12 November 2018 - Record number of consumer comments; place in clinical therapy unclear.

The publication of the Public Summary Document for the initial submission for erenumab (Aimovig) has revealed the following insights:

• The PBAC noted and welcomed the input from 1,886 individuals, 24 health care professionals, and 3 organisations via the Consumer Comments facility on the PBS website.  This is highest number of comments provided by individuals for a given submission to date; the previous highest number was 1,087 for the initial submission for nusinersen sodium (Spinraza). More on this in a later issue of MAESTrO Daily.
  
• "The submission placed erenumab as a later-line therapy in Botox naïve patients following failure of at least three prophylactic agents. The PBAC considered that the clinical place in therapy of erenumab is unclear, but considered that there was no demonstration that prior treatment for chronic migraine modifies treatment effect. As such, the PBAC considered that there was no justification for excluding patients who had previously been treated with Botox, as this patient population may benefit from treatment as shown in clinical trials, but agreed that concomitant use of erenumab and Botox should not be permitted."

There is considerable public interest in the listing of erenumab on the PBS; Novartis and the PBAC have some work to do.