Biotechnology Healthcare - November/December 2008 - (Page T3) TABLE Impact of dose escalation with TNF inhibitor therapy on rheumatoid arthritis (RA) costs Etanercept-treated patients Study Gilbert 2004 Percentage of affected patients (ratio) Mean annual RA-related drug costs per patient Mean annual RA-related health care costs per patient Ollendorf 2005 Percentage of affected patients (ratio) Mean annual RA-related drug costs per patient Mean annual RA-related health care costs per patient 38 percent (474/1236) $10,916 $14,425 62 percent (762/1236) $17,760 $22,283 n/a 63 percent 54 percent 82 percent (778/950) $11,307 $13,865 18 percent (172/950) $11,830 $14,482 n/a 4.6 percent 4.5 percent 42 percent (252/598) $11,224 $16,713 58 percent (346/598) $17,148 $22,283 n/a 52.8 percent 25 percent No dose escalation Dose escalation* % difference Infliximab-treated patients No dose escalation Dose escalation* % difference * Dose escalation with infliximab was defined as at least 1 or 2 occurrences [1 or more by Gilbert 2004 and 2 or more by Ollendorf 2005] per patient of an increase in the number of vials used for the initial maintenance dose, or 2 or more occurrences of infusions with an interval of fewer than 49 days; dose increase for etanercept was defined as 2 or more prescriptions per patient with the average daily dose exceeding the initial maintenance dose. SOURCES: GILBERT 2004, OLLENDORF 2005 associated with insignificant changes in the actual dose, whereas increases from baseline in the infliximab dose ranged from 29 percent to 43 percent. However, these estimates do not reflect dosing fluctuations that occurred during the entire treatment period, limiting their utility from a cost analysis perspective. A claims analysis of 4,426 members of a large health plan showed that the mean weekly dose of etanercept remained stable at 50 mg to 52 mg (Etemad 2005). In con- About the Author Joseph Flood, MD, FACR, is a clinical rheumatologist and educator with more than 20 years of experience in musculoskeletal medicine. He is president of Musculoskeletal Medical Specialists Inc., and is a member of the clinical faculty of The Ohio State University College of Medicine and Public Health in Columbus. Flood teaches medical students in Joseph Flood, MD, all four years of the medical school FACR curriculum at OSU. He is a fellow of the American College of Rheumatology, board certified in Internal Medicine and Rheumatology, and a Certified Clinical Densitometrist. trast, the average dose of infliximab was increased with each subsequent administration, from 282 mg with the first infusion to 383 mg with the eighth infusion. The benefit of this method is that it analyzed dosing patterns over the entire course of treatment. A comparison of the dosing patterns of adalimumab and etanercept was presented at the 2007 meeting of the International Society for Pharmacoeconomics and Outcomes Research. Recognizing that dosing patterns can be characterized along multiple dimensions, Gu (2007) used several methods to measure dose elevation. For example, based on the analysis of pharmacy claims for 1,830 patients, the investigators found that treatment was initiated at a higher-than-standard dose (etanercept 50 mg once weekly, adalimumab 40 mg every other week) in 11.9 percent of adalimumab patients versus 2.8 percent of etanercept patients (P<.001). Further, across the entire 12month treatment period, the average weekly doses of etanercept and adalimumab were above the standard recommended dose in 10.3 percent and 33.6 percent of patients, respectively. Although these examples do not capture all of the dimensions that have been discussed, they reinforce the importance of understanding the initial dose as well as analyzing dosing patterns over the entire course of treatment. 3
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