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