Collagenase clostridium histolyticum for treating Dupuytren's contracture - NICE TAG TA459

1.1 People who meet the inclusion criteria for the ongoing clinical trial (HTA-15/102/04), comparing collagenase clostridium histolyticum (CCH) with limited fasciectomy, are encouraged to participate in the study.

1.2 For people not taking part in the ongoing clinical trial, CCH is recommended as an option for treating Dupuytren's contracture with a palpable cord in adults only if all of the following apply:

• There is evidence of moderate disease (functional problems and metacarpophalangeal joint contracture of 30° to 60° and proximal interphalangeal joint contracture of less than 30° or first web contracture) plus up to 2 affected joints.

• Percutaneous needle fasciotomy (PNF) is not considered appropriate, but limited fasciectomy is considered appropriate by the treating hand surgeon.

• The choice of treatment (CCH or limited fasciectomy) is made on an individual basis after discussion between the responsible hand surgeon and the patient about the risks and benefits of the treatments available.

• One injection is given per treatment session by a hand surgeon in an outpatient setting.

1.3 These recommendations are not intended to affect treatment with CCH that was started in the NHS before this guidance was published. Adults having treatment outside these recommendations may continue their current course without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Collagenase clostridium histolyticum reduces hand contracture compared with placebo in randomised controlled trials. But there were no randomised trials comparing the clinical effectiveness of CCH with current NHS treatment for Dupuytren's contracture (surgery with PNF or limited fasciectomy), which made the results of the cost-effectiveness analysis very uncertain.

CCH is the first pharmacological treatment to get a marketing authorisation for treating Dupuytren's contracture. Although there are uncertainties in the available evidence, it has the potential to offer benefits compared with current treatments, including avoiding a general anaesthetic and a shorter recovery time.

For people with moderate disease (plus up to 2 affected joints), CCH is a potentially cost-effective option when 1 injection per treatment session is given in an outpatient setting and when PNF is not appropriate but limited fasciectomy is an option. However, there is a risk to the NHS in funding a treatment that may not prove to be cost effective when further data become available.

Additional research is needed before a broader recommendation for CCH can be made. A multicentre trial(HTA‑15/102/04) starting in 2017 will provide more clinical and cost-effectiveness evidence for CCH compared with limited fasciectomy. There were concerns that if CCH is recommended for people with moderate Dupuytren's contracture, people may choose to have treatment with CCH rather than take part in the clinical trial, even though there is no evidence to show CCH has better or worse outcomes than limited fasciectomy. CCH is therefore recommended under very specific conditions to allow access to CCH in a way that supports the ongoing trial and manages risk to the NHS while further clinical and cost-effectiveness data are collected.

If recruitment to the ongoing clinical trial falls below predicted levels, the guidance will be considered for early review.

https://www.nice.org.uk/guidance/ta459