Is your medical device clinically sound and cost-effective?
NICE’s online tool helps product developers understand and generate the evidence needed to show that their products are clinically sound and cost-effective. Leeza Osipenko, NICE scientific advice writes.
Today thousands of start-ups, academic centres and small and large companies are inventing and developing medical devices, diagnostic tests and health apps at an ever-increasing pace. Will the market have the capacity to absorb and adopt the new technologies? Will these technologies make a real difference to patients? Can these technologies save resources for cash-strapped healthcare systems?
Consumers might be persuaded to pay for a product based on marketing slogans, but when it comes to procurement in cash-tight health services, promises, packaging, and sleek design become insufficient. Payers want to be reassured with robust clinical evidence and the economic rationale that they are acquiring products which generate savings and improve quality of care.
Technologies of different classes require various levels of evidence packages to convince the payers of their value proposition. Many developers of devices, diagnostics and health apps are unaware of the reimbursement requirements, especially in the earlier stages of product development, or are unable to formulate or narrow down the value proposition for their products to become attractive for national or regional reimbursement.
Evidence generation is expensive and for product developers it makes sense to do all they can to make this process as efficient as possible. Where feasible, companies are encouraged to initiate early dialogues with regulatory authorities and payers to ensure that the evidence generation plans meet key stakeholder requirements. But in many cases, companies are unable to progress towards such detailed discussions for a number of reasons. These can include the inability to formulate relevant questions, early development stages, lack of time and resources, or the lack of relevant staff to lead such engagements, etc.
In July 2017 NICE Scientific Advice launched a new service - an online tool to help product developers understand and generate the evidence needed to show to the payer that their products are clinically and cost effective. The Medtech Early Technical Assessment (META) tool has been brought to market in partnership with Greater Manchester Academic Health Science Network. The tool helps companies efficiently and affordably identify what evidence they already have and what gaps need to be filled to satisfy payer requirements. This process aims to help companies prepare for a dialogue with health technology assessment organisations and payers and potentially speed up time to market.
The original version of the META tool is designed for the UK market and is a paid for service aimed at, but not limited to, small and medium sized companies. Developers can use the service at any time in the product development cycle and it is suitable even for products which are already in the market but which are unable to gain relevant adoption levels in the healthcare system. META provides a rapid assessment of the product to highlight gaps in the evidence via a discussion with a trained facilitator. A key output from the META tool is a set of future steps for the developer to help with their future market access strategy. Importantly, undergoing the META process may help some organisations make decisions about discontinuing or modifying their product development plans.
The META tool can be licensed for use by partner organisations working with medtech companies. These could include Academic Health Science Networks, Healthcare Technology Consortiums and consultancies who may have their own bespoke approaches to using META and assisting product developers prepare their products for adoption into a healthcare setting. This accessibility will maximise META’s potential and make it available to companies not just in the UK but internationally as well. Consulting companies and other organisations interested in acquiring META licenses from NICE receive relevant training and accreditation.