International differences in companion diagnostic approvals: How are we able to manage the differences?

Expert Review of Molecular Diagnostics

Volumn 15, Issue 2, 2015, Pages 157-159

  Shimazawa, Rumiko ^a   Ikeda, Masayuki ^b  

^a OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b KAGAWA UNIVERSITY HOSPITAL   (Japan)

Author keywords

biomarkers; diagnostic test approval; drug approval; individualized medicine; pharmacogenetics; US FDA

Indexed keywords

CETUXIMAB; DENILEUKIN DIFTITOX; EPIDERMAL GROWTH FACTOR RECEPTOR; IVACAFTOR; TOSITUMOMAB; VEMURAFENIB; BIOLOGICAL MARKER;

AUTHORITY; COLORECTAL CANCER; DIAGNOSTIC TEST APPROVAL; DRUG APPROVAL; DRUG INDUSTRY; GENOTYPE; HEALTH CARE; HEALTH CARE MANAGEMENT; HEALTH CARE ORGANIZATION; HEALTH INSURANCE; HUMAN; IN VITRO STUDY; LYMPHOMA; MEDICAID; MEDICARE; METASTATIC COLORECTAL CANCER; NATIONAL HEALTH INSURANCE; PERSONALIZED MEDICINE; REGULATORY MECHANISM; REVIEW; RISK ASSESSMENT; VIRUS ONCOGENE; COMPARATIVE STUDY; DRUG LABELING; JAPAN; UNITED KINGDOM; UNITED STATES;

BIOLOGICAL MARKERS; DIAGNOSTIC TEST APPROVAL; DRUG APPROVAL; DRUG LABELING; GREAT BRITAIN; HUMANS; INDIVIDUALIZED MEDICINE; JAPAN; UNITED STATES;

EID: 84921323128     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/14737159.2015.969243     Document Type: Review

References (20)

1. Ong FS, Das K, Wang J, et al. Personalized medicine and pharmacogenetic biomarkers: progress in molecular oncology testing. Expert Rev Mol Diagn 2012;12:593-602
2. Shimazawa R, Ikeda M. Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan. J Clin Pharm Ther 2014;39:210-14
3. Shimazawa R, Ikeda M. Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom and Japan. J Clin Pharm Ther 2013;38:468-75
4. Shimazawa R, Ikeda M. Are there any differences in the regulations of personalized medicine among the USA, EU and Japan?. Br J Clin Pharmacol 2013;75:1365-7
5. Shimazawa R, Ikeda M. Safety information in drug labeling: a comparison of the USA, the UK, and Japan. Pharmacoepidemiol Drug Saf 2013;22:306-18
6. U.S. Food and Drug Administration. Table of pharmacogenomic biomarkers in drug labels. Available from: www.fda.gov/drugs/.scienceresearch/researchareas/.pharmacogenetics/ucm083378.htm
7. Jorgensen JT. A challenging drug development process in the era of personalized medicine. Drug Discov Today 2011;16:891-7
8. USFDA. Code of Federal Regulations Title 21. Available from: www.accessdata.fda.gov/.scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?. CFRPart=812
9. European Commission. Proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices. Available from: http://ec. europa.eu/health/medical-devices/files/.revision-docs/proposal-2012-541-en.pdf
10. Lievre A, Bachet JB, Le Corre D, et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res 2006;66:3992-5
11. Moroni M, Veronese S, Benvenuti S, et al. Gene copy number for epidermal growth factor receptor (EGFR) and clinical response to antiEGFR treatment in colorectal cancer: a cohort study. Lancet Oncol 2005;6: 279-86
12. Benvenuti S, Sartore-Bianchi A, Di Nicolantonio F, et al. Oncogenic activation of the RAS/RAF signaling pathway impairs the response of metastatic colorectal cancers to anti-epidermal growth factor receptor antibody therapies. Cancer Res 2007;67:2643-8
13. Chalkidou K, Rawlins M. Pharmacogenetics and cost-effectiveness analysis: a two-way street. Drug Discov Today 2011;16:873-7
14. Cohen J, Wilson A, Manzolillo K. Clinical and economic challenges facing pharmacogenomics. Pharmacogenomics J 2013;13:378-88
15. Fujiwara Y. Genomics, health care, and society. N Engl J Med 2011;365:2339
16. Meckley LM, Neumann PJ. Personalized medicine: factors influencing reimbursement. Health Policy 2010;94: 91-100
17. The Centers for Medicare and Medicaid Services. Decision memo for pharmacogenomic testing for warfarin response (CAG-00400N). Available from: www.cms.gov/medicare-coverage-database/.details/nca-decision-memo.aspx?. NCAId=224&fromdb=true
18. Miller I, Ashton-Chess J, Spolders H, et al. Market Access Challenges in the EU for High Medical Value Diagnostic Tests Pers Med. 2011;8:137-48
19. Folino-Gallo P, Walley T, Frolich JC, et al. Availability of medicines in the European Union: results from the EURO-Medicines project. Eur J Clin Pharmacol 2001;57: 441-6
20. Garfield S. Advancing access to personalized medicine: a comparative assessment of European reimbursement systems. Available from: www.personalizedmedicinecoalition. org/Userfiles/PMC-Corporate/file/.pmc-europe-reimbursement.pdf