Biotechnology Healthcare - November/December 2008 - (Page T4) Managed Care Considerations: By Douglas S. Burgoyne, PharmD President, Scrip World, Salt Lake City, Utah reimbursement accounts, and umor necrosis factor (TNF) health savings accounts. But beinhibitors have significantly affected the care of members yond the price of the drug itself, the dose and dosing regimen of with rheumatoid arthritis. Their the medication has the greatest role as effective therapies in the impact on the overall cost course of this disease is of an individual’s drug well established, and therapy. I think it can be agreed Dose escalation is a comupon that they provide mon practice in our society. tangible benefit to our The mentality exists that “if member populations. one is good then two must The cost associated with be better.“ This is not alTNF inhibitors has always been of major concern for Douglas S. Burgoyne, ways the case in drug PharmD therapy management and managed care organizamay have an unintended tions. This issue now is beeffect in terms of cost-effectivecoming more of a physician and ness — two might just cost more member concern, as more and without incremental benefit. more expenses are now borne by members in the world of highThis may indeed be the case in deductible health plans, health RA treatment. Increasing the dose T of a TNF inhibitor may not provide greater therapeutic benefits for all members, and only increase the cost of the treatment. We must be aware of the cost of dosing fluctuations, and take these costs into account when reviewing TNF Inhibitors for formulary placement. As stewards of medical and pharmacy budgets for our customers, managed care decision makers must take dosing and the total cost of therapy into account when evaluating drug regimens. A simple review of cost based on initial dosing or any one-time change in dose is insufficient — we must carefully consider dose escalation and fluctuation over time to determine the true of cost of these medications. Economic impact Several approaches have been used to explore the relationship between dose escalation and treatment costs in RA patients treated with the TNF inhibitors (Etemad 2005, Gilbert 2004, Ollendorf 2005). Etemad (2005) showed that the average ending dose of etanercept did not increase from the baseline dose of 51.3 mg, and the annual cost of therapy remained stable at $17,818. In contrast, the average dose of infliximab increased from 280 mg at the start of treatment to 360 mg at the end of the study period. Although this finding by itself does not reveal the incremental cost impact, the authors did report that this 28.6 percent change in infliximab dose resulted in a 31 percent rise in the annual treatment cost (from $17,799 to $23,332). In two analyses of large claims databases, RA-related costs were stratified by the presence of dose escalation (Gilbert 2004, Ollendorf 2005). Gilbert (2004) compared treatment costs in 1,548 patients treated with etanercept and infliximab during a 12-month follow-up. Ollendorf (2005) evaluated costs in 1,236 patients followed for an average of 15 months after the start of infliximab therapy. Rates of dose escalation reported in these analyses were consistent with overall pooled estimates (Table, page 3). In the Gilbert (2004) study, RA-related drug costs were higher among patients who experienced dose escalation 4 than among those who did not; however, the gap between these groups was substantially greater with infliximab. Namely, in the infliximab cohort, RA-related drug costs were 53 percent higher among patients who experienced some form of dose increase than among their counterparts who did not experience a dose increase. In contrast, in the etanercept cohort, patients who experienced some form of dose increase incurred drug costs that were only 5 percent higher than their counterparts who did not experience an increase. Similar trends were observed with overall RA-related health care costs (Table, page 3). If the entire cohort of infliximab-treated patients described by Gilbert (2004) received a stable dose at the average drug cost seen in infliximab patients without dose escalation, RA drug costs would be reduced by 23 percent. In the etanercept cohort, an analogous assumption would result only in an 0.8 percent savings. Finally, dosing elevations can substantially influence the cost-effectiveness of the TNF inhibitors (Wailoo 2008). A decision-analytic model was developed to inform the Agency of Healthcare Research and Quality and the Centers for Medicare and Medicaid Services of the comparative cost-effectiveness of the TNF inhibitors. The results revealed that if all products were administered consistently according to the standard recommended dosing, the cost-effectiveness of these agents was similar. However,
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