9 May 2016 - Final draft guidance not in accordance with HTA agencies in France & Australia.
NICE is now backing the use of AbbVie’s Humira on the National Health Service (NHS) in England and Wales as the first approved treatment for the skin condition hidradenitis suppurativa.
The agency has published final draft guidance recommending use of adalimumab as per its marketing authorisation - i.e. the treatment of active moderate to severe forms of the condition in adults with an inadequate response to conventional systemic therapy.
Earlier this year, the Institute said it was minded not to recommend adalimumab, because of uncertainties thrown up by the data provided, and thus asked AbbVie to provide more information - including a meta-analysis of the PIONEER I and II trials and revised base-case analyses - to help it better determine Humira’s cost-effectiveness and potential use by the NHS.
The reimbursement of adalimumab for use by patients with hidradenitis suppurativa was rejected by the Transparency Commission in France and by the PBAC in Australia in March this year.
For more details, go to: http://www.pharmatimes.com/Article/16-05-09/NICE_backs_use_of_AbbVie_s_Humira_for_hidradenitis_suppurativa.aspx
View MAESTrO entries for adalimumab for hidradenitis suppurativa