Amcp dossier9/19/2023 ![]() ![]() The Format asks manufacturers to use a validated set of established questions, known as the SF 36, to measure quality of life, according to Tom Johnson, director of clinical pharmacy at WELLPOINT Health Networks. "When we reviewed Thalmid for formulary inclusion, we asked, Will this drug have a big budgetary impact as a treatment for leprosy?'" Fortunately for the manufacturer, the formulary submission also bore out the fact that thalidomide is useful for treatment of multiple myeloma. Once notorious for causing birth defects, thalidomide is now available for the treatment of leprosy. ARBs are more expensive than the old ACE inhibitors, but are beneficial to some patients who develop a slight cough on the latter drug, he said.Īnother example is Thalmid, generically called thalidomide. For example, submissions in regards to new angiotensin reception blockers (ARBs) have been helpful. "We like to ask them, How do you feel your product is going to fit in? Is it going to replace an existing therapy?'" Voytovich continued. Voytovich said NPA has been receiving cooperation in 30 to 40 percent of the formulary submissions it receives. "We haven't actually adopted the Format in whole, but we've been asking for some of the components of it," said Bob Voytovich, senior vice president for professional services. We want to know whether patients can walk farther, use their medicine less and sleep better at night."īenefits managers such as PBM National Prescription Administrators use the Format in conjunction with disease management programs to better help beneficiaries and save system costs. "For example, when manufacturers report results of an asthma medication, they may report very small changes in breathing tests. "We like them to measure patient quality-of-life before and after therapy," he said. One measure of drug effects addressed by AMCP's format is patient satisfaction, according to Marc Mora, MD, chairman of the P&T Committee at Group Health. For a new asthma drug, is there any change in how often patients had to go to the ER, any change in the quality of life and any reduction in overall health costs?" "It's nice that such and such a drug increases lung volume, but what we really want to know is about "The FDA only requires evidence of efficacy, which means placebo-controlled trials," he explained. Pete Fullerton, associate vice president for pharmacy at Regence, said the dossier asks for information considerably beyond what would be included in an FDA study. The Regence method of requesting a complete dossier of specific drug information became the basis for the AMCP Format itself. The Format began to emerge when a number of payers on the West coast, such as Regence Blue Shield and Group Health Cooperative of Puget Sound, began using evidence-based medicine to determine how manufacturers' claims of new value for increased drug prices really stacked up. ![]() Analysts say compiling the dossier can require an expensive amount of work, but some health plans are playing hardball in demanding it from drug manufacturers. ![]() The AMCP Format asks drug manufacturers to submit a comprehensive dossier of information on each new drug submission a manufacturer makes to a health plan's formulary. ![]() Since it was issued about a year ago, the Format has been quickly adopted by pharmacy benefit managers and health plans, who use it to better assess the costs and benefits of adding new drugs to formularieslists of prescription drugs covered under a pharmacy benefit plan. Health plans demand more information to gauge real value of new pharmaceuticalsĮmployers may benefit from more cost-effective drug coverage decisions by their health plans as a result of growing acceptance of the Academy for Managed Care Pharmacy Format for Formulary Submissions (AMCP Format). A new format for making more cost-effective drug coverage decisions takes off ![]()
0 Comments
Leave a Reply.AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |