NICE Medical Technologies Guidance

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This issue of Applied Health Economics and Health Policy includes a detailed description of the National Institute for Health and Clinical Excellence (NICE) guidance, and of its development, on the adoption into practice of the 'PleurX peritoneal catheter drainage system for vacuum-assisted drainage of treatment-resistant, recurrent malignant ascites'.[1] This is the ninth piece of Medical Technologies Guidance on a diverse range of devices and diagnostics (table I).Table I. Published Medical Technologies Guidance (MTG) [Table omitted.] The aim of this Commentary is to provide some background to the NICE Medical Technologies Evaluation Programme (MTEP), and to why the assessment reports - which will be summarized in this journal - are vital to its methodology.1. Background and Principles of OperationIn 2009, NICE was given responsibility for establishing a system to identify and, subject to evaluation, encourage adoption of new or novel medical devices and diagnostic technologies with potential to improve the experience and outcomes of patients and/or to drive efficiencies in the use of health-service resources.The NICE Medical Technologies Programme, and the specialist Diagnostic Assessment Programme, were constructed through a wide-ranging series of discussions with many interested parties - industry, clinicians, commissioners, health-service managers, academics, scientists and patients. The result is a programme where the following principles of operation reflect the distinct characteristics of innovative medical technologies.* All forms of evidence (published and unpublished and with no design or quality threshold) are considered, reflecting the often sparse evidence base for medical technologies.* The evaluation timeline is as short as possible to reflect the often rapid pace of development of technologies.* The initial assessment of a technology is based on the claims made for a single product: to simulate the decision making in health systems and ensure that guidance is as relevant as possible. During evaluation, the guidance is based on a sponsor's submission, including cost modelling (on a template specified by NICE). Clear and explicit value propositions about all aspects of introducing technologies in place of 'current management' are central to evaluations.* System benefits are given equal prominence to patient benefits and sustainability benefits are identified and actively considered.* Technologies are notified to NICE by innovators (usually a commercial sponsor, i.e. manufacturer or distributor) so that the full range of medical technology products is considered.* Products which are novel but not new can be notified and may be evaluated if there is evidence that they have plausible claimed benefits and are not being routinely adopted.* Medical Technologies Guidances specifically examine products which are plausibly resource-releasing. The economic method used is cost-consequences analysis where the inputs and outcomes are costs rather than any patient-based outcome such as quality-adjusted life-years.The programme has a dual function: first, to select the most promising technologies from those notified and route them to the most appropriate NICE programme. Second, to carry out evaluations which are published as Medical Technologies Guidance. Thus, topics such as the PleurX peritoneal drainage system are 'self-referred'. The selection process is designed to ensure that only new or novel products with plausible promise are routed for evaluation. The option to route to the most appropriate NICE programme ensures flexibility in enabling a wide range of products, with different value propositions, to be handled. A particularly important routing option is to the NICE Diagnostics Assessment Programme which was launched in 2010. This is a specialist programme designed to evaluate complex decision problems relating to diagnostic technologies and whose economic methods include cost-effectiveness analysis. …