title: Cost analysis of cetuximab (Erbitux) plus radiotherapy (ERT) versus concomitant cisplatin plus radiotherapy (CRT) within an NHS oncology unit (single institution): a pilot study.
abstract: OBJECTIVE
  The aim of this feasibility study is to define the resource effectiveness of cetuximab vs cisplatin given concomitantly with radiotherapy for squamous cell carcinoma within a National Health Service clinical oncology unit.
  
  
  METHODS
  20 patients with Stage 3 or 4 head and neck squamous cell cancers were randomized to receive either cetuximab with radiotherapy (ERT) or cisplatin with radiotherapy concurrent with external beam radiotherapy 70 Gy in 35 fractions on a 1 : 1 basis over a 12-month duration. The study compared the resource utilization of ERT vs cisplatin with radiotherapy taking into account drug costs, clinical management and the costs of managing treatment-related toxicity from first fraction of radiotherapy to 6 months after the completion of therapy. Outcome measures were quality of life (recorded at the entry, end of radiotherapy, 6 weeks post treatment and 6 months post treatment), admissions to hospital, delays to radiotherapy, locoregional control and survival.
  
  
  RESULTS
  Total drug costs including cost of nutritional supplements for patients treated with cetuximab were £7407.45 compared with £3959.07 for patients treated with cisplatin. Unscheduled admissions for toxicity management were significantly more common in the ERT arm. Healthcare personnel spent significantly more time delivering unscheduled outpatient care for patients receiving cisplatin than for those receiving cetuximab (p = 0.01). No significant difference in the quality of life was suggested at baseline, 6 weeks and 6 months. The mean time to removal of percutaneous gastrostomy (PEG) after completion of radiotherapy was 49.7 weeks in the cisplatin arm and 18.5 weeks in the cetuximab arm (p = 0.04). There was a statistically significant difference in patient-reported use of PEG between the cisplatin and cetuximab arms at 6 months following completion of treatment (p = 0.04). At 21 months, overall survival was 80% in the cisplatin arm vs 50% in the cetuximab (p = 0.332), with disease-free survival being 80% in the cisplatin arm vs 40% in the cetuximab (p = 0.097).
  
  
  CONCLUSIONS
  Cetuximab is still more expensive in simple drug cost terms than cisplatin when delivered with radiotherapy taking into account costs of drugs for toxicity management and nutritional supplements but other resource implications such as inpatient admission, time spent delivering unscheduled care and cost of additional investigations to manage toxicity for patients treated with cisplatin significantly reduce differential. The study suggested significant differences in patient-reported PEG use at 6 months and in time to PEG removal in favour of the cetuximab arm. Advances in knowledge: There is paucity of randomized data on cost analysis for cisplatin vs cetuximab radiotherapy; this trial informs on the cost analysis between the two approaches.
authors.affiliation: 1 Royal Wolverhampton Hospitals Trust, Wolverhampton, UK.
authors.forename: Brammer
authors.initials: B
authors.lastname: Caroline
authors.affiliation: 2 University Hospitals of Birmingham, NHS Foundation Trust, Birmingham, UK.
authors.forename: Yahya
authors.initials: Y
authors.lastname: Sundus
authors.affiliation: 1 Royal Wolverhampton Hospitals Trust, Wolverhampton, UK.
authors.forename: Dawson
authors.initials: D
authors.lastname: Dawn
authors.affiliation: 1 Royal Wolverhampton Hospitals Trust, Wolverhampton, UK.
authors.forename: Glaister
authors.initials: G
authors.lastname: Carol
authors.affiliation: 1 Royal Wolverhampton Hospitals Trust, Wolverhampton, UK.
authors.forename: Merrick
authors.initials: M
authors.lastname: Susan
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000191:economics / Q000628:therapy*; D000068818:Cetuximab / Q000191:economics* / Q000627:therapeutic use; D059248:Chemoradiotherapy / Q000191:economics* / Q000379:methods; D002945:Cisplatin / Q000191:economics* / Q000627:therapeutic use; D003362:Cost-Benefit Analysis / Q000191:economics*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000068818:Cetuximab; D002945:Cisplatin