NICE proposals on value-based assessment of new medicines criticised
Questions raised about the proposed changes to cost-effectiveness of new medicines.
Proposed changes to the formula used to determine the cost-effectiveness of a new medicine have been questioned by the Association of the British Pharmaceutical Industry (ABPI) and the Royal Pharmaceutical Society (RPS).
The National Institute for Health and Care Excellence (NICE), which deems whether treatments should be funded by the NHS, proposes the introduction of two new “modifiers” or factors — burden of illness and wider societal impact – when considering a medicine’s cost-effectiveness.
NICE wants to weight the modifiers in order to make the decision-making process more consistent, transparent and predictable.
But the Royal Pharmaceutical Society (RPS) and the Association of the British Pharmaceutical Industry (ABPI) have questioned the detail of the changes, which were out for public consultation between 26 March 2014 and 20 June 2014.
The RPS says a lack of clarity about how the new measures would be applied means it is impossible to judge whether they would lead to a better system. It says there is little evidence to support the NICE weighting proposals, which will have an impact on how medical conditions are prioritised. The RPS also doubts whether any “simple weighting system” will be practical.
The RPS practice and policy lead for England, Heidi Wright, says: “There are questions to be addressed about both the quantity of the weights to apply and how those weights should be applied.”
The RPS suggests that NICE should launch a wider consultation on any proposed weighting system and says any proposals should be supported by “robust” research methods.
The RPS also expresses doubts about NICE proposals to introduce new quality-adjusted life years (QALYs) comparators as part of the burden of illness and societal impact decision-making process. Introducing “proportional” and “absolute” QALY shortfalls as measures of burden of illness and societal impact illustrates the need for a wider debate about how a patient’s age influences NICE decisions, it says.
And it doubts whether having an “absolute QALY shortfall” would be a true measure of a patient’s ability to interact with society.
The ABPI says it needs more “clarity” from NICE about how the new system would work and it is concerned about “uncertainty” around the aggregation of the new factors.
The industry warns that it would be “unacceptable” if patients were worse off under the new system compared with the present one.
The ABPI’s value and access director Paul Catchpole says: “While the proposals provide a starting point … we are still far from the finish line.”
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065566
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