EXECUTIVE SUMMARY

Introduction

  Founded by an emergency room physician in 1976, Kinetic Concepts Incorporated (KCI) is a global corporation providing leading edge innovation in wound care, pulmonary care, bariatric care, and circulatory improvement in all care settings. KCI manufactures, delivers and services one of the largest offerings of speciality beds and related medical devices. The company is dedicated to taking an active role in the healing process, helping to save patients lives, improve the quality of patients' lives, and reducing the overall cost of healthcare.

  KCI Therapies have clinical evidence and/or are financially justified in more than 350 publications, including approximately 280 peer-reviewed clinical articles. Through research-based protocols and a clinically trained support team, KCI helps ensure that the right patient receives the right therapy for the right length of time.

  KCI welcomes the Health Select Committee's inquiry into the work of the National Institute for Health and Clinical Excellence (NICE).

Overview

  KCI recognises that NICE and its guidance to the NHS is seen as the gold-standard at an international level. Guidance, particularly clinical guidelines, which to date have been of most relevance to KCI, can have beneficial effects in changing NHS practice and in developing the most effective way of managing conditions. For this reason, it is essential that guidance is developed through consultation with the most appropriate clinical experts. It is also vital that the timescales associated with the development of guidance do not result in the publication of advice that is considerably lagging behind medical technology innovation and clinical practice.

Recommendations

—  Research is carried out in the initial phases of the development of clinical guidelines to identify the most relevant clinical experts for that area, who are then invited to be involved in the scoping exercise.

—  There is an assessment of the speed of publication of clinical guidelines and other NICE guidance, including guidance reviews, to ensure that there is a process for timely update to reflect advances in technology and clinical practice.

—  A formal process to monitor how NICE guidance is used in the clinical setting is both developed and implemented.

—  A formal process is developed for the dissemination of clinical guidelines to relevant healthcare professionals.

KCI'S VIEWS ON THE COMMITTEE'S TERMS OF REFERENCE

1.   Why NICE's decisions are increasingly being challenged

  1.1  NICE is recognised across the world for the guidance it provides to the NHS. One of the roles of the Institute is ensuring that the NHS receives the best value from limited resources by assessing clinical and cost effectiveness through technology appraisals. It also provides advice to the NHS on the best ways to manage treatment pathways for certain conditions, through clinical guidelines. Guidance from NICE, especially given the statutory implementation element of technology appraisal guidance, is considered to be the marker by which many NHS organisations make their funding decisions. This is especially true for treatments that are innovative and/or perceived to be "high cost". Often in these instances, funding will not be made available for a treatment unless it is subject to positive guidance from NICE. Therefore, should a treatment either not be subject to NICE guidance or receive guidance that does not recommend its use on the NHS, this can be the end of access to an innovative treatment and acts as a significant barrier to clinical decision-making.

2.   NICE's evaluation process, and whether any particular groups are disadvantaged by the process

  2.1  The most important element of the development of effective and useful clinical guidelines is the scoping phase. It is the opportunity for all the relevant stakeholders to ensure that the remit of the guideline fits with clinical practice and will provide a useful and necessary addition to NHS care. Currently however, it is at this stage that the most appropriate clinical experts are not always consulted. Details of the proposed scope are published by NICE, but it is often not until the guideline is in development, or until it is published that the most relevant clinical experts are aware of the guideline. As the scoping phase is the most important, it is vital for clinical experts to be involved in this process.

  2.2  In order to further ensure that clinical guidelines are the most relevant, it is also vital to ensure that the appropriate clinical experts are included on the guideline development groups. While there is clinical representation on these groups, it is essential that these clinicians and healthcare professionals appropriately reflect the necessary clinical expertise to understand the impact and practical application of a guideline.

3.   The speed of publishing guidance

  3.1  Currently, from the initial scoping and referral phase for a clinical guideline, it takes at least two years for the guidance to be published by NICE. In practice, it is often longer than this time frame, due to adjustments to the guideline as it develops and for logistical reasons. It is then, as standard, at least three years before the guideline is reviewed. The innovative nature of medical technology means there is a relatively rapid pace of development. Clinical practice also alters to reflect this technological change. It is therefore possible for a clinical guideline to be behind both technology and clinical practice by the time it is published by NICE, and significantly behind by the time it is assessed in relation to carrying out a review.

  3.2  This not only means that the NHS is charged with implementing guidance that may no longer be the most appropriate, but that with a potential seven year time frame between the initiation of a guideline and assessment of the need for review, the impetus to develop high standard evidence on a technology is reduced.

4.   Comparison with the work of the Scottish Intercollegiate Guidelines Network (SIGN)

  4.1  Guidance provided by the Scottish Intercollegiate Guidelines Network (SIGN) for NHS Scotland and by NICE for NHS England and Wales, can be beneficial for the development of services and the care of patients. However, in relation to the timing of guidance, the timescales for the review of guidance from SIGN can be greater than those for NICE guidance. As outlined in relation to NICE guidance in the section above, timescales like this can result in significantly out of date guidance.

5.   The implementation of NICE guidance, both technology appraisals and clinical guidelines (which guidance is acted on, which is not and the reasons for this.)

  5.1  KCI's experiences indicate there is a lack of universal implementation within the NHS for NICE clinical guidelines. Without the statutory implementation in terms of funding and timeframe that is associated with technology appraisal guidance, there is a significant diversity in approach to clinical guidelines. NHS organisations charged with implementing guidelines have different levels of awareness of guidance—especially at the appropriate levels to ensure best implementation—and different processes for the dissemination of guidance to relevant front-line healthcare professionals. In order to ensure a more universal implementation of guidance, there needs to be a specific process for the dissemination within the NHS and a formal process for monitoring this by an appropriate independent body.

Claire Weston

KCI Medical

March 2007