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Executive Summary

Per-patient cost savings of $950 could be realized with Miles' oral quinolone Cipro (ciprofloxacin) when used in lieu of a parenteral antibiotic regimen over a 21-day treatment period, Jerome Schentag, PharmD, SUNY at Buffalo School of Pharmacy, maintained in a March 16 presentation at a Drug Information Association (DIA) conference in Hilton Head, South Carolina. The SUNY researcher described preliminary results from an ongoing study in which hospitalized patients receive I.V. antibiotics on days one through three, with half then randomized either to continue on parenteral medication or to receive Cipro. Schentag noted that the cost saving with Cipro is being achieved without affecting cure rate. "It is a little early to talk about clinical outcome but there is a large body of clinical experience that says these [quinolone] drugs ought to work, but clearly continuing all the way through with I.V. [antibiotics] versus giving three days of I.V. and then on to an oral agent is not showing any marked difference in cure or failure," Schentag said. "We are showing that on a 21-day basis . . . switching saves an average of about $950 per case." Cipro, the second of the fluoroquinolone class to reach the market, cleared FDA in October 1987. The product is indicated for infections of the lower respiratory and urinary tracts as well as those of the skin, bones and joints. Merck's Noroxin (norfloxacin), the first fluoroquinolone, is currently indicated for urinary tract infections only. Schentag's analysis is based on the first 20 out of a total 100 patients to be evaluated. Presently, there are 40 patients enrolled in the trial. Eight of 10 patients who continued on I.V. antibiotics after the third day were cured, Schentag reported, with six receiving an aminoglycoside/beta lactam combo, one a third generation cephalosporin, two vancomycin and one an impipenem. A similar clinical response was reported in the group switched to Cipro, with nine cured. Schentag added that some Cipro patients received other oral antibiotics when needed to fill out the anti-bacterial spectrum. Total costs of the drugs administered included acquisition, preparation and administration, estimated at $3 per I.V. dose, and drug monitoring costs, specifically renal monitoring associated with aminoglycoside use. Drug costs for study days 1-3, i.e. before randomization, were $68.34 per day for both days, Schentag reported. Costs for those continuing on I.V. antibiotics edged down slightly for days 4-21, to $60.65 per day, but dropped to $7.93 a day for those randomized to Cipro. Over the mean 21-day treatment period, total drug costs were $1,269.28 for the group remaining on the I.V. regimen compared to $314.34 for those switched to Cipro, or a net saving of $954.94 per case. "We did not assume anything here about discharging early, although its fair to say that many of these patients were," Schentag remarked. "Hospital costs are not even figured in." Miles' ad campaigns for Cipro maintain the product permits "outpatient treatment of many infections that previously required hospitalization." The real difficulty in increasing Cipro usage, Schentag said, is convincing physicians to switch from a parenteral to an oral regimen after three days. Schentag suggested that the outpatient option with Cipro might work against the product in the minds of some MDs. "The single biggest reason why people will not start a ciprofloxacin protocol is because they want to keep the patient in the hospital," Schentag said. "If you switch over to oral on day three in an institution such as mine, the utilization people are trying to kick that patient out of the hospital." Based on Cipro's cost advantage, the SUNY researcher suggested that Miles could have been more aggressive in its pricing. "The other interesting thing that one might observe is that ciprofloxacin is probably priced wrong," he remarked. Miles "could have charged a lot more for this particular agent." Miles has developed a novel therapy that, in addition to having a broader spectrum than other available oral antibiotics, represents a significant cost advantage over parenteral products while having apparently similar clinical results. "We have studied this drug all the way through, assuming it is a conventional oral antibiotic even though it has a broader spectrum," Schentag noted. "But, all of a sudden you can also take that [drug] and say all right, we will take this into a hospital and see if we can save money there, too." With the maturation of managed health care groups and increased Medicare drug controls, the cost benefit issue has become increasingly important. The trend has spurred interest in a need for developing accurate methods to compare the costs of different drug therapies, the focus of DIA's March 14-16 meeting. One essential component of any cost benefit methodology is the cost of treating side effects associated with a given therapy, conference participants agreed. Thus, the drug with the lowest acquisition price may not necessarily be the most cost effective. An example of side effect cost analysis in the treatment of arthritis with salicylates versus nonsteroidal anti-inflammatory drugs (NSAIDs) was presented by Lewis Kolodny, MD, Franklin Square Hospital, Baltimore, Maryland. Kolodny described a retrospective study of 534 rheumatoid disease patients, most of whom were in the 41-65 age group, that factored in the costs of treating side effects. Of the total patient group, 122 were treated with aspirin, 102 with nonacetylated salicylates, and 310 with nonsalicylate NSAIDs. Average cost of each therapy was $11, $38 and $36 per month, respectively, Kolodny said. "Obviously, if you look at basic cost, aspirin is the cheapest," Kolodny remarked. "However, when you add in extra medication, like antacids or H[2] receptor antagonists, aspirin went up in cost 30%, the nonacetylated salicylates 17%, and the non-salicylate NSAIDs 13%. We found that when we added the costs of treating the gastrointestinal effects outside of the hospital, salicylates were almost $20, the nonacetylated about $44.70, and $41.18 for the NSAIDs, so . . . aspirin still came out ahead." However, the rate of hospitalizations resulting from bleeding gastrointestinal ulcers was more than twice that for patients on salicylates than for those receiving nonsalicylates, according to Kolodny. "We found that in our group of patients, those receiving salicylates [both acetylated and nonacetylated] developed ulcers, 3.6%, those receiving the nonsalicylate NSAIDs at a rate of 1.3%," he noted. As a result of the increased rate of hospitalizations, the average cost for aspirin shot up to $121 per month, compared to $112 per month for the nonsalicylate NSAIDs. Costs associated with nonacetylated salicylates uumped to $394 per month, Kolodny called the figure "somewhat biased" because the group included the drug diflunisol (Dolobid), a drug that does not depend on salicylate for its action. "What we are showing here is that in the real world you must consider the cost of treating side effects," Kolodny remarked. He estimated that it would be possible to save $146 mil. every 30 days in the U.S. if nonsalicylates were used instead of salicylates as first-line therapy. "Whether modifying the NSAID gastropathy, [is best] by modifying therapy with H[2] receptor antagonists, sucralfate, prostaglandin E2 analogs and antacids, remains to be seen."

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