Biotechnology Healthcare - July/August 2008 - (Page 43)

Despite disagreement over the benefits of biosimilars, legislators and regulators outside the United States are supporting their development. In 2004, the FDA’s European counterpart, the European Medicines Agency, established regulations governing the development of biosimilars and, in April 2006, approved somatropin (Omnitrope), a biosimilar version of genotropin, a growth hormone (Pavlovic 2008). The U.S. Food and Drug Administration approved the drug the following month, despite lack of a regulatory pathway for biopharmaceuticals in the United States. Since then, legislative proposals have been initiated in Congress to expedite the approval process for biosimilar drugs and to give approval authority to the FDA, but legislation has stalled. short-term direct costs (i.e., prescription medications, physician visits, and hospitalizations). In addition to improving employee health, those individuals and organizations that make decisions regarding employee health benefits from an investment perspective will have a competitive edge compared with those who do not use the full-cost view. More research is needed on the impact of RA on work-related productivity losses and employers’ other indirect costs. Employers tend to be wary of sharing employee productivity data with researchers or allowing their employees to participate in such studies. However, employers seeking to understand and minimize bottomline effects of health conditions in their workforces could benefit from collaboration with researchers. SUMMARY Despite groundbreaking advances in pharmacologic treatments for RA, particularly from the biotech industry, major net economic benefits from the use of biologics remain to be seen by payers, employers, and society. The business world, including the biotech industry, is aware that ROI usually does not occur overnight, and, in the case of RA, it may take many years to document that return. More than any other group, human resource managers should understand that an organization’s biggest asset is its employees. Employees who suffer with RA significantly affect an organization’s bottom line, whether an employer realizes it or not. With the help of proper tools, employers are beginning to see the big picture on costly health interventions from an ROI or a full-cost viewpoint. Considering only the costs of various treatment options for coverage decisions is not in the best interest of either employers or third-party payers, both of which tend to focus heavily on REFERENCES Allaire SH, Anderson JJ, Meenan RF. Reducing work disability associated with rheumatoid arthritis: identification of additional risk factors and persons likely to benefit from intervention. Arthritis Care Res. 1996;9: 349–357. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum. 2002; 46:328–346. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER study: a multicenter, randomized, doubleblind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54:26–37. Bresnihan B. Anakinra as a new therapeutic option in rheumatoid arthritis: clinical results and perspectives. Clin Exp Rheumatol. 2002;20(5 suppl 27):S32–S34. Bresnihan B, Cobby M. Clinical and radiological effects of anakinra in patients with rheumatoid arthritis. Rheumatology (Oxford). 2003;42 (suppl 2):ii22–28. Burton W, Morrison A, Maclean R, Ruderman E. Systematic review of studies of productivity loss due to rheumatoid arthritis. Occup Med (Lond). 2006;56:18–27. Chorus AM, Miedema HS, Wevers CW, van der Linden S. Work factors and behavioural coping in relation to withdrawal from the labour force in patients with rheumatoid arthritis. Ann Rheum Dis. 2001;60:1025–1032. Clarke AE, Zowall H, Levinton C, et al. Direct and indirect medical costs incurred by Canadian patients with rheumatoid arthritis: a 12 year study. J Rheumatol. 1997;24:1051–1060. Cooper NJ. Economic burden of rheumatoid arthritis: a systematic review. Rheumatology (Oxford). 2000;39: 28–33. CVS Caremark. TrendsRx Report 2007. «https://www.caremark.com/portal/ asset/TrendsRxReport_07.pdf». Accessed July 16, 2008. de Croon EM, Sluiter JK, Nijssen TF, et al. Predictive factors of work disability in rheumatoid arthritis: a systematic literature review. Ann Rheum Dis. 2004;63:1362–1367. De Roos AJ, Callahan LF. Differences by sex in correlates of work status in rheumatoid arthritis patients. Arthritis Care Res. 1999;12:381–391. Doeglas D, Suurmeijer T, Krol B, et al. Work disability in early rheumatoid arthritis. Ann Rheum Dis. 1995;54: 455–460. Engel & Novitt LLP. Potential savings that might be realized by the Medicare program from enactment of legislation such as the Access To LifeSaving Medicine Act (H.R. 6257/ S. 4016) that establishes a new cBLA pathway for follow-on biologics. Jan. 2007. «http://www.pcmanet.org/ assets/2008-03-24_Asset_EN%20 Paper%20on%20Follow-on%20 Biologics%20Jan.%202007.pdf». Accessed July 16, 2008. Fautrel B, Guillemin F. Cost of illness studies in rheumatic diseases. Curr Opin Rheumatol. 2002;14:121–126. Genazzani AA, Biggio G, Caputi AP, et al. Biosimilar drugs: concerns and opportunities. BioDrugs. 2007; 21:351–356. Hallert E, Husberg M, Jonsson D, Skogh T. Rheumatoid arthritis is already expensive during the first year of the disease (the Swedish TIRA project). Rheumatology (Oxford). 2004;43: 1374–1382. Holte HH, Tambs K, Bjerkedal T. Becoming a disability pensioner with rheumatoid arthritis in Norway 1971–1990. J Rheumatol. 2001;28: 54–61. IBI (Integrated Benefits Institute). The business case for managing health and productivity: Results from IBI’s JULY/AUGUST 2008 · BIOTECHNOLOGY HEALTHCARE 43 https://www.caremark.com/portal/asset/TrendsRxReport_07.pdf https://www.caremark.com/portal/asset/TrendsRxReport_07.pdf http://www.pcmanet.org/assets/2008-03-24_Asset_EN%20Paper%20on%20Follow-on%20Biologics%20Jan.%202007.pdf http://www.pcmanet.org/assets/2008-03-24_Asset_EN%20Paper%20on%20Follow-on%20Biologics%20Jan.%202007.pdf http://www.pcmanet.org/assets/2008-03-24_Asset_EN%20Paper%20on%20Follow-on%20Biologics%20Jan.%202007.pdf http://www.pcmanet.org/assets/2008-03-24_Asset_EN%20Paper%20on%20Follow-on%20Biologics%20Jan.%202007.pdf

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - July/August 2008

Biotechnology Healthcare - July/August 2008 Openers Contents Editorial/David B. Nash, MD, MBA Drug Track Health Plan Confidential Rheumatoid Arthritis A Decade of Trial, Error, False Starts, and Hope What Path Will Comparative Effectiveness Research Take? RA Therapies in Development: A New Generation of Relief Assessing the Full Impact of RA on Employers and Payers Stem Cells: Health Insurance You Can Bank On Specialty Pharmacy Employer to Employer Personalized Medicine Trends Clinical Briefs

Biotechnology Healthcare - July/August 2008

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