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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 • • • • • 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 • In draft guidance in 2007 and February 2008 NICE recommended against funding Tarceva, mainly because cost was too high in relation to benefit.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