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How will we know whether this technology is appropriate?
ORNew procedures, NICE and
Specialist Societies
Bruce Campbell ChairmanNICE Interventional Procedures Advisory Committee BCIS 30th January 2009
Advanced Cardiovascular Intervention 30th January, 2009
No conflicts to declare
I have been asked to cover
• NICE perspective on introducing new technologies
• Processes leading up to IPGs and TAs
• Tracking effectiveness (e.g. TAVI)
• Specialist Societies – Training/audit
NICE Guidance
• Technology Appraisals
– Clinical and cost effectiveness
– Mandate for funding
• Clinical Guidelines
• Interventional Procedures
– Safety and efficacy
– Not cost No mandate to fund
• Public Health
NICE guidance and new procedures - an ideal
1. Research – provides initial data>>>
2. IP guidance - safety and efficacy (perhaps more data collection)>>>
3. Technology Appraisal – clinical and cost effectiveness>>>
4. Clinical guideline - place in management strategy
Source of topics/procedures
TECHNOLOGY APPRAISALS• Topic Selection Panel >>> debate• Formal referral from DH – list available
INTERVENTIONAL PROCEDURES• Via NICE website• From clinicians, industry, patients, others• Does procedure fit the Programme’s remit?
Remit of the NICE IP Programme
• Procedures used for diagnosis or treatment that involve: – incision, puncture or entry into body cavity – ionising, electromagnetic, acoustic energy
• First use in the NHS (or private sector)
• New concerns about efficacy or safety
Procedures not specific devices
Evidence used by IPAC
• Published studies (not normally abstracts)
• Specialist Adviser information/views• Patient comments• Committee Members’ knowledge
Some differences for TAs• Submissions from stakeholders• Clinical Specialists & Patient Experts attend
………public attend both
What to recommend when evidence for IP is inadequate?
“Special Arrangements” for:
• Governance – tell your hospital
• Consent - tell your patients
• Audit/research – review your outcomes
Possible “1.1” recommendations
• “Normal arrangements”
• “Special arrangements”
• Research only
• Do not use
Other recommendations
• Teams/units – very careful
• Training – need specialist collaboration
• Data collection - but practical difficulties
• Research needed - specify outcomes
Public consultation
Seldom disagreement with recommendationsCommon responses:– Technical details– Indications– Selected centres only– More detail on consent
All considered: often stimulate changes
Registers – our aspirations
• Data collection for procedures with uncertain evidence & “cautious” guidance
• Existing databases if appropriate, or
• Limited datasets focussed on data needed for NICE IP review
• Funding linked to data submission
NICE IP guidance and CCAD
• Guidance recommends submission (18)
• BUT - CCAD may not have specific field
• AND – we need relevant data for review
• AND – CCAD data may be incomplete
CCAD vs HES data on Percutaneous Closure of PFO
2007-8:
CCAD - 332 procedures from 23 hospitals
HES - 632 procedures from 35 hospitals
(manufacturer data support HES)
Data collection on TAVI
“Cautious”guidance because:• Efficacy: small numbers and short term• Safety: potential for serious complications
SUBMISSION TO CCAD RECOMMENDED• NICE collaboration with CCAD• Need some PROMs as well as objective data• Funding: perennial problem/precedent
Thanks to all involved with CCAD
NICE committed to collaboration
Training workshop consensus
• NICE + SOs should identify procedures and NICE should make training recommendations
• SOs should define skills, standards, strategy• Supporting framework necessary• Manufacturers make valuable contributions• Audit data inform review and “benchmark”• NICE should request more detail from SAs
SOs – Specialist Organisations SAs – Specialist Advisers