Massachusetts Medicaid Adds Prior Authorization For Elidel, Protopic
This article was originally published in The Pink Sheet Daily
State’s decision to require prior authorization for Novartis’ Elidel and Astellas’ Protopic comes several months after FDA requested that labeling for the topical eczema agents include a “black box” warning for potential cancer risk. MassHealth removes prior authorization requirement for Berlex’ estrogen patch Menostar.
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Novartis expects labeling negotiations will begin within the next few weeks and says a "black box" is unjustified. A medication guide will also be required for the eczema treatments, FDA says.
Although noting that data suggesting a cancer risk from the topical eczema treatments is not definitive, the panel concludes that a black box warning is the best approach to discourage off-label use. A medication guide should also be mandated, the committee says.
Low estrogen dose reduces need for concomitant progestin therapy in women who have a uterus. Berlex will study longer-term use following June 8 FDA approval.