Freemantle et al CONFIDENTIAL 08 May 2018

OnabotulinumtoxinA in the treatment of overactive bladder: a cost- effectiveness analysis versus best supportive care in England and Wales

Nick Freemantle,1 Kristin Khalaf,2 Clara Loveman,3 Sanja Stanisic,4 Dmitry Gultyaev,5 Johanna Lister,5 Marcus Drake6

1Department of Primary Care and Population Health, UCL Medical School, Rowland Hill Street, London NW3 2PF, UK

2Allergan Inc., 2525 Dupont Drive, Irvine, CA 92612-1599, USA

3Allergan Ltd, Marlow International, The Parkway, Marlow SL7 1YL, UK

4LA-SER ANALYTICA, Corso di Porta Nuova 34, Milan 20121, Italy

5LA-SER ANALYTICA, Meeraner Platz 1, Lörrach 79539, Germany

6School of Clinical Sciences and Bristol Urological Institute, University of Bristol, Southmead Road, Westbury-on-Trym, Bristol BS10 5NB, UK

Corresponding author

Nick Freemantle Department of Primary Care and Population Health, UCL Medical School, Rowland Hill Street, London NW3 2PF, UK. Tel: +44 (0)20 7794 0500 ex34756; Fax: +44 (0)20 7794 1224; email: [email protected]

Target journal: European Journal of Health Economics

1 Freemantle et al CONFIDENTIAL 08 May 2018

Online Resource 3 Cost inputs for the Markov model included in the sensitivity analyses and their respective distributions Parameter Input Distribution Min Max Reference (£) value value OnabotulinumtoxinA 138.20 Gamma 116.28 161.69 BNF [44] (100 U vial) Anticholinergics (per 28.31 Gamma 23.819 33.1219 Average monthly cost patient per month) 8 based on market share of generic and branded anticholinergics, Allergan [data on file] and BNF [44] Antibiotics (per 0.59 Gamma 0.4964 0.69028 BNFa [44] course) 2 Incontinence pads 0.25 Gamma 0.2103 0.29249 NHS supply chain (per pad) 5 Catheters for CIC 0.75 Gamma 0.6310 0.87748 NHS supply chain (per catheter) 4 OnabotulinumtoxinA 219.00 Gamma 184.26 256.224 HRG tariff LB17Z code for administrationb 5 hospital outpatient [45] Specialist physician 102.00 Gamma 74.897 108.402 National Schedule of visit 2 Reference Costs [46] Physician visit to treat 63.00 Gamma 53.007 73.7082 Unit costs of health and UTI 7 social care, PSSRU [47] Removal of 1166.00 Gamma 981.06 1364.19 Estimate from NICE temporary SNS 4 CG171: electrodes Nurse led visit (£70 – non- consultant-led face-to-face outpatient – PSSRU 2011); explants procedure (£1096, HRG code AA21Z – but may be less because this is a small procedure) [19] PNE test (one-stage 1485.00 Gamma 1249.4 1737.41 Estimate from NICE CG171 test) 7 One-stage SNS 8641.00 Gamma 7270.4 10109.7 Costs based on estimate implant (electrode 7 from NICE CG171: and modulator implantation (£2441, HRG implants) code AB01Z, complex neurological pain procedure); patient controlled programmer (£500, NHS, checked by Medtronic, 2012); implantable pulse generator (£5700, NHS, checked by Medtronic, 2012) [19] SNS device explant 923.00 Gamma 776.60 1079.88 OPCS-4 code (A70.2 6 Removal of neurostimulator in peripheral nerve) [48,19] SNS surgical revision 592.00 Gamma 498.10 692.623 Maintenance of 5 neurostimulator. Day case/elective inpatient HRG tariff: AB04Z major pain procedures A70.2 maintenance of neurostimulator in

2 Freemantle et al CONFIDENTIAL 08 May 2018

peripheral nerve [45,19] SNS battery 6623.00 Gamma 5572.5 7748.72 Based on estimate from replacement 4 NICE CG171: device (£5700 – NICE CG171 does not provide further information); replacement (£923 – HRG A70.2 maintenance of neurostimulator in peripheral nerve) [19] SNS follow-up 319.00 Gamma 268.40 373.221 Neurosurgical consultation physician visit 4 WF01B OP Code 150 First Attendance - Single professional [49] BNF, British National Formulary; CG, clinical guideline; CIC, clean intermittent catheterization; HRG, Healthcare Resource Group; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; PNE, percutaneous nerve evaluation; OPCS-4, Office of Population, Censuses and Surveys Classification of Surgical Operations and Procedures (4th revision); PSSRU, Personal Social Services Research Unit; SNS, sacral nerve stimulation; UTI, urinary tract infection

3