SINGLE DOSE INTRAOPERATIVE RADIOTHERAPY FOR BREAST CANCER- NICE RECOMMENDATIONS REVISITED
Author(s)
Vaidya A1, Vaidya P2, Both B3
1University of Alberta, Edmonton, AB, Canada, 2O-Zone 2.0 HEOR Consultancy, Edmonton, AB, Canada, 3Carl Zeiss Meditec AG, Oberkochen, Germany
OBJECTIVES: The National Institute for Health and Clinical Excellence (NICE) provides guidance in England and Wales on funding and use of new health technologies. This study examined the impact of evidence, process and context factors on NICE decision regarding an innovative intraoperative radiotherapy (Intrabeam) for early breast cancer. METHODS: We explored the chronology of events from the time of submission of evidence by the manufacturer followed by the NICE assessment group appraisal and updates provided by the NICE Technology Appraisal Committee on Intrabeam. RESULTS: NICE invited evidence submission by the manufacturer by 06 Jan 2014. Manufacturer claimed that Intrabeam is a cost saving technology which improves the quality of life. NICE assessment group cited concerns based on ‘investment on equipment and staff training, longer term follow-up data and analysis of registry data’ in their report published on 08 May 2014. NICE Technology Appraisal Committee met on 24 June 2014 and issued conditional recommendations for the use of Intrabeam Radiotherapy System as an option for adjuvant treatment of early invasive breast cancer. In committee meetings on 27 August 2014 and 26 August 2015 further information on the clinical effectiveness data was requested. In their last update on 06 November 2015 the committee decided that further work by NICE would be required before it could issue a recommendation to the NHS. CONCLUSIONS: Intrabeam is available for routine use in many countries. Intrabeam, replaces a course of at least 15 (up to 30) postoperative radiotherapy sessions. This could greatly reduce the health care resource burden and enhance the quality of life. Until NICE publishes its final guidance, decisions on whether or not to fund specific treatments are the responsibility of local National Health Service bodies. Incorporation of patients’ perspective with economic/social/ethical dimensions is essential in the evidence synthesis for multi-criteria decision process.
Conference/Value in Health Info
2016-05, ISPOR 2016, Washington DC, USA
Value in Health, Vol. 19, No. 3 (May 2016)
Code
PMD62
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Coverage with Evidence Development & Adaptive Pathways, Decision & Deliberative Processes, Pricing Policy & Schemes
Disease
Oncology