran and $23,065-$57,470 for rivaroxaban. In addition, apixaban was demonstrated to be an economically dominant strategy compared to aspirin and to be dominant or cost-effective ($11,400-$25,059) vs. warfarin. Based on separate indirect treatment comparison meta-analyses, 3 models compared the cost-effectiveness of these new agents and reported conflicting results. Conclusions: Cost-effectiveness models of newer anticoagulants for SPAF have been extensively published. Models have frequently found newer anticoagulants to be cost-effective, but due to the lack of head-to-head trial comparisons and heterogeneity in clinical characteristic of underlying trials and modeling methods, it is currently unclear which of these newer agents is most cost-effective.


2011 ◽  
Vol 105 (05) ◽  
pp. 908-919 ◽  
Author(s):  
Anuraag Kansal ◽  
Stuart Connolly ◽  
Siyang Peng ◽  
John Linnehan ◽  
Carole Bradley-Kennedy ◽  
...  

SummaryOral dabigatran etexilate is indicated for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in whom anticoagulation is appropriate. Based on the RE-LY study we investigated the cost-effectiveness of Health Canada approved dabigatran etexilate dosing (150 mg bid for patients <80 years, 110 mg bid for patients ≥80 years) versus warfarin and “real-world” prescribing (i.e. warfarin, aspirin, or no treatment in a cohort of warfarin-eligible patients) from a Canadian payer perspective. A Markov model simulated AF patients at moderate to high risk of stroke while tracking clinical events [primary and recurrent ischaemic strokes, systemic embolism, transient ischaemic attack, haemorrhage (intracranial, extracranial, and minor), acute myocardial infarction and death] and resulting functional disability. Acute event costs and resulting long-term follow-up costs incurred by disabled stroke survivors were based on a Canadian prospective study, published literature, and national statistics. Clinical events, summarized as events per 100 patient-years, quality-adjusted life years (QALYs), total costs, and incremental cost effectiveness ratios (ICER) were calculated. Over a lifetime, dabigatran etexilate treated patients experienced fewer intracranial haemorrhages (0.49 dabigatran etexilate vs. 1.13 warfarin vs. 1.05 “real-world” prescribing) and fewer ischaemic strokes (4.40 dabigatran etexilate vs. 4.66 warfarin vs. 5.16 “real-world” prescribing) per 100 patient-years. The ICER of dabigatran etexilate was $10,440/QALY versus warfarin and $3,962/QALY versus “real-world” prescribing. This study demonstrates that dabigatran etexilate is a highly cost-effective alternative to current care for the prevention of stroke and systemic embolism among Canadian AF patients.


2021 ◽  
Author(s):  
Xueyan Luo ◽  
Wei Xu ◽  
Quan Yuan ◽  
Han Lai ◽  
Chunji Huang

BACKGROUND Mobile health (mhealth) technology is increasingly used in disease management. Using mhealth tools to integrate and streamline care was found to improve atrial fibrillation (AF) patients’ clinical outcomes. OBJECTIVE This study aimed to investigate the potential clinical and health economic outcomes of mhealth-based integrated care for AF from the perspective of a public healthcare provider in China. METHODS A Markov model was designed to compare outcomes of mhealth-based care and usual care in a hypothetical cohort of AF patients in China. The time horizon was 30 years with monthly cycles. Model outcomes measured were direct medical cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were conducted to examine the robustness of base-case results. RESULTS In the base-case analysis, mhealth-based care gained higher QALYs of 0.0818 with an incurred cost of USD1,778. Using USD33,438 per QALY (three times gross domestic product) as the willingness-to-pay threshold, mhealth-based care was cost-effective, with an ICER of USD21,739 per QALY. The one-way sensitivity analysis found compliance to mhealth-based care had the greatest impact on the ICER. In probabilistic sensitivity analysis, mhealth-based care was accepted as cost-effective in 80.91% of 10,000 iterations. CONCLUSIONS This study suggested that the use of mhealth technology in streamlining and integrating care for AF patients was cost-effective in China.


SLEEP ◽  
2020 ◽  
Author(s):  
Michael Darden ◽  
Colin A Espie ◽  
Jenna R Carl ◽  
Alasdair L Henry ◽  
Jennifer C Kanady ◽  
...  

Abstract Study Objectives To examine the cost-effectiveness and potential net monetary benefit (NMB) of a fully automated digital cognitive behavioral therapy (CBT) intervention for insomnia compared with no insomnia treatment in the United States (US). Similar relative comparisons were made for pharmacotherapy and clinician-delivered CBT (individual and group). Methods We simulated a Markov model of 100,000 individuals using parameters calibrated from the literature including direct (treatment) and indirect costs (e.g. insomnia-related healthcare expenditure and lost workplace productivity). Health utility estimates were converted into quality-adjusted life years (QALYs) and one QALY was worth $50,000. Simulated individuals were randomized equally to one of five arms (digital CBT, pharmacotherapy, individual CBT, group CBT, or no insomnia treatment). Sensitivity was assessed by bootstrapping the calibrated parameters. Cost estimates were expressed in 2019 US dollars. Results Digital CBT was cost beneficial when compared with no insomnia treatment and had a positive NMB of $681.06 (per individual over 6 months). Bootstrap sensitivity analysis demonstrated that the NMB was positive in 94.7% of simulations. Relative to other insomnia treatments, digital CBT was the most cost-effective treatment because it generated the smallest incremental cost-effectiveness ratio (−$3,124.73). Conclusions Digital CBT was the most cost-effective insomnia treatment followed by group CBT, pharmacotherapy, and individual CBT. It is financially prudent and beneficial from a societal perspective to utilize automated digital CBT to treat insomnia at a population scale.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18356-e18356
Author(s):  
Shaji Kumar ◽  
Istvan Majer ◽  
Sumeet Panjabi ◽  
Jean Malacan ◽  
Rohan Medhekar ◽  
...  

e18356 Background: Carfilzomib plus dexamethasone (Kd) dosed once weekly at 70 mg/m2 (QW Kd70) was recently approved in the US for treating patients with relapsed and refractory multiple myeloma (RRMM). To assess the cost-effectiveness (CE) of QW Kd70 vs twice weekly Kd dosed at 27 mg/m2 (BIW Kd27), data from the phase 3 ARROW trial, which directly compared these regimens in patients with 2-3 prior lines of therapy were used. Methods: A partitioned survival model was developed for the CE analysis. Time to treatment discontinuation, progression-free survival, and overall survival (OS) were estimated from the ARROW trial. Long-term OS was extrapolated using Surveillance Epidemiology and End Results registry data after matching characteristics of patients in the registry and ARROW trial. Direct costs were estimated from a US health care payer perspective. Utilities collected in the ARROW trial using the five-level version of the EuroQol questionnaire (EQ-5D-5L) were applied to estimate the quality-adjusted life years (QALYs). Uncertainty was explored using sensitivity analyses. Two subgroups of patients refractory to lenalidomide or bortezomib were assessed. Main outcomes were mean life-years (LYs), QALYs, lifetime costs, and incremental cost-effectiveness ratios (ICERs). Results: For QW Kd70 and BIW Kd27, the model predicted mean LYs of 4.17 and 3.07 years, QALYs of 2.98 and 2.03 years, and mean total lifetime costs of $444,563 and $373,364, respectively. The incremental LYs gain, QALY gain, and incremental costs of QW Kd70 vs BIW Kd27 were estimated to be 1.10 years, 0.95 year, and $71,199, respectively, resulting in an ICER of $64,595 per LY gained and $75,204 per QALY gained. For patients refractory to lenalidomide and bortezomib, similar results were found with ICERs of $79,988 and $76,793, respectively. Conclusions: In line with ARROW trial results, this CE analysis showed that QW Kd70 is expected to provide considerable additional benefit in terms of LYs and QALYs gained compared with BIW Kd27. In the RRMM setting, QW Kd70 is cost-effective with ICERs below accepted willingness to pay thresholds in US and represents an efficient utilization of the health care budget.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
E. M. Saldarriaga ◽  
J. Bravo-Zúñiga ◽  
Y. Hurtado-Roca ◽  
V. Suarez

Abstract Background The Renal Health Program (RHP) was implemented in 2013 as a secondary prevention strategy to reduce the incidence of patients initiating dialysis and overall mortality. A previous study found that adherent patients have 58% protection against progression to dialysis compared to non-adherent. The main objective of the study was to estimate the lifetime economic and health consequences of the RHP intervention to determine its cost-effectiveness in comparison with usual care. Methods We use a Markov model of three health stages to simulate disease progression among chronic kidney disease patients in Lima, Peru. The simulation time-horizon was 30 years to capture the lifetime cost and health consequences comparing the RHP to usual care. Costs were estimated from the payer perspective using institutional data. Health outcomes included years lived free of dialysis (YL) and quality adjusted life years (QALY). We conducted a probabilistic sensitivity analysis (PSA) to assess the robustness of our estimates against parameter uncertainty. Results We found that the RHP was dominant—cost-saving and more effective—compared to usual care. The RHP was 783USD cheaper than the standard of care and created 0.04 additional QALYs, per person. The Incremental Cost-Effectiveness Ratio (ICER) showed a cost per QALY gained of $21,660USD. In the PSA the RHP was dominant in 996 out of 1000 evaluated scenarios. Conclusions The RHP was cheaper than the standard of care and more effective due to a reduction in the incidence of patients progressing to dialysis, which is a very expensive treatment and many times inaccessible. We aim these results to help in the decision-making process of scaling-up and investment of similar strategies in Peru. Our results help to increase the evidence in Latin America where there is a lack of information in the long-term consequences of clinical-management-based prevention strategies for CKD patients.


Author(s):  
Amir Hashemi-Meshkini ◽  
Hedieh Sadat Zekri ◽  
Hasan Karimi-Yazdi ◽  
Pardis Zaboli ◽  
Mohammad Ali Sahraian ◽  
...  

Background: Pegylated (PEG) interferon beta 1a has been approved by the United States Food and Drug Administration (USFDA) as an alternative to interferon beta 1a for multiple sclerosis (MS). Due to its higher price, this study aimed to evaluate the cost-effectiveness of PEG-interferon beta 1-a compared with interferon beta 1a from an Iranian payer perspective. Methods: A Markov model was designed according to health states based on Expanded Disability Status Scale (EDSS) and one-month cycles over a 10-year time horizon. Direct medical and non-medical costs were included from a payer perspective. Results: The incremental cost-effectiveness ratio (ICER) was estimated around 11111 US dollars (USD) per quality-adjusted life-year (QALY) gained for the PEG-interferon versus interferon regimen [with currency rate of 29,000 Iranian Rial (IRR) to 1 USD in 2016]. Conclusion: Considering the cost-effectiveness  threshold in Iran [three times of gross domestic product (GDP) per capita or 15,945 USD], PEG-interferon beta 1-a could be considered as a cost effective treatment for Iranian patients with MS.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15003-e15003
Author(s):  
Linli Yao ◽  
Jiaqi Han ◽  
Longjiang She ◽  
Dong Ding ◽  
Mengting Liao ◽  
...  

e15003 Background: As standard third-line treatments for metastatic colorectal cancer, regorafenib and fruquintinib, compared with placebo, increase median overall survival by 2.5 months and 2.7 months, respectively. Given the incremental clinical benefit, we aim to estimate the cost effectiveness of regorafenib versus fruquintinib in the third-line treatment for patients with metastatic colorectal cancer from Chinese payer perspective. Methods: A mathematical Markov model was established to project the cost-effectiveness of regorafenib versus fruquintinib from the CONCUR and FRESCO clinical trials. Quality-adjusted-life-years (QALYs) were analyzed with extracted data from the trials. Willingness to pay (WTP) of $26508 was used. Drug costs were estimated from the perspectives of the health care system in the People’s Republic of China. One way sensitivity and scenario analyses were performed by varying potentially modifiable parameters of the model. Results: Fruquintinib, compared with regorafenib, provided an additional 0.028 QALYs (0.274 QALYs versus 0.246 QALYs) at less cost ($33536 versus $35607). Conclusions: Fruquintinib is more cost-effective than regorafenib as the third-line management for patients with metastatic colorectal cancer when WTP is $26508.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e22076-e22076
Author(s):  
Elena Parvez ◽  
Teodora Dumitra ◽  
Dimitra Panagiotoglou ◽  
Sarkis H. Meterissian ◽  
Sinziana Dumitra

e22076 Background: The MSLT-II trial demonstrated no survival benefit of completion lymphadenectomy (CLND) compared to nodal observation (NO) and subsequent therapeutic lymphadenectomy (TLND) in the case of macroscopic nodal relapse in patients with melanoma and SLN metastases. NO avoids the upfront cost and morbidity of CLND. However, patients followed with NO must undergo intensive surveillance and if TLND is required, it is associated with a higher complication rate than CLND. The cost-effectiveness of NO versus CLND in light of data from MSLT-II has not been previously studied. Methods: A Markov model with a 10-year time horizon was constructed to simulate two hypothetical cohorts of patients with SLN metastases undergoing NO and subsequent TLND for nodal recurrence or upfront CLND. Transition probabilities between disease states were derived from the MSLT-II trial. Remaining parameters including complication rates and health state utilities were obtained from an extensive review of the literature. Direct health care system costs were obtained from published US Medicare cost data and the literature. Primary outcomes were cost and quality-adjusted life years (QALYs) saved. Incremental cost-effectiveness ratio (ICER) was used to compare treatment strategies. Sensitivity analysis was performed in order to evaluate model uncertainty. A threshold of acceptance of $100,000/QALY was used. Results: Total projected cost over the study period for CLND was $28,609.87, while that of NO was lower at $20,865.27, resulting in $7,744.60 saved for the NO treatment strategy. Ten-year utility was 4.840 for CLND compared to 5.379 for NO, resulting in a gain of 0.539 QALYs in the NO arm. The NO strategy is dominant in the model as it results in both cost-savings and a gain in health effects, with an average ICER of -$14,368.46/QALY gained. Conclusions: From the payer perspective, the strategy of NO compared to CLND in patients with melanoma and SLN metastases is associated with an improvement in health outcomes and reduction in cost. Taking into account MSLT-II trial data, this study demonstrates NO is more cost-effective than CLND.


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