NICE 2000/ 045 Issued: 16 November 2000

At a public meeting held in Llandudno yesterday, the NICE Board voted unanimously to increase the transparency of its technology appraisal process by publishing its provisional and final determinations on its web site.

The requirement for confidential handling of these documents was introduced at the request of the health care industry (ABPI & ABHI), who believe that premature release of the contents of the provisional determinations could be share-price sensitive and might create unnecessary anxiety for patients.

NICE will now consult with its stakeholders and the Financial Services Authority. The results of this consultation will be reported to the January meeting of the Board. Until then the existing arrangements will continue.

Professor Sir Michael Rawlins. Chair of NICE said "It was clear to the Board that the current position regarding confidentiality is unsustainable. There are large numbers of people involved in the consultation process and whilst NICE can guarantee the integrity of its own processes, we can't control what others might do therefore confidential documents have been regularly leaked. This is not in the interests of either the Institute or patients".

Ends

For further information contact:

Anne-Toni Rodgers

 

Notes for Editors:

Background

1. The Board considered a paper prepared by the Chairman of the Institute at its November meeting - this paper is appended to this release. The Board also considered a paper from the ABPI and the ABHI.

2. The Institute currently follows a process in which its provisional determinations are circulated for a four-week consultation process to the national organisations that prepared submissions to the Appraisal. These include patient groups, healthcare professionals, and the manufacturers of the technology. In some cases there have been over 50 consultees, who all will consult within their own organisations. Whilst the Institute can ensure confidentiality within its own teams the partial disclosure of information from other sources has continued.

3. Following the leak of information during the Taxane Appraisal the Institute engaged Deloitte and Touche to conduct an investigation and make recommendations regarding improvements to the process. The Institute implemented the Delloite Touche report and the Board decided at its July public meeting to review their effectiveness in November.

4. NICE introduced confidentiality to the process at the request of key stakeholders in our process, the healthcare Industries. They had three major concerns,

• Firstly, that patients would be concerned by provisional decisions that might change. The Institute has discussed this issue at length with our Partner's Council and with the groups that represent patients and carers at a National Level; they feel that confidentiality should end. These organisations firmly believe that the Institute's provisional views on the availability of treatments relevant to their members should be exposed to public scrutiny; that patients and carers (and indeed the public in general) should have the opportunity to comment on the Institute's provisional advice at a time when this is still at an emergent stage; and that the industry's claim to wish to "protect" patients from unpleasant, but provisional, advice is patronising. In addition the organisations that represent professionals working within the NHS support the patient/carer organisations in their view that the existing confidentiality arrangements have prevented these groups consulting fully with the patients and carers they represent.
• Secondly, that the Institute's provisional thoughts can change, and therefore represent "share-price sensitive" information that might unnecessarily destabilise the stock markets. The Institute considers in fact our current arrangements are liable to create a "false market" and might be subject to severe criticism if there are significant share price movements resulting from the current way we consult on our provisional determinations.
• Thirdly, that the Institute provisional thoughts would have an adverse effect on drug regulatory authorities and re-imbursement agencies, in other markets, who may misunderstand the nature of the Institute's advice. The Institute has not been presented with any evidence to support the suggestion that this is happening in America, Europe and Japan.

5. The decision that the Board made follows months of discussion with key stakeholders, reviews of the Institute's processes and implementation of advice following the investigation carried out into the leak during the Taxane appraisal.

6. The Board concluded that it is essential that the Institute's provisional thoughts should be publicly available. The Institute also recognises that there are groups that will attempt to portray changes between provisional and final determinations as failures in the Institute's decision making, this is clearly not the case. NICE follows a process that allows for consultation and the process would fail if we did not take account of the comments made by consultees.

Appendix: Board Paper

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
SPECIAL HEALTH AUTHORITY
TECHNOLOGY APPRAISAL PROGRAMME - CONFIDENTIALITY

1 Background

The Institute currently restricts the circulation of its Provisional and Final Appraisal Determinations (PAD and FAD) to those originally invited to submit evidence at the start of the process (i.e. the manufacturer, the relevant professional organisations, and the relevant patient bodies).

This arrangement was introduced at the request of the health care industry (especially the ABPI). The industry believes that premature release of the contents of the PAD and the FAD would have adverse effects:

a) It would cause concerns to patients especially in view of the fact that neither the PAD nor the FAD necessarily represents the final guidance of the Institute.

b) It would be "share-price sensitive" information that might unnecessarily destabilise the stock markets at a time when the Institute's final advice is uncertain.

c) It would have an adverse effect on drug regulatory authorities and re-imbursement agencies, in other markets, who may misunderstand the nature of the Institute's advice.

The Institute's confidential treatment of the PAD and the FAD has, however, been the subject of severe criticism by patient groups and the media.

d) Such confidential treatment negates the Institute's claim to be transparent.

e) Organisations representing patients and carers firmly believe that the Institute's provisional views on the availability of treatments relevant to their members should be exposed to public scrutiny; that patients and carers (and indeed the public in general) should have the opportunity to comment on the Institute's provisional advice at a time when this is still at an emergent stage; and that the industry's claim to wish to "protect" patients from unpleasant, but provisional, advice is patronising.

f) The leak of the content of PADs and FADs has unquestionably damaged the Institute's image. Leaks are, inevitably, partial and do not include the reasons underpinning the provisional advice.

The Board agreed that the current arrangement should be continued (with additional safe-guards in place) until November. The Board now needs need to decide what action should be taken. The options are as follows:

Option 1 No Change

Under this option the Institute would continue to provide PADs and FADs to consultees on a confidential basis. Leaks will, unquestionably, continue to occur from time to time. Indeed, since the Board last discussed this matter leaks relating to the Institute's advice on Relenza, Ritalin and drugs for Alzheimer's disease have occurred despite the adoption of further measures to ensure confidentiality. If we chose this option, organisations representing patients and carers will continue to complain and our claims to operate a transparent process will continue to be regarded as fraudulent. Moreover, the Financial Services Authority has already indicated that our current arrangements are liable to create a "false market" and might be subject to severe criticism if there are significant share price movements resulting from our covert way of handling information.

Option 2 Total Transparency

Under this option the Institute would publish its PADs and FADs on its website at the same time as these are sent to consultees. It would be possible (and desirable) for manufacturers to be given some early warning (e.g.2 working days) in order for them to develop a strategy for handling the stock markets and the financial institutions. The Institute would also need to come to some arrangement with the Financial Services Authority to ensure the transparency of the arrangements for disclosure. Whilst measures along these lines would not satisfy the industry's concerns relating to the (allegedly premature) release of information that could cause stock market volatility, this would at least be controlled and we would have done our best to ensure a level playing field. Stock market analysts might even begin to adopt a mature approach to the release of the Institute's provisional views (especially when the number of appraisals reaches a maximum of 48 per annum). Furthermore, in order to prevent the Institute's views from unnecessarily influencing the decisions of drug regulatory authorities in other markets, it could construct a document (in consultation with the ABPI and the ABHI) describing the nature and purpose of NICE's appraisal process. This could then be used, by the industry, to explain matters to overseas drug regulators and re-imbursement agencies.

Option 3 Partial Disclosure

The Institute's normal (default) procedure would be for its PADs and FADs to be published under the arrangements described in Option 2. Under certain circumstances, however, it would be prepared to attempt to maintain confidentiality as described in Option 1 provided all of the following conditions are satisfied:

• that the sponsor of the technology is a commercial company;
• that the sponsor of the technology had applied (at the start of the process) for the contents of the PAD and/or the FAD to remain confidential until its completion; and
• that the technology had not, at the time when the PAD or FAD was available, been licensed/authorised in all the major markets (i.e. Europe, USA, Japan).

  Although this arrangement would not meet all the concerns of the health care industries (particularly in respect of the decisions of re-imbursement agencies) it would go some way towards reducing their anxieties.

The views of the Board are sought as to which of these Options (or some variant of Option 3) we should pursue.

Professor Sir Michael Rawlins
Chairman

October 2000