The drug was approved for use in Europe in July last year as the region’s first treatment specifically designed to prevent migraine.
The monoclonal antibody offers patients a novel therapeutic approach as the first to block the calcitonin gene-related peptide receptor (CGRP-R), which is thought to play a critical role in migraine.
Its mode of action differs from other similar migraine therapies in development, which target CGRP itself as opposed to the receptor pathway.
The rejection comes despite a Phase IIIb LIBERTY trial, which assessed Aimovig in episodic migraine patients who had previously tried two to four therapies without success, showing that patients taking the drug had almost three-fold higher odds of having their migraine days cut by half or more compared to placebo, with more than twice as many patients taking Aimovig achieving this reduction (30.3 percent versus 13.7 percent, respectively).
However, NICE’s committee felt the trial evidence « doesn’t fully reflect patients seen in clinical practice in the NHS and nor does it include all the relevant comparators and outcomes ». Because of this, cost-effectiveness estimates for the drug are higher than what is normally considered to be acceptable when there is substantial uncertainty, it said…