Remap Consulting have recently been accredited by NICE as a META tool facilitating organisation that can support MedTech manufacturers in understanding what evidence is needed to make a convincing case to UK payers to demonstrate the value of their technology to patients and the healthcare system.
What is the META tool?
NICE has recently developed the META (MedTech Early Technical Assessment) tool, to support MedTech manufacturers in the identification of potential evidence gaps, that can hinder a NICE assessment. The outputs of the META tool will help you be able to develop an understanding of the evidence needed to demonstrate your product’s value to the NHS and identify evidence gaps that may delay patient access for your product.
The META tool has been designed to help developers of both large and small, of medical technologies that have, or are expected to obtain, a CE mark. The tool is designed to be used at any stage of development of your product. In the early stages it will help you understand the types of evidence that will be needed further down the development pathway and guide efficient evidence collection. In the later stages it will act as a ‘gap analysis’ to sense check your readiness for submission to NICE or NHS payers.
What are the benefits of using the META tool?
The benefits of assessing your MedTech product with the META tool include:
- Raising awareness of the evidence that payers, commissioners and investors need in order to understand the value your technology offers to patients and healthcare systems
- Increasing understanding of the implications of any evidence gaps
- Helping prioritise investment in your product’s development strategy
- Developing value claims that will stand scrutiny during an HTA
- Providing educational resources to support your understanding of evidence requirements
- Identification of local, regional or national support that is available to help you generate the necessary evidence to support your product’s claims.
What is the process for having my MedTech product evaluated by the META tool?
The META tool process consists of three key stages, which take about four weeks to complete:
- Completion of an online synopsis
The synopsis is a structured questionnaire that allows you to present information and data relevant to the development of your product. It also provides educational resources and links to other sources that may be of relevance.
Information requested within the synopsis includes:
- information about your technology
- what it is indicated for (used to treat)
- what benefits it has for patients and for the wider healthcare system
- what clinical and economic data you have collected so far
- what evidence generation plans you have for the future.
The aim of completing the synopsis is two-fold. Firstly, it is to help you to think about the issues that are important to payers and how their needs are different from the needs of regulators. Secondly, it provides information for the facilitator to prepare for the meeting (step 2)
- A meeting with a trained facilitator, such as Remap Consulting, who has been endorsed by NICE to support companies with the META tool. Following a review of the information provided in your synopsis, the facilitator will have a two-hour meeting with you to provide an opportunity to discuss any evidence gaps identified in your product development plans and how such evidence gaps could be addressed.
- Development of a META report
Following the meeting the facilitator will develop a concise report that summarises the key issues identified by the facilitator during the meeting and the potential next steps that you should consider.
The ultimate goal of the META tool is to reduce the costs and risks associated with product development. The META tool assesses the impact of differences between regulatory and payer frameworks in determining a product’s value, which often highlights that payers needs to support patient access exceed those needed to secure a CE mark. The META tool can also to help you develop an evidence generation plan to support UK patient access to your MedTech product.
If you are currently involved in trying to determine the potential value of a MedTech device and believe that the outputs from a META tool assessment would be of benefit, then please do not hesitate to get in touch with us to discuss how the META tool can be used to support your organisation.