Answers to frequently asked questions about our scientific advice service.
If you cannot find what you're looking for, please contact us for more information.
Why should I seek advice?
Our evaluation programmes require certain types of evidence about the product 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 NICE, our services can still add value by helping you understand how to generate robust evidence that demonstrates the product’s value.
At what stage of development should I seek advice?
The best time to seek advice on the clinical development and evidence generation to support a NICE evaluation can vary from product to product. Typically, the optimum time is during the design and before the initiation of the main registration efficacy studies.
If your product is in the late stages of development and you still want to seek advice, you should make sure that the final advice is received no later than 7 and a half months before the date the product would gain opinion from the Committee for Medicinal Products for Human Use at the European Medicines Agency. This is the earliest point at which the NICE technology appraisals process could begin (through an invitation to participate or ‘ITP’) and so all scientific advice projects should be completed by that point.
It's advisable that companies factor in a gap between receiving advice and starting the appraisal process so they have sufficient time to act on any advice received. Please refer to figure 4 in the guide to the processes of technology appraisal for a summary of the technology appraisals process.
There is generally a lot more variation in how medical devices, diagnostics or digital health technologies are developed. The optimum time to seek advice will be different in each case, depending on the product itself and the evidence you plan to generate. If you're unsure, it's advisable to get in touch and discuss this with us.
How quickly can my project start after I make an enquiry?
Most requests for advice are dealt with on a first-come-first-served basis. Lead times can vary depending on levels of demand at the time. However, from December 2021, there are a limited number of priority slots reserved each month to enable the team to offer timely advice to companies that are developing high priority technologies for the NHS.
We look at several factors to determine whether a product is eligible for a priority slot. These factors will include whether a product is addressing a high unmet need, whether we have previously given advice for the same product in the same indication, whether a company has experience with the appraisal process or not, and when the most recent appraisal for the proposed indication took place. In addition, we will give more weight to requests for joint scientific advice projects with the Medicines and Healthcare products Regulatory Agency (MHRA), Canadian Agency for Drugs and Technologies in Health (CADTH) or any other joint initiatives that NICE chooses to participates in.
If we determine that your project is a high priority for NICE and the NHS, you will be eligible for a priority slot for scientific advice.
It's important to note that NICE Scientific Advice’s services continue to be available to all companies who want to come for advice, and requests for advice will not be rejected. The only difference is that if your product is eligible for a priority slot, we may be able to accommodate your project sooner.
How much does it cost?
NICE Scientific Advice operates on a cost-recovery basis. The fees for our Standard, Express, Parallel (with CADTH or MHRA) and Concurrent advice services are determined by a number of different factors including:
- the breadth and complexity of the issues raised
- the number of external experts required
- the level of background research involved.
As a guide:
|Service||Fee range||Typical cost|
|Standard||£47,467 to £68,316||Around £53,230|
|Express||£54,587 to £70,942||Around £61,214|
|PRIMA (standard)||£31,275 to £36,862|
|PRIMA (express)||£34,933 to £41,357|
For services that work on variable pricing (as above):
- we’ll provide an initial quote based on a draft briefing book
- there’ll be an opportunity to amend the briefing book before submitting a final version
- if the scope changes, a revised project fee will be shared before project initiation.
Services with a fixed fee include:
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 around £29,000.
Our fees are reviewed on an annual basis and updated each financial year to support continued cost recovery.
Are there any health technologies 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.
Can I seek scientific advice on cell and gene therapies?
Yes, we give advice on any type of medicinal product.
Can I seek scientific advice on screening tests?
Yes, 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 service to use?
There are several factors that might influence this including
- stage of development for your product
- the types of questions you would like to explore
- which other markets you are targeting.
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:
- Standard scientific advice
- Express scientific advice
- European concurrent scientific advice
- NICE-MHRA scientific advice
- NICE-CADTH scientific advice
- Preliminary Independent Model Advice (PRIMA).
What questions can I ask and are there any you cannot answer?
The questions we are asked usually relate to:
- clinical trials, design and analysis (including development based on biomarkers)
- trial populations
- health-related quality of life data collection
- economic analyses
- cost-effectiveness modelling
- resource use
We will only comment on proposed clinical development plans, cost effectiveness models and studies and cannot design analyses or endorse any proposed plans.
We will not:
- design a trial or economic model for you
- provide an assessment of the chances of a successful appraisal
- 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, while complying with relevant legislation. 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.
Where can I learn more about how you evaluate new technologies?
We also run seminars and webinars aimed at the life sciences industry that:
- teach the principles of health technology assessment
- show how we apply those principles when evaluating health technologies
- show how you can use this knowledge to develop your products.
We will consider delivering bespoke seminar programmes that meet your particular needs. Please contact us to discuss your requirements.
FAQs for Preliminary Independent Model Advice (PRIMA)
What is PRIMA?
PRIMA is a health economic model advice service from NICE Scientific Advice. We currently provide companies with advice on the design and structure of economic models at the conceptual stage of the development process. PRIMA offers an advanced level of service via an external peer review of models that have been implemented in Excel or other specialist modelling software. Your model will undergo a systematic inspection by a team with years of experience in model development, critique and validation. A detailed report of the PRIMA findings is provided together with recommendations of model enhancements that could be made.
Why use PRIMA?
Healthcare organisations have become increasingly reliant on the output of economic models to support their decision-making process. However, the value of these tools is dependent on their credibility. Errors in the models can lead to flawed decisions which can be costly for the company, healthcare providers and ultimately patients. Model review is therefore a critical part of the development process as it helps to build decision-maker confidence in the model and its output.
PRIMA will be of particular benefit to your organisation if:
- there are internal resource constraints that prevent you from conducting a thorough quality check of your model
- your model has been developed by a third party
- your organisation has limited health economic modelling experience.
PRIMA would also be recommended if your model represents a high-risk to the business should significant errors be identified by the decision-maker.
Are there any models that are not eligible for PRIMA?
PRIMA will be available for wide variety of economic models including those developed for:
- cost-effectiveness analysis
- cost-consequence analysis
- cost-minimisation analysis
- budget model analysis.
Models that have been developed for a NICE technology appraisal will be considered on a case-by-case basis.