Table 1.
Resource use and costs of implementing drug level and immunogenicity testing per patient in a hospital setting
| Type of resource use | Staff member | Mean volume of resource use, minutes | Range of resource use, minutes | Source to obtain resource use | Unit costs for base-case analysis 2015, £a | Range of unit costs 2015, £ | Source to obtain unit costs [reference] | Total costs (£) (minimum to maximum range) |
|---|---|---|---|---|---|---|---|---|
| Phase 1: pre-testing | ||||||||
| Outpatient appointment for discussion about need for test | Consultant rheumatologist | 3.6 min | 2–5 min | Expert estimation | £39.24/h | £33.42–45.06/h | BMA pay scales [12] | £2.35 (£1.11–3.76) |
| Clerical staff (to book the appointment and send out a letter to patient) | Clerical assistant | 8.2 min | 6–11 min | Direct observation | £8.43/h | £7.72–9.12/h | NHS pay scale, band 5 [11] | £1.15 (£0.77–1.67) |
| Appointment for trough blood levels | Phlebotomist/ clinical support worker | Resource use incorporated in unit cost | NA | NA | £102 per appointment | NA | DOH national tariff [14] | £102 (NA) |
| Phase 2: analysis of samples | ||||||||
| Receipt and labelling of samples—central specimen receptionb | Medical lab assistant | 15 min | NA | Expert estimation | £8.86/h | £7.74–9.98/h | NHS pay scale band 5 [11] | £2.22 (£1.94–2.50) |
| Data entry of patient information to lab systemb | Medical lab assistant | 15 min | NA | £2.22 (£1.94–2.50) | ||||
| Sample preparation—extraction of serum from bloodb | Medical lab assistant | 15 min | NA | £2.22 (£1.94–2.50) | ||||
| Transport, receipt and storage of sample—immunology labb | Medical lab assistant | 15 min | NA | £2.22 (£1.94– 2.50) | ||||
| Preparation of reagents (wash solution, setting up assay, conjugate)b | Biomedical scientist | 15 min | NA | Expert estimation | £12.79/h | £11.12–14.45/h | NHS pay scale band 5 [11] | £3.20 (£2.78–3.61) |
| ELISA kit for ADAbs or drug levelsb | NA | NA | NA | NA | £700.00 per ELISA | NA | UK commercial price from Grifolsc | £700.00 |
| Pipette tips for ELISAsb | NA | NA | NA | NA | £6.00 per ELISA | NA | University of Manchester Centre for Musculoskeletal Research laboratory | £6.00 |
| Semi-deep well plates for ELISAsb | NA | NA | NA | NA | £2.20 per ELISA | NA | Laboratory costs | £2.20 |
| Troughs for ELISAsb | NA | NA | NA | NA | £1 per ELISA | NA | Laboratory costs | £1.00 |
| Retrieval of patient/IQC samples from storageb | Biomedical scientist | 10 min | NA | Expert estimation | £12.79/h | £11.12–14.45/h | NHS pay scale- band 5 [11] | £2.13 (£1.85 –2.40) |
| Checking and sorting samples to match worklistb | Biomedical scientist | 10 min | NA | £2.13 (£1.85–2.40) | ||||
| Pipetting samples onto ELISA plateb | Biomedical scientist | 20 min | NA | £4.26 (£3.71– 4.81) | ||||
| Pipetting calibrators, IQC samples and incubation of samplesb | Biomedical scientist | 10 min | NA | £2.13 (£1.85 –2.40) | ||||
| Washing ELISA plate and addition of conjugateb | Biomedical scientist | 10 min | NA | £2.13 (£1.85 –2.40) | ||||
| Washing ELISA plate and addition of substrateb | Biomedical scientist | 10 min | NA | £2.13 (£1.85–2.40) | ||||
| Addition of stop solutionb | Biomedical scientist | 5 min | NA | £1.06 (£0.93 –1.20) | ||||
| ELISA plate reading and printing of resultsb | Biomedical scientist | 10 min | NA | £2.13 (£1.85–2.40) | ||||
| Technical validation involving review of Internal quality controlb | Biomedical scientist | 5 min | NA | £1.06 (£0.93–1.20) | ||||
| Results transcribed to worksheetb | Biomedical scientist | 5 min | NA | £1.06 (£0.93–1.20) | ||||
| Data entry of results to patient record in lab systemb | Biomedical scientist | 10 min | NA | £2.13 (£1.85 – 2.40) | ||||
| Transcribed results/data entry reviewed by a second independent biomedical scientistb | Biomedical scientist | 5 min | NA | £1.06 (£0.93 – 1.20) | ||||
| Clinical authorisation using reference range/delta check failure resultsb | Senior Biomedical scientist or Consultant immunologist | 5 min | NA | Expert estimation | £30.48/h | £15.9–45.06/h | NHS pay scale band 7 assumed [11]; BMA pay scale [12] | £2.54 (£1.33 –3.76) |
| Hardcopy report sent to clinicianb | Clerical assistant | 15 min | NA | Expert estimation | £8.43/h | £7.74 –9.12/h | NHS pay scale [11] | £2.11 (£1.93 –2.28) |
| Phase 3: Treatment decision | ||||||||
| Interpretation of results by rheumatologist | Consultant Rheumatologist | 6 min | 4–10 | Expert estimation | £39.24/h | £33.42–45.06/h | NHS pay scale [11] | £3.92 (£2.23 –7.51) |
| Discussion with patient (phone call) | 5.3 min | 5–6 | £3.47 (£2.79–3.92) | |||||
| Letter with results and decision | 3.3 min | 3–4 | £2.16 (£1.61–2.62) | |||||
| Total costs (best case to worst case scenario)d | £152.52 (£147.68–159.24) | |||||||
a
Mid-point of salary grade used to calculate base–case sample.
b
Resource use estimated per batch (40 samples).
c
Previously known as Progenika Biopharma.
d
Base–case (multiway sensitivity analyses were conducted by varying the following parameters using pre-defined lower and upper ranges of estimated resource use: lowest time taken to perform tasks using the lowest pay grade (best case scenario) and highest amount of time taken to perform procedures using the highest pay grade (worst case scenario). BMA: British Medical Association;
DOH: department of health; ELISA: enzyme-linked immunosorbent assay; IQC: internal quality control; NA: not applicable; NHS: National Health Service.