Managed Care - January 2008 - (Page 42) innovative products,” says Neumann. “Me-too is perhaps a misnomer. It implies same-old, same-old. But me-too products can sometimes have important advantages on tolerability or dosing. It could help create more competition and lower the price. If you have five me-toos, possibly the sixth is something that is a little better. That is for the plans to decide on behalf of their patients. And even if it has the same mechanism of action, more competition could help drive down the price of the entire class. That’s an important influence, with potentially an improvement in health from greater access.” Manufacturers can make their case in a standard dossier that the AMCP created in 2000. “Sean Sullivan at the University of Washington and Regence helped in formatting the dossier,” says Cindy Pigg, a Cigna alumni and executive director of the Foundation for Managed Care Pharmacy. “They had started in value decision-making and a group at the academy worked with Sullivan and Regence and other plans on the format.” And they’ve been working on improving the document, coming out with version 2.1. One of the advantages of presenting drug makers with an information request, Pigg says, is that the unsolicited request allows them to pass along off-label information, which the law would otherwise prohibit. Sherman says it’s not enough. “The dossiers are a piece of what goes into this process,” says Sherman. “But it’s just a piece. And quite often, it’s not even all there. Over 20 percent of the dossiers are missing significant scientific data. Some of it is what manufacturers don’t want us to see, some of it is lack of paying attention to detail, sometimes it’s just oversights, despite involving some of the biggest pharmaceutical companies.” Neumann and a group of colleagues that includes Premera’s pharmacy manager John Watkins — another noted player in the drive to use more evidenced-based medicine in formulary decisions — recently audited a collection of drug company dossiers to see just how good their information was. In general, they didn’t find them all that impressive. The less impressive the drug, the less likely it was to get a thorough review. “Our paper suggests that the quality of evidence is not all that good, at least on the economic evidence,” says Neumann. “Breakthrough drugs may have better dossiers than the me-too drugs. Maybe that’s because the stakes are higher. The drug companies want to support a premium price on the breakthrough products. They get more resources internally. More effort goes into them.” Me-too biologics Neumann’s team didn’t separate the biologics from the traditional medications, but the breakthrough category included a number of biotech drugs. They tended to be among new therapies that are making a better case for themselves. “From the biologic company’s standpoint, they’re supporting a high price with a value story,” says Neumann. “And they may have a better story to tell on the clinical data. There’s a large effect in certain populations. They may include a new product in a class, and can have a good clinical story to tell. “The larger plans in particular may be more discriminating and aggressive about looking at the evidence,” adds Neumann. “This AMCP format has been around six or seven years now, and my sense is that people are using it. WellPoint is coming out with new guidelines that will require dossiers to include cost effectiveness information. I think that is certainly going to be interesting to watch. They may emerge as a real leader in this.” Skill required Going beyond the dossiers and into the arena of evaluating peer-reviewed studies is necessary to understand the reliability of the evidence and requires skills in searching and critical appraisal of the literature. For example, Stuart estimates that only about 10 percent of the peer-reviewed studies that appear in the most prestigious journals are clinically useable. “Of 10,000 articles published each week, some are going to be clinically useful but most are not.” The need is for skills and processes to quickly obtain and evaluate the published literature. “The naive user who doesn’t have these skills will type in beta blocker at PubMed and you’ll get more than 7,000 hits and then be overwhelmed at the sheer volume and not know what to do next,” he adds. “But there are very learnable skills that can be utilized to get at the most potentially reliable information and make sense of the science. When you get good at this, you get down to a few things you need to do.” MC 42 MANAGED CARE / JANUARY 2008
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