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Type: Original article
Published: 15-03-2019

Collagenase injections for Dupuytren’s in Australian public hospitals: a cost analysis

Devlin Elliott MBChB, Randy Bindra MBBS FRCS, Sujoy Roychowdhury MBBS, Tracy Comans, Jason Flecther MBBS

1 

Gold Coast University Hospital
Department of Plastic and Reconstructive Surgery
Southport, Queensland
AUSTRALIA

 

2 

Griffith University School of Medicine
Department of Surgery
Southport, Queensland
AUSTRALIA

3

The University of Queensland
St Lucia, Queensland
AUSTRALIA

 

 

OPEN ACCESS
Correspondence
Name: Devlin Elliott
Address: Gold Coast University Hospital
1 Hospital Blvd
Southport, Queensland, 4215
AUSTRALIA
Email: devlin.elliott@gmail.com
Telephone: + 61 449 770 717
Citation: Elliott D, Bindra R, Roychowdhury S, Comans T, Fletcher J. Collagenase injections for Dupuytren’s in Australian public hospitals: a cost analysis. Aust J Plast Surg. 2019;2(1):17–22. https://doi.org/10.34239/ajops.v2i1.73
Accepted for publication: 15 January 2019
Copyright © 2019. Authors retain their copyright in the article. This is an open access article distributed under the Creative Commons Attribution Licence which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited.

Section: Hand


Abstract

Background: Collagenase clostridium histolyticum (CCH) injection is an established alternative to surgical fasciectomy in selected patients with Dupuytren’s contracture. Collagenase is currently not listed on the Pharmaceutical Benefits Scheme creating a barrier to its use in the Australian public health system. This study compares the cost of CCH delivered in an outpatient setting with a comparable surgical fasciectomy cohort, calculated retrospectively.

Method: A retrospective audit of hospital data was conducted to determine the cost of single-digit surgical fasciectomy compared to CCH treatment delivered in an outpatient setting. Medicare Benefits Schedule coding was used to identify surgical fasciectomy patients between March 2014 and April 2015. The CCH group was prospectively followed from June 2014 to March 2016.

Results: Thirty-seven patients were successfully treated with CCH, with one patient requiring two injections. This group required less follow-up visits (4.0 outpatient clinic and 4.9 allied health) compared to the surgical group (n=38; 4.4 outpatient clinic and 6.1 allied health). The total cost of treatment for the CCH group was AU$2589 compared to a mean total of AU$6155 for the surgical group (AU$3574–AU$14,599)—a potential saving of AU$119,698.

Conclusion: The overall cost of CCH is substantially lower than surgical fasciectomy despite the cost of the medication (AU$1206). Additionally, CCH patients avoid a visit to the operating room thereby freeing up theatre time that is generally under pressure with long public waiting lists.

Key words: collagenase, Dupuytren’s, cost, contracture, public health


Introduction

Dupuytren’s disease is a benign fibroproliferative condition of the palmar fascia characterised by painless, progressive and irreversible contractures of the fingers and subsequent functional limitation. Until recently, fasciectomy remained the treatment of choice.1

Fasciectomy for Dupuytren’s disease is a lengthy procedure requiring several weeks to recover motion and strength in the hand. It can vary from excision of segments of the cord through small incisions, or limited fasciectomy of the involved digits, to extensive dermofasciectomy involving skin and fascia. Complications from surgery include nerve injury leading to numbness, skin breakdown, infection and haematoma which can prolong recovery or may require revision surgery. Surgery is not a cure nor does it prevent recurrence. Reported contracture recurrence rates after surgery vary widely from 27 per cent to 80 per cent depending on the definition of recurrence.2

More recently, enzymatic digestion of the diseased tissue and disruption of the contracted cord has been proposed as an alternative to surgery. In a phase III trial conducted by Badalamente et al,2 collagenase clostridium histolyticum (CCH) injections were shown to be safe and effective for correction of single finger contracture with a low recurrence rate. Their protocol involved the injection of CCH into the diseased cord followed by manipulation and extension of the finger a day later. Treatment is delivered under local anaesthesia in the outpatient setting. In the USA, CCH was approved by the US Food and Drug Administration for the treatment of Dupuytren’s contracture in 2010.

The widespread adoption of CCH (Xiaflex, Endo Pharmaceuticals, PA, USA) in Australia has been hampered by multiple factors. The drug has been denied coverage under the Pharmaceutical Benefits Scheme (PBS) on the basis of its reported efficacy of 50 per cent (compared to 67 per cent for surgery) and a higher recurrence rate.2–4 Therefore, a public hospital offering the treatment has to bear the cost of the injection. As there is no specific diagnosis related group (DRG) code for chemical fasciectomy, there is no defined process for reimbursement of the activity performed at an outpatient service. Although this would seemingly be more cost-effective, it is unclear who bears the cost of the injection, as it is a medical treatment for a surgical condition.

The purpose of this paper is to compare the cost of CCH treatment in an outpatient setting in the Australian public system with single-digit fasciectomy.

Method

We conducted a retrospective audit of hospital data to calculate the cost of surgical fasciectomy. Costings were calculated internally in collaboration with finance and compliance staff using the Medicare benefits schedule (MBS) code 46372 to identify patients who underwent fasciectomy over a 12-month period from March 2014 to April 2015. Only cost calculations for single-digit fasciectomy were included in order to make this cohort comparable to the CCH treatment group. The CCH cost was calculated from participants in a prospective study from June 2014 to March 2016.

The total cost for fasciectomy procedure included all hospital and operating theatre-related expenses such as: medical and surgical costs, operating theatre costs, anaesthetic staff costs, allied health costs, blood products, medical imaging, pathology, pharmacy, prosthesis costs and ward costs. All costs included direct costs and related overheads. Actual figures were obtained from the hospital cost centre in our billing department and were calculated on a cost per patient per hour basis. Overhead costs were calculated as a percentage of total lease cost on a time usage basis. Queensland Payroll assisted in providing the cost of wages of the varied health staff at an hourly rate.

The cost of surgical outpatient and hand therapy appointments were calculated in a similar fashion. The mean values of each of these items were included to estimate the total direct cost of fasciectomy itself and the cost of the outpatient clinic visits related to the surgery or CCH administration. The cost of CCH treatment included the cost of the drug and additional costs of clinic visits and hand therapy costs.

The pathway for patients undergoing CCH treatment was an initial surgical consultation, a clinic visit for the injection, a subsequent visit for joint manipulation and two outpatient reviews at one and three months respectively. The hand therapy protocol was one initial consult for documentation of contracture severity and objective measurements followed by a visit immediately after manipulation for splinting and two subsequent visits for splint adjustment and finger motion exercises.

The surgical group had an initial consultation and then post-operative outpatient followup at one week, one month and three months. Hand therapy following surgery was one initial visit for splinting and subsequent visits as needed for splint adjustment or hand range of motion. The outpatient follow-up in both groups was designed as a guideline. Ongoing subsequent surgical review or hand therapy was customised to the individual patient on an as required basis.

Results

We identified 38 patients who underwent single-digit fasciectomy during the review period. The actual total cost per patient was calculated and compared to CCH treatment (Table 1). The mean cost of surgery for single-digit fasciectomy was AU$4609.61 (AU$2761.44–AU$10,928.67). In terms of fasciectomy component cost, the highest was theatre, followed by medical and surgical staff and then anaesthetic staff. The cheapest variables were imaging, pathology and pharmacy.

Outpatient visits for the fasciectomy group were compared with the CCH group (Table 2). The single-digit fasciectomy group required a mean of 4.4 (2–9) surgical outpatient visits. The mean cost for a single surgical outpatient appointment was AU$303.14 per visit (AU$180.80–AU$4165.20) making the total mean outpatient cost AU$1339.88 (AU$606.28–AU$2728.26). The high cost in some patients was related to preoperative work-up for anaesthesia. The mean number of occupational therapy visits was 6.13 (1–28) in the surgical group with a mean cost of AU$206.27 (AU$33.65–AU$942.20).

Table 1: Surgical and CCH total average costs (AU$)
  Single-digit fasciectomy   CCH injection  
Mean cost Range Mean cost Range
Theatre $1573.3 ($94.07–$3522.95)
Theatre overheads $764.44 ($551.79–$1453.73)
Anaesthetic staff $529.40 ($72.94–$1870.65)
Anaesthetic overhead $79.030 ($29.72–$428.54)
Medical and surgical $685.08 ($205.47–$1975.92)
Medical and surgical overhead $101.88 ($45.43–$257.04)
Ward  $102.06 ($0.31–$580.91)
Ward overhead $46.97 ($0.01–$326.90)
Pharmacy $162.70 ($56.36–$229.38) $1206.15 ($1176.00–$2352.00)
based upon 38 injections
Pharmacy overhead $1.22 ($0.01–$24.48)    
Pathology $15.26 ($0.00–$225.92)
Pathology overhead $0.01 ($0.00–$0.02)
Imaging $10.97 ($0.00–$208.36)
Imaging overhead $0.01 ($0.00–$0.02)
Mean total for theatre alone $4609.61 ($2761.44–$10928.67)
Surgical outpatient costs $1339.88 ($606.28–$2728.26) $1405.74 ($1212.56–$1515.70)
Occupational therapist costs $206.27 ($33.65–$942.20) $134.60  
Occupational therapy overheads
(splint and odema control)
$6155.86 ($3573.99–$14599.13) $30.00  
Overall total for care     $2589.07 ($2376.44–$3091.39)
CCH= Collagenase clostridium histolyticum injection
Table 2: Number of outpatient and hand therapy visits including costs
Mean Mean cost  Range 
Single-digit fasciectomy  Outpatients 4.42 (2–9) AU$1339.88 ($606.28–$2728.26)
  Occupational therapy 6.13 (1–28) AU$206.27 ($33.65–$942.20)
CCH injection Outpatients 4.00 (3–8) AU$1405.74 ($484.32–$1515.75)
  Occupational therapy M4.92 (3–16) AU$164.60 ($102.65–$756.74)
CCH= Collagenase clostridium histolyticum injection

A total of 37 patients underwent 38 CCH injections from June 2014 to March 2016. The cost of the drug in our hospital was AU$1176 per vial. At three-month follow up, a reduction in extension deficit to <5 degrees of full extension for the measured joint was achieved in 48 per cent of joints—66 % metacarpophalangeal (MCP) joint and 19 per cent proximal interphalangeal (PIP) joint. Mean fixed flexion deformity improved by 40 degrees and 25 degrees for MCP joint and PIP joint disease respectively. Mean active range of motion improved by 39 degrees and 18 degrees respectively. While not all patients received full correction, as is usual with all forms of treatment for Dupuytren’s contracture, all but one patient was satisfied with the correction achieved. Only one patient requested a second injection for incomplete correction during the study, thereby the mean drug cost was calculated at AU$1206.15.

The CCH group of patients required a mean of 4 (3–8) visits in outpatient clinic and 4.9 (3–16) in hand therapy. Using an average estimated cost of AU$250.06 per clinic visit and AU$405.50 for the manipulation, we estimated the total cost of outpatient visits to be AU$1405.7.4 The occupational therapy cost for the CCH group was AU$164.60 including the cost of splinting and other materials.

The overall total average cost including surgical and outpatient follow up in a single-digit fasciectomy was AU$6155.86. The overall total cost for CCH was AU$2589.07. The total average surgical cost for all 38 patients was AU$175,165.00. This reveals a potential saving of AU$119,698.00 during our one-year study period (Table 3). While CCH was originally indicated for use in single-finger contracture only, Verheyden has reported the safety and efficacy of one vial of CCH for treatment of contracture of two fingers thereby extending the use and possibly creating additional savings.5

Table 3: Cost of Dupuytren surgery for patients treated at the Gold Coast University Hospital from March 2014 to April 2015 (AU$)
Digits
affected
Number of
injections
Mean Standard
deviation
Minimum Maximum Sum Alternative cost
of CCH injection
Saving
Total 1 38  AU$4610 AU$1905 AU$2761 AU$10,929 AU$175,165 AU$55,467 AU$119,698

Discussion

Fasciectomy has been the mainstay of treatment for many years with some studies supporting better efficacy and a greater mean magnitude of correction for digital contractures.6 There continues to be much debate in the literature about the long-term outcome of CCH and its place in Dupuytren’s treatment. A large systematic review by Sanjuan-Cerveró et al encompassing over 50 studies and 4622 patients demonstrated a satisfactory response to CCH treatment in the short and medium-term.7

Zhou et al’s study showed that CCH was not significantly different from fasciectomy in reducing MCP joint contractures, whereas PIP joint contractures showed slightly better reduction following limited fasciectomy.8 As far as long-term outcome is concerned, Peimer et al’s five-year data on efficacy of CCH has revealed a 47 per cent recurrence rate with CCH injections and this is comparable with reports of surgical fasciectomy.9

Cost-effectiveness of CCH has been studied in other countries with reports favouring injection treatment. In a prospective study on 40 patients in the UK, Mehta et al reported an average cost of partial fasciectomy to be substantially higher at GBP£7115 compared to GBP£2110 in the CCH group, with a potential saving of GBP£5000 per patient. They also found that the CCH group required less physician and physiotherapist follow up.10 In Spain, Cervero et al did a comparison of 48 single or double digit fasciectomies over three years with 43 CCH injections over seven months. They demonstrated a total saving of 29–51 per cent depending on hospital admission and additional allied health requirements.11 Likewise, another study in the United States of America found that treatment with one CCH injection cost 33 per cent less than fasciectomy with equivalent efficacy at six weeks regarding reduction in contracture. The total treatment cost for CCH was US$1418 and for fasciectomy US$2102.12 Chung et al undertook a cost-utility analysis comparing different treatments for Dupuytren’s disease. In their model, open partial fasciectomy is not cost-effective but CCH injection is when priced less than US$945.13

Conclusion

Our study compares the actual cost of single-digit surgical fasciectomy in a retrospective cohort with the cost of CCH in a prospective group. Our cost calculation includes all aspects of care: medication, procedure and therapy. Our findings suggest that CCH injection treatment has a substantially lower cost when compared to surgery for management of single-digit Dupuytren’s contracture. It is substantially cheaper not withstanding indirect costs to the patient for expenses related to fewer clinic visits and possible earlier recovery as suggested by fewer therapy visits. Additionally, by shifting the treatment delivery to the outpatient, CCH treatment increases the availability of theatre for other surgical procedures in a system that is already burdened by the pressures of long surgical waiting times. Our highest cost variable in our fasciectomy analysis was theatre costs.

Our study design has some weaknesses. The surgical group cost was calculated retrospectively and while we only calculated costs related to single-finger contracture, the severity of disease in the two cohorts may not be the same. It is also possible that there is an inherent bias in selecting patients with milder forms of contracture for CCH treatment. Nevertheless, the injection costs are lower than surgery. Additionally, we only report on the immediate outcome of the injection and have not reported on efficacy in the medium- to long-term.

In conclusion, our study highlights the substantially lower total cost of CCH injection for management of single-digit Dupuytrens contracture when compared with surgical fasciectomy. Even accounting for the relatively high cost of the medication, the CCH pathway is cheaper, can be delivered in the outpatients department and patients require less occupational therapy and allied services. The increased availability of operating rooms for other procedures is another vital saving to the public health service. There remains a role for surgery in patients with Dupuytren’s contractures that are severe or involve multiple fingers. Our study suggests that healthcare services in Australian should consider making funding available for CCH treatment as an alternative to surgery in selected patients.

Disclosure

Professor Bindra has been a paid speaker for Actelion Pharmaceuticals Australia.

References

  1. Khashan M, Smitham PJ, Khan WS, Goddard NJ. Suppl 2: Dupuytren’s disease: review of the current literature. Open Orthop J. 2011;5:283. https://doi.org/10.2174/1874325001105010283 PMid:21886694 PMCid:PMC3149852
  2. Badalamente MA, Hurst LC. Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren’s contracture. J Hand Surg. 2007;32(6):767–74. https://doi.org/10.1016/j.jhsa.2007.04.002 PMid:17606053
  3. Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J. Injectable collagenase clostridium histolyticum for Dupuytren’s contracture. New Engl J Med. 2009;361(10):968–79. https://doi.org/10.1056/NEJMoa0810866 PMid:19726771
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  5. Verheyden JR. Early outcomes of a sequential series of 144 patients with Dupuytren’s contracture treated by collagenase injection using an increased dose, multi-cord technique. J Hand Surg-Eur Vol. 2015;40(2):133–40. https://doi.org/10.1177/1753193414530590 PMid:24698852
  6. Muppavarapu RC, Waters MJ, Leibman MI, Belsky MR, Ruchelsman DE. Clinical outcomes following collagenase injections compared to fasciectomy in the treatment of Dupuytren’s contracture. Hand. 2015;10(2):260–65. https://doi.org/10.1007/s11552-014-9704-0 PMid:26034441 PMCid:PMC4447679
  7. Sanjuan-Cerveró R, Vazquez-Ferreiro P, Gomez-Herrero D, Carrera-Hueso FJ. Efficacy of collagenase clostridium histolyticum for dupuytren disease: a systematic review. Revista Iberoamericana de Cirugía de la Mano [Ibero-American Journal of Hand Surgery]. 2017;45(02):070–88. https://doi.org/10.1055/s-0037-1608749
  8. Zhou C, Hovius SE, Slijper HP, Feitz R, Van Nieuwenhoven CA, Pieters AJ, Selles RW. Collagenase clostridium histolyticum versus limited fasciectomy for Dupuytren’s contracture: outcomes from a multicenter propensity score matched study. Plast Reconstr Surg. 2015;136(1):87–97. https://doi.org/10.1097/PRS.0000000000001320 PMid:25829153
  9. Peimer CA, Blazar P, Coleman S, Kaplan FT, Smith T, Tursi JP, Cohen B, Kaufman GJ, Lindau T. Dupuytren contracture recurrence following treatment with collagenase clostridium histolyticum (CORDLESS study): 3-year data. J Hand Surg. 2013;38(1):12–22. https://doi.org/10.1016/j.jhsa.2012.09.028 PMid:23200951
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  11. Cerveró RS, Ferrando NF, Jornet JP. Use of resources and costs associated with the treatment of Dupuytren’s contracture at an orthopedics and traumatology surgery department in Denia (Spain): collagenase clostridium hystolyticum versus subtotal fasciectomy. BMC Musculoskel Dis. 2013;14(1):293. https://doi.org/10.1186/1471-2474-14-293 PMid:24125161 PMCid:PMC3852948
  12. Atroshi I, Strandberg E, Lauritzson A, Ahlgren E, Waldén M. Costs for collagenase injections compared with fasciectomy in the treatment of Dupuytrens contracture: a retrospective cohort study. BMJ Open. 2014;4(1):e004166. https://doi.org/10.1136/bmjopen-2013-004166 PMid:24435894 PMCid:PMC3902506
  13. Chen NC, Shauver MJ, Chung KC. Cost-effectiveness of open partial fasciectomy, needle aponeurotomy, and collagenase injection for Dupuytren contracture. J Hand Surg. 2011;36(11):1826–34. https://doi.org/10.1016/j.jhsa.2011.08.004 PMid:21981831