Justin Stindt Consultants, a leading consulting agency in Pharma, Biotech, and MedTech, specializes in guiding companies through NICE’s “NICE Advice” service. This essential service helps in designing clinical trials and development programs for medicines, medical devices, or diagnostics, enhancing the chances of successful HTA submissions. Our expert team provides comprehensive support, from developing evidence to showcasing product value and integrating cost-effectiveness measures.
Additionally, we assist with NICE’s Medtech Early Technical Assessment (META) Tool and hybrid Medtech advice, aiding in understanding and addressing evidence gaps for medical devices and digital health technologies. As an international consulting firm, Justin Stindt Consultants ensures your technology development aligns with regulatory and HTA expectations, optimizing your product’s pathway to market success.
HTA scientific advice by the British NICE to optimize your trial design and chances for reimbursement in England
The National Institute for Health and Care Excellence (NICE) offers a confidential “NICE Advice” service that allows pharma, biotech and MedTech companies to seek early feedback on their development plans for medicines, medical devices, or diagnostics. This service aims to help companies design robust and relevant clinical trials and development programs, improving the chances of successful HTA submissions later on.
NICE Advice provides pharmaceutical and MedTech companies with the same esteemed scientific guidance and opportunities to engage with the health system as its predecessor services, the NICE Scientific Advice and the Office for Market Access, did.
The services include:
- Helping companies develop evidence that shows the value of your product
- providing detailed feedback on your evidence generation plans
- helping build cost-effectiveness measures into companies’ evidence generation plans
- providing input from leading experts within the NHS and academia
- incorporating the perspective of patient experts
- helping companies understand health technology assessment and the perspective of decision-makers
This “NICE Advice”, which is a fee-based advisory service, can be leveraged at different stages of the technology development process, including the early stage before clinical trials have started, during the clinical development process, and before submission. This is a great opportunity to engage directly with NICE and our international consulting agency is specialized in these engagements. However, formal scientific advice with NICE requires a significant financial and time investment and lead time.
Optimizing HTA Submissions with Tailored Advisory Boards: Leveraging Expertise for Effective Technology Development
An advisory board comprising HTA experts offers a cost-effective tailored alternative our company can support you with. This approach provides the opportunity to obtain valuable insights and guidance at various stages of technology development, akin to NICE’s “NICE Advice” service. Leveraging the expertise of HTA specialists within the advisory board can help optimize the design of clinical trials and economic models, leading to more successful HTA submissions in the future.
Depending on the circumstances, other meetings with specific HTA bodies or teams prior to submission are recommended. One example of these opportunities include meeting with the Scottish Medicines Consortium (SMC) among others.
If you are looking for a supplier for any of these services, Justin Stindt Consultants is here to help.
Navigating NICE’s Services for Medtech: META Tool and Hybrid Medtech Advice for Effective Product Development
Besides scientific advice meetings which are open to both pharmaceutical companies and medtech firms and their products, NICE offers an additional range of services for devices, diagnostics and digital technologies. These include:
- Medtech Early Technical Assessment (META) Tool: The META tool, developed by NICE, is a low-cost platform that helps product developers understand the evidence they need to present to payers and commissioners to demonstrate the value of their technology. In other words, the META tool helps product developers to identify and address any gaps in their evidence base, so that they can make a more compelling case for their product to be funded and adopted.
- Medtech advice: Medtech advice is a hybrid service that combines a META Tool consultation with scientific advice services to help developers of medical devices, diagnostics, and digital health technologies. After completing the META Tool and raising 3 key issues that you’d like to explore, you will take part in a facilitation session with one of their experts, which will also incorporate the views of a clinical expert.
Justin Stindt Consultants is your agency to support you with scientific advice with NICE in the United Kingdom and UK advisory boards
At Justin Stindt Consulting, our team of experts has extensive experience in both supporting the entire process of scientific advice with NICE and facilitating and moderating advisory boards to ensure that our clients develop high-quality evidence generation plans that capture what matters to patients and the healthcare system. Many of our clients have found scientific advice meetings with NICE and UK payer advisory boards very insightful and have adapted clinical trial protocols and statistical analysis plans to better meet the evidence needs of NICE to maximize the chances of successful HTA endorsement.
Are you looking for a vendor to support you with NICE Advice meetings or an advisory board to mirror these? Then pick a supplier with a proven track record of developing and delivering briefing books for NICE and accompanying clients to these scientific advice meetings.
Contact our international consultants today to learn how our agency can tailor our market access services to meet your unique needs and enable you to leverage the Advisory Boards and NICE Advice pathways.
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