HC2. Stewart G, Eddowes L, Hamerslag L, Kusel J

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Wendy Short
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1 HC2 Stewart G, Eddowes L, Hamerslag L, Kusel J

The National Institute for Health and Care Excellence (NICE) apply a cost-effectiveness threshold of between 20,000-30,000 per quality-adjusted life-year (QALY) when appraising new drugs.

2 The National Institute for Health and Care Excellence (NICE) apply a cost-effectiveness threshold of between 20,000-30,000 per quality-adjusted life-year (QALY) when appraising new drugs. The precise threshold is determined by the Appraisal Committee based on a number of different factors. In 2009, supplementary advice was issued for appraising treatments which may extend patients life, towards the end of life. Certainty of ICER Quality of life captured Innovative nature of technology NHS objectives Certainty of ICER Treatments which meet the End-of-Life (EoL) criteria can potentially be recommended at a higher threshold. 2

In 2009, supplementary advice was issued for appraising treatments which may extend patients life, towards the end of life.

3 When appraising treatments that may extend the life of patients with a short life expectancy, all the following criteria must be met: Small patient population Prognosis (<24 months) Life-extension (>3 months) 3

following criteria must be met: Small patient

4 The primary aim of this study was to: assess the impact of the EoL threshold (since it s inception in 2009) on patient access to cancer therapeutics in England and Wales Particular research questions to address included: What effect has the EoL threshold had on recommendations for cancer therapeutics? Is there a consistent threshold applied by NICE when assessing EoL therapeutics? How likely is a submission to be appraised as an EoL intervention, and what factors determine the success of this? 4

EoL threshold had on recommendations for cancer therapeutics?

5 NICE single technology appraisals for cancer therapeutics were reviewed from January 2009 to December 2013 and ICERs were extracted from appraisals evaluated against the end-of-life criteria. Due to the variability in reported ICERs, the most plausible value was extracted where possible. ICERs were extracted from the base case analysis, although subgroups were incorporated where appropriate (TA208). In cases where ICERs were reported through patient access schemes (PAS) or as a range, the lowest most plausible ICER was selected. Cancer therapeutics only were considered in this analysis as these consisted the vast majority of submissions eligible for the EoL criteria. 5

ICERs were extracted from the base case analysis, although subgroups were incorporated where appropriate (TA208).

6 6 *not including subgroups

7 Appraisals (%) Recommended 60 ICER > 50,000 End-of-life (n=6) (n=8) (n=6) (n=6) (n=6) 7

8 ICER ( ) 80,000 60,000 <50,000 40,000 20,000 <30,000 <20,000 0 TA169 TA171 TA179 TA184 TA185 TA189 TA190 TA202 TA208 TA215 TA218 TA222 TA219 TA250 TA255 TA259 TA268 TA269 TA296 TA

9 ICER ( ) 80,000 Recommended Not recommended 60,000 <50,000 40,000 20,000 <30,000 <20,000 0 TA169 TA171 TA179 TA184 TA185 TA189 TA190 TA202 TA208 TA215 TA218 TA222 TA219 TA250 TA255 TA259 TA268 TA269 TA296 TA

TA185 TA189 TA190 TA202 TA208 TA215 TA218 TA222 TA219 TA250

10 Summary of appraisals that did not meet the EoL criteria: Year Appraisals Declined Life Extension (>3 months) Criteria Prognosis (>24 months) Small population Total Over 60% of appraisals declined by the reviewing committee were due to a lack of robust data. 10

2 0 0 2010 3 1 1 2 2011 2 1 1 1 2012 1 0 0 1 2013 4 2 2 1 Total 12 5 4 5 Over 60%

11 Over the last 5 years the EoL criteria has been successful in increasing patient access to cancer therapeutics: 12 EoL cancer drugs were approved in main indication 1 EoL cancer drug was approved in subgroup population However, in recent years, there has been a decrease in approved treatments, potentially due to: A consistent threshold of 50,000 per QALY applied for the EoL criteria A trend towards increasing ICERs for EoL cancer drugs 11

population However, in recent years, there has been a decrease in approved treatments, potentially due to: A

12 If observed trends continue, it is likely that the current EoL criteria implemented by NICE will no longer be effective in improving patient access to new cancer therapeutics. Role of NICE? Plans to reform the way NICE appraises new medicines could represent a turning point in the availability of EoL cancer drugs: Current proposals for a Value Based approach favour removal of the EoL criteria to be replaced by the evaluation of the burden and societal impact of illness. 12

Plans to reform the way NICE appraises new medicines could represent a turning point in the availability of EoL cancer

13 If observed trends continue, it is likely that the current EoL criteria implemented by NICE will no longer be effective in improving patient access to new cancer therapeutics. Role of industry? Continue to explore smaller patient populations to increase the availability and quality of data at this level. Explore ways to decrease drug development costs by using contract research organisations and contract manufacturing organisations. 13

Continue to explore smaller patient populations to increase the availability and quality of data at this

14 Thank you for your attention!? 14

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