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Learn how SMC assesses medicine effectiveness based on Cost per QALY. Explore reasons for non-approval and why some medicines are rejected. Discover the importance of economic evaluation and quality of life considerations.
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Why does SMC say NO We all want the most effective medicines All medicines cost money Health budgets are limited How do we choose?
How would you choose? • Medicine A costs £1m gives 1 person 1 days extra life • Medicine B costs £1m gives a thousand people 1 years extra life • SMC uses Quality Adjusted Life Year or QALY to compare effect of medicine • Cost per QALY compares economics
What is a QALY? • Quality Of Life 1 Perfect health • 0.5 poor health • 1 year @ QOL of 1 is QALY of 1 • 1 year @ QOL of 0.5 is QALY of 0.5 • 2 years @ QOL of 0.5 is QALY of 1 • Cost per QALY is economic value of medicine. Cost, quality and time
Cost per QALY • Using Cost per QALY means that we can compare the economic effectiveness of medicines for different illnesses. • Not perfect, but it is a useful indicator
Reasons for non-approval • No better than cheaper medicine • Not shown to work • Inappropriate comparator • Not sufficiently strong economic case
Inappropriate Comparator • Test against placebo to see if it works • Test against another treatment (comparator) to see if it is better • But can only accept if comparator is a treatment normally used in Scotland
Not sufficiently strong economic case This is one of the most frequent reasons given for non-approval. It does not necessarily mean that it is too expensive. • Doubtful use of clinical data • Over-optimistic assumptions • Inadequate sensitivity analysis • Very high cost per QALY
Very high cost per QALY Can be a reason although very high cost medicines can be accepted. NICE and SMC decisions show that Cost/QALY<£20 000 often accepted £20-30 000 need strong case >£30 000 often rejected
Top reasons for non-approval • Comparator wrong for Scotland • Doubtful use of clinical data • Over-optimistic assumptions • No economic evaluation • Failure to use final health outcome or calculate QALY (where appropriate)