New technologies and the benefits they could bring to the NHS are being held back by a reluctance in the service to commit to embracing such innovations. This must change, argues Neil Moat.
There is great promise in new medical technologies, but the ability of the NHS to embrace and analyse and diffuse them has often been sub-optimal and logistically challenging.
As a result, the NHS’s position as a world leader in fields like my own, cardiothoracic surgery and interventional cardiology, has weakened substantially with many companies avoiding the UK in the early evaluation of new devices.
The announcement in December of an NHS specialised commissioning innovation fund is therefore particularly welcome, providing we can establish a robust and effective model.
At present, methods of introducing new medical technologies for small patient populations are ad hoc and unsustainable. Clinicians and medical technology companies alike are faced with the dilemma of how to get promising devices used in a way that supports best practice and generates useful data for the purpose of evaluation.
To take a case in point, MitraClip is a catheter-based device used to treat people with mitral regurgitation (MR). MR occurs when the mitral valve (situated between the left atrium and the left ventricle) does not close properly and blood flows back into the atrium.
Larger leaks that go untreated can lead to symptoms of heart failure with a very poor quality of life and an increased risk of sudden death. Patients with severe symptomatic MR have a poor prognosis.
In the UK, surgery (mitral valve repair) is still the first line treatment for MR, and the MitraClip is only considered for those who are unable to have or have a very high risk from the conventional operation.
However, securing funding for gaining experience with and evaluation of the clinical and cost effectiveness of such devices - ie device which have been licensed with a CE mark but which have no reimbursement code - is fraught with difficulties.
Because there is no established process for new technologies, companies frequently approach hospitals directly. Hospitals will often have “new technology funds” and may be able to provide initial support for a few procedures. This funding gives clinicians the opportunity to develop some experience with the product, but has major drawbacks.
Such ad hoc funding and practice often leads to uncoordinated activity within a multiplicity of centres performing small procedural volumes. This can hinder the development of clinical expertise with a new product, and potentially adversely effect clinical outcomes.
Moreover, the hospitals that are able and willing to fund a new device may not be the most suitable (in terms of staff or infrastructure) and can often result in marked geographic variation in access to these new technologies.
Commissioners also find themselves at a disadvantage. While hospitals absorb the initial cost of introducing the device, this temporary funding creates demand from both clinicians and patients. Commissioners then receive funding requests for a product of which they have had no previous knowledge and for which there is a lack of robust data. The incentive for industry to sell a product to any hospital with available funds may also lead to inequitable distribution of access.
The Society of Cardiothoracic Surgery in Great Britain and the British Society of Cardiothoracic Surgeons have identified the opportunity to introduce a more structured approach to the introduction of these new technologies and produced sets of principles for new technologies.
However these “position” papers do not have the ability to effect change without funding from the NHS. The new specialised commissioning innovation fund has the potential to resolve this impasse. There is also a need for industry buy in to this process.
The core principles are: the need to commission a limited volume of activity to establish UK experience; desirability of sensible geographic distribution to promote equitable access; importance of designating a number of centres with a minimum level of activity to develop and support good standards of clinical practice, the need for these centres to adopt the same protocols of care and evaluation and the need for centralised data collection to help in the assessment of clinical outcomes.
The announcement of the Specialised Services Commissioning Innovation Fund potentially provides the mechanism to implement these principles and inform the rational allocation of NHS resources to novel technologies. A sufficiently large fund could provide a credible route for active commissioning of new technology rather than the current rather haphazard adoption which is of little benefit to the patient or the NHS.
The designation of appropriate hospitals should assist the development of expertise and optimise both access and outcomes for patients, while generating the necessary data for commissioners to reach longer term decisions.
Most importantly, the fund and these key principles could, for the first time, bring together clinicians, commissioners, patients and industry partners to ensure ongoing innovation in the crucial field of specialised care, helping to restore the NHS’s reputation as an innovator and evaluator of novel health care technologies.