Collagenase Clostridium Histolyticum
Recommended OtherAuthority RequiredNot applicable line 💬 consumer voice
Treatment of Dupuytren's contracture in patients with ≤2 affected rays (fingers) who are unable to simultaneously place the affected finger and palm flat on a table due to a Dupuytren's contracture with a palpable cord and who would otherwise require surgery.
2
Submissions
1 resub
2013–14
On the record
—
ICER range
—
Cost basis
Decisions on record
- Meeting Jul 2014 Recommended 900 microgram injection [1 x 900 microgram vial] (&) inert substance [1 x 3 mL vial] Xiaflex® Actelion Pharmaceuticals Australia Pty Ltd New listing (Major submission) Dupuytren’s contracture Authority required listing for the treatment of Dupuytren’s contracture in patients with two or less rays af
- Meeting Jul 2013 Not recommended Dupuytren's contracture
Access path
- Jul 2013Not recommended
vs surgical fasciectomy
- ↻ resubmittedJul 2014Recommended · restricted
Evidence: RCT → Single-arm
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended listing collagenase clostridium histolyticum as an Authority required benefit for the treatment of Dupuytren’s contracture in patients meeting certain criteria, on a cost analysis basis that assumes equivalent overall treatment costs between and surgical fasciectomy, but accounting for a lower treatment success rate with CCH compared to surgical fasciectomy as well as higher retreatment and recurrent contracture rates for patients …PSD · Jul 2014
7.2 The PBAC noted the re-submission’s request for a more restrictive listing than the previous submission through limiting the use of CCH to patients (a) with ≤ 2 rays affected and (b) who would otherwise require surgery. Whilst the PBAC agreed with the intent of these two particular elements of the restriction and the inclusion of them in the restriction, the PBAC considered that it would be difficult to audit whether these 15PSD · Jul 2014
Economic analysis
6.22 The re-submission presented an updated cost comparison between CCH and surgical fasciectomy, using a similar approach to the previous submission. The ESC noted that given the clinical claim of inferior efficacy, the evaluation questioned whether a cost-utility analysis may have been more appropriate to establish whether any additional savings are worth the health loss.PSD · Jul 2014
The ESC noted that the quality and therefore reliability of data obtained from the surgical studies to populate any potential cost-utility analysis would be low and so this approach to the economic analysis would in practice, as opposed to in theory, be unlikely to provide any additional certainty compared to the current approach.PSD · Jul 2014
Clinical claim
6.19 The re-submission described CCH as inferior in terms of comparative success rate and rate of recurrence, non-inferior in terms of recurrence resulting in subsequent medical or surgical intervention and superior in terms of safety compared to surgical fasciectomy.PSD · Jul 2014
6.20 The ESC considered that the claim of inferiority to surgical fasciectomy is reasonable in terms of comparative success rate and rate of recurrence based on the clinical study outcomes of recurring contracture ≥20° or ≥30°.PSD · Jul 2014
Consumer comments
6.2 The PBAC noted and welcomed the input from health care professionals (6) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with CCH including the ability to return to work earlier, providing full correction of deformity, significantly lower comparative costs for individual patients and from a healthcare system perspective compared to surgery as patients can be managed as ‘out-patients’ and …PSD · Jul 2014
Cost-effectiveness
Document text is incomplete; economic analysis details not provided in the excerpt.
The basis of the requested listing is a cost minimisation analysis based on non-inferiority of CCH versus surgical fasciectomy in terms of comparative efficacy and safety. PSD · 2013
Decision context
PopulationAdults with Dupuytren's contracture affecting ≤2 rays who are unable to simultaneously place the affected finger and palm flat on a table due to a palpable cord and would otherwise require surgery.
Why it was knocked back
- The document is truncated and does not provide the PBAC outcome or rejection reasons in the excerpt provided.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Recommended · restricted | surgical fasciectomy | — | Single-arm · Other |
| Jul 2013 | Not recommended | surgical fasciectomy | — | RCT · Proportion of patients achieving ≤5° contracture 30 days post-procedure |
Consumer voice
Healthcare professionals reported that CCH treatment enables earlier return to work, provides full deformity correction, reduces costs compared to surgery through outpatient management, and demonstrates acceptable safety.
the ability to return to work earlier Consumer comments · PSD
return to worktreatment efficacycost-effectivenessaccess barrierssafety
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ≤2 rays, functional impairment (unable to place palm flat), and surgery-eligible patients; TGA label has no such restrictions.