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Transcatheter aortic valve implantation. Jonathan Howell Consultant in Public Health West Midlands Specialised Commissioning Team. What are the external pressures?. Clinical Patients Commercial Media Political. TAVI.
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Transcatheter aortic valve implantation Jonathan Howell Consultant in Public Health West Midlands Specialised Commissioning Team
What are the external pressures? • Clinical • Patients • Commercial • Media • Political
Did we understand the unmet need and the natural history of the disease? What was the overall “ability to benefit”? If it “worked”, was it good value? The commissioning issues
Commercial marketing had started. The valves “worked”. Reports from case series seen as good. Obvious unmet need. Training came with good governance. The clinician perspective
How the issues developed • January 2008 - considered by 10 regional commissioners (SCGs) in England. • One SCG had already “designated” a local provider. • Health Technology Assessment (HTA) commissioned. • Attempt at a “national” commissioning position.
Autonomous NHS foundation trusts. A sense of competition amongst trusts. NICE guidance. The use of individual funding requests. Commissioning not fully effective in controlling the provider agenda The English perspective
Review of safety & the need for robust evidence • 2692 patients in case series, 1975 patients considered after 2007. • The same high mortality rates : “It is not known what the survival of these patients would have been, had they been treated medically or by conventional surgery.” • Conclusions: “ Safety issues and short term survival represent a major drawback for the implementation of TAVI. Results from an ongoing randomised controlled trial (RCT) should be awaited before further using this technique in routine clinical practice. In the meantime, both for safety concerns and ethical reasons, patients should only be subjected to TAVI within the boundaries of such an RCT.”
Mixed funding in the 10 regions. The professional societies are engaged. Trying to find a better risk indicator for the patients. Setting clear governance arrangements including submission to the BCIS database. Looking to run a prospective cohort study. Edging towards an RCT. Watching the other new heart valve technologies. Where are we now?
Consideration of the UK TAVI Trial
Sharing horizon scanning knowledge in the Euroscan newsletter
Horizon scanning at an early stage. Clarity about the research uncertainties. Work with clinical leaders and the professional societies. Look for mutual agreement on priorities. Try to work on a wide scale. Key lessons