Cost-effectiveness of obeticholic acid for the treatment of non-alcoholic steatohepatitis: an early economic evaluation

2021 ◽  
pp. e20210011
Author(s):  
Chanh-Phong Tran ◽  
John J Kim ◽  
Jordan J Feld ◽  
William WL Wong

Background: Currently, there are no pharmacological options available for the treatment of non-alcoholic steatohepatitis (NASH). In the 18-month interim analysis of an ongoing randomized, placebo-controlled phase 3 trial (REGENERATE), early results demonstrated that obeticholic acid (OCA) 25 mg significantly improved fibrosis with no worsening of NASH among patients with NASH and fibrosis compared to placebo (PBO). This study aimed to assess the potential cost-effectiveness of OCA compared to PBO in NASH patients. Methods: A state-transition model was developed to perform a cost-utility analysis comparing two treatment strategies, PBO and OCA 25 mg, from a Canadian public payer perspective. The model time horizon was lifetime with annual cycle lengths. Cost and utility parameters were discounted at 1.5% annually. The efficacy data were obtained from the REGENERATE trial, and costs and utilities were derived from other published literature. Probabilistic and deterministic sensitivity analyses were performed to test the robustness of the model. Results: Treatment with OCA led to reductions of 3.58% in decompensated cirrhosis cases, 3.95% in hepatocellular carcinoma, 7.88% in liver transplant, and 6.01% in liver-related death. However, at an annual price of CDN$36,000, OCA failed to be cost-effective compared to PBO at an incremental cost-effectiveness ratio of $815,514 per quality-adjusted life year (QALY). An 88% reduction in drug price to an annual cost of $4,300 would make OCA cost-effective at a willingness-to-pay threshold of $50,000/QALY. Conclusions: OCA failed to be cost-effective compared to PBO, despite demonstrating clinical benefits due to a high drug cost. A significant price reduction would be needed to make the drug cost-effective.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8043-8043
Author(s):  
Mavis Obeng-Kusi ◽  
Daniel Arku ◽  
Neda Alrawashdh ◽  
Briana Choi ◽  
Nimer S. Alkhatib ◽  
...  

8043 Background: IXA, CAR, ELO and DARin combination with LEN+DEXhave been found superior in efficacy compared to LEN+DEX in the management of R/R MM. Applying indirect treatment comparisons from a network meta-analysis (NMA), this economic evaluation aimed to estimate the comparative cost-effectiveness and cost-utility of these four triplet regimens in terms of progression-free survival (PFS). Methods: In the absence of direct treatment comparison from a single clinical trial, NMA was used to indirectly estimate the comparative PFS benefit of each regimen. A 2-state Markov model simulating the health outcomes and costs was used to evaluate PFS life years (LY) and quality-adjusted life years (QALY) with the triplet regimens over LEN+DEX and expressed as the incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR). Probability sensitivity analyses were conducted to assess the influence of parameter uncertainty on the model. Results: The NMA revealed that DAR+LEN+DEX was superior to the other triplet therapies, which did not differ statistically amongst them. As detailed in the Table, in our cost-effectiveness analysis, all 4 triplet regimens were associated with increased PFSLY and PFSQALY gained (g) over LEN+DEX at an additional cost. DAR+LEN+DEX emerged the most cost-effective with ICER and ICUR of $667,652/PFSLYg and $813,322/PFSQALYg, respectively. The highest probability of cost-effectiveness occurred at a willingness-to-pay threshold of $1,040,000/QALYg. Conclusions: Our economic analysis shows that all the triplet regimens were more expensive than LEN +DEX only but were also more effective with respect to PFSLY and PFSQALY gained. Relative to the other regimens, the daratumumab regimen was the most cost-effective.[Table: see text]


2021 ◽  
Author(s):  
Antonio Maria Fea ◽  
Francesco Cattel ◽  
Stefano Gandolfi ◽  
Giorgio Buseghin ◽  
Gianluca Furneri ◽  
...  

Abstract BackgroundGlaucoma is a disease characterized by progressive damage of the optic nerve. Several therapeutic options are available to lower intraocular pressure (IOP). In primary open-angle glaucoma (POAG) patients with inadequate IOP control (or controlled with multiple medical therapies or for whom medical therapy is contraindicated), the implantation of micro-invasive glaucoma surgery devices (MIGS) and concomitant cataract surgery has proved to be more effective in reducing intraocular pressure (IOP), as compared to cataract surgery alone. The objective of this study is to assess the cost-effectiveness of iStent inject® device with concurrent cataract surgery vs. cataract surgery alone, in patients with mild-to-moderate POAG, adopting the Italian National Health Service (NHS) perspective.MethodsSimulation of outcomes and costs was undertaken using a Markov model with 4 health states and one-month cycles, that is used to simulate the prognosis of these patients. Efficacy data were obtained from the randomized clinical trial (RCT). A lifetime horizon was adopted in the analysis. A discount rate of 3.5% was applied to both costs and effects. The Italian National Healthcare Service (NHS) perspective was considered, therefore only healthcare direct costs (acquisition of main interventions and subsequent procedures; medications; monitoring and follow-up; adverse events). Model robustness was tested through sensitivity analyses. ResultsResults of the base-case analysis showed that the total lifetime costs were higher in the iStent inject® + concurrent cataract surgery, compared with the cataract surgery alone group (€8,368.51 vs. €7,134.71 respectively). iStent inject® + concurrent cataract surgery was cost-effective vs. cataract surgery alone, with an incremental cost-effectiveness ratio of €13,037.01 per quality-adjusted life year (QALY) gained. Both one-way deterministic and probabilistic sensitivity analyses confirmed robustness of base-case results. The acceptability curve of cost-effectiveness (CEAC) analysis showed that iStent inject® + cataract surgery would have a 98% probability of being cost-effective, compared to cataract surgery alone, when the willingness to pay (WTP) is equal to €50,000 per QALY gained.ConclusionsThe results of the cost-utility analysis confirm that iStent inject® + cataract surgery is a cost-effective option for the treatment of patients affected by mild-to-moderate POAG, compared with cataract surgery alone, when evaluated from the Italian NHS perspective. Trial registration: Not applicable


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1720-1720
Author(s):  
Matti Marklund ◽  
Miaobing Zheng ◽  
J Lennert Veerman ◽  
Jason H Y Wu

Abstract Objectives To assess the potential cost-effectiveness, health gains, and effects on health equality of eliminating industrial trans-fatty acids (TFAs) from the Australian food supply. Methods Markov cohort models were used to estimate the cost-effectiveness and policy impact on (ischemic heart disease) IHD burden and health equity of a national ban of industrial TFAs in Australia. Intake of TFA was assessed using the 2011–2012 Australian National Nutrition and Physical Activity Survey. The IHD burden attributable to TFA was calculated by comparing the current level of TFA intake to a counterfactual setting (0.5% energy per day from TFA; corresponding to TFA intake only from non-industrial sources, e.g., dairy foods). Policy costs, avoided IHD events and deaths, health-adjusted life years (HALYs) gained, and IHD-related healthcare costs saved were estimated over 10 years and lifetime of the adult Australian population. Cost-effectiveness was assessed by calculation of incremental cost-effectiveness ratios (ICER) using net policy cost and HALYs gained. Health benefits and health care cost changes were also assessed in subgroups based on socioeconomic status and remoteness. Results Elimination of industrial TFA was estimated to prevent 2,294 (95% uncertainty interval [UI]: 1,765; 2,851) IHD deaths and 9,931 (95% UI: 8,429; 11,532) IHD events over the first 10 years. The greatest health benefits were accrued to the most socioeconomically disadvantaged quintiles and among Australians living outside of major cities. The intervention was estimated to be cost-saving or cost-effective (i.e., ICER < 169,361 AUD/HALY) regardless of the time horizon, with ICERs of 1,073 (95% UI: dominant; 3,503) and 1,956 (95% UI: 1,010; 2,750) AUD/HALY over 10 years and life time, respectively. The TFA ban was estimated to be cost-saving or highly cost-effective in sensitivity analyses altering assumptions of post-intervention TFA intake, abundance of TFA-containing products, or discount rate. Conclusions A ban of industrial TFAs could avert substantial numbers of IHD events and deaths in Australia and will likely be a highly cost-effective strategy to reduce social-economic and urban-rural inequalities in health. Funding Sources National Health and Medical Research Council; and UNSW.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6558-6558
Author(s):  
K. K. Chan ◽  
K. R. Imrie ◽  
S. M. Alibhai

6558 Background: The 2006 ASCO guideline recommends PP with CSF for elderly patients with diffuse aggressive lymphoma, partially based on previous cost-minimization analyses showing that CSF saved costs when compared with no CSF by reducing hospitalization from febrile neutropenia (FN) when the risk of FN was > 20%. However, these studies examined only one cycle of chemotherapy and did not account for costs of CSF in subsequent cycles, did not consider SP, and did not consider patients’ preferences. Methods: We conducted a cost-utility analysis to compare PP with SP in this setting using a Markov model for a time horizon of 8 cycles of chemotherapy with a government payer perspective. Costs were adjusted to 2006 $CAD. Ontario health economic data were used. The cost of hospitalization for FN was obtained from Ontario Case Costing Initiative. Data for efficacies of CSF, probabilities and utilities were obtained from published literature. Sensitivity analyses were conducted using a threshold of $100,000/QALY. Results: The base case costs for PP and SP were $22,077 and $17,641. The QALYs of PP and SP were 0.254 and 0.248. The incremental cost effectiveness ratio of PP to SP was $739,999/QALY. One-way sensitivity analyses showed that in order for PP to be cost-effective, the cost of hospitalization per episode of FN had to be > $31,138 (i.e. 2.5 times > base case), the cost of CSF per cycle had to be < $896 (base case = $1,960), the risk of FN in the 1st cycle had to be > 48% (base case = 24%), or the relative risk reduction of FN with CSF had to be > 97% (base case = 41%). Our result was robust to all other cost, probability and utility variables. First order microsimulation showed that < 17% of simulations were cost-effective. Conclusions: PP is not cost-effective when compared with SP for this population under most assumptions. PP only becomes attractive in places where the cost of hospitalization for FN is much more than that of Ontario, or the cost of CSF is under $896 per cycle. The costs of CSF and hospitalization in all cycles (instead of just one cycle) should be accounted for in any economic evaluation of CSF. Current guidelines recommending PP in this population should be revisited. No significant financial relationships to disclose.


2005 ◽  
Vol 11 (5) ◽  
pp. 542-551 ◽  
Author(s):  
Michael Iskedjian ◽  
John H Walker ◽  
Trevor Gray ◽  
Colin Vicente ◽  
Thomas R Einarson ◽  
...  

Background: Interferon beta-1a (Avonex®)30 mg, intramuscular (i.m.), once weekly is efficacious in delaying clinically definite multiple sclerosis (CDMS) following a single demyelinating event (SDE). This study determined the cost effectiveness of Avonex® compared to current treatment in delaying the onset of CDMS. Methods: A cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) were performed from Ministry of Health (MoH) and societal perspectives. For CEA, the outcome of interest was time spent in the pre-CDMS state, termed monosymptomatic life years (MLY) gained. For CUA, the outcome was quality-adjusted monosymptomatic life years (QAMLY) gained. A Markov model was developed with transitional probabilities and utilities derived from the literature. Costs were reported in 2002 Canadian dollars. Costs and outcomes were discounted at 5%. The time horizon was 12 years for the CEA, and 15 years for the CUA. All uncertainties were tested via univariate and multivariate sensitivity analyses. Results: In the CEA, the incremental cost of Avonex® per MLY gained was $53 110 and $44 789 from MoH and societal perspectives, respectively. In the CUA, the incremental cost of Avonex® per QAMLY gained was $227 586 and $189 286 from MoH and societal perspectives, respectively. Both models were sensitive to the probability of progressing to CDMS and the analytical time horizon. The CUA was sensitive to the utilities value. Conclusion: Avonex® may be considered as a reasonably cost-effective approach to treatment of patients experiencing an SDE. In addition, the overall incremental cost-effectiveness profile of Avonex® improves if treatment is initiated in pre-CDMS rather than waiting until CDMS.


2021 ◽  
Vol 104 (12) ◽  
pp. 1971-1976

Objective: To evaluate cost-effectiveness of ring wound protector (RWP) used in open appendectomy. Materials and Methods: The present study was a decision-tree-based analysis. Model inputs, including costs, utilities, and probabilities of surgical site infection (SSI), were retrieved from the previous studies. The incremental cost-effectiveness ratio (ICER) represented the cost of one additional quality-adjusted life day (QALD). This ratio was calculated by dividing the incremental cost [Thai Baht (THB)] by the incremental QALD. One-way sensitivity analyses were performed by varying each input parameter to see how ICER change. Monte-Carlo simulation with 5,000 replications was used to estimate probabilistic ICER and construct the acceptability curve, demonstrating how the probability of being cost-effective changed when the willingness-to-pay (WTP) threshold was shifted. Results: The deterministic ICER of 64,630.78 THB/QALD did not favor RWP use compared with the WTP threshold of 10,000 THB/QALD. However, if the threshold was shifted to 100,000 THB/QALD, it would yield approximately 75% probability of being cost-effective from RWP. Threshold analysis indicated that RWP should cost 281, 301, and 661 THB to be cost-effective at the threshold of 500, 1,000, and 10,000 THB/QALD, respectively. Conclusion: Routine RWP use might not be cost-effective when QALD is the outcome of interest. Based on the results from the present study, policy-makers could be informed that the adoption of this health technology might not be suitable. Keywords: Ring wound protector; Appendectomy; Cost-utility analysis; Decision tree model


2021 ◽  
Vol 2 (8) ◽  
pp. 685-695
Author(s):  
Belen Corbacho ◽  
Stephen Brealey ◽  
Ada Keding ◽  
Gerry Richardson ◽  
David Torgerson ◽  
...  

Aims A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care. Methods A cost utility analysis from the NHS perspective was performed. Differences between manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR), and early structured physiotherapy plus steroid injection (ESP) in costs (2018 GBP price base) and quality adjusted life years (QALYs) at one year were used to estimate the cost-effectiveness of the treatments using regression methods. Results ACR was £1,734 more costly than ESP ((95% confidence intervals (CIs) £1,529 to £1,938)) and £1,457 more costly than MUA (95% CI £1,283 to £1,632). MUA was £276 (95% CI £66 to £487) more expensive than ESP. Overall, ACR had worse QALYs compared with MUA (-0.0293; 95% CI -0.0616 to 0.0030) and MUA had better QALYs compared with ESP (0.0396; 95% CI -0.0008 to 0.0800). At a £20,000 per QALY willingness-to-pay threshold, MUA had the highest probability of being cost-effective (0.8632) then ESP (0.1366) and ACR (0.0002). The results were robust to sensitivity analyses. Conclusion While ESP was less costly, MUA was the most cost-effective option. ACR was not cost-effective. Cite this article: Bone Jt Open 2021;2(8):685–695.


2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 800-800 ◽  
Author(s):  
Sebastian Stintzing ◽  
Ilse van Oostrum ◽  
Chris Pescott ◽  
Alma Katharina Steinbach-Buechert ◽  
Bart Heeg ◽  
...  

800 Background: The randomized, phase 3 FIRE-3 trial evaluated 1L FOLFIRI + cetuximab or bevacizumab in patients with RAS wt mCRC; overall survival favored FOLFIRI + cetuximab by > 8 months. The purpose of this analysis was to evaluate the cost-effectiveness of FOLFIRI + cetuximab vs that of FOLFIRI + bevacizumab as 1L treatment for patients in Germany with RAS wt mCRC (including the patient subgroup with RAS wt, left-sided [LS] primary tumors, as LS is a predictive factor). Methods: A standard oncology 3–health-state partitioned survival cost-utility model was developed to analyze the costs and health benefits of FOLFIRI + cetuximab vs those of FOLFIRI + bevacizumab from a German payer perspective based on data from FIRE-3 and the literature. Health outcomes were reported in life-years (LYs) and quality-adjusted life-years (QALYs) gained. A 3.5% discounting rate was applied to the modeled costs and outcomes. Results: Discounted costs, health gains, and incremental cost-effectiveness ratios (ICERs) for patients with RAS wt (base case) and patients with RAS wt, LS (subgroup) mCRC are summarized in the Table. Probabilistic sensitivity analyses showed that at relevant European willingness-to-pay (WTP) thresholds of €55,000 and €80,000, FOLFIRI + cetuximab had a 64.0% and 81.6% (base case) and 80.5% and 92.4% (subgroup) probability of being cost-effective vs FOLFIRI + bevacizumab, respectively. Clinical trial information: NCT00433927. Conclusions: Based on our analyses, FOLFIRI + cetuximab is cost-effective compared with FOLFIRI + bevacizumab in patients in Germany with RAS wt mCRC at official WTP thresholds applied by relevant European health technology assessment agencies. The cost-effectiveness of FOLFIRI + cetuximab is more pronounced in the subgroup of patients with RAS wt, LS tumors.[Table: see text]


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5583-5583
Author(s):  
Irbaz Bin Riaz ◽  
Abdulaali Almutairi ◽  
Daenielle K. Lang ◽  
Noureen Asghar ◽  
Anum Riaz ◽  
...  

5583 Background: FDA has approved three novel AAs [Apalutamide(A), Darolutamide(D) and Enzalutamide(E)] in combination with Androgen deprivation therapy ( ADT) for treatment of (nmCRPC) patients (pts). We report the cost-effectiveness of these drugs from the US perspective to help facilitate the choice of these agents for clinical practice. Methods: A life time Markov state-transition model was constructed with three health states (Metastasis-Free Survival[MFS], Metastatic disease, and Death) to compare cost-effectiveness of AA therapies for treatment of nmCRPC based on US healthcare payer perspective. A network meta-analysis of MFS and OS was conducted due to the lack of head to head trials. An approximation of the original individual-level patient time-to-event data were derived from digitized Kaplan-Meier curves for OS and MFS. Weibull distributions was selected as the best fitted model fitted and extrapolated as per the NICE decision support unit recommendations. Medication costs were based on wholesale acquisition cost. Adverse event (AE) grades 3/4 management costs were incorporated in the model. Discount rate of 3% per year was applied to costs and effects. Life years (LYs) and quality adjusted life years (QALYs) for each treatment as well as the incremental cost effectiveness (ICER) and cost utility (ICUR) ratios were estimated. Base case analyses (BCA) and probabilistic sensitivity analyses (PSA) were estimated. Results: The table summarizes the results form BCA analyses. A+ADT offers best gain in LYs (8.37yrs) and QALYs (5.30 yrs) but at higher cost. Conclusions: Apalutamide was associated with gains in LYs and QALYs traded off with higher lifetime cost relative to other AA alternatives. ADT was associated with lower gains in LYs and QALYs traded off with lower lifetime cost relative to other alternatives. Based on a $150,000/QALY threshold pay off, A+ADT is likely more cost effective compared to E+ADT or ADT alone; while E+ ADT may be more cost effective compared to D+ ADT. [Table: see text]


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Antonio Maria Fea ◽  
Francesco Cattel ◽  
Stefano Gandolfi ◽  
Giorgio Buseghin ◽  
Gianluca Furneri ◽  
...  

Abstract Background Glaucoma is a disease characterized by progressive damage of the optic nerve. Several therapeutic options are available to lower intraocular pressure (IOP). In primary open-angle glaucoma (POAG) patients with inadequate IOP control (or controlled with multiple medical therapies or for whom medical therapy is contraindicated), the implantation of micro-invasive glaucoma surgery devices (MIGS) and concomitant cataract surgery has proved to be more effective in reducing intraocular pressure (IOP), as compared to cataract surgery alone. The objective of this study was to assess the cost-effectiveness of iStent inject® device with concurrent cataract surgery vs. cataract surgery alone, in patients with mild-to-moderate POAG, adopting the Italian National Health Service (NHS) perspective. Methods Simulation of outcomes and costs was undertaken using a Markov model with 4 health states and one-month cycles, that is used to simulate the prognosis of these patients. Efficacy data were obtained from the randomized clinical trial (RCT). A lifetime horizon was adopted in the analysis. A discount rate of 3.5% was applied to both costs and effects. The Italian National Healthcare Service (NHS) perspective was considered, therefore only healthcare direct costs (acquisition of main interventions and subsequent procedures; medications; monitoring and follow-up; adverse events). Model robustness was tested through sensitivity analyses. Results Results of the base-case analysis showed that the total lifetime costs were higher in the iStent inject® + concurrent cataract surgery, compared with the cataract surgery alone group (€8368.51 vs. €7134.71 respectively). iStent inject® + concurrent cataract surgery was cost-effective vs. cataract surgery alone, with an incremental cost-effectiveness ratio of €13,037.01 per quality-adjusted life year (QALY) gained. Both one-way deterministic and probabilistic sensitivity analyses confirmed robustness of base-case results. The cost-effectiveness accessibility curve (CEAC) showed that iStent inject® + cataract surgery would have a 98% probability of being cost-effective, compared to cataract surgery alone, when the willingness to pay (WTP) is equal to €50,000 per QALY gained. Conclusions The results of the cost-utility analysis confirm that iStent inject® + cataract surgery is a cost-effective option for the treatment of patients affected by mild-to-moderate POAG, compared with cataract surgery alone, when evaluated from the Italian NHS perspective.


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