The economic evaluation of personalised oncology medicines: Ethical challenges

Medical Journal of Australia

Volumn 199, Issue 7, 2013, Pages 471-473

  Lewis, Jan R R ^a   Lipworth, Wendy L ^b   Kerridge, Ian H ^a   Day, Richard O ^c  

^a UNIVERSITY OF SYDNEY   (Australia)

^b UNIVERSITY OF NEW SOUTH WALES   (Australia)

^c ST VINCENT S HOSPITAL   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ERLOTINIB; GEFITINIB; PLATINUM COMPLEX;

ARTICLE; AUSTRALIA; CANCER SURVIVAL; COST EFFECTIVENESS ANALYSIS; DISEASE COURSE; DRUG COST; DRUG EFFICACY; DRUG SAFETY; EGFR GENE; EVIDENCE BASED MEDICINE; FUNDING; GENE MUTATION; HEALTH CARE COST; HUMAN; LUNG NON SMALL CELL CANCER; MEDICAL ETHICS; ONCOGENE; OVERALL SURVIVAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RETROSPECTIVE STUDY; SOCIOECONOMICS; SURVIVAL RATE; TUMOR VOLUME;

ANTINEOPLASTIC AGENTS; AUSTRALIA; CARCINOMA, NON-SMALL-CELL LUNG; COST-BENEFIT ANALYSIS; HUMANS; INDIVIDUALIZED MEDICINE; LUNG NEOPLASMS; NEOPLASMS; QUINAZOLINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTOR, EPIDERMAL GROWTH FACTOR; TREATMENT OUTCOME;

EID: 84885135736     PISSN: 0025729X     EISSN: 13265377     Source Type: Journal    
DOI: 10.5694/mja13.10046     Document Type: Article

References (25)

1. Wakelee H, Belani CP. Optimizing first-line treatment options for patients with advanced NSCLC. Oncologist 2005; 10 Suppl 3: 1-10.
2. Ohashi K, Maruvka YE, Michor F, Pao W. Epidermal growth factor receptor tyrosine kinase inhibitor-resistant disease. J Clin Oncol 2013; 31: 1070-1080.
3. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009; 361: 947-957.
4. Maemondo M, Inoue A, Kobayashi K, et al; North-East Japan Study Group. Gefitinib or chemotherapy for non small-cell lung cancer with mutated EGFR. N Engl J Med 2010; 362: 2380-2388.
5. Han JY, Park K, Kim SW, et al. First-SIGNAL: first-line single-agent Iressa versus gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung. J Clin Oncol 2012; 30: 1122-1128.
6. Mitsudomi T, Morita S, Yatabe Y, et al; West Japan Oncology Group. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol 2010; 11: 121-128.
7. Rosell R, Carcenery E, Gervais R, et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol 2012; 13: 239-246.
8. Zhou C, Wu YL, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol 2011; 12: 735-742.
9. Takano T, Fukui T, Ohe Y, et al. EGFR mutations predict survival benefit from gefitinib in patients with advanced lung adenocarcinoma: a historical comparison of patients treated before and after gefitinib approval in Japan. J Clin Oncol 2008; 26: 5589-5595.
10. Lim KH, Huang MJ, Liu HC, et al. Lack of prognostic value of EGFR mutations in primary resected non-small cell lung cancer. Med Oncol 2007; 24: 388-393.
11. Australian Government Department of Health and Ageing. Erlotinib public summary document. Pharmaceutical Benefits Advisory Committee meeting, July 2012. http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2012-07/erlotinib.pdf (accessed Jul 2013).
12. Australian Government Department of Health and Ageing. Gefitinib Public Summary Document. Pharmaceutical Benefits Advisory Committee meeting, November 2012. http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2012-11/gefitinib.pdf (accessed Jul 2013).
13. Birkett DJ, Mitchell AS, McManus P. A cost-effectiveness approach to drug subsidy and pricing in Australia. Health Aff (Millwood) 2001; 20: 104-114.
14. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005; 353: 123-132.
15. Thatcher N, Chang A, Parikh P, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005; 366: 1527-1537.
16. Inoue A, Kobayashi K, Maemondo M, et al; North-East Japan Study Group. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naive non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol 2013; 24: 54-59.
17. Mitsudomi T, Morita S, Yatabe Y, et al. Updated overall survival results of WJTOG 3405, a randomized phase III trial comparing gefitinib with cisplatin plus docetaxel as the first-line treatment for patients with non-small cell lung cancer harboring mutations of the epidermal growth factor receptor. (ASCO annual meeting proceedings, post-meeting edition). J Clin Oncol 2012; 30 (15 suppl): abstract 7521.
18. Zhou C, Wu YL, Liu X, et al. Overall survival results from OPTIMAL (CTONG0802), a phase III trial of erlotinib versus carboplatin plus gemcitabine as first-line treatment for Chinese patients with EGFR mutation-positive advanced non-small cell lung cancer. (ASCO annual meeting proceedings, post-meeting edition). J Clin Oncol 2012; 30 (15 suppl): abstract 7520.
19. Shepherd FA, Tsao MS. Unraveling the mystery of prognostic and predictive factors in epidermal growth factor receptor therapy. J Clin Oncol 2006; 24: 1219-1220.
20. Douillard JY, Shepherd FA, Hirsch V, et al. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol 2010; 28: 744-752.
21. Gridelli C, De Marinis F, Di Maio M, et al. Gefitinib as first-line treatment for patients with advanced non-small-cell lung cancer with activating epidermal growth factor receptor mutation: review of the evidence. Lung Cancer 2011; 71: 249-257.
22. Kobayashi K, Hagiwara K. Epidermal growth factor receptor (EGFR) mutation and personalized therapy in advanced nonsmall cell lung cancer (NSCLC). Target Oncol 2013; 8: 27-33.
23. Korhonen P, Zuber E, Branson M, et al. Correcting overall survival for the impact of crossover via a rank preserving structural failure time (RPSFT) model in the RECORD-1 trial of everolimus in metastatic renal-cell carcinoma. J Biopharm Stat 2012; 22: 1258-1271.
24. Rimawi M, Hilsenbeck SG. Making sense of clinical trial data: is inverse probability of censoring weighted analysis the answer to crossover bias? J Clin Oncol 2012; 30: 453-458.
25. Merlin T, Farah C, Schubert C, et al. Assessing personalized medicines in Australia: a national framework for reviewing codependent technologies. Med Decis Making 2013; 33: 333-342.