HEDS is part of the School of Health and Related Research (ScHARR) at the University of Sheffield. We undertake research, teaching, training and consultancy on all aspects of health related decision science, with a particular emphasis on health economics, HTA and evidence synthesis.

Thursday, 16 October 2014

NICE ACD on ulcerative colitis (and biosimilars)

The NICE says in draft guidance that infliximab, adalimumab and golimumab is not recommended for the treatment of moderate to severe ulcerative colitis.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “The independent committee concluded that there is currently not enough evidence to prove that infliximab, adalimumab and golimumab is clinically and cost effective compared with other treatments currently available to ulcerative colitis patients on the NHS.

“NICE has now opened a consultation on the draft guideline for infliximab, adalimumab and golimumab, and welcomes the manufacturer and stakeholders to comment on the recommendations and if possible provide more information which could potentially enable NICE to make more positive recommendations.”

The Evidence Review Group (ERG) for this was ScHARR-TAG, and being a multiple technology appraisal (MTA), it required a model to be produced by the ERG.  The team was Rachel Archer, Paul Tappenden, Kate (Shijie) Ren, Marrissa Martyn-St James, Rebecca Harvey, Hasan Basarir, John Stevens, Chris Carroll and Anna Cantrell.

Also of note, is that this is one of the first appraisals that considered biosimilars as comparators.  The Committee noted that:

“The European Public Assessment Reports (EPARs) for Inflectra and Remsima acknowledged that the pharmacokinetics, efficacy, safety, and immunogenicity profiles of CT-P13 were similar to those of Remicade in PLANET-AS and PLANET-RA. Although neither of the trials was for ulcerative colitis, the EPAR states that the totality of the data comparing CT-P13 with Remicade allows for the extrapolation of the evidence generated by PLANET-AS and PLANET-RA to all other indications of Remicade.”


“The Committee discussed whether using biosimilar versions of infliximab could improve the cost effectiveness of TNF-alpha inhibitors. Because there was no approved list price in the UK for biosimilars, the Committee was not presented with any evidence on the cost effectiveness of biosimilars. The Committee was therefore unable to make any recommendations on the use of biosimilars.”

Manufacturers of biosimilars, take note!