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Deliberating on diagnostics


Dr Nick Crabb, associate director of the Diagnostics Assessment Programme at NICE, talks to NHE about the complexities of evaluating new diagnostic technologies for use in the health service.


D


iagnostics involves a variety of tests and measurements that can be used to determine what conditions, diseases or syndromes a person may currently have or is likely to develop. These include screening, suggesting diagnoses, ruling out or confirming suspected diagnoses, monitoring chronic conditions, monitoring a patient’s condition following treatment, and predicting future events.


Appropriate use of these technologies can help to determine whether or not treatment is undertaken, which treatment is best suited to which circumstances and at what intensity. Treatment choice is therefore improved and efficient use of NHS resources can be maintained.


As diagnostic technologies can present a significant expense, and often change rapidly as upgrades and capabilities are developed, a long-term assessment programme is necessary to ensure the appropriate adoption of new technologies.


That is why NICE has trialled and now fully implemented the Diagnostics Assessment Programme (DAP). Associate director of the programme, Dr Nick Crabb, talked NHE through the issues surrounding the assessment of diagnostics and how it benefits the NHS.


He said: “The diagnostics programme was set up to evaluate innovative medical diagnostic technologies, with the aim of supporting the NHS in England in adopting clinically and cost effective technologies more rapidly and consistently.”


The next level


Before the programme, some diagnostic topics were evaluated through the NICE Technology Appraisals Programme which evaluates pharmaceuticals and other health technologies. However, there were issues with capacity. Furthermore, the evaluation


24 | national health executive Mar/Apr 12


of diagnostics differs considerably from the assessment of other health interventions.


Dr Crabb explained that this was largely because diagnostics are subject to “a very different regulatory framework” than pharmaceuticals.


He said: “The level of evidence you’re dealing with is typically lower than you would get for pharmaceuticals. In addition, the patient outcome benefits rarely result from the use of the diagnostic directly. You need to be able to assess patient outcomes resulting from the treatments that are informed by the diagnostic. Because of these issues, NICE believed it was better to set up a small, bespoke programme than to simply increase capacity in the existing Technology Appraisal Programme.


“Diagnostics feature in most care pathways and are a significant item of overall NHS spend. Being able to assess diagnostics for clinical and cost effectiveness allows comparison with other types of health interventions (e.g. pharmaceuticals) on a level playing field.”


MTEP and DAP


DAP was established alongside the Medical Technology Evaluation Programme (MTEP) as part of the same overall activity in medical technologies, but the two cover different spheres of work within this.


“The impetus for establishing both MTEP and DAP was a perceived need from the industry and clinical community for NICE to undertake more evaluations of medical technologies,” Dr Crabb said. “There was a lot of lobbying from the medical device and diagnostic industry for NICE to do more.”


Whilst MTEP is the ‘front end’ for both programmes, and performs topic selection and routing for assessment, DAP conducts complex evaluations of diagnostic tests and


technologies, where recommendations can only be made on the basis of clinical utility and cost-effectiveness analysis.


The Medical Technologies Advisory Committee (MTAC) decides if a topic is suitable for a national level evaluation by NICE and where in NICE that evaluation should take place. For a diagnostic, the


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