Select Committee on Health Appendices to the Minutes of Evidence


APPENDIX 27

Memorandum by Aventis Pharma Ltd (NC 122)

  Aventis Pharma Ltd is the UK pharmaceutical company of Aventis SA. Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at satisfying unmet medical needs. Aventis Pharma focuses on important therapeutic areas such as cardiology, oncology, infectious diseases, arthritis, allergies and respiratory disorders, diabetes and the central nervous system disorders. Aventis Pharma has its corporate headquarters in Frankfurt, Germany.

  Aventis Pharma Ltd has had wide experience of NICE. Six of our products have been the subject of eight technology appraisals by NICE. A further five evaluations by the Institute are in progress.

  We welcome the opportunity to submit the following evidence and our suggestions for improvement of the processes of NICE to the Select Committee for consideration. Should the Committee want additional clarification or expansion of any point raised in this submission please contact Dr Anna Sorman, Head of Government Affairs.

  This submission is structured as requested in the Guide to Submitting Evidence, dated 23 November 2001. In order to further help the Committee, our recommendations are presented after each point to which they refer and collectively below.

1.  CRITERIA FOR ASSESSMENT

  1.1  The Institute, in concert with interested parties, should develop and publish a clear set of criteria for both the clinical and the health economic dimensions of assessment for each specific type of technology or therapy area prior to its assessment.

  1.2  There should be an open consultation process between stakeholders and the Institute to agree the relevant criteria to use for a specific technology assessment.

2.  PROCESS DURATION

  2.1  A clear and short timeline is needed for each assessment marked with clear milestone events. We contend that this should be no longer than 180 days, with the provision for "clock-stop" periods if necessary.

  2.2  We recommend that in the long run, the Institute should resource itself adequately in order to be able to conduct its own appraisals rather than commission third-party organisations of varying quality.

  2.3  In the short run, and if it is also necessary in the long run for the Institute to continue to use third-party assessment organisations, they should use the same organisations to assess similar technologies. We contend that this will improve self-learning by NICE and its third-party contractors with benefits accruing to the quality of assessment and hopefully the speed as well.

  2.4  A mechanism for the provision of interim guidance needs to be established to ensure that patients are not denied access to treatments that they and their doctors consider of benefit when the Institute has been either tardy or negligent or both.

3.  TRANSPARENCY OF APPRAISAL COMMITTEE DATA USE AND DECISION MAKING

  3.1  Introduce a consultative mechanism for stakeholders to be able to address the Appraisal Committee in the early stage of their work and after the first draft of the Appraisal Determination has been issued.

  3.2  Introduce a mechanism for the Appraisal Committee to explain its decisions by publishing the reasons for decisions and inviting oral questions with answers, in public, as part of the consultation process.

4.  THE DEPTH AND BREADTH OF EXPERT OPINION AVAILABLE TO THE APPRAISAL COMMITTEE

  4.1  Publish the list of expert opinion that the Appraisal Committee will refer to prior to the start of the appraisal of the data and submissions by the Committee; inviting additions and challenges to the experts selected.

  4.2  As the Institute clears its backlog of appraisals it will increasingly appraise cutting edge technologies. Expert opinion should not be limited to UK experts but include experts irrespective of their place of abode or clinical or scientific practice.

  4.3  The breadth and depth of expert view should not be arbitrarily limited by number of experts but only be limited by predefined scope of opinion required to achieve a sound decision.

5.  INDEPENDENT APPEALS PROCESS

  5.1  Establish an appeals process for Final Appraisal Determinations and NICE Guidance that is independent of the NICE executive.

  5.2  Appeals should be possible on the merits and substance of the decision and not limited to Wednesbury unreasonable: "perverse".

6.  CLARIFY THAT THE OUTPUT OF NICE IS GUIDANCE NOT DICTUM

  6.1  A clear footnote must be written into all published guidance setting out that the document is only guidance and that no patient should be disadvantaged by this guidance if sound clinical reasons for deviating from it can be made by their attending physician.

  6.2  The nature of the content and process to establish reasonable justification for using a treatment that is not the subject of positive NICE guidance should not be so onerous as to act as an effective barrier to the patient receiving the treatment.



 
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