Dupuytren’s contracture is the condition where the fingers gradually bend in towards the palm of the hand and cannot be straightened. NICE’s previous draft guidance, published in February, was withdrawn to allow the company to submit further information.
“Although there are surgical treatments available for people with Dupuytren’s contracture, collagenase clostridium histolyticum is the first drug to be developed for treating the condition” said Professor Carole Longson MBE, director of the centre for health technology evaluation at NICE.
“The independent Committee felt the treatment is innovative and shows real promise, particularly in people with moderate disease. However, the Committee agreed with comments from patients and clinicians that further research into the clinical effectiveness of collagenase clostridium histolyticum compared with other treatments for Dupuytren’s contracture is needed before NICE is able to determine whether it represents a clinically and cost effective option for routine use in the NHS.
“This draft guidance therefore recommends that collagenase clostridium histolyticum is used in the context of research, which we hope will help to clarify the potential benefits this treatment could provide for patients.”
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.
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.
Collagenase clostridium histolyticum 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.
The final draft guidance is now with consultees, who have the opportunity to appeal against it.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 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 /guidance/indevelopment/GID-TAG364 from Wednesday 16 September.
2. The final draft recommendations are:
1.1 Collagenase clostridium histolyticum is not recommended for treating Dupuytren’s contracture with a palpable cord, except in the context of research.
1.2 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.
1.3 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 or ‘PNF’).
5. For the overall population, collagenase clostridium histolyticum was dominated by limited fasciectomy in the Assessment Group’s base case, meaning that collagenase clostridium histolyticum was more costly and less effective than limited fasciectomy.
6. For the subgroup of patients with moderate disease and up to 2 affected joints, using the Committee’s preferred recurrence rates and parameters from the CORD trials, the ICER was £31,100 per QALY gained for collagenase clostridium histolyticum compared with PNF. The Committee discussed alternative analyses that assumed fewer injections of collagenase clostridium histolyticum, a higher success rate for limited fasciectomy and PNF, or a longer recovery time after limited fasciectomy. These analyses did not result in a lower ICER. The Committee concluded that the ICER for collagenase clostridium histolyticum compared with PNF for the moderate-disease subgroup was likely to be at least £31,100 per QALY gained.
7. For the subgroup of patients with severe disease and up to 2 affected joints, collagenase clostridium histolyticum was dominated by both PNF and limited fasciectomy in the base case.
8. Collagenase clostridium histolyticum 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.
9. Collagenase clostridium histolyticum 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
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