Alert - UpdatesPlus-IBD: NICE draft guidance recommending against NHS reimbursement of TNF inhibitors use in ulcerative colitis highlights the case for price reductions or tailored dosing

NICE issues draft guidance recommending against NHS reimbursement of Remicade, Simponi and Humira for patients with ulcerative colitis [link]

• NICE has concluded that none of the TNFis currently approved for ulcerative colitis have been proven to be more cost effective than currently available treatments including corticosteroids and mercaptopurine or azathioprine

• Of interest it was concluded that network meta-analysis did not allow a conclusion to be drawn on the relative effectiveness of the 3 TNF products under evaluation

• The draft guidance has been issued despite NICE acceptance that both disease symptoms and the AEs of steroid treatment significantly diminish QoL, and that TNFis may offer long term remission or at least a bridge to eventual surgery

• Two clinical issues that may have influenced NICE's decision were the lack of rigid guidance on treatment discontinuation in cases of modest responses and of predictors of responsiveness

• The preliminary recommendations are now available for public consultation until Oct 15. Comments received during this consultation will be considered when producing the final guidance, expected in Jan 2015

Comments:  NICE's draft guidance underlines the need for individualized therapy, including greater clinical guidance on when/how to stop or intensify treatment in cases of failure to respond or when a response is achieved.  As highlighted in our previous issue of UpdatesPlus-IBD, Abbvie is investigating a tailored therapy approach although data will not be available until around 2016.  Also of note is a UK post-marketing study opened by Merck earlier this year.  This will allow an analysis of efficacy and healthcare costs associated with Simponi however it seems unlikely that data will be available in time for the final NICE guidance.  Taking these points into consideration, the arrival of biosimilar infliximab in the UK, possibly as soon as next year could be a landmark moment for UK ulcerative colitis patients.  In the next issue of UpdatesPlus-IBD we will look at the guidance in greater detail and attempts to model the price reduction that biosimilar companies may need to target.  In addition we will consider the potential impact of the draft guidance on discounting to the NHS.  Likewise, we will be seeking further clarity at the upcoming European Gastroenterology Week on the potential impact of NICE guidance.  Each of these issues are important from both the point of view of pharma revenues and public health expenditure of the NHS.  It is estimated that 25,000 ulcerative colitis patients are living with severe disease within the NHS.  Of these approximately 50% will have one relapse/year (NICE figures), therefore costing the NHS upwards of £0.4B ($0.65B) each year (based on the an induction therapy cost with Remicade of £5035 and monthly maintenance therapy costs of £839.24*)

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*Note that this figure is being verified as it is higher than calculated by NICE