USP CEO SAYS FORMULARY GUIDELINES REPRESENT COMPROMISE
The final model guidelines for Medicare drug formularies represent a practical compromise that is focused on the needs of patients and practitioners, according to the head of U.S. Pharmacopeia (USP), which recently released the guidelines.
"It has a flexibility that can be used by drug plans as they craft their benefit, yet it also acknowledges the need for some very important new drugs and drugs that have been available for many years ... that are very important to patient care," said Roger Williams, executive vice president and CEO of USP.
The USP final model guidelines maintain the 146 therapeutic categories and classes that were found in the draft guidance released in August 2004. These groupings must have at least two drugs each.
The final model guidelines, however, scrapped the draft's recommended 235 subcategories -- which would have required at least one drug each -- and replaced it with a separate listing of "formulary key drug types." This drug listing is not required for plans that use the model guidelines, but USP said the Centers for Medicare & Medicaid Services could use it as a guide in evaluating formularies.
Williams said in a recent media briefing that the goal was to provide categories and classes that are flexible enough for drug plan sponsors to actually use them. Williams also said USP recognized four main parties with interests in the model guidelines: drug plans, drug manufacturers, practitioners and patients.