Cost-effectiveness evaluation of abiraterone in the treatment of patients with castration-resistant prostate cancer who previously received docetaxel.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15107-e15107
Author(s):  
Akhil Chopra ◽  
Stefan Gluck ◽  
Alberto J. Montero ◽  
Kiran Kumar Venkata Raja Avancha ◽  
Gilberto Lopes

e15107 Background: Treatment with abiraterone improves overall survival (OS), time to prostate-specific antigen progression and radiologic progression-free survival when added to prednisone and best supportive care in patients with advanced castrate-resistant prostate cancer (CRPC) who previously received docetaxel. Little is known about its cost-effectiveness in the United States. Methods: In order to raise awareness of pharmacoeconomics concepts and inform policy-makers in the US, this study aimed to assess the cost-effectiveness of abiraterone in the treatment of advanced CRPC patients, from a payer perspective. We created a decision-analytical model using clinical data from the pivotal phase III trial: COU-AA-301. Health utilities were derived from the available literature. Costs for drug acquisition, physician visits and laboratory tests were obtained from the Center for Medicare Services Drug Payment Table and Physician Fee Schedule and are represented in 2011 US dollars. Life-years saved (LY), Quality-adjusted life years (QALY) and Incremental Cost Effectiveness Ratio (ICER) were calculated using updated survival data presented at the 2011 ASCO meeting. Other main scenarios used the original median survival data published in the New England Journal of Medicine article and adjusted median OS to represent an overall survival hazard ratio of .66. Sensitivity analyses were performed using the confidence intervals for median OS in the pivotal study as well as by halving or doubling all other model inputs. No discounting was used due to the short time-horizon. Results: Abiraterone added 0.38 LY and 0.30 QALY with an incremental cost of $39,320 and therefore a cost of $102,600/LY and an ICER of $129,000/QALY. The main drivers of the model were drug acquisition cost, median OS, and health utility values. The results of the model were robust in different scenarios and sensitivity analyses. Conclusions: Using commonly accepted willingness-to-pay thresholds, such as those suggested by the World Health Organization, treatment of patients with advanced CRPC patients with abiraterone is likely to be cost-effective in the US.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 294-294 ◽  
Author(s):  
J. A. Carter ◽  
S. J. Snedecor ◽  
S. Kaura ◽  
M. Botteman

294 Background: Dmab has been approved in the US for prevention of SREs in mBC on the basis of the results of a phase III trial comparing Dmab vs. ZOL in mBC. In this trial, overall survival, disease progression, and serious adverse events (SAEs) were similar across treatments. The cost of a Dmab injection ($1650) is nearly 2x that of ZOLs ($887). This analysis assessed the cost effectiveness of Dmab vs. ZOL in mBC from a US managed care perspective. Methods: A literature-based Markov model was developed to estimate the survival, quality-adjusted life-years (QALYs), number and costs of SREs, and drug and administration (Dmab=$32.46; ZOL=$153.86) costs for patients (pts) receiving Dmab or ZOL. Inputs were selected to reproduce the phase III trial outcomes up to 28 months. QALYs were estimated by assigning utilities to health states (prior to SRE; SRE; post-SRE, and death). SRE-related costs and utilities were obtained from the literature. Per-event SRE costs ranged from $4,039 (vertebral fracture) to $20,734 (bone surgery). In sensitivity analysis, SAEs were included ($15,441/pt with a SAE). Future outcomes were discounted at 3%/year. Results: Dmab resulted in fewer SREs, more QALYs, and lower SRE-related costs, but higher drug-related and total costs vs. ZOL, resulting in an incremental cost of $6,884/pt (TABLE). The cost per QALY gained was $644,000 when excluding SAEs ($613,000/QALY when including SAEs). Conclusions: Dmab is predicted to result in an incremental cost/QALY gained >$600,000. This high cost/QALY is due to the higher drug acquisition cost of Dmab, combined with the limited prevention of SREs and lack of overall survival/disease progression benefits vs. ZOL. The cost/QALY of Dmab is far higher than what is considered to be good value for a medical intervention ($50,000 to $100,000/QALY), thus raising questions regarding Dmab's value in mBC. [Table: see text]


2018 ◽  
Vol 34 (6) ◽  
pp. 576-583 ◽  
Author(s):  
Saeed Taheri ◽  
Elham Heidari ◽  
Mohammad Ali Aivazi ◽  
Mehran Shams-Beyranvand ◽  
Mehdi Varmaghani

Objectives:This study aimed to assess the cost-effectiveness of ivabradine plus standard of care (SoC) in comparison with current SoC alone from the Iranian payer perspective.Methods:A cohort-based Markov model was developed to assess the incremental cost-effectiveness ratio (ICER) over a 10-year time horizon in a cohort of 1,000 patients. The baseline transition probabilities between New York Heart Association (NYHA), mortality rate, and hospitalization rate were extracted from the literature. The effect of ivabradine on mortality, hospitalization, and NYHA improvement or worsening were retrieved from the SHIFT study. The effectiveness was measured as quality-adjusted life-years (QALYs) using the utility values derived from Iranian Heart Failure Quality of Life study. Direct medical costs were obtained from hospital records and national tariffs. Deterministic and probabilistic sensitivity analyses were conducted to show the robustness of the model.Results:Ivabradine therapy was associated with an incremental cost per QALY of USD $5,437 (incremental cost of USD $2,207 and QALYs gained 0.41) versus SoC. The probabilistic sensitivity analysis showed that ivabradine is expected to have a 60 percent chance of being cost-effective accepting a threshold of USD $6,550 per QALY. Furthermore, deterministic sensitivity analysis indicated that the model is sensitive to the ivabradine drug acquisition cost.Conclusions:The cost-effectiveness model suggested that the addition of ivabradine to SoC therapy was associated with improved clinical outcomes along with increased costs. The analysis indicates that the clinical benefit of ivabradine can be achieved at a reasonable cost in eligible heart failure patients with sinus rhythm and a baseline heart rate ≥ 75 beats per minute (bpm).


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6607-6607 ◽  
Author(s):  
E. Remák ◽  
C. D. Mullins ◽  
E. Akobundu ◽  
C. Charbonneau ◽  
K. Woodruff

6607 Background: A randomized phase III trial of sunitinib vs. IFN-a as first-line therapy for patients with mRCC is ongoing. An interim analysis of this study demonstrated superiority for the primary endpoint, progression-free survival (PFS), in the sunitinib arm vs. the IFN-a arm (median PFS = 11 months [95% CI: 10–12] vs. 4 months [95% CI: 4–6]; P<0.000001). Because of the clinical significance of these results, the objective of this study was to demonstrate the economic value of sunitinib vs. IFN-a in this setting from a US third-party payer perspective. Methods: Two Markov models with a 5- and 10-year time horizon were developed to evaluate the cost- effectiveness of sunitinib vs. IFN-a. The models projected survival and costs in 6-week cycles based on extrapolation of the trial survival data. Model 1 looked at first-line treatment followed by palliative care only, while Model 2 incorporated second-line treatment. Effectiveness was measured in terms of progression-free months (PFM) in Model 1, and life-years (LY) gained and quality adjusted life-years (QALY) gained in Model 2. Resource utilization included drugs, tests, scans, monitoring, physician visits, hospitalizations and treatment of adverse events. Costs and survival benefits were discounted annually at 3% and 5% in Model 1 and 2, respectively. All costs were adjusted to 2006 US dollars. Scenario and probabilistic sensitivity analyses were conducted. Results: Projected PFS and overall survival were longer for sunitinib than for IFN-a. The incremental cost-effectiveness ratios of sunitinib vs. IFN-a over 5- and 10-years were $7,769 and $7,782/PFM, respectively, in Model 1. Model 2 results at 10 years were $67,215/LY and $52,593/QALY gained. The key drivers of the model results were survival and sunitinib drug costs. Both models were robust in the tested scenarios. Conclusions: Both analyses found that sunitinib is a cost-effective alternative to IFN-a as first-line treatment in mRCC, with cost-effectiveness ratios within the established threshold that society is willing to pay for health benefits (i.e. $50,000–100,000/LY or QALY). No significant financial relationships to disclose.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 87-87 ◽  
Author(s):  
A. Parthan ◽  
N. Pruttivarasin ◽  
D. Taylor ◽  
D. Davies ◽  
G. Yang ◽  
...  

87 Background: The study assessed the cost-effectiveness of CyberKnife (CK) compared to surgery and radiation therapy for the treatment of prostate cancer (PC) from a third-party and societal perspective. Methods: For patients > 65 yrs with localized PC, a Markov model compared treatment with CK, intensity modulated radiation therapy (IMRT), surgery or proton therapy (PT). Following treatment, patients were at risk of long-term toxicity: genitourinary (GU); gastrointestinal (GI); and sexual dysfunction (SD). Long-term toxicity was defined as adverse events >grade 2 on Radiation Therapy Oncology Group scale occurring at least 12 months following treatment. Markov states included all possible combinations of GI, GU, and SD long-term toxicities, no toxicity, and death. During each year patients remained in the same Markov state or died. Costs and utilities were assigned using published sources. Toxicity probabilities were derived using meta-analytical techniques to pool results from multiple studies. It was assumed that long-term disease control would not differ across treatments. The model projected expected lifetime costs and quality adjusted life years (QALYs) for each treatment and incremental cost-effectiveness of CK vs comparators as cost per QALY gained. Costs from societal perspective included lost productivity. Extensive sensitivity analyses were conducted. Results: Surgery was the least expensive treatment option followed by CK. CK patients had higher expected QALYs (8.11) than other treatment options (7.72- 8.06). From a payer perspective, total lifetime costs were $25,904, $22,295, $38,915, and $58,100 for CK, surgery, IMRT and PT, respectively. Incremental cost per QALY gained for CK versus Surgery was $9,200/QALY. Compared to IMRT and PT, CK was less costly and resulted in higher QALYs (dominance). At a threshold of $50,000/QALY, CK was cost effective in 86%, 79%, and 91% of simulations compared to surgery, IMRT, and PT, respectively. From a societal perspective, CK costs $4,200/QALY compared to surgery and remained dominant vs IMRT and PT. Results were most sensitive to costs of surgery and CK. Conclusions: Initial CK costs are higher than surgery, but CK patients have better quality of life. CK patients have lower lifetime costs and higher QALYs than IMRT and PT patients. [Table: see text]


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16525-e16525
Author(s):  
Alberto J. Montero ◽  
Kiran Kumar Venkata Raja Avancha ◽  
Stefan Gluck ◽  
Gilberto de Lima Lopes

e16525 Background: Eribulin was FDA approved in 2010 for pts previously receiving >2 prior chemotherapeutic regimens for MBC. This approval was based on the phase 3 trial (EMBRACE) which demonstrated that E significantly improved median overall survival (OS) relative to different TPC by 2.5 months [HR 0.81; p=0.041]. Methods: The aim of this study was to assess the cost-effectiveness of E versus the 3 most commonly selected TPC in EMBRACE. We also evaluated the cost effectiveness of E compared to other approved drugs for MBC. We created a decision-analytical model using clinical data from the EMBRACE trial. Health utilities were derived from the published literature. Costs for drug acquisition, physician visits, and laboratory tests were obtained from Medicare Services Drug Payment Table and Physician Fee Schedule and are represented in 2011 USD. Life-years saved (LY), Quality-adjusted life years (QALY), and Incremental Cost Effectiveness Ratio (ICER) were calculated using the EMBRACE median OS data. TPC cost was calculated with 3 most commonly used drugs: vinorelbine (V), gemcitabine (G), and capecitabine (X), comprising 60% of pts in the TPC arm. Other drugs analyzed included liposomal doxorubicin (D), nab-paclitaxel (A), and ixabepilone (I). Greater GCSF use with E vs. TPF was also accounted for in our model. Results: E added 0.208 LY and 0.119 QALY with an incremental cost over TPC of $24,035; and therefore a cost of $115,369/LY and an ICER of $201,790/QALY. The main drivers of the model were drug acquisition cost, OS, and health utility values. The results of the model were robust in sensitivity analyses. Because of the very low cost of V and G, we looked at the cost-effectiveness of E relative to several other drugs commonly used in this setting, but used in fewer pts in the pivotal trial. Relative to ixabepilone, liposomal doxorubicin, nab-paclitaxel, and capecitabine the ICER for E was $85,130, $98,538, $119,029, and $154,591, respectively. Conclusions: Using commonly accepted willingness-to-pay thresholds, E appears to be cost effective in the treatment of MBC relative to D, A, X, and I; with marginal cost effectiveness for less expensive drugs such as V and G.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17552-e17552 ◽  
Author(s):  
Trefor Jones ◽  
W. Robert Simons

e17552 Background: The Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389 (EMBRACE) established clinical benefits. This study evaluates its translation into comparative economic value. Methods: Because of superior survival benefits and a non-inferior safety profile, we use a cost-effectiveness analysis. Costs include medication and administration costs, cost of toxicity management, and indirect cost. The primary endpoint is the ratio of incremental means of costs and quality adjusted life years (QALY) yielding an incremental cost effectiveness ratio (ICER). Partitioned survival analyses were evaluated using a log-logistic function for overall survival, progression free survival, response duration, and toxicity time. Health state utilities or quality weights are applied to each component and aggregated. Sensitivity analyses assessed the influence of variability in a number of parameters. Results: Overall survival based on the log-logistic extrapolation was 686 days in the eribulin group compared to 550 days in the TPC group for a difference of 136 days. Mean time without progressive disease was 214 days and 160 days, respectively, for a difference of 59 days. Time spent with Grade 3 and 4 toxicity were 3.62 and 2.25 days in the eribulin group versus 2.25 and 0.98 days in the TPC group. Response times were 15.62 and 9.64 days, 5.98 days longer in the eribulin group. After weight components of overall survival with corresponding utilities and converting to years, the QALY were 1.166 in the eribulin group compared to 0.926 in the TPC group for a mean incremental improvement of 0.24 years. Mean treatment costs were $14,302.80 AUD and $1,672.02 AUD for a difference of $12,630.78 AUD. Total incremental cost is $13,794.35 AUD. The ICER with and without discounting is $48,134.29 AUD and $45,770.97 AUD, respectively. Survival time and drug cost were the most influential variables on the ICER. Conclusions: At a threshold of $50,000 AUD per QALY, eribulin is good value at $48,134 AUD per QALY. Clinical trial information: NCT00388726.


BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031019 ◽  
Author(s):  
Xiaohui Zeng ◽  
Xiaomin Wan ◽  
Liubao Peng ◽  
Ye Peng ◽  
Fang Ma ◽  
...  

ObjectivesEvaluating the cost-effectiveness of pembrolizumab plus standard chemotherapy in the first-line setting for patients with metastatic non-small cell lung cancer (NSCLC) from the US payer perspective.DesignA Markov model was constructed to analyse the cost-effectiveness of pembrolizumab plus chemotherapy in the first-line treatment of metastatic NSCLC. Health outcomes were estimated in quality-adjusted life-years (QALYs). The cost information was from Medicare in 2018. One-way and probabilistic sensitivity analyses examined the impact of uncertainty and assumptions on the results.SettingThe US payer perspective.ParticipantsA hypothetical US cohort of patients with previously untreated metastatic nonsquamous NSCLC without EGFR or ALK mutations.InterventionsPembrolizumab plus chemotherapy versus chemotherapy.Primary outcome measuresCosts, QALYs, incremental cost-effectiveness ratio (ICER) of pembrolizumab plus chemotherapy expressed as cost per QALY gained compared with chemotherapyResultsThe base case analysis demonstrated that pembrolizumab plus chemotherapy provided an additional 0.78 QALYs at incremental cost of $151 409, resulting in an ICER of $194 372/QALY. ICER for pembrolizumab plus chemotherapy was >$149 680/QALY in all of our univariable and probabilistic sensitivity analyses.ConclusionsPembrolizumab in addition to chemotherapy provides modest incremental benefit at high incremental cost per QALY for the treatment of previously untreated metastatic NSCLC.


2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 43-43
Author(s):  
Rahul Ramesh Khairnar ◽  
Joseph Levy ◽  
Mark Mishra

43 Background: A hydrogel rectal spacer (HRS) is an FDA-approved medical device used to increase the separation between the rectum and the prostate. A recent phase III trial demonstrated a small reduction in the incidence of RT toxicities associated with use of HRS. We conducted a cost-effectiveness analysis of HRS use in PC patients undergoing intensity modulated radiation therapy (IMRT). Methods: A multi-state Markov model was constructed to examine the cost-effectiveness of HRS in men with localized PC receiving IMRT in the US (arms: IMRT alone vs. IMRT + HRS). Subgroups included delivery site of IMRT (hospital vs. ambulatory) and baseline sexual function (SF) (general population vs. those with good SF). Based on previous studies, recurrence and survival were assumed equal for both arms. Data on SF, gastrointestinal and genitourinary toxicities incidence, as well as potential risks associated with HRS implantation were obtained from a recently published clinical trial. Health utilities and costs were derived from the literature and 2018 Physician Fee Schedule. Quality-adjusted life years (QALYs) and costs were modeled for a 5-year period from receipt of RT. Probabilistic sensitivity analysis (PSA) and value-based threshold analysis were conducted. Costs and utilities were discounted at 3% annually. Results: The per-person 5-year incremental cost for HRS administered in a hospital was $4,008 and the incremental effectiveness was 0.0273 QALYs. The incremental cost-effectiveness ratio (ICER) was $146,746 (95% credible interval from PSA $125,638 – $178,049) for PC patients undergoing HRS insertion in a hospital vs. $73,359 ($66,732 – $86,767) for patients undergoing HRS insertion in an ambulatory facility. For men with good SF, the ICER was $55,153 ($46,002 – $76,090) and $26,542 ($17,399 – $46,044) in hospital vs. ambulatory facility. Conclusions: This study is the first to evaluate the cost-effectiveness of HRS based on long-term toxicity data. Based on the current Medicare Physician Fee Schedule, HRS is cost-effective in men with good SF at a willingness to pay threshold of $100,000 and it is marginally cost-effective for the entire population depending on the facility where the HRS is inserted.


2021 ◽  
Vol 11 ◽  
Author(s):  
Weiting Liao ◽  
Huiqiong Xu ◽  
David Hutton ◽  
Qiuji Wu ◽  
Kexun Zhou ◽  
...  

BackgroundThe INVICTUS trial assessed the efficacy and safety of ripretinib compared with placebo in the management of advanced gastrointestinal stromal tumors.MethodWe used a Markov model with three health states: progression-free disease, progression disease and death. We parameterized the model from time-to-event data (progression-free survival, overall survival) of ripretinib and placebo arms in the INVICTUS trial and extrapolated to a patient’s lifetime horizon. Estimates of health state utilities and costs were based on clinical trial data and the published literature. The outcomes of this model were measured in quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs). Uncertainty was tested via univariate and probabilistic sensitivity analyses.ResultsThe base-case model projected improved outcomes (by 0.29 QALYs) and additional costs (by $70,251) and yielded an ICER of $244,010/QALY gained for ripretinib versus placebo. The results were most sensitive to progression rates, the price of ripretinib, and health state utilities. The ICER was most sensitive to overall survival. When overall survival in the placebo group was lower, the ICER dropped to $127,399/QALY. The ICER dropped to $150,000/QALY when the monthly cost of ripretinib decreased to $14,057. Probabilistic sensitivity analyses revealed that ripretinib was the cost-effective therapy in 41.1% of simulations at the willingness-to-pay (WTP) threshold of $150,000.ConclusionAs the fourth- or further-line therapy in advanced gastrointestinal stromal tumors, ripretinib is not cost-effective in the US. Ripretinib would achieve its cost-effectiveness with a price discount of 56% given the present effectiveness.


2014 ◽  
Vol 3 ◽  
Author(s):  
Carina Bektur ◽  
Talgat Nurgozhin

Introduction. Bone mass loss (BML) is one of the adverse effects of oncological chemotherapy, especially in cases of hormonal types of cancer, such as a prostate cancer (PC). BML is strongly associated with skeletal-related events (SREs), therefore decreasing the quality of patient’s life. Denosumab shows an advantage over zoledronic acid (ZA) in delaying the first onset of SREs and subsequent SREs in adults with PC in several phase III clinical trials. Since generic ZA recently became available, the purpose of the present study was to assess the cost-effectiveness of denosumab vs. brand or generic ZA in the prevention of SREs in Kazakhstani patients with PC.Methods. A Markov model was constructed in Tree-Age Pro 2013 software program with 4-week model cycles to analyze the cost-effectiveness of the treatments from the perspective of Ministry of Health (MoH) over a 10-year PC cohort. Direct costs (in Kazakhstani monetary units “tenge” in 2014) included costs of drug, SRE (pathologic fracture, surgery to bone, radiation to bone, spinal cord compression), and adverse events treatment. All costs were discounted for 3% per year. Effectiveness was appraised based on the number of SREs. Health states were defined according to SRE occurrence, SRE history, and death. The model assumed that a maximum of 1 SRE could occur in each cycle. Transition probabilities were derived from the relevant phase III trials. Results were present in the incremental total cost per SRE avoided. One-way sensitivity analyses were performed to examine the robustness of the model.Results. Over the 10-year period, denosumab incurred 103,091 tenge higher costs than brand ZA, 677,133 tenge higher costs than generic ZA, and 0.58 fewer SREs per patient with PC. The estimated incremental total direct costs per SRE avoided with the use of denosumab were 177,743 tenge (instead of brand ZA) and 1,167,470 tenge (instead of generic ZA). Results were robust to one-way sensitivity analyses.Conclusions.With the assumption that brand and generic ZAs are equally effective in the prevention of SREs in PC patients, denosumab seems to be a cost-effective alternative for brand ZA (insignificant difference in costs – less than 5%) and a costly alternative for generic ZA from the perspective of MoH of Kazakhstan.


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