Benefits Plans - Prescription Drug Plan: Drug Plan Updates and New Drug Releases -
Elidel® and Protpic®

Page last updated: Wednesday, 26-May-2010 20:51:22 EDT

Recently the FDA’s Pediatric Advisory Committee met to discuss the level of adverse events and malignancies reported with the use of Novartis’ Elidel® and Fujisawa’s Protopic®. According to the FDA neither agent is genotoxic and do not interact directly with DNA, however, they may have a potential to impair local immune system function. A data summary of the cancer related adverse events reported can be found at:

For Elidel® http://www.fda.gov/cder/drug/infopage/elidel/default.htm
For Protopic® http://www.fda.gov/cder/drug/infopage/protopic/default.htm

The FDA Pediatric Advisory Committee recommendations to the FDA were to implement a “Black Box” warning and patient medication guide for both agents.

Both agents are approved for second-line use in atopic dermatitis in patients two years of age and older in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.

Effective 4-1-2005, the University of Michigan Prescription Plan will not cover Elidel® or Protopic® for children under the age of 2 years.

Limitations
The University of Michigan in its sole discretion may modify, amend, or terminate the benefits provided with respect to any individual receiving benefits, including active employees, retirees, and their dependents. Although the university has elected to provide these benefits this year, no individual has a vested right to any of the benefits provided. Nothing in these materials gives any individual the right to continued benefits beyond the time the university modifies, amends, or terminates the benefit. Anyone seeking or accepting any of the benefits provided will be deemed to have accepted the terms of the benefits programs and the university's right to modify, amend or terminate them.