Managed Care - January 2008 - (Page 38) as a simpler dosing schedule or route of administration — only 13 percent offered greater efficacy in combating disease or confronted an unmet medical need. Most of these pharmaceuticals were simply “metoo” drugs, said the Blues plans, offering no added value to members when compared to what was already available. In addition, the trend lines showed a dramatic increase in these therapeutic agents, jumping from 27 percent of the therapies reviewed in their 2004–2005 study. “Even with the biotech drugs, there’s still a lack of innovation,” says Atheer Kaddis, who recently left his post as director of clinical pharmacy services for the Michigan Blues to take up a new post with a specialty pharmaceutical company. “I think a lot of it has to do with just getting a drug on the market,” adds Kaddis. “They’re coming up with new products using the same science that is already understood, going after more indications for an existing drug, as opposed to spending money on R&D on a breakthrough drug, which can be very difficult.” Even when drug developers tout successful trials, they’re often falling far short of the goals Sherman, Kaddis, and other pharmacy directors now expect. For developers, there’s a big attraction in arranging trials that are quick, relatively cheap, and likely to deliver the desired data, says Stuart. Instead of mounting a large, well-designed, well-executed, and well-reported study involving thousands of patients to determine mortality rates for a new ACE inhibitor, he says by way of example, it’s possible to mount a smaller trial that looks at a drug’s ability to lower blood pressure compared to a placebo — an intermediate marker that indicates the drug is doing what it should be doing. However, there’s no evidence of its effect on stroke or death. “Why do we need another drug for lowering blood pressure when we have so many options out there — unless it provides added value?” asks Stuart. “But along comes another drug, there’s a newer study out now, and this one lowers blood pressure, Information on medications too often incomplete Out of 115 dossiers that drug companies submitted to Premera Blue Cross between 2002 and 2005, slightly less than half included economic data. Those with economic data included 106 economic analyses, and the content varied widely. Only 1 in 5 stated all assumptions clearly and fewer than 1 in 10 reported that comparator drugs could be superior, given changes in assumptions. Here is a breakdown on the 106 analyses: Proportion of economic analyses with recommended methods represented in dossiers (2002–2005) Recommended method State the research question State the time horizon for costs and benefits State the primary outcome measure for economic evaluation State the form of economic evaluation used, even if wrong Report all results that are supported by data Report of any sensitivity analysis performed State the rationale behind the choice of comparators Report of the prices of resources and currency State the viewpoint of the analysis Compare all relevant, or at least those most relevant, alternatives Report incremental analysis, even if wrong formulas were used Report the quantity of resources consumed — separate from their costs State all assumptions clearly Report conclusions with appropriate, specific caveats Report productivity changes State that comparators might be superior given changes in assumption Percentage 82 78 77 59 54 43 41 40 38 37 26 21 20 18 13 8 Source: Colmenero F, et al. “Quality of clinical and economic evidence in dossier formulary submissions,” Am J Man Care. 2007: 13(7):401–7. 38 MANAGED CARE / JANUARY 2008
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