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Ipilimumab cost

Jason Roszik, Lauren E Haydu, Kenneth R Hess, Junna Oba, Aron Y Joon, Alan E Siroy, Tatiana V Karpinets, Francesco C Stingo, Veera Baladandayuthapani, Michael T Tetzlaff, Jennifer A Wargo, Ken Chen, Marie-Andrée Forget, Cara L Haymaker, Jie Qing Chen, Funda Meric-Bernstam, Agda K Eterovic, Kenna R Shaw, Gordon B Mills, Jeffrey E Gershenwald, Laszlo G Radvanyi, Patrick Hwu, P Andrew Futreal, Don L Gibbons, Alexander J Lazar, Chantale Bernatchez, Michael A Davies, Scott E Woodman
BACKGROUND: While clinical outcomes following immunotherapy have shown an association with tumor mutation load using whole exome sequencing (WES), its clinical applicability is currently limited by cost and bioinformatics requirements. METHODS: We developed a method to accurately derive the predicted total mutation load (PTML) within individual tumors from a small set of genes that can be used in clinical next generation sequencing (NGS) panels. PTML was derived from the actual total mutation load (ATML) of 575 distinct melanoma and lung cancer samples and validated using independent melanoma (n = 312) and lung cancer (n = 217) cohorts...
October 25, 2016: BMC Medicine
Pol Specenier
The treatment of melanoma is evolving rapidly over the past few years. Areas covered: We conducted a comprehensive review of the literature on the role of nivolumab in melanoma Expert commentary: Nivolumab is approved by FDA and EMA for the treatment of patients with metastatic melanoma. Nivolumab is superior to chemotherapy and to ipilimumab in previously untreated patients and to chemotherapy in ipilimumab pre-treated patients. The addition ipilimumab to nivolumab is associated with a higher response rate and a better PFS, particularly in patients with PD-L1 negative tumors, albeit at the cost of an increase in grade 3-4 adverse event rate...
November 7, 2016: Expert Review of Anticancer Therapy
S Pinar Bilir, Qiufei Ma, Zhongyun Zhao, Elizabeth Wehler, Julie Munakata, Beth Barber
BACKGROUND: Little has been reported on the costs of managing the adverse events (AEs) associated with current therapies for patients with regional or distant metastatic melanoma. OBJECTIVES: To identify treatment-related AEs in patients with metastatic melanoma and to estimate the associated costs of treating these AEs in the United States. METHODS: A cost-estimation study for AEs associated with treatment of metastatic melanoma was conducted from 2012 to 2013 by identifying grades 3 and 4 AEs through the use of a comprehensive search of drug labels and English-language, published phase 2/3 studies in PubMed, conference abstracts, and the National Comprehensive Cancer Network guidelines...
June 2016: American Health & Drug Benefits
Ivar S Jensen, Emily Zacherle, Christopher M Blanchette, Jie Zhang, Wes Yin
BACKGROUND: Although a number of monoimmunotherapies and targeted therapies are available to treat BRAF+ advanced melanoma, response rates remain relatively low in the range of 22-53% with progression-free survival (PFS) in the range of 4.8-8.8 months. Recently, combination targeted therapies have improved response rates to about 66-69%, PFS to 11.0-12.6 months and overall survival (OS) to 25.1-25.6 months. While combination immunotherapies have improved response rates of 67 compared with 19-29% with monotherapies and improved PFS of 11...
2016: Drugs in Context
Abhishek Tripathi, Marina D Kaymakcalan, Nicole R LeBoeuf, Lauren C Harshman
PURPOSE OF REVIEW: Immune checkpoint inhibitors such as those that target the programmed cell death (PD)-1 pathway harness the host immune system to elicit an antitumor response. Their remarkable clinical benefit has led to regulatory approvals in several malignancies including the genitourinary cancers, renal cell carcinoma, and urothelial carcinoma. This review will focus on the management of the toxicities encountered with these agents. RECENT FINDINGS: Although generally well tolerated, a small proportion of patients (10-20%) treated with PD-1 directed agents as monotherapy can develop severe autoimmune manifestations, also known as, immune-related adverse events...
November 2016: Current Opinion in Urology
Pol Specenier
INTRODUCTION: The treatment of melanoma is evolving rapidly over the past few years. Patients with BRAFv600 mutations can be treated with a combination of a BRAF-inhibitor and an MEK-inhibitor. Patients with BRAF wild-type tumors and BRAFv600 mutated tumors can be treated with immunotherapy i.e. check point inhibitors. AREAS COVERED: We conducted a comprehensive review of the literature on the efficacy and predictive markers, safety, and pharmacoeconomics of ipilimumab in melanoma Expert commentary: Ipilimumab was the first check point inhibitor reaching the clinic, gaining FDA and EMA approval for metastatic melanoma in 2011...
August 2016: Expert Review of Anticancer Therapy
D Lee, J Porter, N Hertel, A J Hatswell, A Briggs
BACKGROUND: In the absence of head-to-head data, a common method for modelling comparative survival for cost-effectiveness analysis is estimating hazard ratios from trial publications. This assumes that the hazards of mortality are proportional between treatments and that outcomes are not polluted by subsequent therapy use. Newer techniques that compare treatments where the proportional hazards assumption is violated and adjust for use of subsequent therapies often require patient-level data, which are rarely available for all treatments...
August 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Lucia Gozzo, Andrea Navarria, Valentina Drago, Laura Longo, Silvana Mansueto, Giacomo Pignataro, Americo Cicchetti, Salvatore Salomone, Filippo Drago
BACKGROUND AND OBJECTIVE: Appropriate pricing of medications is one of the ultimate goals for decision makers, but reliable data on the risk/benefit ratio are often lacking when a Marketing Authorization Application is submitted. Here we propose a method to consistently evaluate price adequacy, which we applied to six anticancer medications approved in Italy in recent years. METHODS: We obtained ratios of cost per survival per day (cost/survival/day) by dividing the total costs of evaluated medications for the median survival gain in days...
July 2016: Clinical Drug Investigation
Hampig R Kourie, Jean A Klastersky
PURPOSE OF REVIEW: After the dramatic and often long-standing response rates of checkpoint inhibitors as single agents, the new era for checkpoint inhibitors is combined therapy (either with other checkpoint inhibitors, chemotherapies, targeted therapies or immunotherapies) that is aiming to do even better. Although one can speculate that these combinations will result in improved results, high cost and potential toxicity are limiting factors for their use. In this review, we plan to report on the different side-effects of the checkpoint inhibitor-based combination therapies and to discuss the future perspectives of these new modalities...
July 2016: Current Opinion in Oncology
Katja Vouk, Ursula Benter, Mayur M Amonkar, Alessia Marocco, Ceilidh Stapelkamp, Sylvie Pfersch, Laure Benjamin
OBJECTIVE: To estimate per-event cost and economic burden associated with managing the most common and/or severe metastatic melanoma (MM) treatment-related adverse events (AEs) in Australia, France, Germany, Italy, and the UK. METHODS: AEs associated with chemotherapy (dacarbazine, paclitaxel, fotemustine), immunotherapy (ipilimumab), and targeted therapy (vemurafenib) were identified by literature review. Medical resource use data associated with managing AEs were collected through two blinded Delphi panel cycles in each of the five countries...
September 2016: Journal of Medical Economics
Beatriz Guglieri-López, Alejandro Pérez-Pitarch, Begoña Porta Oltra, Francisco Ferriols-Lisart, Ángeles Royo-Peiró, Mónica Climente-Martí
To evaluate the effectiveness and toxicity profile of ipilimumab treatment and to examine the cost-effectiveness relation in a real-world sample of patients with metastasic melanoma. This was a multicenter, observational, retrospective cohorts study. To assess the effectiveness and safety of ipilimumab treatment progression-free survival (PFS), overall survival (OS) and adverse events were registered. An economic evaluation was performed and cost-effectiveness ratios (CERs) were calculated. Eleven patients were included, mean age 59 (SD=11) years...
August 2016: Anti-cancer Drugs
Alysson Wann, David Ashley, Mustafa Khasraw
PURPOSE: Data on the use of targeted therapies at the end of life are scarce. This study reviews the pattern of use of targeted and potentially futile, toxic, or costly therapies at an Australian cancer centre. METHODS: This retrospective single-centre review of data from patients who died within 3 months of having targeted therapy examined demographic characteristics, types of cancers, types of therapy, age, and lines of prior therapy. RESULTS: Over 24 months, two groups were analysed...
July 2016: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Patrick J Medina, Val R Adams
Immune checkpoint inhibitors are designed to restore a patient's own antitumor immune response that has been suppressed during tumor development. The first monoclonal antibodies against the immune checkpoint programmed death 1 (PD-1) receptor, nivolumab and pembrolizumab, are now approved for clinical use. Both agents are indicated for the treatment of advanced melanoma, as well as for the treatment of metastatic non-small cell lung cancer (NSCLC). Nivolumab is also approved for the treatment of advanced renal cell carcinoma...
March 2016: Pharmacotherapy
A S Golikov, A V Tikhomirova
BACKGROUND: In Russia, the incidence of melanoma is increasing steadily. The approved standard of specialized medical care for melanoma of the skin defined the range of drugs, recommended for the provision of quality health care. However, it appears that the most effective innovative and safe medicines are at the same time the most expensive drugs. The most important is the assessment of drug use, taking into account their relative efficacy, safety (risk/benefit) and cost (economic efficiency), which may help to create the conditions for controlling their use...
2015: International Journal of Risk & Safety in Medicine
D Rosselli, C Castañeda-Cardona, J G Bayona, Y R Díaz Toro, S A Saenz Ariza
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
E Marriott, C Praet, R Aguiar-Ibáñez, J Pellissier, R Xu, J Wang
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
M Bohensky, K Pasupathi, A Gorelik, H Kim, J P Harrison, D Liew
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
J Zaragoza, A Caille, N Beneton, G Bens, F Christiann, H Maillard, L Machet
BACKGROUND: There is an unmet need to identify markers predictive of response to ipilimumab in patients with melanoma because the number of responders to ipilimumab is low and its cost is very high. An increase in absolute lymphocyte count (ALC) or low neutrophil/lymphocyte ratio (NLR) just before the third infusion has been reported to be associated with better overall survival (OS). OBJECTIVES: Our aim was to determine whether NLR measured before the first infusion was associated with OS...
January 2016: British Journal of Dermatology
Taehwan Park, Scott K Griggs, Dong-Churl Suh
BACKGROUND: Monoclonal antibody (mAb)-based orphan drugs have led to advances in the treatment of diseases by selectively targeting molecule functions. However, their high treatment costs impose a substantial cost burden on patients and society. OBJECTIVES: The study aimed to systematically review cost-effectiveness evidence of mAb orphan drugs. METHODS: Ovid MEDLINE(®), EMBASE(®), and PsycINFO(®) were searched in June 2014 and articles were selected if they conducted economic evaluations of the mAb orphan drugs that had received marketing approval in the USA...
August 2015: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Edmond L Toy, Francis Vekeman, Michael C Lewis, Alan K Oglesby, Mei Sheng Duh
OBJECTIVE: To estimate real-world healthcare costs, resource utilization, and treatment patterns among metastatic melanoma (MM) patients who received a therapy recommended in current treatment guidelines during 2011 and 2012, following approval in the US of novel therapies (ipilimumab and vemurafenib). RESEARCH DESIGN AND METHODS: Administrative claims data were used in a retrospective, longitudinal, open cohort study. Adult MM patients were identified using ICD-9 codes...
August 2015: Current Medical Research and Opinion
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