RESULTS:THE P&T COUNCIL’S FORMULARY DECISION
After examining the available data, the Department of Defense Pharmacy and Therapeutics Executive Council (DoD P&T Council), in a meeting held on August 7, 2002, voted to add meloxicam canadian to the formulary but emphasized that it should be used only after a traditional nonselective NSAID has been unsuccessful. The Council acknowledged that although meloxicam was associated with fewer serious GI events than the less COX-2-selective NSAIDs were, its use in patients who are at low risk of GI ADEs is inappropriate.
Although the Council members were convinced that the evidence for a GI-sparing effect with rofecoxib was strong, they did not add it to the formulary because of its cost and because of concerns about its cardiovascular safety. However, the Council agreed that the evidence showing a reduction in the incidence of complicated upper GI events, compared with non-selective NSAIDs, was most conclusive with rofecoxib.
After analyzing the GI safety data, the Council concurred (1) that meloxicam were similar in terms of their GI-sparing effects and (2) that although available whole-blood assay and endoscopic erosion data showed valdecoxib to be highly COX-2-selective, further studies are needed. Because of the insufficient data concerning the clinical utility and GI-sparing effect of etodolac, the Council decided not to add it to the formulary despite its cost advantages.
The algorithm in its present form was presented to the DoD pharmacoeconomic committee in San Antonio, Texas, in August 2002. The DoD specifically requested the algorithm for its review and positioned to follow generic NSAIDs.
Several hospitals and clinics in the federal system have already altered their formularies based on this analysis, including Tri-care 11 (Northwest Military Region), Madigan Army Medical Center, Nellis Air Force Base Medical Center, Tripler Army Medical Center, and William Beaumont Army Medical Center.
The VA pharmacy benefit management is using the algorithm format with the GI SCORE, as developed three to four years ago, to include celecoxib canadian and rofecoxib. Algorithms are now in place at various Veterans Integrated Service Networks (VISNs) throughout the U.S. These include VISNs 1, 2, 4, 18, and 22, which have implemented algorithms similar to the one described here. VISNs are regional VA formularies that encompass multiple VA hospitals and clinics within a region of the U.S.
When used for the appropriate patients, COX-1-sparing agents reduce the risk of the most common complication of NSAID therapy (GI bleeding), with potential savings of millions of dollars for acute hospitalization and management. Models that can help to estimate the risks of serious GI complications related to NSAID therapy are now available. By stratifying patients according to their risk of GI bleeding, P&T committees will be able to compare the costs of more expensive medications versus the costs of treating complications that arise when the therapy is not utilized. When drug costs are taken into account, a “cut-off point for the price of these more expensive and safer medications can be determined, and an algorithm can be developed to guide the use of these drugs. Such algorithms are presently being implemented in the regional VA formularies throughout the U.S. in efforts to control costs and to improve the quality of care.
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The advent of COX-1-sparing drugs has revolutionized the way in which physicians treat osteoarthritis and rheumatoid arthritis. Because of their significant costs, however, careful use of these medications is essential.