Transcript Deliberating Tarceva: a case study of how NHS managers

Deliberating Tarceva: a case study of how
NHS managers decide whether to purchase a
high-cost drug in the shadow of NICE
guidance
David Hughes and Shane Doheny,
Swansea University
NICE guidance & decisions by local panels
• NICE publishes technology appraisals whose
recommendations are mandatory for
commissioners and also advisory guidelines.
• Local discretion is important because:
- time lag before TAs are published;
- advice is released in stages & may change;
- advice may apply only to some patients, some
stages of disease and certain defined indications;
- local panels may use an efficacy criterion that does
not match NICE’s cost effectiveness criterion.
Tarceva/Erlotinib
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New generation cancer drug for NSCLC
Suppresses epidermal growth factor receptor
Easy oral administration & limited side effects
Cost about £6800 per course in early 2008
Marketing authorisation in the UK in
September 2005 and under consideration by
NICE since 2006
Method
• Part of wider study of contracting in England
& Wales
• Observation and audio recording of 11
morning long Welsh LHB IPC panel meetings
• Covered 29 referrals, including 7
resubmissions (10 relating to Tarceva)
• Also qualitative interviews with 5 panel
members
The case study
• Examines how the IPC panel adjusted its decision
making as MICE guidance changed.
• In draft guidance in 2007 and February 2008 NICE
recommended against funding Tarceva, mainly
because cost was too high in relation to benefit.
• In Nov 2008 this changed in the final TA when NICE
recommended funding in second-line use when cost
did not exceed that of main alternative, Docetaxel.
• Paper traces shifting position through a series of
meetings.
Habermas on discourse
• The study may be seen as example of linguisticsensitive ethnography, but with a Habermasian twist.
• It portrays a series of meetings where routine
decision making based on shared understandings
gives way to a moment of doubt – a punctuation - as
existing assumptions are challenged by a new NICE
recommendation.
• This is followed by reflection and repair of shaken
understandings, which accords with Habermas’s
(1984) theory about the reflective and transformative
capacity of communicative action.
Extract 1 – efficacy & exceptionality
• Is the drug effective & does patient differ from
general population so as to get greater benefit?
• Initial discussion focuses on case made by
referring consultant, not NICE guidance.
• Efficacy is equated with match between patient
referred and characteristics of trial patients.
• IPCP uses individualised discourse: re negative
NICE recommendation turns to exceptionality.
• To be exceptional must be different in such a
way as to benefit more.
Extract 2 : the punctuation
• The change is NICE guidance is noted but the
implications are not immediately digested.
• However the moment arrives when the panel
realises that the new recommendation curtails its
autonomy to make local decisions, and will need
to change a long standing policy on not funding
Tarceva.
• This gives rise to a need to reflect on how NICE
could find a drug effective which they believed
was not.
Extract 3 – reflection and repair
• The panel realise that if NICE says that Tarceva is cost effective
this implies clinical effectiveness.
• Yet previously the panel found evidence showed not effective.
• The panel deliberation of why this is so suggests different
understandings of how NICE appraisals work – effectiveness
first and CE second or a simultaneous balancing of levels of
benefit and cost.
• The panel finally decide that the difference is due to different
valuations of the two months average survival gain – NICE see
this as a statistically significant difference while the panel
judges that - in terms of real life benefit – it isn’t enough to
count as efficacy.
• Later in the discussion, the realisation dawns that the panel
now has limited scope for local judgements – it must shift its
approach to conform with the NICE criteria.
Extract 4: adjustment
• In last extract we see the panel adjusting to the
practicalities of funding Tarceva in line with NICE
guidance.
• For cases that meet the criteria there is little of
substance to discuss.
• The panel focus more on a discounted funding
arrangement than on efficacy & exceptionality.
• The issue becomes whether they can identify 10
cases that will benefit from a 27% price cut
before the discount falls to 14% - best value
purchasing rather than rationing per se.
Some conclusions
• One explanation of the observed events was that the
panel participants lacked the necessary expertise to
grapple with highly complex and conditional NICE
guidance.
• We think the panel members did their best to operate
with integrity and consistency, but believe there may be
issues of capacity and capability to address complex
decisions when small organisations like LHBs are involved.
• This will be partly addressed by the move to 7 bigger LHBs
in Wales, and recent recommendations to increase the
clinical representation in IPC panels & introduce a ingle
national appeals process.
Clinical and population-based perspectives
• Yet a bigger clinical voice may not get to the bottom of
one of the sources of tension we observed.
• Our meetings generally preserved a strongly
individualised focus, so that decisions about a
particular case were made on its particular merits.
• This sometimes sat uneasily with the population-based
probabilistic evidence in NICE guidance.
• It is unlikely in the foreseeable future that refinements
in the technical basis of NICE decisions and improved
expertise within panels will remove this clash of world
views within the health community