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Article of the Week: NICE Guidance. Sepsis – recognition, diagnosis and early management

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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.

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

Sepsis: recognition, diagnosis and early management

 

Overview
This guideline covers the recognition, diagnosis and early management of sepsis for all populations. The guideline
committee identified that the key issues to be included were: recognition and early assessment, diagnostic and prognostic value of blood markers for sepsis, initial treatment, escalating care, iden tifying the source of infection, early monitoring, information and support for patients and carers, and training and education.
Who is it For?
•People with sepsis, their families and carers.
•Healthcare professionals working in primary, secondary and tertiary care. Recommendations
People have the right to be involved in discussions and make informed decisions about their care, as described in
your care [https://www.nice.org.uk/about/nice-communities/public-involvement/your-care].Making decisions  using NICE guidelines [https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-guidelines/using-NICE-guidelines-to-make-decisions] explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

 

More Information
You can also see this guideline in the NICE pathway on sepsis [https://pathways.nice.org.uk/pathways/sepsis].
To find out what NICE has said on topics related to this guideline, see our web page on infections [https://www.nice.org.uk/guidance/conditions-and-diseases/infections]. See also the guideline committee’s discussion and the evidence reviews (in the full guideline [https://www.nice.org.uk/Guidance/NG51/evidence]), and information about how the guideline was developed [https://www.nice.org.uk/Guidance/NG51/documents], including details of the committee. Recommendations for Research The guideline committee has made the following recommendations for research.

 

© NICE (2017) Sepsis: recognition, diagnosis and early management

 

NICE Guidance: Routine preoperative tests for elective surgery

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Overview

This guideline covers routine preoperative tests for people aged over 16 who are having elective surgery. It aims to reduce unnecessary testing by advising which tests to offer people before minor, intermediate and major or complex surgery, taking into account specific comorbidities (cardiovascular, renal and respiratory conditions and diabetes and obesity). It does not cover pregnant women or people having cardiothoracic procedures or neurosurgery. To Get accurate insights into your health with an at-home blood test visit https://www.numan.com/blood-tests.

Who is it for?

  • Healthcare professionals
  • People having elective surgery, their families and carers

This guideline updates and replaces NICE guideline CG3 (published June 2003).

Recommendations

People have the right to be involved in discussions and make informed decisions about their care, as described in your care [https://www.nice.org.uk/about/nice-communities/public-involvement/your-care].

We expect you to take our guidance into account. But you should always base decisions on the person you are working with.

Making decisions using NICE guidelines [https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-guidelines/using-NICE-guidelines-to-make-decisions] explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Guidance on consent for young people aged 16–17 is available from the reference guide to consent for examination or treatment [https://www.gov.uk/government/publications/reference-guide-to-consent-for-examination-or-treatment-second-edition] (Department of Health).

The tests covered by this guideline are:

  • chest X-ray
  • echocardiography (resting)
  • electrocardiography (ECG; resting)
  • full blood count (haemoglobin, white blood cell count and platelet count)
  • glycated haemoglobin (HbA1c) testing
  • haemostasis tests
  • kidney function (estimated glomerular filtration rate, electrolytes, creatinine and sometimes urea levels)
  • lung function tests (spirometry, including peak expiratory flow rate, forced vital capacity and forced expiratory volume) and arterial blood gas analysis
  • polysomnography
  • pregnancy testing
  • sickle cell disease/trait tests
  • urine tests.

The recommendations were developed in relation to the following comorbidities:

  • cardiovascular
  • diabetes
  • obesity
  • renal
  • respiratory.

Recommendations relevant for all types of surgery

A colour poster version of these recommendations can be downloaded from tools and resources [https://www.nice.org.uk/guidance/ng45/resources].

  • 1.1

    Communication

    • 1.1.1
      When offering tests before surgery, give people information in line with recommendations (including those on consent and capacity) made in the NICE guideline on patient experience in adult NHS services [https://www.nice.org.uk/guidance/cg138].
    • 1.1.2
      Ensure that the results of any preoperative tests undertaken in primary care are included when referring people for surgical consultation.
  • 1.2

    Considering existing medicines

    • 1.2.1
      Take into account any medicines people are taking when considering whether to offer any preoperative test.
  • 1.3

    Pregnancy tests

    • 1.3.1
      On the day of surgery, sensitively ask all women of childbearing potential whether there is any possibility they could be pregnant.
    • 1.3.2
      Make sure women who could possibly be pregnant are aware of the risks of the anaesthetic and the procedure to the fetus.
    • 1.3.3
      Document all discussions with women about whether or not to carry out a pregnancy test.
    • 1.3.4
      Carry out a pregnancy test with the woman’s consent if there is any doubt about whether she could be pregnant.
    • 1.3.5
      Develop locally agreed protocols for checking pregnancy status before surgery.
    • 1.3.6
      Make sure protocols are documented and audited, and in line with statutory and professional guidance.
  • 1.4

    Sickle cell disease or sickle cell trait tests

    • 1.4.1
      Do not routinely offer testing for sickle cell disease or sickle cell trait before surgery.
    • 1.4.2
      Ask the person having surgery if they or any member of their family have sickle cell disease.
    • 1.4.3
      If the person is known to have sickle cell disease and has their disease managed by a specialist sickle cell service, liaise with this team before surgery.
  • 1.5

    HbA1c testing for people without diagnosed diabetes

    • 1.5.1
      Do not routinely offer HbA1c testing before surgery to people without diagnosed diabetes.
  • 1.6

    HbA1c testing for people with diabetes

    • 1.6.1
      People with diabetes who are being referred for surgical consultation from primary care should have their most recent HbA1c test results included in their referral information.
    • 1.6.2
      Offer HbA1c testing to people with diabetes having surgery if they have not been tested in the last 3 months.
  • 1.7

    Urine tests

    • 1.7.1
      Do not routinely offer urine dipstick tests before surgery.
    • 1.7.2
      Consider microscopy and culture of midstream urine sample before surgery if the presence of a urinary tract infection would influence the decision to operate.
  • 1.8

    Chest X-ray

    • 1.8.1
      Do not routinely offer chest X-rays before surgery.
  • 1.9

    Echocardiography

    • 1.9.1
      Do not routinely offer resting echocardiography before surgery.
    • 1.9.2

      Consider resting echocardiography if the person has:

      • a heart murmur and any cardiac symptom (including breathlessness, pre-syncope, syncope or chest pain) or
      • signs or symptoms of heart failure.

Before ordering the resting echocardiogram, carry out a resting electrocardiogram (ECG) and discuss the findings with an anaesthetist.

Recommendations for specific surgery grades (minor, intermediate, and major or complex) and ASA grades

The following recommendations are specific to surgery grade and ASA grade.

Surgery grades
Surgery grades Examples
Minor
  • excising skin lesion
  • draining breast abscess
Intermediate
  • primary repair of inguinal hernia
  • excising varicose veins in the leg
  • tonsillectomy or adenotonsillectomy
  • knee arthroscopy
Major or complex
  • total abdominal hysterectomy
  • endoscopic resection of prostate
  • lumbar discectomy
  • thyroidectomy
  • total joint replacement
  • lung operations
  • colonic resection
  • radical neck dissection
ASA grades

The ASA (American Society of Anesthesiologists) Physical Status Classification System [https://www.asahq.org/resources/clinical-information/asa-physical-status-classification-system] is a simple scale describing fitness to undergo an anaesthetic. The ASA states that it does not endorse any elaboration of these definitions. However, anaesthetists in the UK often qualify (or interpret) these grades as relating to functional capacity – that is, comorbidity that does not (ASA 2) or that does (ASA 3) limit a person’s activity.

ASA 1 A normal healthy patient
ASA 2 A patient with mild systemic disease
ASA 3 A patient with severe systemic disease
ASA 4 A patient with severe systemic disease that is a constant threat to life
Key to recommendations in tables

[Yes] Offer the test

[Not routinely] Do not routinely offer the test

[Consider] Consider the test (the value of carrying out the test may depend on specific patient characteristics)

Table 1. Minor surgery
Test ASA grade
ASA 1 ASA 2 ASA 3 or ASA 4

  1. AKI, acute kidney injury. 1See recommendation 1.1.8 of the NICE guideline on acute kidney injury [https://www.nice.org.uk/guidance/cg169/chapter/1-Recommendations#assessing-risk-factors-in-adults-having-surgery].
Full blood count Not routinely Not routinely Not routinely
Haemostasis Not routinely Not routinely Not routinely
Kidney function Not routinely Not routinely Consider in people at risk of AKI1
ECG Not routinely Not routinely Consider if no ECG results available from past 12 months
Lung function/arterial blood gas Not routinely Not routinely Not routinely
Table 2. Intermediate surgery
Test ASA grade
ASA 1 ASA 2 ASA 3 or ASA 4

  1. AKI, acute kidney injury. 1Note that currently the effects of direct oral anticoagulants (DOACs) cannot be measured by routine testing. 2See recommendation 1.1.8 of the NICE guideline on acute kidney injury [https://www.nice.org.uk/guidance/cg169/chapter/1-Recommendations#assessing-risk-factors-in-adults-having-surgery].
Full blood count Not routinely Not routinely Consider for people with cardiovascular or renal disease if any symptoms not recently investigated
Haemostasis Not routinely Not routinely Consider in people with chronic liver disease

  • If people taking anticoagulants need modification of their treatment regimen, make an individualised plan in line with local guidance
  • If clotting status needs to be tested before surgery (depending on local guidance) use point-of-care testing1
Kidney function Not routinely Consider in people at risk of AKI2 Yes
ECG Not routinely Consider for people with cardiovascular, renal or diabetes comorbidities Yes
Lung function/arterial blood gas Not routinely Not routinely Consider seeking advice from a senior anaesthetist as soon as possible after assessment for people who are ASA grade 3 or 4 due to known or suspected respiratory disease
Table 3. Major or complex surgery
Test ASA grade
ASA 1 ASA 2 ASA 3 or ASA 4

  1. AKI, acute kidney injury. 1Note that currently the effects of direct oral anticoagulants (DOACs) cannot be measured by routine testing. 2See recommendation 1.1.8 of the NICE guideline on acute kidney injury [https://www.nice.org.uk/guidance/cg169/chapter/1-Recommendations#assessing-risk-factors-in-adults-having-surgery].
Full blood count Yes Yes Yes
Haemostasis Not routinely Not routinely Consider in people with chronic liver disease

  • If people taking anticoagulants need modification of their treatment regimen, make an individualised plan in line with local guidance
  • If clotting status needs to be tested before surgery (depending on local guidance) use point-of-care testing1
Kidney function Consider in people at risk of AKI2 Yes Yes
ECG Consider for people aged over 65 if no ECG results available from past 12 months Yes Yes
Lung function/arterial blood gas Not routinely Not routinely Consider seeking advice from a senior anaesthetist as soon as possible after assessment for people who are ASA grade 3 or 4 due to known or suspected respiratory disease
Access the full article

Article of the Month: NICE Guidance – Routine preoperative tests for elective surgery

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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 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 accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and 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.

NICE Guidance – Routine preoperative tests for elective surgery

 

Read the full article

Overview

This guideline covers routine preoperative tests for people aged over 16 who are having elective surgery. It aims to reduce unnecessary testing by advising which tests to offer people before minor, intermediate and major or complex surgery, taking into account specific comorbidities (cardiovascular, renal and respiratory conditions and diabetes and obesity). It does not cover pregnant women or people having cardiothoracic procedures or neurosurgery.

Who is it for?

  • Healthcare professionals
  • People having elective surgery, their families and carers

This guideline updates and replaces NICE guideline CG3 (published June 2003).

Recommendations

People have the right to be involved in discussions and make informed decisions about their care, as described in your care [https://www.nice.org.uk/about/nice-communities/public-involvement/your-care].

We expect you to take our guidance into account. But you should always base decisions on the person you are working with.

Making decisions using NICE guidelines [https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-guidelines/using-NICE-guidelines-to-make-decisions] explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Guidance on consent for young people aged 16–17 is available from the reference guide to consent for examination or treatment [https://www.gov.uk/government/publications/reference-guide-to-consent-for-examination-or-treatment-second-edition] (Department of Health).

The tests covered by this guideline are:

  • chest X-ray
  • echocardiography (resting)
  • electrocardiography (ECG; resting)
  • full blood count (haemoglobin, white blood cell count and platelet count)
  • glycated haemoglobin (HbA1c) testing
  • haemostasis tests
  • kidney function (estimated glomerular filtration rate, electrolytes, creatinine and sometimes urea levels)
  • lung function tests (spirometry, including peak expiratory flow rate, forced vital capacity and forced expiratory volume) and arterial blood gas analysis
  • polysomnography
  • pregnancy testing
  • sickle cell disease/trait tests
  • urine tests.

The recommendations were developed in relation to the following comorbidities:

  • cardiovascular
  • diabetes
  • obesity
  • renal
  • respiratory.

 

Read more articles of the week

Editorial: Viewpoint – Rationing and Surgical Care

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Limitation in the provision of surgical care has many causes. In a nationalised healthcare system, this often reflects lack of funds, leading to rationing of clinical services. Rationing itself takes a number of forms. Deliberate exclusion of specific operations (usually elective) or specific patient groups (smokers, obese) are the most common examples, but strategic extension of waiting times by the removal of ‘target’ times can also be used as a rationing tool.

Many surgeons are dismayed by these decisions. They feel that the surgical patient is unfairly targeted as the clinical and cost-effectiveness of many planned surgical interventions have been well characterised. Surgeon and institutional outcomes are freely available – unlike the situation in many non-surgical specialties, so how can it be fair to pick on the surgical patient?

The idea that non-urgent elective surgery falls into neat categories where delay has no adverse consequences for the patient mystifies many surgeons. Whilst all would advocate a healthy diet, exercise, weight loss and smoking cessation, decisions to withhold surgery from the obese or those who smoke is rarely evidence-based. Rationing based on such prejudice soon becomes illogical. Why should the obese cancer patient receive an operation when the obese incontinent patient cannot?

In the long term, the absence of a substantial volume of ‘routine’ surgery damages training as exposure to such procedures is limited. Surgery has become the soft target for rationing clinical services. Surgeons should make their patients aware of how this process will affect them. Healthcare planners need to hear a public voice as well as that of the clinicians.

Just occasionally, an apparent limitation can be beneficial. In this issue of the BJUI, the National Institute for Health and Care Excellence (NICE) provides clear guidance on preoperative testing. This is based on sensible recommendations such as: avoiding routine urine dipstick testing, routine chest X-rays, and glycated haemoglobin (HbA1c) in non-diabetic patients. All surgeons irrespective of their specialty would benefit from paying close attention to these important guidelines [1].

Derek Alderson

President of the Royal College of Surgeons of England; Emeritus Professor of Surgery, University of Birmingham; Editor-in-chief of BJS Open.

Read the full article

Reference

1 National Institute of Health and Care Excellence (NICE). Routine preoperative tests for elective surgery: © NICE (2016) Routine preoperative tests for elective surgery. BJU Int 2018; 121: 12–6

 

Article of the Month: Bladder cancer: diagnosis and management of bladder cancer

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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 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 accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation. There is also a podcast created by a Urology Resident.

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

Read the full article

Introduction

Bladder cancer is the seventh most common cancer in the UK. It is 3–4 times more common in men than in women. In the UK in 2011, it was the fourth most common cancer in men and the thirteenth most common in women. There were 10,399 people diagnosed with bladder cancer and 5081 deaths from bladder cancer in 2011. The majority of cases occur in people aged over 60. The main risk factor for bladder cancer is increasing age, but smoking and exposure to some industrial chemicals also increase risk.

Bladder cancer is usually identified on the basis of visible blood in the urine or blood found on urine testing, but emergency admission is a common way for bladder cancer to present, and is often associated with a poor prognosis.

Most bladder cancers (75–80%) do not involve the muscle wall of the bladder and are usually treated by telescopic removal of the cancer (transurethral resection of bladder tumour [TURBT]). This is often followed by instillation of chemotherapy or vaccine-based therapy into the bladder, with prolonged telescopic checking of the bladder (cystoscopy) as follow-up. Some people in this group who are at higher risk are treated with major surgery to remove the bladder (cystectomy). People with cancer in or through the bladder muscle wall may be treated with intent to cure using chemotherapy, cystectomy or radiotherapy, and those who have cancer too advanced to cure may have radiotherapy and chemotherapy.

The involvement of the urogenital tract and the nature of the treatments give this cancer a strong psychological impact, in addition to the physical impact of the disease and its treatments, which is often profound. The prevalence of the condition and the nature of its management make bladder cancer one of the most expensive cancers for the NHS.

There is thought to be considerable variation across the NHS in the diagnosis and management of bladder cancer and the provision of care to people who have it. There is evidence that the patient experience for people with bladder cancer is worse than that for people with other cancers.

This guideline covers adults (18 years and older) referred from primary care with suspected bladder cancer and those with newly diagnosed or recurrent bladder (urothelial carcinoma, adenocarcinoma, squamous-cell carcinoma or small-cell carcinoma) or urethral cancer. There was insufficient high-quality evidence on which to make specific recommendations for non-urothelial bladder cancer (adenocarcinoma, squamous-cell carcinoma or small-cell carcinoma).

It does not cover people aged under 18 or adults with bladder sarcoma, urothelial cancer of the upper urinary tract, or secondary bladder or urethral cancer (for example, bowel or cervix cancer spreading into the bladder).

Medicines

The guideline assumes that prescribers will use a medicine’s summary of product characteristics to inform decisions made with individual patients.

This guideline recommends some medicines for indications for which they do not have a UK marketing authorisation at the date of publication, if there is good evidence to support that use. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. The patient (or those with authority to give consent on their behalf) should provide informed consent, which should be documented. See the General Medical Council’s Prescribing guidance: prescribing unlicensed medicines for further information. Where recommendations have been made for the use of medicines outside their licensed indications (‘off-label use’), these medicines are marked with a footnote in the recommendations.

Read more articles of the week

Editorial: NICE guidance and the BJUI

/1 Comment/by

As the year comes to an end, one cannot help but reflect on the successes of 2017. The impact factor of the BJUI has gone up to 4.439. Our infographics have introduced an entirely different level of interaction with our readers, some of whom are hard pressed for time. We have simply relied on the age old idiom – ‘a picture is worth a thousand words’. And we have credited our reviewers for giving up their valuable time, through Publons and the entirely new Four Seasons, where we will recognise the best reviewers each quarter through BJUI blogs.

Figure 1. Tower Bridge, London. ©John W. Davis 2017.

But perhaps the greatest accomplishment this year has been the publication of National Institute of Health and Care Excellence (NICE) Guidance for the very first time in the BJUI. Guidelines in general are now regarded as perhaps the highest level of evidence, which is obvious from the many hundred citations attracted by guidelines from the EAU and AUA. An absolute classic is the American Cancer Society Breast Cancer Screening Guideline from 2003, which was updated in 2015. In keeping with modern times and shorter attention spans, JAMAenhanced the guideline with an amazing infographic of a digital hand and pen drawing across a white paper! Whilst admiring such stunning quality, the team at the BJUI became acutely aware of our major weakness of being an international journal – we do not have society guidelines to publish. Until now…

NICE guidelines are based not just on the highest level of evidence; every effort is made to eliminate bias as far as possible. Every committee has at least two lay members. The processes and methods are based on internationally accepted criteria of quality, as detailed in the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrumen ns are clear and unambiguous, making them easier to implement and understand.

A unique feature of NICE Guidance is not just ‘clinical effectiveness’ but engagement with economists to make clear statements on ‘cost effectiveness’. It is no wonder that although NICE is based mainly in London, these guidelines are now popular worldwide and not just for the NHS.

We have earlier published NICE Guidance on the GreenLight XPS laser for BPH avoiding high risk patients such as those with risk of bleeding, prostate volume >100 mL, and urinary retention [1]. This technology would be cost effective if used on a day case basis.

NICE have also weighed the evidence for enzalutamide in hormone-relapsed prostate cancer before chemotherapy [2], in patients with mild symptoms, provided it is made available by the manufacturer on the agreed discounted price. Although expensive, it is regarded as an effective treatment amongst the new emerging therapies to prolong the lives of patients with prostate cancer.

In this issue of the BJUI, we feature the NICE Guidance on diagnosis and management of bladder cancer [3]. Not only is smoking cessation important in these patients, but perhaps somewhat controversially, NICE recommend discharge to primary care of patients with low-risk non-muscle-invasive bladder cancer with no recurrence within 12 months. They make a number of research recommendations on biomarkers that are increasingly becoming important with next generation sequencing but also patient satisfaction, which is what ultimately matters in this cancer that can adversely affect quality of life of those who suffer with it.

Wishing you all Greetings of the season!

Prokar Dasgupta

Editor in Chief, BJUI

References

1 National Institute of Health and Care Excellence (NICE). GreenLight XPS for treating benign prostatic hyperplasia: ©NICE (2016) GreenLight XPS for treating benign prostatic hyperplasia. BJU Int2017; 119: 823–30

 

2 National Institute of Health and Care Excellence (NICE). Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated: ©NICE (2016) Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated. BJU Int 2017; 120: 168–84

 

3 National Institute of Health and Care Excellence (NICE). Bladder cancer: diagnosis and management of bladder cancer: ©NICE (2015) Bladder cancer: diagnosis and management of bladder cancer. BJU Int2017; 120: 755–6

 

NICE Guidance: Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated

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Overview

Evidence-based recommendations on enzalutamide (Xtandi) for treating metastatic, hormone-relapsed prostate cancer for people in whom chemotherapy is not yet clinically indicated.

Summary of Appraisal Committee’s Key Conclusions

TA377 Appraisal title: Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is clinically indicated Section
Key conclusion

Enzalutamide is recommended, within its marketing authorisation, as an option for treating metastatic hormone-relapsed prostate cancer:

  • in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated
  • and only when the company provides it with the discount agreed in the patient access scheme.

The Committee concluded that, with its preferred assumptions, the resulting incremental cost-effectiveness ratio (ICER) for enzalutamide compared with best supportive care was likely to be between £31,600 and £34,800 per quality-adjusted life year (QALY) gained. This range was dependent on the method used to adjust survival estimates for active treatments not used in the NHS. Furthermore, it was likely to be nearer to the lower end of this range.

The Committee concluded that enzalutamide is innovative, and that taking into account factors, which had not been fully accounted for in the modelling, agreed that the ICER for enzalutamide compared with best supportive care was below £30,000 per QALY gained, and enzalutamide could be considered a cost-effective use of NHS resources.

 1.1, 4.15, 4.18, 4.19
Current practice
Clinical need of patients, including the availability of alternative treatments

Enzalutamide is a well-tolerated treatment, and people welcome having more treatment options to delay cytotoxic chemotherapy.

Enzalutamide and abiraterone (taken before chemotherapy is clinically indicated) are currently available through the Cancer Drugs Fund. Although abiraterone before docetaxel is available to some people, it is not embedded within current NHS funding arrangements because its future is not guaranteed. It was therefore not considered as a comparator.

There are some people who can have enzalutamide but not abiraterone in clinical practice (people who can’t take corticosteroids, people with visceral disease and people with severe liver disease).

 4.4, 4.1, 4.2, 4.18
The technology

Proposed benefits of the technology

How innovative is the technology in its potential to make a significant and substantial impact on health-related benefits?

 Enzalutamide is the preferred treatment option for people with visceral disease and liver dysfunction, in whom abiraterone is contraindicated at this position in the treatment pathway, or for people who can’t take corticosteroids. Although enzalutamide is not a new treatment, it is the only treatment that can give these benefits at this position in the treatment pathway and so is innovative. 4.18
What is the position of the treatment in the pathway of care for the condition? Enzalutamide is indicated for people with metastatic hormone-relapsed prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy, before chemotherapy is indicated. 4.1
Adverse reactions Enzalutamide is a well-tolerated treatment. 4.4
Evidence for clinical effectiveness
Availability, nature and quality of evidence The efficacy estimates for enzalutamide came from PREVAIL. Enzalutamide increased overall survival (OS) compared with placebo. The Committee considered that adjusting the OS estimated from the trial for subsequent life-extending treatments taken by people in the trial, but which are not available in the UK, was appropriate. 4.6
Relevance to general clinical practice in the NHS The Committee was aware that in PREVAIL, once the disease progressed, people on enzalutamide could move on to subsequent treatments. It was also aware that the company considered that some of these treatments (such as abiraterone, enzalutamide, cabazitaxel, sipuleucel-T, cytotoxic chemotherapy other than docetaxel and investigational treatments) would not be used in England at this position in the treatment pathway. The Committee agreed that it was appropriate to adjust the survival estimates for people having these treatments. 4.6
Uncertainties generated by the evidence The extent of adjustment needed to the OS estimates (to account for subsequent treatments that people had in PREVAIL that are not available in clinical practice in England) was uncertain. It was unclear which of the methods the company had used for adjustment (the Inverse Probability of Censoring Weights or the two-stage method) was better, however IPCW was associated with fewer assumptions. 4.7
Are there any clinically relevant subgroups for which there is evidence of differential effectiveness? None identified. –
Estimate of the size of the clinical effectiveness including strength of supporting evidence Enzalutamide increased OS compared with placebo, but the extent of the difference was uncertain because some people went on to have further active treatments in both study arms. The company tried to adjust for this but there was uncertainty about which method of adjustment was appropriate. 4.6, 4.7
Evidence for cost effectiveness
Availability and nature of evidence The company developed a new model and needed to extrapolate OS and time to treatment discontinuation from the trial data in its model. 4.9. 4.11, 4.12
Uncertainties around and plausibility of assumptions and inputs in the economic model

The model structure was appropriate in terms of the sequence of treatments people would have in clinical practice in England, but there was uncertainty about whether time spent on treatments after enzalutamide reflected clinical practice.

The Committee was concerned that that the company had not further checked the validity of the extrapolated data. This was particularly important because of the immaturity of the trial data and because of the small population at risk at the end of the trial follow-up (those who had not died or had been otherwise censored). This meant that a large proportion of the estimated survival benefit was based on the extrapolated period rather than the trial data.

 4.9, 4.11

Incorporation of health-related quality-of-life benefits and utility values

Have any potential significant and substantial health-related benefits been identified that were not included in the economic model, and how have they been considered?

 The Committee considered whether the model captured the benefits of delaying chemotherapy, which is important to patients. The Committee agreed that the model predicted that people having enzalutamide had more time with better utility than people on best supportive care, but it was unclear whether the benefit of delaying chemotherapy had been fully captured by the utility values included in the modelling. The Committee concluded that enzalutamide is innovative. 4.18, 4.19
Are there specific groups of people for whom the technology is particularly cost effective? None. –
What are the key drivers of cost effectiveness? The data cut-offs from PREVAIL that are used in the modelling and the utility value estimates. 4.11, 4.12, 4.13
Most likely cost-effectiveness estimate (given as an ICER) The most plausible ICER for enzalutamide compared with best supportive care was nearer to £31,600 than to £34,800 per QALY gained. The Committee also concluded that enzalutamide is innovative and taking into account factors, which had not been fully accounted for in the modelling, agreed that the ICER for enzalutamide compared with best supportive care was below £30,000 per QALY gained. 4.15, 4.18, 4.19
Additional factors taken into account
Patient access schemes (PPRS)

The company has agreed a patient access scheme with the Department of Health. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme would not constitute an excessive administrative burden on the NHS.

The company revised its patient access scheme over the course of this appraisal to increase the discount to the cost of enzalutamide for the NHS.

 2.3, 4.14
End-of-life considerations

The company did not make a case for enzalutamide meeting end-of-life criteria.

The Committee considered that the first criterion for end of life (the treatment is indicated for patients with a short life expectancy, normally <24 months) had not been met. Therefore, the Committee did not consider the other criteria and concluded that enzalutamide did not meet end-of-life criteria for treating metastatic hormone-relapsed prostate cancer in people for whom chemotherapy is not yet indicated.

 4.17
Equalities considerations and social value judgements No equality issues were raised. –

 

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Article of the Month: GreenLight XPS for treating benign prostatic hyperplasia

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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 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 accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and 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.

GreenLight XPS for treating benign prostatic hyperplasia

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This National Institute for Health and Care Excellence (NICE) guidance is the current, unaltered NICE guidance at time of publication. BJUI publishes selected NICE guidance relevant to urologists to extend their distribution and promote best practice.

 

 Recommendations

  • 1.1
    The case for adopting GreenLight XPS for treating benign prostatic hyperplasia is supported in non-high-risk patients. GreenLight XPS is at least as effective in these patients as transurethral resection of the prostate (TURP), but can more often be done as a day-case procedure, following appropriate service redesign.

 

  • 1.2

    There is currently insufficient high-quality, comparative evidence to support the routine adoption of GreenLight XPS in high-risk patients, that is those who:

    • have an increased risk of bleeding or
    • have prostates larger than 100 ml or
    • have urinary retention.

    NICE recommends that specialists collaborate in collecting and publishing data on the comparative effectiveness of GreenLight XPS for high-risk patients to supplement the currently limited published evidence.

 

  • 1.3
    Cost modelling indicates that in non-high-risk patients, cost savings with GreenLight XPS compared with TURP are determined by the proportion of procedures done as day cases. Assuming a day-case procedure rate of 36%, and that the GreenLight XPS console is provided at no cost to the hospital (based on a contracted commitment to fibre usage), the estimated cost saving is £60 per patient. NICE’s resource impact report estimates that the annual cost saving for the NHS in England is around £2.3 million. In a plausible scenario of 70% of treatments being done as day cases, the cost saving may be up to £3.2 million.

 

  • 1.4
    NICE recommends that hospitals adopting GreenLight XPS plan for service redesign to ensure that day-case treatment can be delivered appropriately.

 

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