Wireless Life Sciences Alliance (WLSA) and United Kingdom Trade & Industry Host Dr. Bruce Campbell, National Institute for Health and Clinical Excellence (NICE) in Educational Forum
The WLSA and UKTI jointly hosted an educational networking forum on October 27th for WLSA members and other wireless/mobile health industry leaders to discuss ways in which global UK government oversight agencies can better work together. The event helped to educate US companies on the UK regulatory process for issuing guidance on health and medical technologies.
Rob McCray, CEO of WLSA and Harrison Shapira, Vice Consul of UKTI introduced Dr. Bruce Campbell, Chairman of the Medical Technologies Advisory Committee (MTAC) of the National Institute for Health and Clinical Excellence (NICE – http://www.nice.org.uk/) who spoke at the forum and exchanged ideas with WLSA members and wireless industry company executives. Dr. Campbell explained that the history and purpose of NICE was created in response to problems in healthcare with a mission to improve access, standardize quality care and increase efficiency in healthcare expenditures. NICE has since developed an international reputation as a role model for development of clinical guidelines in many countries and has the power to advise English National Health Services (NHS) and Welsh NHS on the efficacy and cost effectiveness of new technologies and procedures. Its guidance has proved to be very influential with regulators in a number of countries outside the United Kingdom.
Within NICE there are six programs that are charged with establishing different categories of guidance: cancer service, clinical, diagnostic, interventional, medical technologies, public health and technology appraisals (http://guidance.nice.org.uk/). Medical technologies review is one of the newest programs (http://guidance.nice.org.uk/MT). As the Chairman of the Medical Technologies Advisory Committee (MTAC), Dr. Campbell spoke about the MTAC’s role and impact on the appraisal and approval of wireless health devices in the UK. A few take-away points are summarized below:
- The key value of a positive guidance to companies is the endorsement of cost effectiveness. This guidance is device and company specific and the organization provides informal feedback to applicants to help them avoid negative findings. No prejudice is attached to the withdrawal of an application for guidance.
- Cost effectiveness is based on an assessment of how the device will function in the real world of British healthcare. This means that the “real world” clinical and institutional response to a new technology must be addressed.
- To enter into the NICE technology guidance process, the claim has to involve a medical device. The program is challenged by wireless health applications that merely add transmission or connectivity functionality to devices.
- If the new device involves a new medical procedure that has never been reviewed by NICE, two evaluations are completed: the device is reviewed by MTAC and the procedure is reviewed by the clinical guideline branch of NICE.
- In the medical diagnostic program of NICE, claims that will effect less significant changes of the clinical pathways will have a higher likelihood of approval than claims that require big changes. In addition, claims that demonstrate cost reduction have better chances than claims that only demonstrate improvement of quality of patient’s life.
- Prior negative evaluation of device will not affect the subsequent appraisal of other devices in the same category or a re-appraisal of the device once improved.
- At the evaluation both the “wow” factor and the evidence will be reviewed. Case-by-case, MTAC seeks to find a balance between “wow” and the data, sometimes requiring them in equal parts or more of one than the other. In terms of data, MTAC would like to see data in peer-reviewed publications; however it is flexible and will consider alternative sources of information.
- MTAC will consider clinical data from any geography; however, given its focus on cost effectiveness in the UK, data from the UK and from English-speaking regions that have cost and healthcare models similar to that of the UK is more influential.
- In light of the fact that a manufacturer may sell to different hospitals at different prices, NICE will stipulate that the price range at which a device provides cost-effective benefits.
- There is no fee associated with undergoing an evaluation at NICE.
- NICE has a consulting role in helping manufacturers of devices assess the timing of the submission and to assimilate into the NICE guideline system. (http://www.nice.org.uk/getinvolved/currentniceconsultations/current_nice_consultations.jsp).
WLSA and UKTI plan to actively collaborate on future endeavors in pursuit of mutual goals to bring valuable wireless health innovations to global markets. For additional information please contact Molly Cogan at firstname.lastname@example.org or Andrea Jackson (email@example.com)
UK Trade & Investment (UKTI) is the commercial branch of the UK Government and works with UK-based businesses to ensure their success in international markets and encourage the best overseas companies to look to the UK as their global partner of choice. UKTI has a co-ordination role across government to establish a more systematic approach to relationships with companies which are the most economically significant investors and exporters.
The National Institute for Health and Clinical Excellence (NICE) provides guidance, sets quality standards and manages a national database to improve people’s health and prevent and treat ill health.
The Wireless-Life Sciences Alliance (WLSA) is a trade organization for global wireless and mobile technology innovators, scientists, physicians, and policy makers. The WLSA is committed to accelerating the adoption of connected health to create value, improve health and wellness for consumers, caregivers and all sectors of the life sciences and technology ecosystem. WLSA partners and companies are using wireless health innovations to simplify the management of chronic conditions, preempt disease and improve lives around the world.