DEC methods for appraising new drugs

Editor—Freemantle and Mason are quite right to explore the difficult task that the National Institute for Clinical Excellence (NICE) will face in appraising new drugs.1 However, it is disappointing that there was so much in their article which misrepresented the work of our development and evaluation committee (DEC), and no recognition of the considerable activity of the committee relating to different interventions that are not new. One of the main summary points stated that: “New drugs should be appraised in terms of physical outcomes that mean something to doctors and patients.” This principle is a major influence in all the deliberations of our development and evaluation committee. For example, in the recent appraisal of β interferons for multiple sclerosis, our discussions gave far more weight to possibly becoming wheelchair bound than to proxy measures such as changes on multiple resonance imaging. The debate also considered the impact of relapses on patients and their families, together with a whole range of issues relating to carers, health service delivery, and the complex matter of both documented and hidden costs. This breadth of discussion is exactly what Freemantle and Mason are proposing in their section on systematic profiles and is a routine part of appraisal by a development and evaluation committee. They also advocate “including the right people”—for example general practitioners “if a drug will mostly be prescribed in primary care.” Our committee includes two general practitioners and a lay member because we believe that their views are important across the whole range of interventions. The NICE appraisal committee is likely to do the same, including a broad range of interests. With regard to getting all the information about new drugs, our development and evaluation committee aims to address focused questions about the application of new drugs within quite a short time frame, pointing out areas of uncertainty in the published literature, and giving an early “update category” when further information is likely to become available. It has been our experience that pharmaceutical companies have been rather slow to release information, which is often presented in a somewhat selective form, and which has not been subjected to peer review. For these reasons the committee is cautious about making decisions that may affect allocation of NHS resources on the basis of unpublished data. Estimates of cost effectiveness are difficult, and “cost per QALY” ranges may be wide in an attempt to allow for all the possible variables and assumptions. However, with the explicit “cost per QALY” thresholds2 which our committee uses, a wide range does not influence our judgment unless it crosses one of the threshold values; in practice this seldom happens. We hope that NICE will build on the experience of the development and evaluation committees in its appraisal work.