Health Committee Written evidence from Deltex Medical (PE 25)

Summary

We believe the NHS can help meet the £20 billion efficiency challenge by improving its use of money-saving technologies. Our innovative solution to fluid optimisation has been shown by NICE to save on average two bed days and more than £1,000 for every patient undergoing major or high risk surgery. However, despite being available for more than 10 years, and the clear evidence base, ODM is currently used in less than 3% of relevant NHS operations.

The challenge we have faced as a medical technology company has been to match local NHS practice on technology adoption with national-level guidance. We include in this submission clear recommendations to improve uptake of innovation to deliver efficiencies, including mandatory funding of medical technologies, an “information revolution” for medical devices and a national CQUIN for enhanced recovery. We would be very happy to provide oral evidence.

1. Introduction

1.1 Deltex Medical welcomes the opportunity to provide evidence to the Committee’s inquiry into Public Expenditure and NHS efficiency savings.

1.2 We believe the NHS can go a long way to meeting its predicted £20 billion funding shortfall by improving its use of money-saving technologies. Our innovative solution to fluid optimisation has been shown by NICE to save on average two bed days and more than £1,000 for every relevant surgical patient. We set out below new data, derived from NICE estimates, of cost-savings that could follow from improved NHS uptake and use of the Oesophageal Doppler Monitor.

1.3 As an overall estimate, NICE figures suggest there is potential to save more than £800 million in just one year simply by improving fluid management in surgery. Yet the challenge we have faced as a medical technology company has been to match local NHS practice on technology adoption with national-level guidance.

1.4 We include in this submission clear recommendations to ensure the NHS benefits from the money-saving potential of innovative technologies. A key theme of these recommendations is to incentivise procurement of technologies that have an evidence base to support clinical and cost-effectiveness claims. These recommendations include:

mandatory funding for NICE-recommended medical technologies, to ensure that clinically and cost-effective medical devices gain the same status as pharmaceuticals;

a system of national contracts for NICE-recommended technologies to ensure swift procurement;

a national CQUIN for enhanced recovery to provide financial incentives for more efficient surgery; and

an NHS “information revolution” for technology adoption to encourage greater compliance through transparency.

1.5 We would be very happy to provide oral evidence to the Committee to inform this inquiry. As a small British medical technology company, with a solid evidence base for the clinical and cost-effectiveness of our device, and first-hand experience of the challenges in the NHS, we believe we can provide a unique perspective.

2. Deltex Medical and CardioQ-ODM

2.1 Deltex Medical is a small British medical technology company that has developed and pioneered Oesophageal Doppler Monitoring. Our CardioQ-ODM provides an innovative solution to fluid management during surgery and in critical care by enabling clinicians accurately and safely to measure and optimise blood flow around the central circulation.

2.2 In March 2011 NICE published final guidance recommending the use of CardioQ-ODM in surgery. The NICE guidance shows that such use:

reduces each of post-operative complications, the need for recovery in intensive care units, re-operation and readmission rates; and

can cut hospital stays by on average two days and save £1,100 per patient.

2.3 With more than 800,000 relevant operations annually in the NHS in England, the NICE guidance means that the NHS could save more than 1.6 million bed days and £800 million each year through wider uptake.

2.4 With wider NHS uptake, there is also the potential for the NHS to support UK exports and economic growth through the life sciences. A strong home market is a critical first-step to growing the export market in part by supporting demand and building an evidence base. The CardioQ-ODM is manufactured in the UK with exports currently worth £3 million per year. A conservative estimate of the annual global market opportunity created by our technology is in excess of £1 billion.

2.5 However, despite being available for more than 10 years, with a series of positive appraisals and a clear evidence base (see Appendix), ODM is currently used in less than 3% of relevant NHS operations. This low level of usage – contrary to the recent NICE guidance – prevents the NHS form realising significant cost savings for every relevant surgical procedure. We set out the potential cost-savings in the tables below.

3. Cost Savings Data

3.1 The following tables outline NICE estimates of annual cost-savings if usage of ODM were to reach 50% or 100% amongst the relevant patient population. These newly-presented data are derived from NICE estimates published in March 2011 alongside its clinical guidelines:

Use of ODM in 50% of relevant operations annually would save the NHS over £413 million – or 2% of the £20 billion target in one year, and 8% over four years.

Use of ODM in 100% of relevant operations annually would save the NHS over £840 million – or 4% of the £20 billion target in one year, and 17% over four years.

3.2 These potential cost-savings represent a significant opportunity for clinical teams and patients in every constituency as capacity released through quicker post-surgical recovery could be redeployed in other areas.

Table 1

COST SAVINGS IN ENGLAND

Usage of ODM amongst eligible annual population (all PCTs)

2.7% (current)

50%

100%

Estimated cost saving (£)

7

413

842

Proportion of £20 billion in one year (%)

0

2

4

Proportion of £20 billion over four years (%)

0

8

17

Table 2

COST SAVINGS BY STRATEGIC HEALTH AUTHORITIES

Cost-savings (£m)

Total units

Select Committee Member

50% usage

100% usage

North East

20.7

42,235,007

20

Grahame M. Morris

North West

55.7

113.5

57

Rosie Cooper

Yvonne Fovargue

Yorkshire & Humberside

42.0

85.5

29

East Midlands

35.2

71.7

15

Stephen Dorrell

David Tredinnick

West Midlands

43.6

88.9

33

Valerie Vaz

East of England

45.8

93.3

25

Dr Daniel Poulter

London

61.5

125.5

122

Virendra Sharma

South West

41.6

84.8

30

Andrew George

Chris Skidmore

Dr Sarah Wollaston

South East

34.5

70.4

61

South Central

32.6

66.4

33

Table 3

COST-SAVINGS IN SELECT PRIMARY CARE TRUSTS

Select Committee Member

PCT

Cost-savings (£m)

50% usage

100% usage

Rosie Cooper

NHS Central Lancashire

3.5

7.2

Stephen Dorrell

Leicestershire County & Rutland

5.2

10.7

Yvonne Fovargue

Ashton, Leigh & Wigan

2.4

5.0

Andrew George

Cornwall and Isles of Scilly

4.3

8.7

Grahame M. Morris

County Durham

4.1

8.4

Dr Daniel Poulter

Suffolk

4.8

9.8

Virendra Sharma

Ealing

2.6

5.3

Chris Skidmore

Bristol

3.5

7.1

South Gloucestershire

2.0

4.0

David Tredinnick

Leicestershire County & Rutland

5.2

10.7

Valerie Vaz

Walsall Teaching

2.0

4.1

Dr Sarah Wollaston

Devon

5.9

12.1

4. Policy Recommendations

4.1 If the NHS is to find £20 billion in efficiencies while improving patient outcomes then it will have to start investing in money-saving innovations rather than crudely cost-cutting in ways that could harm care.

4.2 Unlike pharmaceuticals, which in many cases can simply be purchased and used, the adoption of medical devices can require a change in systems or service delivery. Deltex urges the Committee to consider the following recommendations.

Recommendation 1: Mandatory funding for medical technologies

4.3 NICE is a world-leader in technology assessment and evaluation. Its guidance and recommendations should be sufficient to determine the technologies which should be prioritised for rapid adoption by the NHS.

4.4 Medical technologies should be given the same status as medicines in the NHS Constitution, with mandatory funding providing an incentive to procure technologies that can improve NHS efficiency.

4.5 The present patient right under the NHS Constitution to be treated with NICE-recommended technologies covers only technologies assessed under NICE’s Health Technology Appraisal programme. This excludes those recommended under the Medical Technology Evaluation Pathway, which was established after the NHS Constitution was published.

4.6 To ensure procurement decisions are evidence-based, Trusts should be obliged to adopt technologies that have been recommended by NICE rather than risking time and money on imitation technologies that lack equivalent evidence, evaluation or endorsements.

Recommendation 2: A national CQUIN for enhanced recovery

4.7 The annual NHS Operating Framework was an effective tool for communicating priorities to local NHS. It included in 2010-11 as a national priority screening and prevention of venous thromboembolism (VTE). Whether or not the Operating Framework is phased out, the Commissioning for Quality and Innovation (CQUIN) payment framework can continue to provide incentives around specific areas of care.

4.8 CQUINs were introduced in April 2009 as a national framework for locally-agreed quality improvement schemes. The current CQUINs for acute providers must also include two national goals, one of which relates to VTE. This shows how a specific national priority on the NHS Operating Framework has transferred to the CQUIN scheme.

4.9 There is a local enhanced recovery CQUIN covering six hospitals in North Central London (Whittington, Barnet and Chase Farm, Royal National Orthopaedic, Royal Free Hampstead, North Middlesex University and UCLH). This has successfully reduced length of stay by an average of five days for orthopaedic and colorectal surgical patients across the sites.

4.10 There is a strong case for a national CQUIN on enhanced recovery and Doppler-guided fluid management. This could help speed up technology uptake, save hospital bed days, and deliver better post-surgical outcomes for patients. Other national CQUIN schemes could be developed where the case for innovation and improvement is similarly strong.

4.11. Recommendation 3: Swifter procurement through National Contracts and iTAPP

4.12 An automatic process should be established to develop national procurement contracts for NICE-recommended technologies. This would assist procurement of technologies that have been recommended for their clinical and cost effectiveness. Such contracts should have delivery obligations on suppliers consistent with national CQUINs. So that suppliers are contractually obliged to invest in providing the NHS with the requisite technical, educational and training support to enable effective adoption.

4.13 The Innovative Technology Adoption Procurement Programme (iTAPP) should focus on procurement and implementation rather than evaluation. Consideration should be given to providing sufficient funding to iTAPP to allow it to meet this objective.

Recommendation 4: Oversight of the National Commissioning Board to ensure compliance and technology adoption

4.14 NHS structural reforms will set a new context for commissioning. This provides an opportunity to build a requirement into these processes to provide commissioning support for technologies recommended by NICE.

4.15 As part of its national remit to drive improvements in outcomes, promote innovation, and ensure a comprehensive service, the National Commissioning Board should be proactive in ensuring compliance with NHS guidance and national CQUIN indicators.

Recommendation 5: An “information revolution” to drive compliance and uptake

4.16 The Government’s Plan for Growth committed to release prescribing data. An equivalent approach could be developed for medical devices. This “information revolution” could ensure Trusts are held to account for their uptake of innovative technologies and compliance with national guidelines.

4.17 Following the publication of NICE guidelines, Trusts should be required to publish implementation plans within a fixed time period (say 90 days) and subsequently to collect data on uptake. Performance could be published and benchmarked against other Trusts.

4.18 Better monitoring could also be introduced to improve compliance. Trusts and clinical teams should be required to comply with NICE recommendations or explain why they are not able to do so (“comply or explain”).

Recommendation 6: Improved clinical awareness of money-saving technologies

4.19 Clinicians must feel confident about the range of devices that could make more efficient use of NHS resources. The professional associations should be required to provide and promulgate advice and guidance to their members on the use of NICE recommended technologies. Use of clinical “checklists” should be widely promoted to ensure all patients receive a recommended standard of care.

5. Conclusion

5.1 Improving patient outcomes at a time of financial pressure is not an easy task, but nor do we believe it is impossible.

5.2 Our message to the Committee is simple: for every relevant operation, your local hospital could save over £1,000 per patient and two bed days. In the handful of minutes it takes to undertake Doppler guided fluid management, the NHS could work towards saving £800 million every year. However, with surgical usage at just 3%, the NHS is failing to make significant and simple efficiency savings.

5.3 The challenge for the Committee is to determine why uptake has been poor, and what mechanisms could improve the situation.

5.4 As a case study of a British medical technology manufacturer, with a strong evidence base supporting our product, we believe we are in a strong position to inform this inquiry. We would be very happy to provide oral evidence, and believe we can help demonstrate how improved use of medical devices such as the CardioQ-ODM can help the NHS deliver on the quality and efficiency challenge.

September 2011

APPENDIX

DELTEX MEDICAL/CARDIOQ MILESTONES

The following table details key milestones and endorsements of CardioQ-ODM over the past two decades. Current usage of CardioQ-ODM in the NHS is 2.7%.

Year

Development

Reference

1995

Mythen and Webb – first RCT of ODM (on cardiac patients)

http://archsurg.ama-assn.org/ cgi/content/abstract/130/4/423

1997

Sinclair and Singer – benefits of ODM in reducing length of stay in FNoF surgery (hip replacement)

http://www.bmj.com/cgi/content/ full/315/7113/909

2004

Leading surgeons, as part of the Improving Surgical Outcomes Group outlined key measures to improve outcomes and reduce length of stay, recommending Enhanced Recovery Programmes.

Recommendation on ODM:

“Haemodynamic optimisation and other interventions significantly reduce both the rates of post-operative complications and mortality, as well as significantly reducing both the length of hospital stay and the overall number of ICU / HDU bed days used.”

http://www.reducinglengthofstay. org.uk/doc/isog_report.pdf

2005

NICE concluded that there was no need to investigate ODM within its Interventional Procedures Programme “because oesophageal Doppler monitoring is considered standard clinical practice with risks and benefits that are sufficiently well-known.”

http://www.nice.org.uk/guidance/ index.jsp?action=byID&o=11268

2005

UK study (Howard Wakeling) proves benefit of CardioQ in prospective clinical trial.

Recommendation on ODM:

“The use of ODM was associated with a 1.5 day median bed stay reduction, producing significant cost savings. Patients recovered gut function significantly faster and suffered less gastrointestinal and overall morbidity. Patients monitored by the CardioQ were back on a full diet a day earlier and ready for discharge a day and a half earlier. They suffered fewer digestive complications, by a factor of more than five, and saved the hospital approximately £25,000 in reduced bed days.”

http://bja.oxfordjournals.org/cgi/ content/abstract/aei223v1

2006

A double-blind RCT study at the Freeman Hospital, published in the British Journal of Surgery.

Recommendation on ODM:

Within an enhanced recovery programme, ODM:

reduced the length of stay for “open” surgery by two days (seven days, down from nine, with patients actually fit for discharge after six)

Reduced the length of stay for keyhole surgery by two days (four days down from six)

fewer complications (2% in the ODM group had complications compared to 15% of the control group)

could help to reduce mortality – the mortality rate for this kind of surgery is normally - 6%, whilst the ODM group in the study had a rate of 0%.

http://www.reducinglengthofstay. org.uk/freemanstudy.html

2006

ISOG released their second, follow-up report, looking at the implementation of their recommendations and showcasing important case studies.

Recommendation on ODM:

“A collaboration between anaesthetists and surgeons using fluid optimisation during surgery resulted in savings of £1.1 million. Part of this money was used to finance a new 10-bed surgical HDU. This was achieved through patients going home on average three days sooner, saving around £800 per patient.” Medway Maritime Hospital, Gillingham, Kent

http://www.reducinglengthofstay. org.uk/doc/ISOG3.pdf

2007

Lord Ara Darzi published his NHS London review, which noted that “Seven randomised trials have shown simple use of cheap ultrasound technology to reduce length of stay consistently by two to three days in elective intra-abdominal surgery. The evidence-base is clear here and changes should be rapidly implemented across London.” [page 71]

Recommendation on ODM:

Page 71: “A long-running study in Melbourne, Australia has seen the average length of stay in intensive care and the mortality rates for patients with major abdominal surgery fall dramatically. This was achieved by improvements in pre-operative assessment, peri-operative care and post-operative support.

When integrating the Melbourne model of treatment into a care package with other evidence-based interventions (such as early feeding/topping up of fluids) quality of care is further improved and length of stay reduced. Seven randomised trials have shown simple use of cheap ultrasound technology to reduce length of stay consistently by two to three days in elective intra-abdominal surgery.

The evidence-base is clear here and changes should be rapidly implemented across London.”

http://www.healthcareforlondon. nhs.uk/assets/Publications/ A-Framework-for-Action/ aFrameworkForAction.pdf

2007

The US Federal Government-funded Centres for Medicare and Medicaid Services (CMS) published a report on ODM which concluded that the evidence for CardioQ-ODM is sufficiently strong to recommend its use and reimbursement.

Recommendation on ODM:

“CMS was asked to reconsider our current national coverage determination (NCD) on ultrasound diagnostic procedures. CMS has determined that there is sufficient evidence to conclude that esophageal Doppler monitoring of cardiac output for ventilated patients in the ICU and operative patients with a need for intra-operative fluid optimization is reasonable and necessary.”

https://www.cms.hhs.gov/mcd/ viewdecisionmemo.asp?from2= viewdecisionmemo.asp&id= 196&

2008

The Centre for Evidence-based Purchasing gave ODM a rating of “significant potential”, noting that ODM can save hospitals between £642 and £4,421 per additional patient (depending on where bed days were saved on wards or in ICU).

Recommendation on ODM:

“In patients undergoing high-risk surgery, addition of ODM-guided fluid administration to CVP monitoring plus conventional clinical assessment…is likely to result in fewer deaths, fewer complications, and a short hospital stay. The costs of ODM are likely to be offset by reductions in both complications and length of hospital stay.”

CEP08012:

http://www.pasa.nhs.uk/ PASAWeb/NHSprocurement/ CEP/CEPproducts/CEP+ catalogue.htm

2009

The National Institute for Health Research Health Technology Assessment Programme reported on the clinical and cost-effectiveness of ODM, and showed that the NHS would need to spend between £642 and £4,441 extra on each additional survivor of surgery before ODM would no longer be considered cost effective.

Recommendation on ODM:

“Results show that ODM strategies are likely to be considered cost-effective. More specifically, the threshold value for the extra cost per additional survivor that would need to be incurred before ODM would no longer be considered cost-effective was estimated. The required magnitude of these costs ranged from £581 to £11,600.”

http://www.hta.ac.uk/project/ 1633.asp

2010

The NHS Technology Adoption Centre (NTAC) published a “How to Why to” guide on intra-operative Doppler-guided fluid management. The guide sets out a clear process to introduce ODM into routine clinical practice within typical NHS hospitals; it includes details of the dramatic reductions in patient complications and mortality, length of stay, readmissions, reoperations and bed day and cost-savings that the Trusts have achieved as a result.

Recommendation on ODM:

Based on the data from eight RCTs, it estimated that if Doppler-guided fluid management was used throughout the NHS, it could help to save hundreds of thousands of bed days and hundreds of millions of pounds for the NHS.

Results summary:

Three and half day reduction in length of stay (LOS).

Three and a half day reduction in Post-op LOS.

23% decrease in CVC insertion rate.

29% decrease in re-admission rate.

30% decrease in re-operation rate.

12% decrease in mortality.

Five day reduction in LOS within critical care level three.

http://www.ntac.nhs.uk/HowTo WhyToGuides/DopplerGuided Intraoperative/Doppler- Executive-Summary.aspx

2011

The NICE Medical Technology Advisory Committee (MTAC) published guidance recommending that the use of oesophageal Doppler monitoring (ODM) in surgery.

Recommendation on ODM:

“CardioQ-ODM should be considered for patients undergoing surgical procedures who would otherwise require invasive cardiac monitoring. This new device offers potential cost savings for the NHS together with improved experiences for patients.

Results summary:

The official findings show that ODM, which measures blood flow during surgery:

leads to a cost saving of about £1,100 per patient;

reduces length of hospital stay by on average two days per patient;     and

reduces complications by half.

http://guidance.nice.org.uk/ MTG3

Prepared 23rd January 2012