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Editorial: Translating cost-utility modelling into the real world – the case of focal high-intensity focussed ultrasound and active surveillance

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Health economic modelling is always a challenge. The inputs are never quite what we want them to be. The literature that we have at our disposal suffers from the inevitable deficiencies of lack of maturity, ever diminishing relevance, and questionable applicability as practice evolves. The modelling can never quite reflect the nuances and vagaries of clinical practice. However, the process is an important and in some cases (evaluation by the UK’s National Institute of Clinical and Care Excellence) a necessary one. Knowing the cost of achieving a given health status over a defined time frame is an important consideration in the allocation resource in any finite system of care.

The paper by Bénard et al. [1] is most useful in helping us to understand what the issues are and how our decision-making might impact on cost in the context of low-to-moderate risk prostate cancer.

The issue with these types of analyses is the degree to which the inevitable assumptions made by the investigators are consistent with current practice. Below I have tried to identify some of the areas in which the assumptions diverge from current knowledge and ‘know-how’, in order to illustrate just how difficult the task that Bénard et al. [1] have undertaken.

The first relates to the assumption that both strategies can be applied to the same population. They cannot, or perhaps more correctly – should not. For instance, nobody I know would offer a man focal treatment who had well-characterised micro-focal low-volume Gleason 3+3 (or Gleason Grade Group 1) [2]. We know, from what now constitutes a considerable body of level-1 evidence, that there is no benefit to be derived from intervening in disease that confers little, if any, risk of premature death [3]. Today, focal therapy tends to be applied to men with well-characterised, visually localised Gleason Grade Group ≥2, who want to avoid radical whole gland therapy and the genitourinary side-effects associated with them [4].

The second relates to the synergies between the two treatments. Increasingly men who opt for active surveillance (AS) upfront have an increasing tendency to opt for focal treatment on radiological progression of any lesion under scrutiny. This makes quite a bit of intuitive sense. These are men who appear comfortable with the process of observation, are likely to place high utility on genitourinary function, may have exhibited a very stable background prostate (apart from the expanding lesion depicted on MRI), are likely to be very well informed, and will, by now, be very well-characterised histologically. These, as it happens, are the ideal attributes for a candidate for focal therapy.

The third is a reflection on the relevance of the literature to inform the question being posed. It is no fault of the authors that AS has changed beyond recognition in the last few years. This change has been driven by the use of MRI in the risk stratification process for candidate selection, the substation of temporal biopsy assessment by imaging and the reduction, and at times elimination, of the re-classification vs progression error that confounds most of the literature on
surveillance. Modelling events on historical single-institution cohorts (as AS has never been evaluated in a randomised setting apart from one comparison against focal therapy) is probably unhelpful in helping us to understand and inform our future [5].

The fourth concerns scope. Why limit this analysis to focal high-intensity focussed ultrasound? All focal therapies, irrespective of energy source, seem to produce very similar outcomes, both in terms of freedom from failure (time to radical treatment and/or metastasis) and in relation to preservation of genitourinary function. Broadening the scope, by including vascular targeted photo-therapy and cryotherapy, would have meant that randomised trials could have been
included as inputs, with the effect of possibly reducing the high levels of uncertainty that bedevil the current analysis [5,6].

The fifth recognises the dynamic nature of the progression risk in AS cohorts. This is an important, but poorly recognised, attribute of the mature AS cohorts that we tend to rely upon. These cohorts are dynamic entities that have as entrants men of increasingly lower risk (due to a recent improvement in risk stratification) and, at the same time, continually exit the very men with the highest risk, i.e., the ‘progressors’. Thus, over time, the cohort undergoes a gradual, but inevitable, reduction in risk. The more mature the cohort, the greater the reduction. By referencing mature cohorts (when trying to predict the fate of future patients) we
will, therefore, have a tendency to over-estimate the benefit/safety of AS in a contemporary setting.

This is not to say that we should not endeavour to estimate the cost of achieving a given health state. We need this, perhaps more than ever. What we need to strive towards are models that represent both the reality of practice and the very latest, and most subtle, distillation of the current evidence.

by Mark Emberton

 

References

  1. Bénard A, Duroux T, Robert G. Cost-utility analysis of focal high-intensity focussed ultrasound vs active surveillance for low- to intermediate-risk prostate cancer using a Markov multi-state model. BJU Int 2019; 124: 962–71
  2. Klotz L, Emberton M. Management of low risk prostate cancer-active surveillance and focal therapy. Nat Rev Clin Oncol 2014; 11: 324–34
  3. Hamdy FC, Donovan JL, Lane JA et al. 10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. N Engl J Med 2016; 375: 1415–24
  4. Elliott D, Hamdy FC, Leslie TA et al. Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation vs radical prostatectomy for unilateral localised prostate cancer. JU Int 2018; 122: 970–7
  5. Azzouzi AR, Vincendeau S, Barret E et al. Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial. Lancet Oncol 2017; 18: 181–91
  6. Donnelly BJ, Saliken JC, Brasher PM et al. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer. Cancer 2010; 116: 323–30

 

 

Residents’ podcast: NICE Guidance – Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

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Nikita Bhatt is a Specialist Trainee in Urology in the East of England Deanery and a BURST Committee member @BURSTUrology

NICE Guidance – Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

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Recommendations

  • 1.1 The evidence on transurethral water jet ablation for lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) raises no major safety concerns. The evidence on efficacy is limited in quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
  • 1.2 Clinicians wishing to do transurethral water jet ablation for LUTS caused by BPH should:
    • Inform the clinical governance leads in their NHS trusts.
    • Ensure that patients understand the uncertainty about the procedure’s efficacy and provide them with clear written information to support shared decision‐making. In addition, the use of the National Institute for Health and Care Excellence (NICE) information for the public is recommended.
    • Audit and review clinical outcomes of all patients having transurethral water jet ablation for LUTS caused by BPH. NICE has identified relevant audit criteria and has developed an audit tool (which is for use at local discretion).
  • 1.3 The procedure should only be done by clinicians who have been trained in the technique.
  • 1.4 NICE encourages further research into transurethral water jet ablation for LUTS caused by BPH and may update the guidance on publication of further evidence. Further research should report long‐term follow‐up and include re‐intervention rates.
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Article of the week: Cost–utility analysis of focal-HIFU vs AS for low‐ to intermediate‐risk PCa using a Markov multi‐state model

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Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an editorial written by a prominent member of the urology community and a video prepared by the authors; we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this week, it should be this one.

Cost–utility analysis of focal high‐intensity focussed ultrasound vs active surveillance for low‐ to intermediate‐risk prostate cancer using a Markov multi‐state model

Antoine Bénard*†, Thomas Duroux* and Gregoire Robert‡

*Univ. Bordeaux, Inserm, UMR 1219, Bordeaux Population Health Research Center, Team EMOS, †CHU de Bordeaux, Pôle de santé publique, Service d’information Médicale, USMR & CIC-EC 14-01, and ‡CHU de Bordeaux, Service d’urologie, Andrologie et Transplantation Renale, Université de Bordeaux, Bordeaux, France

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Abstract

Objectives

To estimate the relative cost‐effectiveness of focal high‐intensity focussed ultrasound (F‐HIFU) compared to active surveillance (AS) in patients with low‐ to intermediate‐risk prostate cancer, in France.

Patients and Methods

A Markov multi‐state model was elaborated for this purpose. Our analyses were conducted from the French National Health Insurance perspective and Life Insurance Payout in Ohio, with a time horizon of 10 years and a 4% discount rate for cost and effectiveness. A secondary analysis used a 30‐year time horizon. Costs are presented in 2016 Euros (€), and effectiveness is expressed as quality‐adjusted life years (QALYs). Model parameters’ value (probabilities for transitions between health states, and cost and utility of health states) is supported by systematic literature reviews (PubMed) and random effect meta‐analyses. The cost of F‐HIFU in our model was the temporary tariff attributed by the French Ministry of Health to the overall treatment of prostate cancer by HIFU (€6047).

Our model was analysed using Microsoft Excel 2010 (Microsoft Corp., Redmond, WA, USA). Uncertainty about the value of the model parameters was handled through probabilistic analyses.

Results

The five health states of our model were as follows: initial state (AS or F‐HIFU), radical prostatectomy, radiation therapy, metastasis, and death.

Transition probabilities from the initial F‐HIFU state relied on four articles eligible for our meta‐analyses. All were non‐comparative studies. Utilities relied on a single cohort in San Diego, CA, USA.

For a fictive cohort of 1000 individuals followed for 10 years, F‐HIFU would be €207 520 more costly and would yield 382 less QALYs than AS, which means that AS is cost‐effective when compared to F‐HIFU. For a threshold value varying from €0 to 100 000/QALY, the probability of AS being cost‐effective compared to F‐HIFU varied from 56.5% to 60%. This level of uncertainty was in the same range with a 30‐year time horizon.

Conclusion

Given existing published data, our results suggest that AS is cost‐effective compared to F‐HIFU in patients with low‐ and intermediate‐risk prostate cancer, but with high uncertainty. This uncertainty must be scaled down by continuing to supply the model with new published data and ideally through a randomised clinical trial that includes cost‐effectiveness analyses.

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Residents’ podcast: NICE Guidance – Prostate cancer: diagnosis and management

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Mr Joseph Norris is a Specialty Registrar in Urology in the London Deanery. He is currently undertaking an MRC Doctoral Fellowship at UCL, under the supervision of Professor Mark Emberton. His research interest is prostate cancer that is inconspicuous on mpMRI. Joseph sits on the committee of the BURST Research Collaborative as the Treasurer and BSoT Representative.

NICE Guidance – Prostate cancer: diagnosis and management

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Context

Prostate cancer is the most common cancer in men, and the second most common cancer in the UK. In 2014, there were over 46,000 new diagnoses of prostate cancer, which accounts for 13% of all new cancers diagnosed. About 1 in 8 men will get prostate cancer at some point in their life. Prostate cancer can also affect transgender women, as the prostate is usually conserved after gender-confirming surgery, but it is not clear how common it is in this population.

More than 50% of prostate cancer diagnoses in the UK each year are in men aged 70 years and over (2012), and the incidence rate is highest in men aged 90 years and over (2012 to 2014). Out of every 10 prostate cancer cases, 4 are only diagnosed at a late stage in England (2014) and Northern Ireland (2010 to 2014). Incidence rates are projected to rise by 12% between 2014 and 2035 in the UK to 233 cases per 100,000 in 2035.

A total of 84% of men aged 60 to 69 years at diagnosis in 2010/2011 are predicted to survive for 10 or more years after diagnosis. When diagnosed at the earliest stage, virtually all people with prostate cancer survive 5 years or more: this is compared with less than a third of people surviving 5 years or more when diagnosed at the latest stage.

There were approximately 11,000 deaths from prostate cancer in 2014. Mortality rates from prostate cancer are highest in men aged 90 years and over (2012 to 2014). Over the past decade, mortality rates have decreased by more than 13% in the UK. Mortality rates are projected to fall by 16% between 2014 and 2035 to 48 deaths per 100,000 men in 2035.

People of African family origin are at higher risk of prostate cancer (lifetime risk of approximately 1 in 4). Prostate cancer is inversely associated with deprivation, with a higher incidence of cases found in more affluent areas of the UK.

Costs for the inpatient treatment of prostate cancer are predicted to rise to £320.6 million per year in 2020 (from
£276.9 million per year in 2010).

This guidance was updated in 2014 to include several treatments that have been licensed for the management of
hormone-relapsed metastatic prostate cancer since the publication of the original NICE guideline in 2008.
Since the last update in 2014, there have been changes in the way that prostate cancer is diagnosed and treated. Advances in imaging technology, especially multiparametric MRI, have led to changes in practice, and new evidence about some prostate cancer treatments means that some recommendations needed to be updated.

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Article of the week: The impact of prostate‐specific antigen persistence after radical prostatectomy on the efficacy of salvage radiotherapy in patients with primary N0 prostate cancer

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Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an editorial written by a prominent member of the urology community and a visual abstract created by our talented infographics team; we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this week, it should be this one.

The impact of prostate‐specific antigen persistence after radical prostatectomy on the efficacy of salvage radiotherapy in patients with primary N0 prostate cancer

Detlef Bartkowiak*, Alessandra Siegmann†, Dirk Böhmer†, Volker Budach† and Thomas Wiegel*

*Department of Radiation Oncology, University Hospital Ulm, Ulm and †Department of Radiation Oncology, Charité University Hospital, Berlin, Germany

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Abstract

Objective

To test whether salvage radiotherapy (SRT) in patients with lymph node negative (N0) prostate cancer is equally effective with persistent prostate‐specific antigen (PSA) and PSA rising from the undetectable range (<0.1 ng/mL) after radical prostatectomy (RP).

Patients and methods

We assessed post‐SRT PSA progression‐free survival (PFS) in 555 patients with prostate cancer and the use of cancer care nurses is the best option for this. The entire cohort was compared with a risk‐adjusted subgroup of 112 patient pairs with matching pre‐RP PSA level (±10 ng/mL), Gleason score (≤6 vs 7 vs ≥8), and pre‐SRT PSA level (±0.5 ng/mL).

Results

The median follow‐up was 6.1 years. After RP, PSA was undetectable in 422 and persistent in 133 patients. PSA persistence and a pre‐SRT PSA level of ≥0.5 ng/mL reduced Kaplan–Meier rates of PFS significantly. In multivariate analysis of the entire cohort and after risk adjustment, the pre‐SRT PSA level but not post‐RP PSA persistence was a significant parameter. In the matched cohort’s subgroup with early SRT at a PSA level of <0.5 ng/mL, a trend towards a worse outcome with post‐RP PSA persistence was observed. Delayed SRT with a PSA level ≥0.5 ng/mL led to a PFS of <30%, irrespective of the post‐RP PSA level.

Conclusion

In patients with N0 prostate cancer with post‐RP PSA persistence, early SRT at a PSA level <0.5 ng/mL seems to be less effective than in recurrent patients with post‐RP undetectable PSA. They might benefit from intensified therapy ans the use of several supplements like the lgd-4033, but larger case numbers are required to substantiate this conclusion. In patients with a PSA level ≥0.5 ng/mL and higher‐risk features associated with post‐RP PSA persistence, SRT alone is unlikely to provide long‐term freedom from further progression.

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Editorial: PSA persistence after radical prostatectomy needs more than standard therapeutic options to improve outcomes

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In their retrospective study, Bartkowiak et al. [1] report the therapeutic outcomes of salvage radiation therapy (sRT) after radical prostatectomy (RP) for lymph‐node‐negative prostate cancer in 422 and 133 patients with biochemical relapse or persistently detectable PSA, respectively. In the total cohort, patients with persistent PSA serum levels ≥0.1 ng/mL postoperatively had significantly shorter progression‐free survival as compared to patients with undetectable PSA levels (P < 0.001). After risk‐matched analysis, PSA persistence was not a risk factor associated with poor outcome and only a PSA serum concentration ≥0.5 ng/mL at time of sRT was associated with early relapse in both patients with detectable and those with undetectable PSA levels postoperatively.

Although this retrospective study adds some additional evidence to support the already well‐known recommendation to initiate sRT as early as possible [2], there are various issues that need to be considered when it comes to the interpretation of sRT results in patients with PSA persistence. The patient cohort is heterogeneous since the men underwent surgery between the years 1989 and 2012 and sRT between the years 1997 and 2012. The treatment strategies and techniques used with regard to surgery and sRT are outdated and no longer reflect current practice. No patient underwent modern imaging studies to identify extent and anatomical distribution of relapsing lesions, and neither was a risk‐adapted approach realized using nomograms or molecular markers in order to stratify treatment dependent on the biological aggressiveness of the disease.

PSA persistence is associated with an increased risk of metastases and impaired cancer‐specific survival as compared to undetectable PSA levels after RP for patients with negative and positive lymph nodes [3,4,5]. In fact, the majority of patients with persisting PSA serum levels postoperatively have locally advanced prostate cancer, positive lymph nodes, positive surgical margins and high Gleason scores. In almost all published studies, PSA persistence has been identified as an independent risk factor for the development of systemic metastases and poor survival. Similar results have already been reported by Wiegel et al. [5] when analysing outcomes among 74 patients with PSA persistence after RP; postoperatively detectable PSA was associated with significantly poorer outcomes in terms of metastasis‐free (84% vs 93%) and overall survival (68% vs 86%), and remaining without androgen deprivation therapy (ADT) during follow‐up (57% vs 92%).

PSA persistence needs to be taken seriously even at low serum concentrations, necessitating the implementation of new imaging methods and combination therapies. Because PSA persistence is associated with adverse pathological features, a treatment strategy to avoid PSA persistence is initiated already at the time of RP, integrating preoperative MRI, intra‐operative frozen‐section analysis and extended pelvic lymphadenectomy in order to achieve complete resection of the prostate cancer with undetectable PSA levels 6 weeks postoperatively.

In addition to properly conducted surgery, innovative imaging techniques, such as 68gallium (68Ga) prostate‐specific membrane antigen (PSMA)‐positron emission tomography (PET)/CT, should be integrated into treatment to differentiate locoregional recurrences from systemic metastases. In this context, Schmidt‐Hegemann et al. [6] evaluated the impact of 68GaPSMA‐PET/CT on subsequent treatment in 129 patients, of whom 48% demonstrated PSA persistence. In their analysis, patients with persistently detectable PSA serum levels more often demonstrated PSMA‐positive lesions (70% vs 50%), less frequently experienced local recurrences only (12% vs 26%), and more often had positive lymph nodes (13% vs 5%) with or without a macroscopically persisting tumour in the prostatic fossa (45% vs 19%). Results from PSMA‐PET/CT changed the initial treatment of sRT in so far as all patients with positive lesions underwent a combination of sRT and ADT. In patients with isolated, intrapelvic lymph node metastases attributable to an improperly performed extended pelvic lymphadectomy, salvage lymphadectomy might also be integrated into the therapeutic armamentarium, resulting in a long‐term relapse‐free survival of ~40%.

Even patients with persisting PSA serum concentrations after undergoing RP exhibit a heterogeneous clinical course of the disease, therefore, a risk‐adapted, personalized approach stratifying biologically aggressive from less aggressive prostate cancer should be adopted. In a retrospective study in 925 patients who underwent sRT, PSA persistence was associated with a significantly lower 8‐year metastasis‐free survival rate when compared to patients with PSA relapse following undetectable postoperative PSA serum concentrations [3]. Furthermore, it was shown that PSA persistence and a Gleason score ≥8 were independent, statistically significant predictors for systemic metastases, with a hazard ratio of 4.64 (95% CI 3.06–7.02; P < 0.001) and 8.37 (95% CI 4.15–16.88; P < 0.001), respectively. Patients with both PSA persistence and Gleason score ≥8 had a significantly lower 8‐year metastasis‐free survival rate as compared with patients with only PSA persistence (62% vs 74%); therefore, the latter might be best treated with a combined approach of sRT and ADT.

Integration of molecular markers might be helpful to identify those patients who will benefit from sRT. Spratt et al. [7] evaluated whether a 22‐gene genomic classifier could independently predict development of metastasis in 477 patients with PSA persistence postoperatively. Among those with detectable PSA, the 5‐year metastasis rate was 0.90% for genomic low/intermediate and 18% for genomic high risk (P < 0.001). Genomic high risk remained independently prognostic on multivariable analysis (hazard ratio 5.61, 95% CI 1.48–22.7; P = 0.01) among patients with detectable PSA. The C‐index for the combination of the genomic classifier with Cancer of the Prostate Risk Assessment (CAPRA) score was 0.82.

In summary, modern management of persistent PSA serum concentrations after RP needs to take into consideration the pathohistology of the RP and lymph node specimens, results from PSMA‐PET/CT, molecular markers associated with relapse and response as well as individualized therapeutic strategies such as sRT ± ADT, salvage lymphadenectomy and additional salvage radiation to oligometastatic sites.

by Axel Heidenreich and David Pfister

References

  1. Bartkowiak D, Siegmann A, Böhmer D, Budach V, Wiegel T. The impact of PSA persistence after prostatectomy on the efficacy of salvage radiotherapy in primary N0 patients. BJU Int 2019; 124: 785-91
  2. NICE guidelines on prostate cancer 2019. BJU Int 2019; 124: 9– 26
  3. Fossati N, Karnes RJ, Colicchia M et al. Impact of early salvage radiation therapy in patients with persistently elevated or rising prostate‐specific antigen after radical prostatectomy. Eur Urol 2018; 73: 434-44.
  4. Preisser F, Chun FKH, Pompe RS et al. Persistent prostate‐specific antigen after radical prostatectomy and its impact on oncologic outcomes. Eur Urol 2019; 76: 106– 14
  5. Wiegel T, Bartkowiak D, Bottke D et al. Prostate‐specific antigen persistence after radical prostatectomy as a predictive factor of clinical relapse‐free survival and overall survival: 10‐year data of the ARO 96‐02 trial. Int J Radiat Oncol Biol Phys 2015; 91: 288– 94
  6. Schmidt‐Hegemann NS, Fendler WP, Ilhan H et al. Outcome after PSMA PET/CT based radiotherapy in patients with biochemical persistence or recurrence after radical prostatectomy. Radiat Oncol 2018; 13: 37
  7. Spratt DE, Dai DLY, Den RB et al. Performance of a prostate cancer genomic classifier in predicting metastasis in men with prostate‐specific antigen persistence postprostatectomy. Eur Urol 2018; 74: 107– 14

 

Visual abstract: The impact of PSA persistence after RP on the efficacy of salvage radiotherapy in patients with primary N0 PCa

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Residents’ podcast: NICE guidelines: Urinary tract infection

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Nikita Bhatt is a Specialist Trainee in Urology in the East of England Deanery and a BURST Committee member @BURSTUrology

NICE guideline: Urinary tract infection (lower): antimicrobial prescribing

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This guideline sets out an antimicrobial prescribing strategy for lower urinary tract infection (also called cystitis) in children, young people and adults who do not have a catheter. It aims to optimise antibiotic use and reduce antibiotic resistance.

See also the following related NICE guidelines: Complicated UTIS; and Sepsis

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BJUI Podcasts now available on iTunes, subscribe here https://itunes.apple.com/gb/podcast/bju-international/id1309570262

Article of the month: Guideline of guidelines: testosterone therapy for testosterone deficiency

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Every month, the Editor-in-Chief selects an Article of the Month from the current issue of BJUI. The abstract is reproduced below and you can click on this Testogen review to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is a visual abstract produced by one of our creative urologist colleagues and a video prepared by the authors; we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this month, it should be this one.

Guideline of guidelines: testosterone therapy for testosterone deficiency

Carolyn A. Salter and John P. Mulhall

Department of Urology, Memorial Sloan Kettering Cancer Center, New York, NY, USA

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Abstract

We analysed the guidelines for testosterone therapy (TTh) produced by major international medical societies including: the American Urological Association, European Association of Urology, American Association of Clinical Endocrinologists, British Society for Sexual Medicine, Endocrine Society, International Society for Sexual Medicine, and the International Society for the Study of the Aging Male, and compared their recommendations.

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All the organisations were in general agreement concerning the following key points:

  • Only men meeting the criteria for testosterone deficiency (TD) should be treated.
  • Consider screening asymptomatic men with certain conditions that increase the risk of TD.
  • Exogenous TTh causes impairment of spermatogenesis.
  • There is no evidence that TTh causes prostate cancer.
  • Men on TTh require careful laboratory monitoring.
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