| 15 | The Department of Health will regularly and systematically examine all the interventions on the short-list, focussing in particular on those interventions which are expected to be launched in about 6 years' time or less, and applying the criteria set out in Annex B. Where it seems likely that an intervention will be selected for appraisal and there is a clear sponsoring company, the Department will notify the company of its provisional view and invite comments. The judgement that a particular intervention is likely to qualify for appraisal will be reviewed annually in the light of changing intelligence and the sponsoring company notified of any changes. The Department will share its provisional judgements with NICE to help plan the forward work programme of appraisals. It will also consult regularly with the NHS and with patient and professional groups, setting out the short list of potentially significant interventions and the Department's views on which should be appraised. |
| 16 | Where there is no obvious sponsoring company, the Department will consider whether any research should be commissioned through the NHS R&D programme. |
| 17 |
When an intervention has been provisionally selected for appraisal, and intelligence suggests that it is likely to be marketed to the NHS within the next 12 months, the Department will carry out a final review of its selection decision and will give the sponsoring company (if one has been identified) a final opportunity to make representations. Subject to this, |
| i | the company will be formally notified that an appraisal will be needed and invited to submit evidence by, generally, no later than 4 months before the intended launch, or, in the case of pharmaceuticals, the time of submission to the licensing authorities; | |
| ii | similarly any relevant patient groups will be invited to submit any views by the same deadline; and | |
| iii |
NICE will be formally invited to carry out the appraisal. |
| 18 | It is intended that the "thresholds" on the various appraisal criteria will be initially fixed in order to select about 20-30 new interventions each year for appraisal. We envisage that this will cover the key interventions on which the NHS would welcome guidance. In addition, the appraisal function should have the capacity to appraise the most significant of existing interventions (see paras 44-45 below) and to review previous appraisals as necessary (see para 43). The selection thresholds will be kept under review and may be revised from time to time after giving due notice to interested parties. |
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Comments are invited on
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