NICE Would Expand Devicemaker Input on Technology Assessments

May 15, 2015

Devicemakers should be at the table when rules around interventional procedures are developed, the UK’s health cost watchdog recommends.

According to the National Institute for Health and Care Excellence, two-thirds of interventional procedures involve medical devices, but manufacturers can observe and comment on NICE committee work only as members of the public. Conversations with trade groups convinced NICE that a more formal interaction would benefit both the agency and industry by bringing more evidence and information to the technology assessment discussions.

NICE proposed the heightened collaboration in a draft update to its Interventional Procedures Programme Manual released May 8.

The revised manual would allow NICE to identify devicemakers as possible interested parties while guidance documents are being drafted and ask them for information that could help guide the development process. This might include company data, planned trials and the names of hospitals using specific devices. In addition, the companies would attend committee meetings to answer questions about their products that could help with the assessment.

Comments on the draft manual are due July 31, and a final version will be released in February 2016. View the draft at www.fdanews.com/05-18-15-interventional.pdf. — Elizabeth Orr