Why seek advice?

Our evaluation programmes require certain types of evidence about the technology being appraised. Our advice ensures that your proposed development plans produce evidence that is relevant for a future NICE evaluation. If you are unsure whether your product will be evaluated by us, our services can help you understand how to generate robust evidence that demonstrates the value of your product.

You can visit our topic selection and programme pages for information about how products are selected and the processes involved in NICE evaluation programmes.

 

At what stage of product development should I seek your advice?

Pharmaceuticals 

The best time to seek advice on the clinical development and evidence generation to support NICE evaluations of investigational medicinal products will vary for different investigational products. Typically the optimum time is during the design and prior to the initiation of the main registration efficacy studies.

If your technology is in the late stages development and you still wish to seek advice, you should aim to finalise the scientific advice project no later than 38 weeks before your expected NICE Technology Appraisal committee meeting, which is generally aligned with the date the technology would gain CHMP opinion from the Committee for Medicinal Products for Human Use at the European Medicines Agency. This will leave approximately 8 weeks between receiving the final advice from NICE and the Decision Problem meeting with the Centre for Health Technology Evaluation. Please refer to figure 4 in the Guide to the Processes of Technology Appraisal  for a summary of the process.

We can provide advice any time after the completion of the first in-human trials (with the exception of selected medtech products or products for particularly rare conditions) although advice is typically sought during the planning stages of a pivotal trial programme.

Medical technologies

Please speak to us for more information on time frames.

Please bear in mind that for both, it is generally considered too late to seek advice from us if:

  • your product is due to enter the scoping phase of a NICE technology appraisal
  • your product is under 12 months away from receiving marketing authorisation in the UK and/or EU.

However, this also depends on the product and the advice you are seeking. If you think you may have left it too late to seek scientific advice please contact us to discuss alternative options.

 

How far in advance should I contact you to book a project?

The project can start at an agreed time; we suggest you contact us as early as possible to discuss your requirements.

Depending on which service you choose, you may need to prepare a project synopsis form and a briefing book up to 22 weeks before you anticipate receiving our advice report. You should factor this into your plans. Read our guidance on completing a briefing book.

 

How much does it cost?

We're introducing a new approach to pricing from April 2019 that'll apply to both our standard and express advice services.

There'll be a greater range of price points than the existing structure more closely aligned to the scope of the advice being sought. 

The price will be determined by several factors including:

  • the breadth and complexity of the issues raised
  • the number of external experts needed
  • the level of background research involved.

This means that:

  • Prices for a standard project will now range from £30,000 to £75,000 with a typical project coming in at around £46,000.
  • Prices for an express project will now range from £38,000 to £70,000 with a typical project coming in at around £51,000.
  • Light advice has now been incorporated into our standard scientific advice service. Small and medium-sized enterprises can talk to us about more affordable options, starting from £20,000.
  • For standard and express services, we'll provide an initial quote based on the draft briefing book. There'll then be an opportunity to make changes to the briefing book before submitting a final version. In cases where the scope is reduced or increased, a revised final quote will be shared prior to project initiation. You can have a look at our process timeline for further details.

Are there any products that are not eligible for your advice?

We generally do not give advice on:

  • generics and biosimilars
  • new formulations of existing products unless they are developed in new therapeutic indication 
  • anti - HIV medicinal products

However, you can still choose to use our advice service, even if your product is unlikely to be evaluated by NICE. Doing so can help generate robust evidence and build a value proposition for your product to present to payers in other settings.

If you contact us about such a product, our technical team can discuss it with you and help you decide whether to proceed with our advice.

 

Can I seek scientific advice on gene or cell therapy products?

Yes we give advice on any type of medicinal product (e.g. advanced therapy medicinal products and orphan drugs), please contact us for an informal discussion.

 

Can I seek scientific advice on screening tests?

Yes, we are collaborating with Public Health England and the UK National Screening Committee to help companies developing screening tests. Please contact us for an informal discussion to see if your product can be considered.

 

Can I seek scientific advice on antibiotics?

Yes, please contact us for an informal discussion to see if your product can be considered. 

 

How do I decide which type of advice to apply for?

It depends on the stage of development of your product and on the questions you would like to explore.

We will be happy to explain the options and help you decide which advisory service to pursue.

 

How long does an advice project take and what are the stages of the project?

You can find out more about our processes by looking at the process pages:

  Scientific advice 

NICE-MHRA scientific advice

 European Early Dialogues 

 Advice for small and medium size enterprises 

 

What questions can I ask and are there any you can't answer?

The questions we are asked usually relate to:

  • clinical trials, design and analysis (including development based on biomarkers) 
  • trial populations 
  • outcomes
  • comparators
  • health-related quality of life data collection
  • economic analyses
    • cost-effectiveness modelling
    • extrapolation
    • resource use
    • costs.

We will only comment on proposed clinical development plan, cost effectiveness models and studies and cannot design analyses or endorse any proposed plans.

Therefore we will not:

  • design a trial or economic model for you
  • provide an assessment of the chances of a successful appraisal
  • guess at the committee's opinion about any part of a submission
  • provide advice on pricing.
 

How do you handle confidential and commercially sensitive information?

Any information labelled as Official-Sensitive-Commercial will be treated as such, whilst complying with relevant legislation (such as the Freedom of Information Act 2000). All staff and experts involved will have signed confidentiality undertakings. The information you provide, and the advice we issue, will not be shared with any appraisal committee or with other teams within NICE. 

 

Will seeking advice from NICE guarantee a future appraisal?

Engagement with our service, and the advice given, will not guarantee a future appraisal with NICE. Our topic selection and programme pages explain how products are selected and the processes involved in NICE evaluation programmes.

 

Where can I learn more about how you evaluate new technologies?

Take a look at our methods guide and process guide to begin with.

We run one-day seminars aimed at developers of pharmaceuticals, medical technologies or cell and gene therapies that:

  • teach the principles of health technology assessment
  • show how we apply those principles when evaluating these technologies
  • show how you can use this knowledge to develop your products.

We will consider visiting external sites to deliver bespoke seminar programmes that meet your particular needs. Please contact us to discuss your requirements.

 

What happens at a site visit?

We will visit your office and deliver a presentation on the opportunities to engage with us early on in product development.

The usual visit duration is between 2 and 3 hours. You may request a customised agenda for the visit by liaising with our team in advance. Company staff based at other sites can join the meeting via web, video or teleconference.

You can:

  • Learn why early scientific advice engagement with payers is important.
  • Find out how to product the best briefing book.
  • Choose from a range of exciting services that we offer to product developers.
  • Ask our team your questions.

Contact us to discuss or book a site visit to your company.

Site visits are free of charge but any travel or accommodation expenses would need to be covered.

You can download our site visit flyer PDF 2.6MB.