Find out about the types of projects we've worked on previously and the advice we've provided to industry.
Neil Stentiford, Managing Director at SOE Health Ltd, manufacturers of the SoeMac device , talks about his experience of using the META tool, and the benefits that have accrued from this.
“We used the META Tool to find out more about what we may need to change or add to our product development plan. Our main goal was to achieve a NICE recommendation for our product for sale to the NHS and the tool seemed like a great way to sense check that this may be possible.
We completed the online submission and then met with NICE in their Manchester office to discuss their findings, observations and requirements. The META report gave us a clear plan of what we needed to do.
This formed the framework for the next stages of our project and has given a clear structure to what we are doing. The report gave a concise conclusion and as a result we, we have focussed:
- Our clinical data collection and the need for a robust study, with a clear population. We will also work with suitable NHS clinical staff to understand the treatment pathway and put together a suitable study plan.
- Obtaining the CE mark and using a professional regulatory advisor
- Developing our general value proposition
- Focusing on the patient and system benefits
- Collecting economic data
- Exploring funding and commissioning options within the NHS.
"As a result of focusing on and acting on each of these points, we have obtained the CE mark, and are in the process of running a robust clinical study, with a strong team of experts from the NHS, Derby University and the community respiratory groups.
An initial health economics assessment has been completed and we await the study results before engaging with NICE. The META Tool has helped us plan and navigate our way through the process and has been a massive help in making us think about next steps in a structured and measured way.”
Ross Selby, head of global patient access at Takeda Oncology talks to us about how scientific advice now plays an essential part of their strategy building.
"I attended an introductory session run by NICE and thought scientific advice sounded like a great idea from day one.
"As a team, we decided to use the services to help overcome any uncertainty we had with the clinical trial design. For example, the different comparators, the end points and the impact on the clinical trial outcomes. The scientific advice team supported us in refining our value proposition and optimising our trials, ready for the health technology appraisal (HTA). We made sure we engaged early enough so our clinical development teams could further optimise the trials after the advice was given.
"Our clinical development teams are predominantly based in the USA and at that time were unaware of how challenging a HTA environment can be outside of the USA. I spent a lot of time with them explaining the HTA process and the challenges that can be experienced to gain patient access. While reinforcing that many of these challenges are a result of sub-optimal clinical trial design. Once they understood the challenges, the scientific advice process seemed like a great option for them and helped contribute to the decision to go ahead.
"Once we received the scientific advice report, we were able to make changes to the secondary end points on our pivotal clinical trials. This helped NICE and other HTA bodies to assess our medicine further past the primary end point. The advice on our patient reported outcome measures and when to measure them has been particularly useful for our outcomes research teams.
"The experience with the NICE scientific advice outreach seminar programme has really helped to educate our teams on NICE's remit and principles. Everyone's passionate about the medicines they work on and the input from NICE is seen as highly constructive.
"To summarise, I would say that the scientific advice services have been fantastic. There is a spirit of support amongst the team and this reinforces that NICE want to approve valuable medicines; they just need the appropriate evidence to do it. I would thoroughly recommend their services, for me it's a 'no brainer'. If someone had offered to sit down with me and help optimise my studies before my A levels, I'd have jumped at the opportunity!
Uncertainty is the prime reason that medicines struggle with health technology assessment. Scientific advice is a mechanism to reduce that challenge - so take it."
The team recently worked with the University of Newcastle and AMLo Biosciences to provide a consultation on evidence development plans for early prognostic tests for melanoma. Key issues discussed included:
- the study design
- the treatment pathway
- the proposed economic evaluation.
Dr Marie Labus, chief executive officer at AMLo Biosciences Ltd talks about the scientific advice they received and how it's helped them. AMLo Biosciences were the 2017/18 winners of the NICE AdviseMe prize.
"It was a competition where smaller companies and academics could apply to receive scientific advice on a product. The product had to have potential to prolong survival, improve quality of life and/or improve NHS efficiency or access to healthcare," says Marie. "It was great to see that this opportunity was available to us. We'd heard about the benefits of talking to NICE as early as possible in the development process and, having done just that, we can see why.
"The feedback we received really helped us to nail our value proposition at the right point in the process. Typically, there's a danger that companies may amble along without any clear idea about what value their product adds. The 2 hour meeting with NICE is a standard part of the advice process. It was great that we could do this over the phone so we could get everyone together.
"During the call, the team asked us some difficult and challenging questions about our plans. These questions were designed to offer advice on the development plan and model. They also encouraged us to think carefully about how we articulated our product offering in order to make it clearer.
"The final advice report from NICE was excellent and helped us to re-focus on our clinical studies. The report reinforced that we were on the right track. But it also set out areas that we could improve on and address in a different way. Ultimately, it made sure we considered the cost effectiveness of the product much earlier on in the process than we would have done normally. It also highlighted that our economic model was extremely comprehensive and that simplifying this could be more appropriate for NICE.
"I can’t recommend seeking scientific advice enough. It's great to see that small companies and academia have the support and the opportunity to receive scientific advice and make their clinical studies relevant to the NHS. It's so important to talk to NICE or other health technology assessment bodies as early as you can in the development process. It ensures you're on the right track. And it helps avoid making costly mistakes further down the line when it can be too late to correct them.”
Tim Wheeldon, Managing Director UK and Ireland at Fresenius Medical Care talks about their experience using our META tool.
"Our team chose to use the META tool to seek assurance that our evidence base would be suitable for the needs of payers, particularly the NHS.
"It was a simple and quick process involving 3 key steps:
- We completed the online synopsis, answering questions about our technology.
- A few weeks later we met the NICE team to discuss the gaps identified in the synopsis.
- We then received the META tool report consolidating all the key issues and the next steps to consider.
"As a result of the consultation, we gained several helpful insights including:
- A good understanding of the NHS perspective to ensure our resources would be spent in the most efficient and effective way.
- Valuable discussion around the position of the device in the patient pathway and how to define it according to the relevant comparator.
- Productive discussion about the evidence plans, possibilities in applications for reimbursement and return on investment.
- A great summary report, providing us with the means to communicate the gaps to the rest of the company and the next steps we would need to take to fill them.
"Overall, we found the experience positive, transparent and timely, with a clear focus on the final deliverable. The team’s expert and open communication was truly valuable for us. We would certainly recommend using the META tool to other companies to ensure they generate appropriate and robust evidence for their technology."
Melanie Calvert is Professor of Outcomes Methodology and Director of the Centre for Patient Reported Outcomes Research (CPROR) at the University of Birmingham. She talks about the advice they received from NICE Scientific Advice and the Medicines and Healthcare products Regulatory Agency (MHRA).
"We were awarded £1.1 million by UK Research & Innovation (UKRI)’s Innovate UK to develop an innovative digital solution to investigate patients’ experience of cell and gene therapies. The project is a joint venture between the Midlands & Wales Advanced Therapy Treatment Centre, CPROR, Dignio Ltd, working in collaboration with the Cell and Gene Therapy Catapult and the Advanced Therapy Treatment Network.
"As part of the commercial development, we had developed several value propositions and wanted to explore these propositions in depth and to establish what evidence would be required for reimbursement in the NHS.
"The joint advice process with NICE and the MHRA was productive; we know that stakeholder input is crucial for us to ensure the product and testing fulfils the current and future requirements of regulators and policy makers. We found it helped us understand what was needed from the study and the necessary comparators.
"Expert input from the MHRA and NICE allowed us to prioritise our value propositions and inform commercial development plans. The report provided clear regulatory and NICE guidance and directly informed the business plans. The team now feel more confident that the product addresses key stakeholder needs.
"The meeting also facilitated further dialogue regarding the broader activities within the Centre for Patient Reported Outcomes at the University of Birmingham with NICE. The Centre has led the development of international guidance to optimise the design and reporting of clinical trials involving patient reported outcomes and is working closely with NICE to help promote the uptake and implementation of this guidance.
"We would highly recommend other researchers consider early engagement with NICE and the MHRA, particularly as they offer a range of services that suit a range of needs in all stages of product development.”
The views expressed are those of Melanie Calvert and not necessarily those of the NIHR, or the Department of Health and Social Care.
NICE's scientific advice services have been fantastic. I would thoroughly recommend them - for me it's a 'no brainer'.Ross Selby, head of global patient access, Takeda Oncology