HUMIRA NOW LICENSED FOR POSTERIOR UVEITIS

BUS learned this week that AbbVie, the manufacturer of Humira (adalimumab), has received approval from the European Medicines Agency for an extension of its marketing authorisation for Humira to treat certain forms of non-infectious uveitis. This means that in Europe, including the UK, and also in the US, “Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.”

AbbVie’s press release is attached here.

The updated ‘Summary of Product Characteristics’ (SPC) – the official product data sheet for Humira – can be found here: https://www.medicines.org.uk/emc/medicine/31860

The patient information leaflet for the Humira pen can be found here: PIL Humira July 2016

NICE MULTIPLE TECHNOLOGY APPRAISAL

BUS has also been invited to participate in the NICE Multiple Technology Appraisal which is looking at Ozurdex (dexamethasone) intravitreal implant and Humira (adalimumab) injection with a view to getting NHS funding approved for them to be prescribed for non-infectious posterior uveitis. We are currently preparing our ‘patient organisation statement’ to submit to NICE in August.  We have also nominated a number of ‘patient experts’ and a ‘consultant expert’ and we hope that one or two of them may be invited to put the patient’s viewpoint across at the Appraisal Meeting in February 2017.

We would like to thank those members who took part in our short survey last year about Humira and Ozurdex.  The anonymised information from these questionnaires has been very helpful in preparing BUS’s ‘organisation statement’.

Watch this space as this story unfolds.

POSSIBLE FORTHCOMING HUMIRA TRIAL

BUS is also trying to help get a trial under way to provide the practical evidence that Humira (adalimumab) can work for certain hard-to-treat cases of Birdshot as well as for other complicated, rare forms of autoimmune posterior uveitis.   Our team of experts led by Professor Andrew Dick, Ms Srilakshmi Sharma and Mr Alastair Denniston hope to put in an application in September to the National Institute for Health Research (NIHR) for possible funding, and we will know if we are successful by early next year.  We are all aware we need to provide as strong evidence as possible and in particular to show which groups of patients are best treated or will best benefit from treatment in order to convince NICE and commissioners to support use of expensive treatments for other conditions. The Birdshot team is going to give this its best shot, and we will keep you posted.