Scientific advice consultancy service

NICE offers product-specific scientific advice to pharmaceutical companies and device manufacturers about products which they have in development that may be referred for a technology appraisal.

Based on a briefing book, written questions submitted by the company and a face-to-face meeting, NICE will provide an advice report. There is a fee for this service.

Advice given by NICE will be in response to the written questions asked and documentation submitted. The advice cannot account for future changes and developments in scientific knowledge or appraisal requirements.

Join us at our scientific advice workshops in 2012

Why seek advice?

NICE's technology appraisal processes require certain types of evidence about the product being appraised. A company may wish to seek advice from NICE to ensure that their clinical and cost-effectiveness studies can produce evidence that is relevant for a NICE technology appraisal.

More information about NICE's technology appraisal methods.

When can advice be sought?

The optimal time for requesting scientific advice is usually during phase II studies, before the planning of phase III studies. The earlier in the development process, the less specific the advice can be, and the later in the process the less likely it is that companies will be able to make changes to the design of clinical trials. NICE cannot give advice on products that are currently the subject of a NICE technology appraisal for that indication.

What advice can be requested?

NICE will comment on your proposed development plans. Scientific advice can be given on many issues connected with the development of evidence for post-regulatory evaluation bodies. For example:

• Interpretation of NICE technology appraisal methods guidance and its relevance for the product's evidence development plans.
• Research design considerations or preferences to support each proposed indication. For example:
  • study population
  • duration
  • comparator(s)
  • endpoint(s)
  • type of study.
• Economic evaluation design considerations or preferences. For example:
  • form of evaluation and approaches to benefit measurement
  • modelling versus trials
  • relevant trial(s) for economic evaluation
  • approaches to the generation of quality-adjusted life years (QALYs).
• Methods issues. For example:
  • selection of instruments or research to derive QALYs
  • extrapolation of long-term outcomes
  • planning for indirect comparisons.
• Considerations and insights from existing models. For example:
  • expected value of perfect information (EVPI)
  • calculations to highlight greatest areas of uncertainty and assist with trial design
  • Bayesian simulations.

Scientific Advice Workshops at NICE

Are you involved in the development of medical devices and diagnostics? Find out how to demonstrate the value of your product at one of a series of workshops to be held at NICE offices in the autumn. Please visit this page over the coming weeks for more information.

Save the date

When	Where	Who can attend
1 October 2012	London	Diagnostics Developers
15 October 2012	Manchester	Device Developers
29 October 2012	London	TBD
12 November 2012	Manchester	TBD

Registration information and workshop details will be available in June. Please check this page for updates.

How does NICE provide advice?

1. The standard NICE advice process

After reviewing the briefing book which describes your proposed plans and the questions you want to ask NICE, we assign a technical team to the project. The technical team will be made up of NICE staff experienced in the area of technology appraisal. NICE will also seek input from external experts, usually clinical experts and health economists. These individuals will attend a face-to-face meeting with the company and help to produce the written responses to your questions in the formal advice report.

All experts involved in advice projects must declare their interests before being involved in the project. Conflicts of interest declared by experts are managed in accordance with NICE's conflict of interest policy. For the purposes of this programme, the policy applies to external experts as if they were ‘expert advisers'.

All NICE staff and external experts sign a confidentiality agreement.

2. Parallel advice with regulatory or other HTA agencies.

NICE welcomes requests to give advice in parallel with other agencies. Please contact NICE well in advance to discuss your proposal and determine the best process.

Stages of the standard advice process

Each individual advice project consists of the following stages:

• Telephone or email NICE to discuss your request and the availability of slots
• Submit a request for an advice slot
• Agree terms and sign contracts (one month before briefing book submission)
• Initial payment
• Submission of a briefing book by the company
• NICE confirms project size
• NICE clarifies any issues relating to your briefing book in writing and the company responds in writing
• Face-to-face meeting attended by company representatives, NICE staff and experts
• Written advice report from NICE
• Follow-up and clarification by the company if required
• Final payment

The Scientific Advice process map shows a flowchart of these stages.

1. Booking an advice slot

NICE has a limited number of slots available so it is advisable to contact us well in advance i.e. at least 25 weeks before the company wishes to receive the final advice report from NICE. Once the key dates have been established and agreed, we will then hold the slot for a project. On occasion we can accommodate requests at short notice but this cannot be guaranteed.

In the event that a development programme is delayed, we will endeavour to reschedule the project to a later slot provided we are given plenty of advance notice.

To request a slot please email scientificadvice@nice.org.uk.

To speak with someone about processes and timelines, please contact Richard Chivers Tel +44 (0)161 870 3241. If you wish to discuss the technical aspects of the project please contact Seren Phillips Tel +44 (0)161 870 3164.

2. Producing a briefing book on your product

In order to receive scientific advice from NICE about a product the company must produce a briefing book. As far as possible, this should contain the following information:

• Abbreviations
• Name or code name of product.
• Background:
  • disease area and indication
  • treatment pathways or sequences and associated outcomes
  • treatment guidelines or recommendations
  • current unmet needs and future outlook for treatment developments.
• Data currently available on the product:
  • name or code of product, mode of action or pharmacological class, proposed dosing regimen and route of administration
  • product value proposition
  • results of clinical studies performed to date
  • proposed positioning (treatment sequence, disease severity, patient characteristics).
  • product value proposition
• Proposed evidence plans for product:
  • proposed clinical trial design, including study population, comparator, endpoints, duration of observation, statistical analyses
  • proposed plan for economic evaluation including modelling versus trials, availability of existing models, sources of data, measurement of benefit, budget impact.
• Questions for discussion. These may be placed at the end of the briefing book or throughout the text, must be clearly indicated as questions and must be numbered sequentially.

If your product is a device, please contact us to discuss what additional information may need to be included in the briefing book.

It may not be possible to provide all of the above information. The company should provide information appropriate to the circumstances to help NICE offer the best advice available. The questions posed to NICE by the company should be as clear and precise as possible.

The briefing book should not exceed 50 pages, including appendices. It should be labelled ‘commercial-in-confidence' (not ‘confidential').

3. Agreement of terms and start of project

Prior to the agreed date of briefing book submission, NICE will send the company a copy of the standard contract to be agreed and signed. This should be completed at least one month before the briefing book submission date. Once signed, the company will receive a signed letter confirming the details of the face to face meeting.

On receipt of the briefing book, NICE will inform the company of the project size and confirm the total cost of the project. This will be based on the number and complexity of the questions asked in the company's briefing book.

4. Clarification questions and answers

NICE will send the company any clarification questions about the briefing book within 5 weeks of receiving the briefing book. The company should reply to these questions within 2 weeks.

5. Face-to-face meeting

A face-to-face meeting will be scheduled to take place approximately 12 weeks after the project starts. The meeting will be held at the NICE offices in Manchester (or on occasions, in London). Meeting attendees will include company representatives, NICE staff and external experts (for example, clinical experts and health economists). The purpose of the meeting is to generate a greater understanding of the key issues for the development plans from NICE's perspective. The meeting will therefore focus on the identification of and general discussion around the key issues rather than a direct response to the questions in the briefing book. Opinions expressed in the meeting will not necessarily be reflected in the advice report. There will normally be a brief introduction as to how the Appraisal committees form decisions on new technologies. The meeting will last approximately 3 hours. It will not be formally minuted and meeting notes will not be circulated.

6. Advice report

NICE will send a written advice report to the company approximately 6 weeks after the face to face meeting for a medium project and 8 weeks after the face-to-face meeting for a large project. The report will be formally signed off by NICE before it is released to the company.

7. Follow-up and clarification

The company may ask one set of clarification questions in response to the advice report. These questions should be limited to the advice given and should be intended to clarify the meaning of the advice. New information or new requests for information will not be considered as part of the current project. The company may submit a new request for further scientific advice at any time.

Clarification questions should be received by NICE within 3 weeks of issuing the advice report. NICE will reply to these questions within 4 weeks. Any additional questions or a request for a new face-to-face meeting will be considered a new project and an additional fee will be charged.

Binding status of advice

Companies seeking scientific advice should be aware that any scientific advice given is not legally binding with regard to any future appraisal of the product concerned, on the part of NICE or the company. Advice cannot be taken as indicative or suggestive of any future position, and will not be regarded as relevant to any future decision that may be taken by NICE.

The advice given by NICE is based on the questions and documentation submitted, and the scientific knowledge publicly available at the time of the advice. The advice cannot account for future changes and developments in scientific knowledge, regulatory requirements or health technology assessment methodology.

Companies should be aware that the advice provided is without prejudice to applicable legislation relating to the particulars and documents that should be submitted in support of any marketing authorisation (or other) application; it is also without prejudice to any intellectual property rights of third parties.

Fees

The fee structure is determined by the complexity of the advice request, the number of questions asked by the company and whether or not a written report is required.

Further information about the scientific advice programme

For further information about the scientific advice programme, contact:

Seren Phillips
Associate Director
Scientific Advice Programme
NICE
Level 1A, City Tower
Piccadilly Plaza
Manchester M1 4BD
United Kingdom

Telephone: 0161 870 3164
Email: seren.phillips@nice.org.uk

General enquires about the work of NICE

If your question is not about the scientific advice consultancy services and is an enquiry about the work of NICE then you should direct it to our Communications team:

Email: nice@nice.org.uk or Tel: 0845 003 7780