‘Robosurgeons vs. robosceptics’: can we afford robotic technology or can we afford not to?

Abstract

Aim:

To investigate the clinical effectiveness and cost-effectiveness of robotic technology in robotic-assisted radical prostatectomy in comparison with laparoscopic radical prostatectomy and open radical prostatectomy.

Methods:

Cochrane, Medline and Embase databases were searched for randomised controlled trials to date on robotic-assisted radical prostatectomy versus laparoscopic radical prostatectomy and robotic-assisted radical prostatectomy versus open radical prostatectomy to assess clinical effectiveness. The British Association of Urology Surgeons database (2014–2016) and Cancer Research UK (2012–2014) were accessed in conjunction with media; keywords included: ‘Da Vinci’, ‘first robotic prostatectomy’, ‘hospital’ to estimate the cost-effectiveness of robotic-assisted radical prostatectomy in the National Health Service.

Results:

Functional outcome rates improved with robotic-assisted radical prostatectomy; this benefits the National Health Service financially although the clinical effectiveness may not meet the threshold of clinical importance. Regarding cost-effectiveness, approximately 12/43 (27.9%) centres achieved 150 robotic-assisted radical prostatectomies per year while 26/43 (60.4%) centres have managed to meet 100 robotic-assisted radical prostatectomies per year in 2014–2016. A national mean of 120–130 robotic-assisted radical prostatectomies per year for 2014–2016 was estimated.

Conclusion:

The cost of robotic-assisted radical prostatectomy is adequately justified if a high volume of surgeries (>150) are performed in high volume centres by high volume experienced surgeons per year. This can be achieved by subsidising the cost of robotic technology, centralisation and establishing robotic training centres.

Keywords

Oncology (prostate)prostate cancer robotics laparoscopy training

Introduction

The debate between robotic-assisted radical prostatectomy (RARP) versus laparoscopic radical prostatectomy (LRP) and open radical prostatectomy (ORP) has been ongoing. Many ‘robosceptic’ articles have criticised the cost (£1.7–2.5 million) of robotic technology despite Da Vinci robots proving to be the sine qua non of minimal-access surgery. The technology gives a three-dimensional view, greater dexterity and tremor-free benefit to surgeons.¹

In urology, the National Institute for Health and Care Excellence (NICE) have only supported RARP based on health technology assessment (HTA) reports by providing an estimate of relative clinical effectiveness and cost-effectiveness within specified margins of uncertainty.² Clinical effectiveness is assessed by safety and efficacy of a technology whereas cost-effectiveness is determined by allocating resources to the technology that yields maximum benefit.² Patient demand always exceeds supply, therefore NICE applies the ‘£ per quality adjusted life years (QALY)’ metric to justify the cost-effectiveness of a technology.² Hence, this paper will evaluate the clinical effectiveness and cost-effectiveness of RARP versus LRP and RARP versus ORP to justify its expense in the National Health Service (NHS).

Methods

A single reviewer performed a literature search on the Cochrane Database of Systemic Reviews (up to March 2018), Medline (1946 to March 2018) and Embase (1974 to March 2018) with an identical search strategy to that of Salinas et al., 2013.³ Abstracts that were included were screened with identical eligibility criteria in Wang et al., 2017.⁴ PRISMA guidelines were followed for gathering clinical evidence, as demonstrated by the flow chart below (Figure 1).

Clinical effectiveness of RARP

Current systematic reviews and meta-analyses have been inadequately robust to prove the superiority of robotic outcomes as they include low quality non-randomised trials.^5–7 Furthermore, the UK Laparoscopic, Open, and Robot-Assisted Radical Prostatectomy (LOPERA) RCT study of prostatectomy was discontinued because only a quarter of men were willing to be randomly assigned. Only RCTs available to date (Table 1) were used as a goal standard to assess the efficacy and safety for RARP versus LRP and RARP versus ORP based on perioperative, oncological, postoperative and functional outcomes.

Table 1.

Description of studies.

Study	Type	Criteria	Intervention	Sample size	Characteristics
Asimakopoulos et al., 2011¹¹	RCT (Italy)	Inclusion: men with clinically localised prostate cancer (cT1–cT2), <70 years, serum PSA <10 ng/mL, Gleason score ⩽7, normal preoperative erectile function (IIEF-6 >17), normal preoperative continence (IPSS) Exclusion: preoperative incontinence, moderate or severe erectile dysfunction (IIEF 6 <17), neoadjuvant therapy, previous prostate, bladder neck or urethra surgery, positive MRI for extracapsular extension, non-bilateral nerve preservation	RARP vs. LRP	RARP: n=64 LRP: n=64	(i) Single surgeon trial, with experience of 900 LRP and 300 RARP (ii) Continence was defined as absence of leakage or no need of use of protective pads (iii) Potency was defined as ‘capability of intercourse’ and as an IIEF-6 scale score equal to or greater than 17, with or without the use of phosphodiesterase type 5 inhibitors (iv) Biochemical recurrence definition was not reported (v) Follow-up 12 months
Porpiglia et al., 2013¹⁰	RCT (Italy)	Inclusion: men with clinically localised prostate cancer according to TNM 2009 (T1–T2N0M0), remitted to institution for prostatectomy; between 40 and 70 Exclusion: previous radiotherapy and/or transurethral resection of the prostate gland	RARP vs. LRP	RARP: n=60 LRP: n=60	(i) Single surgeon trial, experience of >600 LRP and 100 RARP (ii) Continence was defined as the requirement of one or less safety pads per day (iii) Potency was defined as having an IIEF-5 scale score equal to or greater than 17 (iv) Biochemical recurrence was defined as PSA >0.2 ng/mL (v) Follow-up 12 months
Porpiglia et al., 2016¹²	RCT (Italy) follow-up				(i) Biochemical recurrence rates at 5 years(ii) Continence and potency follow-up at 5 years
Yaxley et al., 2016¹⁵	RCT-phase 3 (Australia)	Inclusion: age 35–75 years, newly diagnosed clinically localised prostate cancer; no previous history of head injury, dementia, or psychiatric illness; no concurrent other cancer; estimated life expectancy ⩾10 yearsExclusion: evidence of non-localised prostate cancer, PSA >20 ng/mL, previous laparoscopic hernia repair, previous pelvic radiotherapy or major pelvic surgery, another malignancy within past 5 years	RARP vs. ORP	RARP: n=157ORP: n=151	(i) Single centre trial: 1 surgeon with experience of >200 RARPs, 1 surgeon >1500 ORPs(ii) Primary outcomes: urinary continence, erectile function, oncological outcomes(iii) Secondary outcomes: pain, physical and mental functioning, fatigue, bowel function, prostate cancer distress, psychological distress, time to return to work(iv) Ongoing study, results pending

Adapted from Salinas et al., 2013³ and Wang et al., 2017.⁴

IIEF: international index of erectile function questionnaire; IPSS: international prostate symptom score; LRP: laparoscopic radical prostatectomy; MRI: magnetic resonance imaging; PSA: prostate-specific antigen; ORP: open radical prostatectomy; PSM: positive surgical margin; RARP: robotic-assisted radical prostatectomy; TNM: tumour staging (tumour, lymph node, metastasis).

Analysis

RARP versus LRP RCTs show no significance between perioperative, postoperative and oncological outcome measures contrary to a HTA report⁸ that found less positive surgical margins in RARP versus LRP. Only non-randomised trials with a low risk of bias in another HTA report showed similar oncological outcomes to the RCTs.⁹ Of note, the functional benefit of continence in RARP versus LRP was statistically significant at 12 months in one RCT,¹⁰ although both RCTs^10,11 showed 11% greater urinary continence recovery at 12 months. Both RCTs showed statistically significant benefit of erectile function recovery in favour of RARP at 12 months.^10,11 Achieving continence (odds ratio (OR) 2.47, P<0.021) and potency (OR 2.35, P<0.028) was also more than doubled in favour of RARP over 5 years.¹²

A phase 3 RARP versus ORP RCT suggested a statistically significant benefit of RARP in reducing hospital stay and decreasing blood loss similar to observational studies.^13,14 Positive surgical margins and functional benefit at 12 weeks were statistically insignificant.¹⁵ Although a multicentre retrospective study found no change in erectile function up to 6 months (P=0.076), a statistically significant change at 12 months (52.5% salvage RARP having no erections vs. 69.8% in salvage ORP, P=0.03) was noted.¹⁶ Continence function was also improved with salvage RARP at 6 months (22.3% vs. 38.1% in salvage ORP having severe incontinence using three or more pads per day, P=0.02) and 12 months (severe incontinence 9.8% vs. 34.2% salvage ORP, P=0.04).¹⁶

QALY re-evaluation

Ramsay et al.¹⁷ used costs and QALY to determine if the expense of RARP is justifiable compared to LRP. A limitation in the HTA analysis was that the QALY calculated was heavily influenced by positive surgical margins and biochemical recurrence. Although the costs for continence and erectile dysfunction were modelled for, they were not included in meta-analysis as studies were unreliable and paucity of data had implications on the economic evaluation.¹⁷

Despite the limited sexual function benefit of RARP versus LRP (P=0.004) and RARP versus ORP (P=0.002),¹⁸ in 2012 the NHS spent over £80 million on erectile dysfunction treatment.¹⁹ Forty per cent of patients who were sexually active preoperatively will experience worsening sexual function postoperatively.¹⁷ While the RCT for RARP versus ORP might be too early to suggest no functional improvement over 3 years,²⁰ RCTs for RARP versus LRP definitively show a 26–45% (P=0.02) (Table 2) improved erectile function postoperatively at 12 months. This could save the NHS £20–36 million annually, suggesting that a revised QALY is timely.²¹ Potentially, fewer than 150 RARPs per year may be the case for RARP to be cost-effective.

Table 2.

Comparison of prostatectomy outcomes.

Outcome	Yaxley et al., 2016¹⁵			Asimakopoulos et al., 2011¹¹			Porpiglia et al., 2013 and 2016^10,12
	ORP(151)	RARP(157)	P value	LRP(60)	RARP(52)	P value	LRP(60)	RARP(60)	P value
Lost to follow-up				4 (6.25%)	12 (18.75%)		0	0
Operative time (min)	280.37 (36.36)	246.08 (55.12)	<0.0001				138.1 (29.7)	147.6 (27.1)	0.068
Blood loss (mL)	1338.14 (591.47)	443.72 (294.29)	0.0001				234.1 (150.1)	202 (124.0)	0.203
Transfusion	6 (4%)	1 (1%)	0.12	3 (5)	0 (0)	0.1
Catheterisation time (days)	8.42 (3.28)	8.21 (3.64)	0.59	7.45 (2.3)	7.25 (2.7)	0.14	7.0 (0.5)	7.5 (3.9)	0.322
Hospitalisation time (days)	3.27 (1.49)	1.55 (2.61)	<0.0001				4.6 (2.1)	4.8 (1.9)	0.5853
Postoperative complications
Total complications	14 (9%)	6 (4%)	0.052	5 (8)	8 (15)	0.24	7 (11.6)	10 (16.6)	0.433
Positive margins
pT2				4 (7.7)	3 (7)	0.89	6/37 (16.2)	5/37 (13.5)	0.744
pT3				2 (25)	5 (55.6)	0.2	6/22 (27)	11/22 (50)	0.122
Total	15 (10)	23 (15)	0.21	6 (10)	8 (15.4)	0.39	12 (20)	16 (26.6)	0.388
Biochemical relapse				2 (3)	4(8)	0.3
Biochemical relapse-free survival rate at
12 months							98%	92.5%	0.190
5 years							81.6%	81.6%	0.649
Recovery of urinary continence at
6 weeks	74.50	71.10	0.09
12 weeks	83.80	82.50	0.48
12 months				50 (83)	49 (94)	0.07	50 (83.30)	57 (95)	0.04
2 years							51 (85.0)	58 (96.7)	<0.001
3 years							51 (86.4)	57 (96.6)	<0.001
4 years							50 (86.2)	56 (96.6)	<0.001
5 years							49 (84.5)	55 (96.5)	<0.001
Urinary continence recovery time (months)				3.03 (2.92)	2.56 (4.21)	0.27
Recovery of erectile function at
6 weeks	30.70	32.70	0.45
12 weeks	35.00	38.90	0.18
12 months				19 (32)	40 (77)	<0.0001	19 (54.2)^a	28 (80)^a	0.02
2 years							21 (60)	29 (82.9)	<0.001
3 years							19 (54.3)	27 (77.1)	<0.001
4 years							19 (54.3)	27 (77.1)	<0.001
5 years							18 (51.4)	26 (74.3)	<0.001
Sexual potency recovery (months)				6.32 (5.16)	2.37 (2.27)	0.0001

Adapted from Salinas et al., 2013³ and Wang et al., 2017.⁴

ORP: Open radical prostatectomy; LRP: laparoscopic prostatectomy; RARP: robotic-assisted radical prostatectomy; POP: postoperative. Values expressed as numbers (percentage) or mean (standard deviation) accordingly.

Bold text represents statistically significant outcomes.

Nerve-sparring surgery subgroup (on each arm).

Cost-effectiveness of RARP

The economic evaluation by Ramsay et al. also attempted to estimate the costs of robotic surgery.¹⁷ In two studies identified from the HTA report, despite excluding capital purchasing costs, RARP was $500–700 more expensive compared to LRP per surgery¹⁷ and a base case analysis of another HTA report (Ontario) shows that RARP is $6234 more expensive per ORP patient performed.⁴ The additional maintenance costs of a single Da Vinci robot is approximately $340,000 per year depending on the model used.¹⁷ Ramsay et al. also concluded that the incremental cost per QALY was less than £30,000 provided 150 RARPs per year were performed,¹⁷ which was supported by NICE in 2014.²

The British Association of Urology Surgeons (BAUS) prostatectomy audit 2014–2015 showed 13,920 radical prostatectomy procedures were performed by 179 surgeons across 86 centres, of which 65% were RARPs.²² The median radical prostatectomies performed over 2 years were 63.5 per surgeon and 164 per centre; however, the RARPs per year were not identified. To justify the expense we must assess RARPs per year as per NICE guidance.²³

Analysis

This study has identified the main reasons why fewer than 150 RARPs per centre were achieved, as stated below:

Saturation of RARP centres (Figure 2).

Recent procurement of Da Vinci robot (blue zone, Table 3).

Surgeons with lack of RARP training.

Table 3.

Total RARP performed from 1 January 2014 to 31 December 2016 (BAUS database).

Hospital	City	Number of RP cases expected	Data return from this unit (%)	Actual RP cases	Robotic surgery volume in centre (%)	Total RARP in 2014, 2015 and 2016	Estimated average volume of 2014-2016 volume of (RARP/year)
Guy’s and St Thomas’s Hospital	London	827	113.4	921	100	921 (2004)	307
University College Hospital	London	1049	84.8	890	99.33	884 (2012)	295
Southmead Hospital	Bristol	1010	75.5	762	98.95	755 (2009)	252
Addenbrooke’s Hospital	Cambridge	689	109.7	756	99.74	754 (2005)	251
Royal Devon and Exeter Hospital	Exeter	739	95.8	708	99.86	707 (Dec 2012)	236
Kent and Canterbury Hospital	Kent	649	100.9	655	100	655 (May 2011)	218
Southampton General Hospital	Hampshire	447	99.3	444	27.84	124 (June 2016)	^a124 ÷ (7/12) y = 213
Norfolk and Norwich University Hospital	Norfolk	388	97.7	379	30.87	117(May 2016)	^a[117 ÷ (7/12) y] = 201
Royal Hallamshire Hospital	Sheffield	644	102.5	660	87.88	580 (2013)	193
Royal Marsden hospital	London	559	103	576	99.83	575 (2007)	192
Freeman Hospital	Newcastle	512	100	512	99.41	509 (2012)	170
Lister Hospital, Stevenage	Hertfordshire	441	109.8	484	99.79	483 (July 2009)	161
Christie NHS Foundation Trust	Manchester	365	119.7	437	99.77	436 (2008)	145
St James University Hospital	Leeds	454	96	436	96.56	421 (2006)	140
Castle Hill Hospital	East Yorkshire	434	99.8	433	51.27	222 (June 2015)	^a222 ÷ [(7/12) + 1 y] = 140
Bradford Royal Infirmary	West Yorkshire	452	93.6	423	97.87	414 (Aug 2012)	138
New Cross Hospital	Wolverhampton	386	103.1	398	100	398 (2011)	133
St George’s Hospital	London	417	95.9	400	98.75	395 (2008)	132
Royal Bournemouth General Hospital	Bournemouth	415	94.5	392	99.75	391 (2013)	130
Arrowe Park Hospital	Wirral	351	112	393	95.42	375 (2013)	125
Stepping Hill Hospital	Stockport	325	95.4	310	63.23	196 (June 2015)	^a196 ÷ [(7/120 + 1 y] = 124
University Hospital Coventry	Coventry	368	100	368	97.83	360 (Feb 2014)	^a360 ÷ [(11/12) + 2 y] = 123
Royal Liverpool Hospital	Liverpool	366	96.7	354	100	354 (2011)	118
Cheltenham General Hospital	Gloucestershire	341	95	324	89.81	291 (March 2014)	^a291 ÷ [(10/12) + 2 y] = 103
Royal Sunderland Hospital	Sunderland	281	112.8	313	95.90	303 (Oct 2013)	101
The James Cook Hospital	Middlesbrough	338	106.8	361	60.11	217 (Nov2014)	^a217 ÷ [(2/12) + 2 y] = 100
Queen Alexandria Hospital	Oxford	308	96.1	296	100	296 (2012)	99
Leicester General Hospital	Leicestershire	236	99.2	234	91.45	214 (Nov 2014)	^a214 ÷ [(2/12) + 2 y] = 98
Royal Surrey County NHS trust	Guildford	608	118.1	680	42.9	292 (Dec 2009)	97
Royal Berkshire Hospital	Reading	290	88.6	257	100	257 (Oct 2008)	86
Nottingham City Hospital	Nottinghamshire	263	100.7	265	94.72	251 (Feb 2014)	^a251 ÷ [(11/12) + 2 y] = 86
Eastbourne District General Hospital	Sussex	305	75.4	230	61.30	141 (March 2015)	^a141 ÷ [(10/12) + 1 y] = 77
Royal Blackburn Hospital	Lancashire	105	103	108	90.74	98 (Sept 2015)	^a98 ÷ [(4/12) + 1 y] = 74
Churchill Hospital	Oxford	303	75.3	228	94.30	215 (2010)	72
Derriford Hospital	Plymouth	244	79.1	193	61.66	119 (April 2015)	^a119 ÷ [(9/12) + 1 y] = 68
Wexham Park Hospital	Berkshire	100	136	136	100	136 (Nov 2014)	^a136 ÷ [(2/12) + 2 y] = 62
Royal Derby Hospital	Derbyshire	214	96.7	207	52.17	108 (Dec 2014)	^a108 ÷ [(1/12) + 2 y] = 52
Bristol Oncology Centre	Bristol	6	916.7	55	89.09	49 (data 2014–2015)	49
St Mary Hospital	London	–	72.4	–	97.69	127 (2000)	42
University Hospital of North Staffordshire	Staffordshire	144	95.1	137	73.72	101 (July 2014)	^a101 ÷ [(6/12) + 2 y] = 40
Queen Elizabeth hospital	Birmingham	621	99	615	13.5	83 (Jan 2014)	28
Burnley General Hospital	Burnley	62	103	64	4.76	3 (data 2014–2015)	3
Manchester Royal Infirmary	Manchester	210	99.5	209	0.96	2 (data 2014–2016)	2

RARP: robotic-assisted radical prostatectomy; RP: radical prostatectomy; BAUS: British Association of Urology Surgeons.

Denotes >RARP 150/year. Denotes centres >95% RARP.

Denotes > or ≈RARP 100/year. Denotes centres > or ≈90% RARP.

Denotes <RARP 100/year. Denotes centres <90% RARP.

Denotes hospitals that received Da Vinci late in BAUS audit period (between 2014 and 2016).

(Month, year) based on media reports of Da Vinci robot installation in hospitals.

Denotes calculation of RARP/year for centres. Other centres total RARP/3 years.

Centralisation of RARP

Centralisation of complex cancer surgery between 2010 and 2017 has seen robotic centres more than triple from 12/65 in 2010 to 42/49 in 2017. Fewer high-volume complex cancer centres and a rise in the number of men approaching robotic centres have prompted the installation of Da Vinci robots, seeing that 16 centres that did not closed.²⁵ In 2018, approximately 60 robotic centres exist, 20 more compared to previous recommendations.²⁶

Most centres in the red and amber zone (Table 3) are affected by the incidence rates of prostate cancer (Figure 2) as it is proportional to case volume. Red arrow regions have a greater case volume compared to green arrow regions; however, the saturation of RARP centres in the south west, south central, west midlands and north west results in insufficient RARPs performed. Da Vinci robots should be distributed according to geography and population density.²⁶ Centres performing RARP should also consider the incidence rates of prostate cancer. The uptake of second Da Vinci robots should only be focused at centres already achieving more than 150 RARPs per year (e.g. Southmead Hospital, Guy’s and St Thomas Hospital).²⁶ Three to four centres in red arrow regions and two to three centres in amber and green arrow regions are ideal.

Cost subsidisation

Approaching charities and capitalising on fundraisers with other multiple specialties strengthening the business case to raise a minimum £1 million of donations is pivotal to guarantee the service contract and Da Vinci instrument costs for a defined period beyond installation.²⁷ The Clinical Commissioning Group has also approved reimbursing providers as per the national tariff for da Vinci robotic-assisted surgery 2014–2015²⁸ provided centres:

meet RARPs 150 per year;

establish robotic-training programmes;

conduct local audits;

participate in national audits (e.g. BAUS audits).

Joint partnerships with private companies can be a good investment by sharing facilities, for instance with 2 days use in NHS at NHS tariff ratings.²⁹ Intuitive surgical has also released an interim cost-effective model Da Vinci X (2017) for prostatectomies. Additional Xi functions can be added on or X can be upgraded to Xi later on with this system.³⁰ Furthermore, CMR surgical (UK) has also released Versius, which has good potential in reducing the cost of robotic technology in the NHS.

Training centres

BAUS have proposed a five-stage robotic surgical curriculum³¹ to increase RARP because ORP was found to be dominant in lower-volume surgeons and centres.²² While the learning curve for RARP is shorter than for LRP, it is postulated that 50–200 cases is ideal before urologists are proficient in performing RARP.³² The skills learnt are also transferrable to other robotic urology procedures such as partial nephrectomies.³³ The study by Yaxley et al.¹⁵ is unique as it compares the outcome between senior and junior surgeons. The early findings demonstrate that RARP is only cost-effective in the hands of an experienced surgeon.³⁴ Hence, training centres should invest in dual consoles for each robot to increase the quality of training of junior surgeons as a senior and junior surgeon may operate simultaneously, which can reduce the learning curve.³⁵

Conclusion

While the clinical effectiveness only shows that RARP has a marginal advantage compared to LRP and ORP, the financial implications of the marginal benefits could save the NHS millions. The future shows that robotic technology has a place to stay, with the caveat that the uptake per centre is carried out responsibly and we look to newer cost-effective models such as Versius. Robotic technology can be sustainable following the proposed algorithm in Figure 3.

Footnotes

Acknowledgements

The author would like to express his gratitude to Professor Toby Page for assessing his BAUS essay and providing valuable feedback. He would also like to thank Professor Hashim Hashim for his guidance and the opportunity to participate in the BAUS medical student essay prize 2018.

Conflicting interests

The author declares that there is no conflict of interest.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Ethical approval

Ethical approval was not required in the manuscript. All data used from the BAUS prostatectomy database and respective studies had previously undergone appropriate ethical approval.

Informed consent

Not applicable.

ORCID iD

Jasmesh Sandhu

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