Implications of "not me" drugs for health systems: Lessons from age related macular degeneration

BMJ (Online)

Volumn 344, Issue 7855, 2012, Pages

  Campbell, Robert J ^a   Dhalla, Irfan A ^b   Gill, Sudeep S ^a   Bell, Chaim M ^b  

^a QUEEN S UNIVERSITY   (Canada)

^b ST MICHAEL'S HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; RANIBIZUMAB; ANGIOGENESIS INHIBITOR; MONOCLONAL ANTIBODY;

BLINDNESS; CLINICAL TRIAL (TOPIC); COST EFFECTIVENESS ANALYSIS; DRUG APPROVAL; DRUG CHOICE; DRUG COST; DRUG EFFICACY; DRUG INDICATION; DRUG LEGISLATION; DRUG MECHANISM; DRUG PENETRATION; DRUG QUALITY; DRUG SAFETY; DRUG USE; ECONOMIC EVALUATION; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; HEALTH CARE FINANCING; HEALTH CARE POLICY; HEALTH INSURANCE; HEALTH PROGRAM; HUMAN; MEDICAL DECISION MAKING; MEDICARE; OFF LABEL DRUG USE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; REIMBURSEMENT; RETINA MACULA AGE RELATED DEGENERATION; RISK BENEFIT ANALYSIS; SHORT SURVEY; ARTICLE; DRUG INDUSTRY; ECONOMICS; FINANCIAL MANAGEMENT; RETINA MACULA DEGENERATION;

ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL, HUMANIZED; DRUG APPROVAL; DRUG INDUSTRY; FINANCIAL SUPPORT; HUMANS; MACULAR DEGENERATION;

EID: 84860629023     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.e2941     Document Type: Short Survey

References (22)

1. Lee T. "Me-Too" products: friend or foe? N Engl J Med 2004;350:211-2.
2. Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med 2008;358:2606-17.
3. Ip MS, Scott IU, Brown GC, Brown MM, Ho AC, Huang SS, et al. Anti-vascular endothelial growth factor pharmacotherapy for age-related macular degeneration - a report by the American Academy of Ophthalmology. Ophthalmology 2008;115:1837-46.
4. Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 2006;355:1432-44. (Pubitemid 44511558)
5. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2006;355:1419-31. (Pubitemid 44511557)
6. Tufail A, Patel PJ, Egan C, Hykin P, da Cruz L, Gregor Z, et al. Bevacizumab for neovascular age related macular degeneration (ABC trial): multicentre randomised double masked study. BMJ 2010;340:c2459.
7. CATT Research Group, Martin DF, Maguire MG, Ying G, Grunwald JE, Fine SL, et al. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med 2011;364:1897-908.
8. Campbell RJ, Bronskill SE, Bell CM, Paterson JM, Whitehead M, Gill SS. Rapid expansion of intravitreal drug injection procedures, 2000 to 2008: a population-based analysis. Arch Ophthalmol 2010;128:359-62.
9. Brechner RJ, Rosenfeld PJ, Babish JD, Caplan S. Pharmacotherapy for neovascular age-related macular degeneration: an analysis of the 100% 2008 Medicare fee-for-service Part B claims file. Am J Ophthalmol 2011;151:887-95.
10. Levinson DR. Review of Medicare Part B Avastin and Lucentis treatments for age-related macular degeneration (A-01-10-00514) [internet]. 2011 http://oig.hhs.gov/oas/reports/region10/11000514.pdf.
11. Pollack A. Maker seeks to restrict cancer drug use on eye New York Times 2007 Oct 12. www.nytimes.com/2007/10/12/business/12eye.html?ref=avastindrug.
12. Novartis. New analysis representing largest available dataset highlights relative safety of Lucentis (ranibizumab) compared to unlicensed intravitreal Avastin (bevacizumab). Press release, 4 May 2011. www.novartis.com/newsroom/ media-releases/en/2011/1512519.shtml.
13. Pollack A. A rule on eye treatment is likely to cost millions. New York Times 2009 Oct 1 www.nytimes.com/2009/10/02/business/02avastin.html.
14. Aron I. Avastin/Lucentis Update 33: the wording of the CMS order for repricing of Avastin. 2009. http://irvaronsjournal.blogspot.com/2009/11/ avastinlucentis-update-33-wording-of.html.
15. Foote SB, Wholey D, Rockwood T, Halpern R. Resolving the tug-of-war between Medicare's national and local coverage. Health Aff 2004;23:108-23. (Pubitemid 38952391)
16. Roche. Finance report 2010. www.roche.com/investors/annual-reports.htm.
17. Clement FM, Harris A, Li JJ, Yong K, Lee KM, Manns BJ. Using effectiveness and cost-effectiveness to make drug coverage decisions. JAMA 2009;302:1437-43.
18. Levy AR, Mitton C, Johnston KM, Harrigan B, Briggs AH. International comparison of comparative effectiveness research in five jurisdictions: insights for the US. Pharmacoeconomics 2010;28:813-30.
19. National Institute for Health and Clinical Excellence. Exploratory work of bevacizumab in eye conditions. 2010. www.nice.org.uk/ourguidance/ niceguidancebytype/technologyappraisals/proposedappraisals/ bevacizumabineyeconditions.jsp.
20. Novartis takes legal action over trusts' advice to use bevacizumab for wet AMD. BMJ 2012;344:e2959
21. Pollack A. Doctors grow wary of Avastin for eye treatment. New York Times 2011 Oct 4. http://prescriptions.blogs.nytimes.com/2011/10/04/doctors-grow- wary-of-avastin-for-eyetreatment/.
22. Pollack A. Genentech offers secret rebates for eye drug New York Times 2010 Nov 3. www.nytimes.com/2010/11/04/business/04eye.html?pagewanted=all.