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https://www.readbyqxmd.com/read/29524005/the-cost-effectiveness-of-nivolumab-monotherapy-for-the-treatment-of-advanced-melanoma-patients-in-england
#1
Yang Meng, Nadine Hertel, John Ellis, Edith Morais, Helen Johnson, Zoe Philips, Neil Roskell, Andrew Walker, Dawn Lee
BACKGROUND: Nivolumab was the first programmed death receptor 1 (PD-1) immune checkpoint inhibitor to demonstrate long-term survival benefit in a clinical trial setting for advanced melanoma patients. OBJECTIVE: To evaluate the cost effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England. METHODS: A Markov state-transition model was developed to estimate the lifetime costs and benefits of nivolumab versus ipilimumab and dacarbazine for BRAF mutation-negative patients and versus ipilimumab, dabrafenib, and vemurafenib for BRAF mutation-positive patients...
March 9, 2018: European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care
https://www.readbyqxmd.com/read/29456865/a-real-world-example-of-coverage-with-evidence-development-in-australia-ipilimumab-for-the-treatment-of-metastatic-melanoma
#2
Hansoo Kim, Samantha Comey, Karl Hausler, Greg Cook
Background: Australian Government subsidisation of ipilimumab for the treatment of patients with metastatic melanoma was conditional on the sponsor entering a 'managed entry scheme' to assess the 2-year overall survival rate in metastatic melanoma patients who received ipilimumab in the first year of Pharmaceutical Benefits Scheme listing. Methods: All unresectable stage IIIc / IV metastatic melanoma patients treated with at least one dose of ipilimumab therapy in Australia from the PBS listing date to a time point 12 months later (i...
2018: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/29444609/optimization-of-resources-by-drug-management-a-multicentred-web-administered-study-on-the-use-of-ipilimumab-in-italy
#3
V Damuzzo, A Russi, M Chiumente, C Masini, B Rebesco, F Gregis, S Nozza, J Pigozzo, V Chiarion-Sileni, A C Palozzo
Objective In a scenario of new expensive cancer therapies entering the market, strategies of optimisation and cost containment are crucial in oncology care. Better management of drug waste and centralization of drug preparation can be effective strategies to achieve these goals. The aim of this work is to describe the economic management of a high cost anticancer drug (ipilimumab) in some Italian reference centres. Methods This was an observational, multicentred study in which economical and clinical data of 21 cancer centres (418 patients) were collected during the enrollment period from February 2013 to August 2014...
January 1, 2018: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/29285547/association-of-immunotherapy-with-durable-survival-as-defined-by-value-frameworks-for-cancer-care
#4
Omer Ben-Aharon, Racheli Magnezi, Moshe Leshno, Daniel A Goldstein
Importance: Modern immuno-oncology agents have generated great excitement because of their potential to provide durable survival for some patients. However, there is concern regarding the cost of cancer care, and multiple frameworks have been developed to assess value. The American Society of Clinical Oncology (ASCO) framework awards bonus points if substantial durable survival is demonstrated. Objective: To assess whether modern immuno-oncology agents reach defined efficacy thresholds in value frameworks...
March 1, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29284380/potential-cost-savings-by-dose-down-rounding-of-monoclonal-antibodies-in-a-community-cancer-center
#5
Mehmet S Copur, Curtis Gnewuch, Megan Schriner, Mark Tharnish, Mithat Gonen, Monica McDonald, Jami Kezeor, Ryan C Ramaekers, Dron Gauchan, Douglas Clark, Lois Greenwalt, Mary Mickey, Max Norvell
Purpose Increasing new cancer cases and approval of effective but expensive new drugs extending survival have led to unsustainable cancer care costs. Potential cost savings by a hypothetical dose down-rounding project of monoclonal antibodies at a community-based cancer center is presented. Methods From October 2014 through October 2015, metastatic cancer patients receiving monoclonal antibodies at CHI-Health St Francis Cancer Treatment Center in Grand Island, Nebraska, were identified through electronic health records...
March 2018: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/29239194/-immunotherapy-of-renal-cell-carcinoma
#6
A Poprach, R Lakomý, T Büchler
Treatment of renal cell carcinoma is still palliative. Targeted therapy increases response rates and prolongs overall survival and progression-free survival compared with cytokines and chemotherapy. Checkpoint inhibitors constitute the up-date of therapeutic approaches, and anti-PD-1 antibody, one checkpoint inhibitor, is now well established as a second and/or third palliative treatment for patients with renal cell carcinoma. In this study, we present the latest data from current studies on cytokines, cancer vaccines, ipilimumab, and nivolumab...
2017: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/28964438/cost-effectiveness-of-pembrolizumab-for-advanced-melanoma-treatment-in-portugal
#7
COMPARATIVE STUDY
Luis Silva Miguel, Francisca Vargas Lopes, Bernardete Pinheiro, Jingshu Wang, Ruifeng Xu, James Pellissier, Pedro Almeida Laires
BACKGROUND: The aim of this study was to assess the cost-effectiveness of pembrolizumab in treating patients with ipilimumab-naïve advanced melanoma in Portugal. METHODS: A cost-effectiveness model was developed to analyze the costs and consequences of treatment with pembrolizumab compared to treatment with ipilimumab in patients with advanced melanoma not previously treated with ipilimumab. The model was parameterized by using data from a head-to-head phase III randomized clinical trial, KEYNOTE-006...
September 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28866758/modelling-the-survival-outcomes-of-immuno-oncology-drugs-in-economic-evaluations-a-systematic-approach-to-data-analysis-and-extrapolation
#8
Eddie Gibson, Ian Koblbauer, Najida Begum, George Dranitsaris, Danny Liew, Phil McEwan, Amir Abbas Tahami Monfared, Yong Yuan, Ariadna Juarez-Garcia, David Tyas, Michael Lees
BACKGROUND: New immuno-oncology (I-O) therapies that harness the immune system to fight cancer call for a re-examination of the traditional parametric techniques used to model survival from clinical trial data. More flexible approaches are needed to capture the characteristic I-O pattern of delayed treatment effects and, for a subset of patients, the plateau of long-term survival. OBJECTIVES: Using a systematic approach to data management and analysis, the study assessed the applicability of traditional and flexible approaches and, as a test case of flexible methods, investigated the suitability of restricted cubic splines (RCS) to model progression-free survival (PFS) in I-O therapy...
December 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28827234/multiple-treatment-comparison-of-seven-new-drugs-for-patients-with-advanced-malignant-melanoma-a-systematic-review-and-health-economic-decision-model-in-a-norwegian-setting
#9
Eva Pike, Vida Hamidi, Ingvil Saeterdal, Jan Odgaard-Jensen, Marianne Klemp
OBJECTIVE: To assess the relative effectiveness and cost-effectiveness of seven new drugs (cobimetinib, dabrafenib, ipilimumab, nivolumab, pembrolizumab, trametinib and vemurafenib) used for treatment of patients with advanced malignant melanoma in the Norwegian setting. DESIGN: A multiple technology assessment. PATIENTS: Patients with advanced malignant melanoma aged 18 or older. DATA SOURCES: A systematic search for randomised controlled trials in relevant bibliographic databases...
August 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28703084/case-study-on-an-ipilimumab-cost-containment-strategy-in-an-italian-hospital
#10
Alberto Russi, Vanna Chiarion-Sileni, Vera Damuzzo, Francesca Di Sarra, Jacopo Pigozzo, Angelo Claudio Palozzo
OBJECTIVES: Ipilimumab is the first licensed immune checkpoint inhibitor for treatment of melanoma. The promising results of the registration clinical study need confirmation in real practice and its clinical success comes together with a relevant budget impact due to the high price of this drug. The aim of this work is to describe a new model of economical sustainability of ipilimumab developed in an Italian reference center for melanoma treatment. METHODS: This retrospective, observational, and monocentric study was carried out at the Veneto Institute of Oncology...
July 13, 2017: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/28559410/case-report-encephalitis-with-brainstem-involvement-following-checkpoint-inhibitor-therapy-in-metastatic-melanoma
#11
Simon Bossart, Selina Thurneysen, Elisabeth Rushing, Karl Frontzek, Henning Leske, Daniela Mihic-Probst, Hannes W Nagel, Johanna Mangana, Simone M Goldinger, Reinhard Dummer
Checkpoint inhibitors are increasingly being used in the treatment of malignant melanoma and other cancers. With the use of such therapies, autoimmune-mediated adverse events in the central and peripheral nervous system are likely to occur more frequently. We report a unique case of brainstem encephalitis with a sudden lethal outcome following ipilimumab and pembrolizumab therapy in a patient with malignant melanoma. The autopsy showed a diffuse nodular activation of microglia in the whole encephalon with prominent intraparenchymal and perivascular lymphocytic infiltration of the brainstem...
June 2017: Oncologist
https://www.readbyqxmd.com/read/28530525/cost-effectiveness-of-nivolumab-ipilimumab-combination-therapy-compared-with-monotherapy-for-first-line-treatment-of-metastatic-melanoma-in-the-united-states
#12
Anna Oh, Dang M Tran, Leann C McDowell, Dor Keyvani, Jay Andrew Barcelon, Oscar Merino, Leslie Wilson
BACKGROUND: The approval of new immunotherapies has dramatically changed the treatment landscape of metastatic melanoma. These survival gains come with trade-offs in side effects and costs, as well as important considerations for third-party payer systems, physicians, and patients. OBJECTIVE: To develop a Markov model to determine the cost-effectiveness of nivolumab, ipilimumab, and nivolumab-ipilimumab combination as firstline therapy in metastatic melanoma, while accounting for differential effectiveness in programmed death-ligand 1 (PD-L1) positive and negative patients...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28526721/health-care-resource-utilization-and-associated-costs-among-metastatic-cutaneous-melanoma-patients-treated-with-ipilimumab-intuition-study
#13
Grant A McArthur, Peter Mohr, Paolo Antonio Ascierto, Ana Arance, Ana Banos Hernaez, Peter Kaskel, Michael Weichenthal, Reshma Shinde, Kendall Stevinson
BACKGROUND: There are limited real-world data on health care resource utilization (HCRU) among advanced melanoma patients. The objective of this study was to describe HCRU and health care costs associated with the management of advanced melanoma patients receiving ipilimumab. METHODS: This retrospective multinational, observational study included advanced melanoma patients from Australia, Germany, Italy, and Spain who had received at least 1 dose of ipilimumab. Data extracted from medical charts included inpatient admissions, outpatient visits, surgical procedures, laboratory investigations, radiation therapy, imaging studies, and concomitant medications...
August 2017: Oncologist
https://www.readbyqxmd.com/read/28417343/adjuvant-therapy-for-melanoma
#14
REVIEW
Aya Agha, Ahmad A Tarhini
Systemic adjuvant therapy for surgically resected cutaneous melanoma that is at high risk for disease recurrence and death targets residual micrometastatic disease which is the source of future local or distant relapse. Interferon-alfa (IFNα) has been the most extensively studied in regimens that varied by dosage, route of administration, formulation, and duration of therapy. Most regimens have demonstrated improvements in relapse-free survival (RFS), while the regimen administered at high dosage (HDI) showed improvements in overall survival (OS) in two out of three RCTs...
May 2017: Current Oncology Reports
https://www.readbyqxmd.com/read/28408015/accounting-for-cured-patients-in-cost-effectiveness-analysis
#15
Megan Othus, Aasthaa Bansal, Lisel Koepl, Samuel Wagner, Scott Ramsey
BACKGROUND: Economic evaluations often measure an intervention effect with mean overall survival (OS). Emerging types of cancer treatments offer the possibility of being "cured" in that patients can become long-term survivors whose risk of death is the same as that of a disease-free person. Describing cured and noncured patients with one shared mean value may provide a biased assessment of a therapy with a cured proportion. OBJECTIVE: The purpose of this article is to explain how to incorporate the heterogeneity from cured patients into health economic evaluation...
April 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28316007/talimogene-laherparepvec-for-treating-metastatic-melanoma-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#16
REVIEW
Nigel Fleeman, Adrian Bagust, Angela Boland, Sophie Beale, Marty Richardson, Ashma Krishan, Angela Stainthorpe, Ahmed Abdulla, Eleanor Kotas, Lindsay Banks, Miranda Payne
The National Institute for Health and Care Excellence (NICE) invited the manufacturer (Amgen) of talimogene laherparepvec (T-VEC) to submit clinical and cost-effectiveness evidence for previously untreated advanced (unresectable or metastatic) melanoma as part of the Institute's Single Technology Appraisal process. The Liverpool Reviews and Implementation Group (LRiG) at the University of Liverpool was commissioned to act as the Evidence Review Group (ERG). This article presents a summary of the company's submission of T-VEC, the ERG review and the resulting NICE guidance (TA410), issued in September 2016...
October 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28303311/-immunotherapy-of-cancer-with-checkpoint-inhibitors-not-only-in-malignant-melanoma
#17
A Neubauer
The newest weapon in cancer therapy is checkpoint inhibition, which is the result of basic immunology research. The success of this therapy is based on the fact that upon light microscopy, many solid tumors harbor lymphocytic cells infiltrating the tumor (TILs), and in many solid tumors, the presence of these TILs are prognostic. Ipilimumab was the first monoclonal antibody developed against a target present on T cells after becoming activated, CTLA-4. In malignant melanoma, ipilimumab showed its beneficial effect as compared to a placebo peptide...
April 2017: Der Internist
https://www.readbyqxmd.com/read/28141932/an-expanded-portfolio-of-survival-metrics-for-assessing-anticancer-agents
#18
Jennifer Karweit, Srividya Kotapati, Samuel Wagner, James W Shaw, Steffan W Wolfe, Amy P Abernethy
OBJECTIVES: With the introduction of more effective anticancer agents that prolong survival, there is a need for new methods to define the clinical value of treatments. The objective of this preliminary qualitative and quantitative analysis was to assess the utility of an expanded portfolio of survival metrics to differentiate the value of anticancer agents. STUDY DESIGN: A literature review was conducted of phase 3 trial data, reported in regulatory submissions within the last 10 years of agents for 6 metastatic cancers (breast cancer, colorectal cancer [CRC], melanoma, non-small cell lung cancer [NSCLC], prostate cancer [PC], and renal cell cancer [RCC])...
January 2017: American Journal of Managed Care
https://www.readbyqxmd.com/read/28125365/cost-effectiveness-of-pembrolizumab-versus-ipilimumab-in-ipilimumab-na%C3%A3-ve-patients-with-advanced-melanoma-in-the-united-states
#19
Jingshu Wang, Bartosz Chmielowski, James Pellissier, Ruifeng Xu, Kendall Stevinson, Frank Xiaoqing Liu
BACKGROUND: Recent clinical trials have shown that pembrolizumab significantly prolonged progression-free survival and overall survival compared with ipilimumab in ipilimumab-naïve patients with unresectable or metastatic melanoma. However, there has been no published evidence on the cost-effectiveness of pembrolizumab for this indication. OBJECTIVE: To assess the long-term cost-effectiveness of pembrolizumab versus ipilimumab in ipilimumab-naïve patients with unresectable or meta-static melanoma from a U...
February 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28057179/biomarqueurs-pr%C3%A3-dictifs-de-r%C3%A3-ponse-aux-traitements-bloquant-les-voies-de-costimulation-inhibitrices
#20
REVIEW
Franck Pagès, Clémence Granier, Amos Kirilovsky, Carine Elsissy, Eric Tartour
Immunotherapies targeting co-inhibitory receptors recently open a new promising approach of cancer treatment. Indeed, an objective clinical response was observed after treatment by anti-CTLA-4 and anti-PD-1 in many indications but the treatment still failed in 70 to 80 % of cases treated. Given the adverse effects and the high cost of these therapies, there is a need for the development of biomarkers. This review focus on potential predictive biomarkers. In peripheral blood, high level of Il-2 soluble receptor at baseline and absence of ICOS+ CD4-T lymphocytes induction may be associated with the absence of clinical response for melanoma patients treated by ipilimumab (anti-CTLA-4)...
November 2016: Bulletin du Cancer
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