scholarly journals Cost‑effectiveness analysis of hexaminolevulinate (Hexvix®) guided cystoscopy in Non‑Muscle Invasive Bladder Cancer patients (NMIBC) in Italy

Author(s):  
Craig Bennison ◽  
Stephanie Stephens ◽  
Giario Natale Conti

OBJECTIVE: To estimate the incremental cost‑effectiveness of hexaminolevulinate (Hexvix®) + Blue Light (H+BL) cystoscopy (compared to white light cystoscopy only) when used at initial transurethral resection of the bladder tumour (TURBT) for patients diagnosed with non‑muscle invasive bladder cancer (NMIBC) in Italy.METHODS: A cost‑effectiveness model has been developed to estimate the incremental cost‑effectiveness of introducing H+BL at initial TURBT for patients diagnosed with NMIBC in Italy. The model consists of two parts: 1) a short term decision tree which estimates the outcome of the initial diagnostic procedure, and 2) a Markov cohort model which is used to estimate long term outcomes through extrapolation based on data and assumptions about patient management, the natural history of the disease and the empirical efficacy of H+BL in improving diagnosis detection and reducing recurrence. Cost‑effectiveness results are expressed as incremental costs per QALY gained. Univariate and probabilistic sensitivity analyses are conducted to test the robustness of the model to changes in inputs and assumptions.RESULTS: Base case results suggest that Hexvix® is a dominant strategy when used in the resection of NMIBC. Hexvix® is expected to be associated with 0.070 incremental QALYs, with cost savings of € 435 per patient. Sensitivity analyses suggest that the cost of Hexvix® and the relative risk of recurrence in intermediate and low risk groups are key drivers in the model. Probabilistic analyses indicate that Hexvix® is expected to be cost‑effective in >99% of iterations, assuming a willingness to pay threshold of € 25,000 per QALY.CONCLUSION: In conclusion, Hexvix® is expected to be a cost‑effective strategy when used in the resection of NMIBC in Italy. 

2017 ◽  
Vol 11 (6) ◽  
pp. 173 ◽  
Author(s):  
Zachary Klaassen ◽  
Kathy Li ◽  
Wassim Kassouf ◽  
Peter C. Black ◽  
Alice Dragomir ◽  
...  

Introduction: Previous studies have suggested cost-savings using blue light cystoscopy (BLC) with hexaminolevulinate (HAL) compared to white light cystoscopy (WLC) during transurethral resection of bladder tumour (TURBT) for non-muscle-invasive bladder cancer (NMIBC), secondary to improvements in recurrence and progression rates; however, these studies have used ‘best case scenario’ recurrence rate probabilities, thus decreasing generalizability of the findings. The objective of this study was to perform a contemporary cost-effectiveness assessment of BLC compared to WLC at the time of TURBT.Methods: A decision and cost-effectiveness model with a five-year time horizon following initial TURBT was used. The model was created from the healthcare payer perspective. Comprehensive literature review was performed to obtain contemporary recurrence and progression rates. These values were meta-analyzed for inclusion into the model. Cost variables included in the model were from three large Canadian bladder cancer centres. Model outputs were number of recurrences prevented, bed days saved, and overall costs. One-way sensitivity and scenario analyses were performed to assess model robustness.Results: The five-year amortized cost of using BLC with HAL on all incident NMIBC compared to WLC assistance was $4 832,908 for Ontario (n=4696; $1372/patient); $1 168 968 for British Columbia (n=1204; $1295/patient); and $2 484, 872 (n=2680; $1236/patient) for Quebec. Use of BLC with HAL would result in 87‒338 fewer recurrences annually. On sensitivity/scenario analyses for Ontario data, if BLC with HAL equipment were provided to the province at no cost, five-year costs would be $4 158 814 and $1181 cost per patient. If BLC with HAL were only used for cystoscopically appearing aggressive tumours, the five-year amortized cost would be $3 874 098, with a cost per patient of $1222. If there was a 20% or 50% improvement in progression rates with BLC plus HAL, the five-year amortized cost would be $2 660 529 and -$598 039 (cost-saving), respectively.Conclusions: TURBT using BLC with HAL for patients with NMIBC is associated with a five-year cost of approximately $1–5 million for jurisdictions of 4–13 million people. Although this translates to a cost of $1200–1400 per patient for their initial TURBT, BLC with HAL improves patients care, reduces recurrences, and decreases the need for hospital beds after TURBT. If this diagnostic procedure eventually improves progression rates, there would be considerably improved cost-effectiveness.


BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e022268
Author(s):  
Zafer Tandogdu ◽  
Rebecca Lewis ◽  
Anne Duncan ◽  
Steven Penegar ◽  
Alison McDonald ◽  
...  

IntroductionBladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective.Methods and analysisPHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients’ lifetime.Ethics and disseminationFormal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.Trial registration numberISRCTN84013636.


2016 ◽  
Vol 98 (8) ◽  
pp. 547-551 ◽  
Author(s):  
VA During ◽  
GM Sole ◽  
AK Jha ◽  
JA Anderson ◽  
RT Bryan

INTRODUCTION In the 75–80% of urothelial bladder cancers (UBC) presenting as non-muscle invasive bladder cancer (NMIBC), transurethral resection of bladder tumour (TURBT) is the key treatment and staging procedure. In the 20–25% of patients with muscle invasive bladder cancer (MIBC), further cross-sectional imaging is required to complete the staging process before considering radical treatment. Given the adverse effects of ionising radiation, clinicians identify patients believed to have MIBC, and so requiring further imaging pre-TURBT, at the tumour histology/stage based on the tumour’s visual characteristics. There is minimal evidence describing the accuracy of such predictions in newly-diagnosed patients. METHODS Over a 6-year period, a database of patients undergoing resection of newly-diagnosed bladder lesions in a single UK centre was prospectively established. Predictions based on histology were simultaneously recorded, and the accuracy of these predictions of histology/stage subsequently assessed. RESULTS One hundred and twenty two (73.1%) patients with histologically confirmed NMIBC had predictions recorded versus 45 (26.9%) patients with MIBC. Visual assessment predictions of MIBC had a sensitivity of 88.9% (95% confidence interval [CI] 76.5%–95.2%) and a specificity of 91.0% (95% CI 84.6%–94.9%), giving a positive predictive value of 78.4% (95% CI 65.4%–87.5%) and a negative predictive value of 95.7% (95% CI 90.3%–98.1%). CONCLUSIONS We find that visual assessment is accurate in predicting the presence of MIBC. This supports the practice of stratifying patients at the time of initial cystoscopy for those requiring further radiological staging pre-TURBT.


2020 ◽  
Vol 10 (3) ◽  
pp. 34-38
Author(s):  
Ashok Kumar Kunwar ◽  
Kabir Tiwari ◽  
Sanjesh Bhakta Shrestha ◽  
Srijana Thapa ◽  
Ashish Kumar Panthee ◽  
...  

Background: Trans-urethral resection of bladder tumor is an essential diagnostic tool as well as effective treatment modality for non-muscle invasive bladder cancer. We aimed to evaluate the recurrence and progression of the non-muscle invasive bladder cancer in Nepalese patients. Methods: This was a retrospective study of 43 patients with non-muscle invasive bladder cancer, who underwent trans-urethral resection of bladder tumour followed by adjuvant intravesical instilla­tion of chemo or immunotherapy between January, 2013 to December, 2018. Patients were divided into low, intermediate and high-risk groups according to the clinical and pathological factors used by the European Organization for Research and Treatment of Cancer scoring system. Outcomes were calculated in terms of recurrence and progression in each group. Results: Out of 43 patients, 11 (25.58%) patients had low risk, 18 (41.86%) patients had intermediate risk and 14 (32.56%) patients had high risk of recurrence categories. No recurrence and progression of the disease noted in low risk group. In the intermediate risk group, out of 18 patients, 4 (22.2%) patients developed recurrence and 2 (11.1%) patients had progression of disease. In high risk group, out of 14 patients, 4 (26.8%) patients developed recurrence and 2 (14%) patients developed progres­sion of the disease. Conclusions: Even in a low volume centre of bladder cancer, effective treatment for non-muscle inva­sive bladder cancer with trans-urethral resection of bladder tumour followed by adjuvant intravesical chemo or immunotherapy can be given safely to reduce recurrence and progression of the disease.


2018 ◽  
Vol 12 (2) ◽  
pp. 129-133 ◽  
Author(s):  
Daniel Chalk ◽  
Neil Trent ◽  
Sarath Vennam ◽  
John McGrane ◽  
Mark Mantle

Objective: To develop a simulation model to identify key bottlenecks in the bladder cancer pathway at Royal Cornwall Hospital and predict the impact of potential changes to reduce these delays. Materials and methods: The diagnosis and treatment of muscle-invasive bladder cancer can suffer numerous delays, which can significantly affect patient outcomes. We developed a discrete event computer simulation model of the flow of patients through the bladder cancer pathway at the hospital, using anonymised patient records from 2014 and 2015. The changes tested in the model were for patients suspected to have muscle-invasive disease on flexible cystoscopy. Those patients were ‘fast-tracked’ to receive their transurethral resection of bladder tumour (TURBT) treatment using operating slots kept free for these patients. A staging computed tomography scan was booked in the haematuria clinic. Pathology requests were marked as 48 hour turnaround. The nurse specialist would then speak to the patient whilst they were on the ward following their TURBT to give information about their ongoing treatment and provide support. Results: The model predicted that if the changes were implemented, delays in the system could be reduced by around 5 weeks. The changes were implemented, and analysis of 3 months of the data post-implementation shows that the average time in the system was reduced by 5 weeks. The environment created by the changes in the pathway improved referral to treatment times in both muscle-invasive and non-muscle-invasive groups. Conclusion: The simulation model proved an invaluable tool for facilitating the implementation of changes. Simple changes to the pathway led to significant reductions in delays for bladder cancer patients at Royal Cornwall Hospital. Level of evidence: Not applicable for this cohort study.


2018 ◽  
Author(s):  
Cristina Sampaio ◽  
Rui Batista ◽  
Pedro Peralta ◽  
Paulo Conceição ◽  
Amílcar Sismeiro ◽  
...  

AbstractBladder cancer is the most frequent malignancy of the urinary system and is ranked the seventh most diagnosed cancer in men worldwide. About 70-75% of all newly diagnosed patients with bladder cancer will present disease confined to the mucosa or submucosa, the non-muscle invasive bladder cancer (NMIBC) subtype. Of those, approximately 70% will recur after transurethral resection (TUR). Due to this high rate of recurrence, patients are submitted to an intensive follow-up program that should be maintained throughout many years, or even throughout life, resulting in an expensive follow-up, with cystoscopy being the most cost-effective procedure for NMIBC screening. Currently, the gold standard procedure for detection and follow-up of NMIBC is based on the association of cystoscopy and urine cytology. As cystoscopy is a very invasive approach, over the years, many different non-invasive (both in serum and urine samples) assays have been developed in order to search genetic and protein alterations related to the development, progression and recurrence of bladder cancer.TERTpromoter mutations andFGFR3hotspot mutations are the most frequent somatic alterations in bladder cancer and constitute the most reliable biomarkers for bladder cancer. Based on these findings, an ultra-sensitive assay called Uromonitor®was developed that corresponds to a urine-based assay capable of detecting trace amounts of the two most common alterations in NMIBC,TERTpromoter andFGFR3mutation, in urine samples. The Uromonitor®test was performed in a cohort of 72 patients, firstly diagnosed with bladder cancer and under surveillance for NMIBC, to access its sensitivity and specificity in the detection of NMIBC recurrence. Uromonitor®was shown to be highly sensitive and specific in detecting recurrence of bladder cancer in patients under surveillance of non-muscle invasive bladder cancer.


Urology ◽  
2015 ◽  
Vol 85 (2) ◽  
pp. 381-387 ◽  
Author(s):  
Bashir Al Hussein Al Awamlh ◽  
Richard Lee ◽  
Bilal Chughtai ◽  
S. Machele Donat ◽  
Jaspreet S. Sandhu ◽  
...  

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