AMCP launches standardized template to help pharmacists obtain clinical and economic data on new drugs from manufacturers for formulary consideration
If a new drug would cost your health plan millions of dollars, wouldn't you want your P&T committee to have complete, rather than selective, information about the product for informed formulary decision-making?
The answer is obvious, but the reality is that much of the formulary decision-making in this country is based on incomplete informationi.e., only the traditional measures of safety and efficacy are evaluated, not cost-effectiveness.
According to speakers at the recent Academy of Managed Care Pharmacy's annual meeting in Tampa, Fla., many countries, such as Australia, Canada, and some European nations, are way ahead of the United States in terms of eliciting outcome and economic data from manufacturers, in the form of dossiers. The United States is a laggard in comparison.
To help health plan pharmacists in this country obtain both clinical and economic data to support their formulary considerations, AMCP has developed a tool, called the Format for Formulary Submissions. This tool was finalized at AMCP's educational conference in San Diego (Drug Topics, Nov. 20, 2000) and promoted in Tampa last month.
A standardized template, the AMCP Format provides a consistent way for pharmacists to obtain dossiers of information from manufacturers, in lieu of the glossy formulary kits drug companies now give out when launching a drug. Pharmacists can then use these dossiers to compare drugs side by side systematically.
While the Format is available free of charge at www.amcp.org , pharmacists are advised not to pull it from the Web site and use it without prior training, cautioned Steven G. Avey, executive director of the Foundation for Managed Care Pharmacy.
To train pharmacists on the use of this tool, an invitational conference, sponsored by the University of Washington and AMCP, will be held in Vancouver in June. AMCP will follow up that meeting with regional training programs throughout the country in the next six months, Avey told Drug Topics.
Another activity AMCP is engaged in is looking for pharmacies to pilot test the Format. Avey said discussions are under way with some pharmacies, but no facility is under contract yet. Test sites must be willing to accommodate AMCP's efforts to evaluate the Format's effectiveness.
Actually, the AMCP Format builds on guidelines developed by another groupRegence BlueShield of Washington. According to D. S. Pete Fullerton, v.p. for pharmacy service at Regence BlueShield, outcomes analysis is a new science for most pharmacy directors. It was for him, when he first became involved in it in 1998. Regence now requires manufacturers to submit a dossier for each product it considers for placement on its formulary, except in the case of orphan drugs.
Fullerton noted that many manufacturers have hired staffers who are skilled in pharmacoeconomics, so they increasingly have experts who can respond to pharmacists' concerns. He told the audience that they could ask manufacturers for the dossiers they have prepared for Regence.
Drug companies would be happy to provide this information to pharmacists. "You just have to ask them," he said. But, just in case some drug companies don't provide all the information requested, Regence does a Medline search to make sure the information it has is complete, he added.
Prime Therapeutics, a pharmacy benefit manager in Minnesota, is one organization that's planning to use AMCP's Format. "Although we could have developed our own system or used the Regence guidelines, we have chosen the AMCP Format because it enhances the Regence guidelines and should increase acceptance by manufacturers because of the standardization it brings," explained Dell Mather, director of pharmacotherapy assessment and policy there.
Mather said some issues pharmacies should address are, Should dossiers be a request only or a requirement with teeth behind it? Also, should dossiers be demanded only for new molecular entities or for other product introductions as well?
AMCP is hoping its Format will become the industry standard. The bottom line, said Fullerton, is that by following AMCP guidelines, health plans are saying to manufacturers, "Prove your value." And many manufacturers are willing to do just that, he said.
Judy Chi. AMCP positions its new formulary tool as industry standard.