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2 results on '"Müller, Martin C."'

1. Cost-effectiveness of Tyrosine Kinase Inhibitor Treatment Strategies for Chronic Myeloid Leukemia in Chronic Phase After Generic Entry of Imatinib in the United States.

Author

Padula, William V, Larson, Richard A, Dusetzina, Stacie B, Apperley, Jane F, Hehlmann, Rudiger, Baccarani, Michele, Eigendorff, Ekkehard, Guilhot, Joelle, Guilhot, Francois, Mahon, Francois-Xavier, Martinelli, Giovanni, Mayer, Jiri, Müller, Martin C, Niederwieser, Dietger, Saussele, Susanne, Schiffer, Charles A, Silver, Richard T, Simonsson, Bengt, and Conti, Rena M

Subjects
COST effectiveness, IMATINIB, LEUKEMIA treatment, GENERIC drugs, ANTINEOPLASTIC agents, COMPARATIVE studies, RESEARCH methodology, MEDICAL cooperation, PROBABILITY theory, PROTEIN-tyrosine kinases, RESEARCH, SURVIVAL analysis (Biometry), EVALUATION research, CHRONIC myeloid leukemia, TREATMENT effectiveness, QUALITY-adjusted life years, STATISTICAL models, CHEMICAL inhibitors, PROTEIN kinase inhibitors, ECONOMICS, THERAPEUTICS
Abstract

Background: We analyzed the cost-effectiveness of treating incident chronic myeloid leukemia in chronic phase (CML-CP) with generic imatinib when it becomes available in United States in 2016. In the year following generic entry, imatinib's price is expected to drop 70% to 90%. We hypothesized that initiating treatment with generic imatinib in these patients and then switching to the other tyrosine-kinase inhibitors (TKIs), dasatinib or nilotinib, because of intolerance or lack of effectiveness ("imatinib-first") would be cost-effective compared with the current standard of care: "physicians' choice" of initiating treatment with any one of the three TKIs.Methods: We constructed Markov models to compare the five-year cost-effectiveness of imatinib-first vs physician's choice from a US commercial payer perspective, assuming 3% annual discounting ($US 2013). The models' clinical endpoint was five-year overall survival taken from a systematic review of clinical trial results. Per-person spending on incident CML-CP treatment overall care components was estimated using Truven's MarketScan claims data. The main outcome of the models was cost per quality-adjusted life-year (QALY). We interpreted outcomes based on a willingness-to-pay threshold of $100 000/QALY. A panel of European LeukemiaNet experts oversaw the study's conduct.Results: Both strategies met the threshold. Imatinib-first ($277 401, 3.87 QALYs) offered patients a 0.10 decrement in QALYs at a savings of $88 343 over five years to payers compared with physician's choice ($365 744, 3.97 QALYs). The imatinib-first incremental cost-effectiveness ratio was approximately $883 730/QALY. The results were robust to multiple sensitivity analyses.Conclusion: When imatinib loses patent protection and its price declines, its use will be the cost-effective initial treatment strategy for CML-CP. [ABSTRACT FROM AUTHOR]

Published
2016
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2. Impact of baseline BCR-ABL mutations on response to nilotinib in patients with chronic myeloid leukemia in chronic phase.

Author

Hughes T, Saglio G, Branford S, Soverini S, Kim DW, Müller MC, Martinelli G, Cortes J, Beppu L, Gottardi E, Kim D, Erben P, Shou Y, Haque A, Gallagher N, Radich J, and Hochhaus A

Subjects
Australia, Benzamides, Drug Resistance, Neoplasm genetics, Europe, Gene Expression Regulation, Enzymologic, Gene Expression Regulation, Leukemic, Humans, Imatinib Mesylate, Korea, Leukemia, Myelogenous, Chronic, BCR-ABL Positive enzymology, Piperazines therapeutic use, Time Factors, Treatment Outcome, United States, Antineoplastic Agents therapeutic use, Fusion Proteins, bcr-abl antagonists & inhibitors, Fusion Proteins, bcr-abl genetics, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy, Leukemia, Myelogenous, Chronic, BCR-ABL Positive genetics, Mutation, Protein Kinase Inhibitors therapeutic use, Pyrimidines therapeutic use
Abstract

Purpose: Nilotinib is a second-generation tyrosine kinase inhibitor indicated for the treatment of patients with chronic myeloid leukemia (CML) in chronic phase (CP; CML-CP) and accelerated phase (AP; CML-AP) who are resistant to or intolerant of prior imatinib therapy. In this subanalysis of a phase II study of nilotinib in patients with imatinib-resistant or imatinib-intolerant CML-CP, the occurrence and impact of baseline and newly detectable BCR-ABL mutations were assessed., Patients and Methods: Baseline mutation data were assessed in 281 (88%) of 321 patients with CML-CP in the phase II nilotinib registration trial., Results: Among imatinib-resistant patients, the frequency of mutations at baseline was 55%. After 12 months of therapy, major cytogenetic response (MCyR) was achieved in 60%, complete cytogenetic response (CCyR) in 40%, and major molecular response (MMR) in 29% of patients without baseline mutations versus 49% (P = .145), 32% (P = .285), and 22% (P = .366), respectively, of patients with mutations. Responses in patients who harbored mutations with high in vitro sensitivity to nilotinib (50% inhibitory concentration [IC(50)] 150 nM; Y253H, E255V/K, F359V/C) had less favorable responses, as 13%, 43%, and 9% of patients with each of these mutations, respectively, achieved MCyR; none achieved CCyR., Conclusion: For most patients with imatinib resistance and with mutations, nilotinib offers a substantial probability of response. However, mutational status at baseline may influence response. Less sensitive mutations that occurred at three residues defined in this study, as well as the T315I mutation, may be associated with less favorable responses to nilotinib.

Published
2009
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