Cost-effectiveness of Pembrolizumab in Second-line Advanced Bladder Cancer

Sarfaty, Michal; Hall, Peter; Chan, Kelvin; Virik, Kiran; Leshno, Moshe; Gordon, Noa; Moore, Assaf; Neiman, Victoria; Rosenbaum, Eli; Goldstein, Daniel A.

doi:10.1016/j.eururo.2018.03.006

Cited by 49 publications

(37 citation statements)

References 12 publications

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“…Sarfaty et al [25] recently reported on the costeffectiveness of pembrolizumab as second-line therapy for advanced urothelial carcinoma. However, their study ICER = incremental cost-effectiveness ratio; RPSFT = rank-preserving structural failure time; LY = life years; QALY = quality-adjusted life years; P/D/ = paclitaxel/ docetaxel; P/D/V = paclitaxel/docetaxel/vinflunine.…”

Section: Discussionmentioning

confidence: 99%

“…The RPSFT adjustment method was the second best method in this scenario. was subject to limitations of data availability and suboptimal modeling methods for survival, utility, and costs [20,25]. Our analysis has several strengths that explain the difference in results.…”

Section: Discussionmentioning

confidence: 99%

“…Our model uses EQ-5D utility values estimated by health state directly from KEYNOTE-045 trial. In addition to drug costs, administration costs, and AE costs as used by Sarfaty et al [25], we modeled disease management costs by health state as well as terminal care costs. Our comparators include vinflunine, taxanes (paclitaxel and docetaxel), and the entire KEYNOTE-045 control arm, thus providing a comprehensive evaluation of the cost-effectiveness of pembrolizumab in comparison to different comparators as second-line therapy for advanced urothelial carcinoma after platinum-based chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

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Cost-effectiveness of Pembrolizumab as Second-line Therapy for the Treatment of Locally Advanced or Metastatic Urothelial Carcinoma in Sweden

Srivastava¹,

Prabhu

et al. 2020

European Urology Oncology

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Background: Urothelial carcinoma (UC) is the most common subtype of bladder cancer. The randomized phase 3 KEYNOTE-045 trial showed that pembrolizumab, used as second-line therapy significantly prolonged overall survival with fewer treatment-related adverse events than chemotherapy for advanced UC. Pembrolizumab has been approved by the European Medicines Agency for the treatment of locally advanced or metastatic UC in adults who have received platinum-containing chemotherapy. Many European countries use cost-effectiveness analysis to inform reimbursement decisions. Objective: To assess the cost-effectiveness of pembrolizumab as second-line therapy for the treatment of advanced UC from a Swedish health care perspective. Design, setting, and participants: We developed a partitioned-survival model to assess the costs and effectiveness of pembrolizumab compared with vinflunine (base case), paclitaxel, or docetaxel monotherapy in patients with advanced UC over a 15-yr time horizon. We obtained Kaplan-Meier estimates for survival endpoints, adverse events, and utility data from KEYNOTE-045. Outcome measurements and statistical analysis: We performed parametric extrapolations to estimate overall and progression-free survival beyond the clinical trial period. Swedish costs and utility weights were used to estimate total costs, qualityadjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). We performed deterministic and probabilistic sensitivity analyses to assess the robustness of the model results. Results and limitations: In the base-case analysis, pembrolizumab resulted in a mean survival gain of 1.66 years (1.38 QALYs) at an incremental cost of s69 852 and an ICER of s50 529/QALY gained versus vinflunine monotherapy. ICERs for other chemotherapies were s81 356/QALY for pembrolizumab versus paclitaxel or docetaxel monotherapy, and s71 924/QALY for pembrolizumab versus paclitaxel, docetaxel, or vinflunine monotherapy. Long-term follow-up from KEYNOTE-045 and real-world data are needed to validate the extrapolations.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Cost-effectiveness of Pembrolizumab as Second-line Therapy for the Treatment of Locally Advanced or Metastatic Urothelial Carcinoma in Sweden

Srivastava¹,

Prabhu

et al. 2020

European Urology Oncology

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“…However, there appears to be uncertainty in the cost-effectiveness of pembrolizumab. A 2018 analysis by Sarfaty et al, based off data from KEYNOTE-045 determined that for this indication relative to chemotherapy pembrolizumab did not produce the quality-adjusted life years (QALY) gains at a willingness-to-pay threshold of $100,000 in the U.S. [ 79 ]. QALY is a measure of the incremental health improvement provided by a new treatment compared to previous treatment options.…”

Section: Health Economic Factorsmentioning

confidence: 99%

Targeted Molecular Therapeutics for Bladder Cancer—A New Option beyond the Mixed Fortunes of Immune Checkpoint Inhibitors?

Bednova

Leyton

2020

IJMS

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The fact that there are now five immune checkpoint inhibitor (ICI) monoclonal antibodies approved since 2016 that target programmed cell death protein 1 or programmed death ligand-1 for the treatment of metastatic and refractory bladder cancer is an outstanding achievement. Although patients can display pronounced responses that extend survival when treated with ICIs, the main benefit of these drugs compared to traditional chemotherapy is that they are better tolerated and result in reduced adverse events (AEs). Unfortunately, response rates to ICI treatment are relatively low and, these drugs are expensive and have a high economic burden. As a result, their clinical efficacy/cost-value relationship is debated. Long sought after targeted molecular therapeutics have now emerged and are boasting impressive response rates in heavily pre-treated, including ICI treated, patients with metastatic bladder cancer. The antibody-drug conjugates (ADCs) enfortumab vedotin (EV) and sacituzumab govitecan (SG) have demonstrated the ability to provide objective response rates (ORRs) of 44% and 31% in patients with bladder tumor cells that express Nectin-4 and Trop-2, respectively. As a result, EV was approved by the U.S. Food and Drug Administration for the treatment of patients with advanced or metastatic bladder cancer who have previously received ICI and platinum-containing chemotherapy. SG has been granted fast track designation. The small molecule Erdafitinib was recently approved for the treatment of patients with advanced or metastatic bladder cancer with genetic alterations in fibroblast growth factor receptors that have previously been treated with a platinum-containing chemotherapy. Erdafitinib achieved an ORR of 40% in patients including a proportion who had previously received ICI therapy. In addition, these targeted drugs are sufficiently tolerated or AEs can be appropriately managed. Hence, the early performance in clinical effectiveness of these targeted drugs are substantially increased relative to ICIs. In this article, the most up to date follow-ups on treatment efficacy and AEs of the ICIs and targeted therapeutics are described. In addition, drug price and cost-effectiveness are described. For best overall value taking into account clinical effectiveness, price and cost-effectiveness, results favor avelumab and atezolizumab for ICIs. Although therapeutically promising, it is too early to determine if the described targeted therapeutics provide the best overall value as cost-effectiveness analyses have yet to be performed and long-term follow-ups are needed. Nonetheless, with the arrival of targeted molecular therapeutics and their increased effectiveness relative to ICIs, creates a potential novel paradigm based on ‘targeting’ for affecting clinical practice for metastatic bladder cancer treatment.

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“…Cost-effectiveness studies derived from the KEYNOTE-045 study show that the cost of pembrolizumab to gain one quality-adjusted life-year is $122, 557 in the US, which is higher than the cost in other developed countries, but it is considered cost-effective only in the US because of significantly higher threshold for willingness-to-pay. 45 Based on the studies, pembrolizumab is also considered as cost-effective, first-line treatment for NSCLC when compared to other chemotherapies that express high levels of PD-L1 with TPS ≥50%. 46 Such studies are not yet available for gastric or GEJ cancers.…”

Section: Introductionmentioning

confidence: 99%

Pembrolizumab for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer: an evidence-based review of place in therapy

Mehta¹,

Shah²,

Almhanna

2018

OTT

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Gastric and esopahgeal cancers account for the six most common causes of cancer death worldwide. Locally advanced resectable cancers have a 5-year life expectancy of 30%. Despite use of chemotherapy, median overall survival for stage IV cancer rarely exceeds 1 year. A subset of gastric cancers such as microsatellite-instable tumor and Epstein–Barr virus-positive tumors have a rich immune infiltrate that makes them more responsive to immune-directed therapies. Tumors can evade T-cell-mediated “immune surveillance” by activating the programmed cell death receptor 1 (PD-1)/programmed death ligand 1 (PD-L1) pathway. Targeting PD-1 and thus de-engaging them from its ligands can help restore immunogenicity. Pembrolizumab is the first immunotherapy to be approved by US FDA for PD-L1 expressing gastric and gastroesopahgeal junction (GEJ) cancers after they have progressed on at least two prior lines of treatment. While PD-L1 positivity does not define tumor’s responsiveness to pembrolizumab, PD-L1-positive tumors have better overall response rates. The treatment is usually well tolerated and has a favorable adverse events profile. The exact setting for use of pembrolizumab remains to be determined. Pembrolizumab failed to improve overall survival when administered as second-line treatment for advanced, metastatic gastric and GEJ cancers. There are several ongoing studies with various combinations and different settings not only with pembrolizumab but also with other checkpoint inhibitors.

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Cost-effectiveness of Pembrolizumab in Second-line Advanced Bladder Cancer

Cited by 49 publications

References 12 publications

Cost-effectiveness of Pembrolizumab as Second-line Therapy for the Treatment of Locally Advanced or Metastatic Urothelial Carcinoma in Sweden

Cost-effectiveness of Pembrolizumab as Second-line Therapy for the Treatment of Locally Advanced or Metastatic Urothelial Carcinoma in Sweden

Targeted Molecular Therapeutics for Bladder Cancer—A New Option beyond the Mixed Fortunes of Immune Checkpoint Inhibitors?

Pembrolizumab for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer: an evidence-based review of place in therapy

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