SUMMARY

—  Deltex Medical produce an innovative medical device called the CardioQ which accurately monitors changes in blood flow during surgery. Numerous independent clinical studies have shown that the CardioQ reduces the number and severity of post-operative complications leading to reduced hospital stays.

—  NICE's Interventional Procedure Programme (IPP) has declared the CardioQ technology "standard clinical practice" yet this has done little if anything to encourage uptake.

—  NICE has not undertaken any technology appraisal of the CardioQ and has no plans to do so. However, NHS management often use the absence of such an appraisal to justify its refusal to invest in the technology.

—  As a result 49 out of 50 NHS patients undergoing major surgery are being denied potentially life saving technology which has the proven potential to save the NHS over £400 million a year.

—  The NICE appraisal process for new technologies must be altered so that "no-brainer" technologies are not disadvantaged simply because they have proven economic as well as clinical benefit.

INTRODUCTION: ABOUT DELTEX MEDICAL AND CARDIOQ

  1.   Deltex Medical is a small innovative British Healthcare company which has developed a device, the "CardioQ" Oesophageal Doppler monitor (ODM), to accurately monitor blood flow during surgery and in critical care. Reduced circulating blood volume is known as hypovolemia, which leads to insufficient oxygen being delivered to the organs, causing medical complications including peripheral and major organ failure resulting in longer hospital stays and in some cases death. Using the CardioQ allows the clinical team to better manage the patient during this time (haemodynamic optimisation), reducing complications and mortality.

  2.  Clinical evidence has shown that there are approximately 1 million NHS patients each year who would derive a clear clinical benefit from haemodynamic optimisation. If lengths of hospital stay for these patients were reduced by two days each, the NHS would free up about 5,500 beds, with a saving of at least £350 million a year. Were NHS managers to embrace the CardioQ technology and work with their clinical colleagues towards implementing it effectively they would significantly improve the experience of hundreds of thousands of their patients undergoing operations. By freeing up hospital beds they could choose whether to treat more patients, close beds or redeploy resources to meet local priorities.  

  3.  In 2004 managers and doctors at the Medway Maritime NHS Trust worked together to audit the impact of the CardioQ in over 200 operations in a four month. They found that CardioQ reduced the average length of patient stay after surgery by over three days for the broad range of moderate and major risk surgery where it was used. This equated to an approximate saving of £800 per patient, and a realised saving of £1 million a year for the Trust in its first phase implementation. Chief Executive of the Trust Andy Horne underlined the effectiveness of CardioQ commenting : "We have used the CardioQ in around 200 operations over the last four months and had very good results. It has improved the quality of care for patients as they are healthier when they leave theatre, need less post-operative care and get home quicker."  

  4.  In May 2006 the Royal Alexandra hospital in Paisley used CardioQ in a study of thirty patients who underwent major colorectal surgery. The result was a 20% reduction in the average length of post operative hospital bed stay and a saving of over £1,000 per patient.

  5.  In August 2006 the British Journal of Surgery published the results of a major new randomised controlled clinical trial of the CardioQ during surgery. The study on bowel surgery patients at the Freeman hospital in Newcastle-Upon-Tyne was funded by the Royal College of Surgeons and was the seventh high quality CardioQ outcome study to be published in a leading peer-reviewed journal. It demonstrated that in those patients whose circulating blood volume was optimised using the CardioQ, serious post-operative complications, emergency post-operative admissions to critical care units and emergency readmissions to hospital were almost entirely eliminated. The study found that CardioQ patients were also fit to go home three days earlier than non-CardioQ patients.

  6.  Routine use of the CardioQ during surgery is now a core part of the Freeman hospital's "enhanced recovery" or "fast-track" programme for major bowel surgery. This programme delivers amongst the lowest mortality rates, the lowest readmission rates and the shortest lengths of stay not just in the UK but in the whole of the developed world.

DELTEX MEDICAL'S EXPERIENCE OF NICE

  7.  Deltex Medical wrote to the Chief Executive of NICE on 25 November 2004 seeking advice as to whether it should actively seek a NICE appraisal in the context of "NICE blight". As a small company that has been loss-making for sixteen years we had concerns about losing our momentum on waiting up to two years for a NICE recommendation. We asked whether the clinical and economic benefits our technology is proven to deliver (ie 25% to 40% reductions in length of stay) even fall within the NICE remit to review marginal cases.  

  8.  At a subsequent meeting with NICE representatives in January 2005, Deltex Medical was advised that NICE believed the CardioQ did fall within NICE's remit, but that even if it were selected for a NICE assessment, it was unlikely any such assessment would be completed before 2010.  

  9.  Deltex Medical has attended a number of presentations by NICE staff over the last two years which have stressed that NICE's focus for technology appraisals is on technologies which improve care but at a higher cost to the NHS; the purpose being to enable NICE to issue guidance to the NHS on difficult decisions as to whether the additional benefits of a new treatment merit the additional costs. These presentations made it clear that NICE does not look at technologies such as the CardioQ which improve the quality of care but at reduced cost to the NHS; such technologies are labelled "no-brainers" by NICE and are outside the scope of its technology appraisal system.

  10.  At a time of scarce resources across the NHS, this creates the absurd situation whereby NHS managers divert money which might have funded the introduction of "no-brainer" technologies such as the CardioQ in order to fund technologies or drugs recommended by NICE, even though these may well not have the clinical benefit of the CardioQ. By contrast, accelerated implementation of no-brainer technologies might allow earlier adoption of more of the effective but expensive technologies that are the subject of NICE appraisals.

  11.  Following enquiries it made to the Department of Health, Deltex Medical was informed in December 2006 that "NICE only has the capacity to look at the most significant new and existing technologies and with a NICE appraisal costing over £200,000 it is a tool we need to use selectively." Furthermore the Department noted "the paucity of trial evidence on new non-drug technologies".  

  12.  The Department further informed Deltex Medical that the Centre for Evidence-based Purchasing (CEP) had accepted a proposal to include the CardioQ in its work programme.  

  13.  We welcomes the involvement of CEP, however it is unclear what form any CEP conclusions might take and whether CEP recommendations have the necessary authority, if indeed they will have any authority, to accelerate adoption of new medical technologies by the NHS.

  14.  The NHS procurement process is unnecessarily bureaucratic and hinders the uptake of new technology (as outlined in our submission to the Committee's inquiry into NHS deficits in June 2006). However, unless CEP is shown to be effective, NICE further complicates the process by actually disadvantaging those trying to promote the use of new technology in the NHS. NICE itself claims that it does not have time to look at every new technology, particularly if they already have proven benefits. However the result is that patients are being denied potentially life saving technology, and the NHS is being denied technology which has the potential to save it over £400 million a year because of an inherently flawed assessment process.

  15.  Deltex Medical is a British company which has brought to market a British technology: the vast majority of the clinical and "real-world" evidence supporting the CardioQ comes from British hospitals. Yet the company has found its dealings with the Department of Health and the NHS consistently frustrating over many years. Our recent experiences with the equivalent bodies in the USA have been in marked contrast. In the USA the decision making process is more transparent, faster and considerably less bureaucratic with clearly defined roles for the various bodies and agencies involved.  

  16.  The Centers for Medicare & Medicaid Services (CMS), the US Federal Government body responsible for determining coverage for the reimbursement of medical technologies in the US, recently (26 February 2007) published a favourable draft decision on ODM following an application originally submitted on 22 August 2006. If a technology is "covered" it is possible for hospitals to receive a payment (reimbursement) that covers the costs associated with the purchase and use of that technology.  

  17.  In reaching its proposed decision, CMS had commissioned a Health Technology Assessment (HTA) on ODM from the US Government Agency for Healthcare Research and Quality (AHRQ). The AHRQ report was delivered to CMS on 16 January 2007 and published on CMS's website on 14 March 2007. It grades evidence whether a technology does or does not work into four categories: "strong", "moderate", `weak" and "inconclusive". Strong evidence is where "it is highly unlikely that new evidence will lead to a change in this conclusion". The HTA concluded that in "patients undergoing surgical procedures with an expected substantial blood loss or fluid compartment shifts requiring fluid replacement" the clinical evidence for ODM was "strong" in respect of the following three statements:

(a)  "Doppler-guided fluid replacement during surgery leads to a clinically significant reduction in major complications";

(b)  "Doppler-guided fluid replacement during surgery leads to a clinically significant reduction in the total number of complications"; and

(c)  "Doppler-monitored fluid replacement leads to a reduction in hospital stay".

RECOMMENDATIONS

  18.  The NHS needs a transparent, fast-track process for the promotion of uptake of new technologies which are proven to work. The role of NICE in inadvertently hindering this process must be addressed.  

  19.  If CEP is to champion the adoption of `no-brainer' technologies, its recommendations must, as a minimum, be no less binding on the NHS than those recommendations arising from NICE technology appraisals.

Deltex Medical Group plc

March 2007