Appraisal of the Use of Inhaler Systems (Devices) in Children Under Five Years of Age With Chronic Asthma

Decision of the Appeal Panel

1. Introduction

1.1 The Appeal Panel met at 12:30 am on 31 August 2000 to consider an appeal by 3M Health Care Ltd (“the Appellants” or “3M”) against the Institute’s Guidance to the NHS on the use of inhaler systems (devices) in children under five years of age with chronic asthma, dated August 2000 (“the Guidance”).

1.2 The Appeal Panel comprised Professor Tony Culyer (Chair of the Appeal Panel and non-executive Board member), Mrs Mary McClarey (non-executive Board member), Professor Sir Michael Rawlins (non-executive Board member and Chair of the Institute), Dr Michael Carter (industry representative, formerly of Zeneca) and Ms Maxine Whitton (independent member and member of the Institute’s Partners Council).

1.3 At the beginning of the hearing, Dr Carter informed the Appellants that he is in receipt of a pension from AstraZeneca, a manufacturer of inhaler systems and one of the parties consulted as part of this appraisal. Professor Culyer gave the Appellants the opportunity to object on the basis of this interest to Dr Carter’s inclusion on the Appeal Panel. The Appellants confirmed that they had no objection.

1.4 The Appeal Panel considered a presentation from Mr Matthew McGlennon (Healthcare Policy Adviser) and submissions from Dr Richard Spiers (Medical Director, UK and Republic of Ireland) and Dr Carole Longson (Director Evidence Research Unit, CMC UK) on behalf of 3M. The Appeal Panel also considered the prior written submissions made by 3M.

1.5 In addition, representations were considered from Professor Philip Routledge, a member of the Appraisal Committee, Dr Rod Taylor (the Institute’s Technical Lead for this appraisal) and Ms Anne-Toni Rodgers (the Institute’s Executive Lead for this appraisal).

1.6 The three grounds upon which the Appeal Panel can hear an appeal are:

1. The Institute has failed to act fairly and in accordance with the Appraisal Procedure set out in the Interim Guidance for Manufacturers and Sponsors;
2. The Institute has prepared guidance which is perverse in the light of the evidence submitted;
3. The Institute has exceeded its powers

1.7 3M appealed on the second ground.

2. Appeal Ground Two: The Institute has prepared Guidance which is perverse in the light of the evidence submitted.

2.1 The Appellants raised one point in the letter of Appeal. This was that the phrase in the second sentence of section 1.2 of the Guidance, viz. “In the case of children aged 3-5 years, a dry powder inhaler (DPI) may also be considered.”, ought to be amended to read “In children aged 3-5 years, a dry powder inhaler (DPI) may be considered for bronchodilator therapy.”. They noted that the British Thoracic Society (BTS) consensus-based guidelines recommended that, in cases involving children aged 3-5 years where other devices were judged inappropriate, DPIs might be considered for possible use in the administration of bronchodilators but were not recommended for the administration of corticosteroids. This BTS guidance had been included in the Institute’s Guidance. They also noted that the Institute’s Guidance had commented that the evidence on which its recommendations were based was “relatively small and of poor quality”. The Appellants agreed that, in cases where other devices were judged inappropriate, it might be appropriate to use a DPI and Dr Spiers himself had on occasion prescribed their use for children aged 3-5 years. It was further noted by the Appeal Panel that the BTS response to the Guidance had raised no objection to this element of the Institute’s Guidance.

2.2 The Appeal Panel concluded that the omission of the phrase “for bronchodilator therapy” did not constitute unreasonable Guidance in the light of the evidence before the Appraisals Committee and therefore dismissed this point.

2.3 During the hearing, the Appellants also objected to the structure of paragraph 1.2 of the Institute’s Guidance, where they felt that the same second sentence of the paragraph did not make it clear that a DPI ought to be considered for use only where other devices had been judged inappropriate.

2.4 The Appeal Panel noted that the BTS had raised no objection to the structure of this paragraph and members considered that the recommended circumstances under which DPIs might be considered for use were perfectly clear in the context of Section 1 of the Guidance and did not constitute perverse advice. The Appeal Panel therefore dismissed this second point.

2.5 The Appeal Panel therefore rejected the Appellants’ submissions and was satisfied that the Guidance was not perverse in the light of the evidence submitted to the Appraisal Committee.

3. The Appeal

3.1 Having found against the Appellants, the Appeal Panel dismissed the appeal.

4. Further Appeal

4.1 There is no possibility for a further appeal within the Institute against this decision of the Appeal Panel. The decision of the Appeal Panel and the Institute’s decision to issue the Guidance may be challenged by an interested party through an application to the High Court for permission to apply for judicial review. Any application must be made promptly and in any event within three months of receipt of this Decision or the issue of the Guidance, as applicable.