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Following a public consultation, NICE has revised its draft recommendation on a treatment for Dupuytren’s contracture – the condition where fingers gradually bend in towards the palm of the hand and cannot be straightened.

The NICE independent Appraisal Committee examined the clinical and cost effectiveness of using collagenase clostridium histolyticum (Xiapex) for treating Dupuytren’s contracture in adults.  The first draft guidance proposed to not recommend collagenase clostridium histolyticum (CCH) for this use. Following the public consultation on the draft recommendation, the committee has taken into account the consultation responses received.  As a result, in the final draftguidance the committee now recommends further research rather than routine use.

This is draft guidance – NICE has not yet issued final guidance to the NHS.

Dupuytren’s disease is a progressive condition which affects fingers and the hand. It occurs when collagen – the fibrous protein in the connective tissue in the hand – thickens to form a small lump, or ‘nodule’.  This collagen nodule may then form cords of tissue, which can contract and pull the finger in towards the palm.  As the disease progresses the fingers can become fixed in a bent position. When the fingers cannot be straightened, the disease is called Dupuytren’s contracture. The condition can limit a person’s ability to use their hand, cause pain and affect routine daily activities.  CCH is given as an injection into the collagen cord. The collagenase enzymes in the treatment break down the collagen fibres which weakens the cords, and then a procedure to extend the finger can be performed.

There were just over 18,000 hospital admissions for Dupuytren’s contracture in England over the year 2012/2013.  Around 2 million people in the UK are thought to have Dupuytren’s disease (but not all will have the contracture), and most don’t seek or need treatment. 

Professor Carole Longson MBE, director of the NICE centre for health technology evaluation, said: “Following the public consultation on the draft guidance, the independent Appraisal Committee received comments from patients and clinicians with the view that collagenase clostridium histolyticum (CCH) is an innovative and effective treatment. Further stakeholder comments called for additional research.

“The committee fully considered these comments along with their previous review of the evidence on CCH, which included evidence on the nature of Dupuytren’s contracture, the views of people with the condition, those who represent them, and clinical experts. The committee understood that the condition can have a significant impact on a person’s life, employment and social activities, and it acknowledged that CCH is the first pharmacological treatment to gain a marketing authorisation for treating Dupuytren’s contracture and that patients are keen to access new treatments.

“Taking the consultation responses into account, the committee concluded that there was promise but still substantial uncertainty about the effectiveness of CCH compared with other treatments. This meant that the Committee could not recommend CCH for routine use of NHS resources. However, it wanted to encourage further research to compare the effectiveness of the treatments for Dupuytren’s contracture. Therefore in this final draft guidance, the committee plans to recommend that CCH is used in the context of research, which we hope will help to clarify potential benefits that this treatment could provide for patients.”

The final draft guidance is now with consultees, who have the opportunity to appeal against it. Until final guidance is issued to the NHS, NHS organisations should make decisions locally on the funding of specific treatments.

For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

About the draft guidance

1. The final draft guidance (also called the final appraisal determination or FAD) is available at http://www.nice.org.uk/guidance/indevelopment/GID-TAG364 from Thursday 26 February.

2. The final draft recommendations are:
a) Collagenase clostridium histolyticum is not recommended for treating Dupuytren’s contracture with a palpable cord, except in the context of research.
b) Such research should be designed to generate robust evidence about the benefits of collagenase clostridium histolyticum compared with limited fasciectomy and percutaneous needle fasciotomy in people with moderate Dupuytren’s contracture. The Committee identified that success rates, recurrence rates and effects on health-related quality of life were the main areas of uncertainty in the current research. The Committee heard from patient and clinical experts that recovering hand function was more important to patients than reducing contracture.
c) People whose treatment with collagenase clostridium histolyticum is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue their current course of collagenase clostridium histolyticum until they and their NHS clinician consider it appropriate to stop.

3. Collagenase clostridium histolyticum (Xiapex) is manufactured by Swedish Orphan Biovitrum AB.

4. There is no cure for Dupuytren’s contracture and the goal of treatment is to restore hand function. Surgical treatments such as limited fasciectomy, dermofasciectomy and fasciotomy are widely used. Limited fasciectomy involves removing the connective tissues from the affected area. Dermofasciectomy involves removing both the connective tissues and the overlying skin followed by a skin graft. Fasciotomy involves cutting the connective tissue to relieve the contraction and it can be carried out using a scalpel, or percutaneously using a needle (known as percutaneous needle fasciotomy).

5. The economic analysis for the overall population showed that CCH was more costly and less effective than limited fasciectomy. For the subgroup of patients with moderate disease and up to 2 affected joints the Committee concluded that the ICER for CCH compared with PNF was likely to be at least £39,400 per QALY gained. For the subgroup of patients with severe disease and up to 2 affected joints, CCH was dominated by both PNF and limited fasciectomy in the base case. CCH was also dominated by either PNF or limited fasciectomy in all the sensitivity analyses. The independent Appraisal Committee concluded that the ICERs did not fall within the range usually considered cost effective.

6. CCH costs £650.00 per 0.9 mg vial excluding VAT (British national formulary edition 68). The summary of product characteristics states that the recommended dose for treating Dupuytren’s contracture is 0.58 mg per injection. The company estimates that the average cost of a course of treatment is £1248.00, assuming that there are 1.92 injections per patient and there is no vial sharing. Costs may vary in different settings because of negotiated procurement discounts.

7. CCH (Xiapex) is accepted for restricted use within NHS Scotland (http://www.scottishmedicines.org.uk/SMC_Advice/Advice/715_11_collagenase_clostridium_histolyticum_Xiapex/collagenase_Xiapex_RESUBMISSION)

About NICE

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