I am pleased to report that, following an appeal process to the National Institute of Health and Clinical Excellence (NICE) back in November, when I represented the British Society for Surgery of the Hand, our appeal has been partially upheld in two main areas.
What this means for a patient is that, at present, there is no restriction on the use of Xiapex in an appropriate clinical setting both in the NHS or private sector.
We will keep you updated on this website as eventually fall over the next a few months.
Here is a recent communication from SOBI, the distributor of Xiapex in Europe.
“I am writing to update you about the ongoing National Institute of Health and Clinical Excellence (NICE) evaluation of Xiapex (collagenase clostridium histolyticum, CCH). Xiapex is indicated for the treatment of Dupuytren’s contracture (DC) in adult patients with a palpable cord.
The original NICE decision was appealed at a hearing on 30th November 2015 and representatives of Sobi, the British Dupuytren’s Society (BDS) and members of the BSSH independently made their separate cases that Xiapex should be allowed to be used to treat Dupuytren’s contracture on the NHS.
The Appeal Panel announced on June 27th 2016 that the existing NICE Final Appraisal Determination (FAD) was unreasonable, and have referred the matter back to the Appraisal Committee for reconsideration.
The Appeal Panel upheld two out of four appeal points:
· It was unreasonable for the Appraisal Committee not to reach a conclusion on the use of CCH (either to recommend or not recommend CCH) for the sub-group of patients for whom percutaneous needle fasciotomy (PNF) was not clinically appropriate.
· It was unreasonable for the Appraisal Committee to use a cost of £225 for PNF.
The Appeal Panel did not uphold the following points:
. That NICE had failed to make sufficient allowance for the innovative nature of Xiapex
. That PNF was not an appropriate comparator against Xiapex
NICE are assessing the work necessary to move forward with this appraisal, and will schedule a further committee discussion. Stakeholders will be informed of the details in due course.
This appeal decision means that there are currently no restrictions in place preventing the appropriate clinical use of Xiapex meaning your patients may still receive Xiapex as a treatment option where indicated.
The Appeal Panel’s decision can be viewed on the NICE website at:
https://www.nice.org.uk/guidance/indevelopment/gid-tag364
We hope that this decision and the subsequent reanalysis that will be performed by the committee will lead to a positive recommendation for Xiapex. As soon as I have any further details I will, of course, write to you. However, what this means is that you can continue using Xiapex, and the NHS should continue to pay for that therapy, until further notice.
Sobi have prepared a business case to show how using Xiapex will save money in any individual case compared to limited fasciectomy or dermofasciectomy, and is comparable in cost to needle fasciotomy. This business case can be individually tailored to your own Trust, based on local population demographics. If you would like to receive a visit from your local Key Account Manager to discuss this in more detail, please contact my office at the phone number, email address or postal address given at the foot of this communication.
Yours sincerely,
Mark Bell, Business Unit Director, Sobi UK”