QoL research has to be done; in fact it is critical if we want to get drugs licensed for use in the UK. NICE assesses drugs based on their impact and this includes their impact on QoL; they need to know this to be able to assess their cost effectiveness. NICE do this by assessing what the direct costs of the drug are to NHS and use the cost of the quality-adjusted life year (QALY) for this purpose. The QALY is the measure of disease burden that health economists have developed; the QALY includes both the quality and the quantity of life lived. In relation to MS DMTs we think that NICE set the threshold at £30,000 to £36,000 per QALY to approve DMTs. Interferon beta and glatiramer acetate did not pass this threshold, which is why we have the Department of Health’s risk-sharing scheme. This latter scheme was meant to assess the impact of these drugs over time and if they did not deliver the necessary effectiveness the cost of the drugs would need to be reduced. In comparison, natalizumab was considered to be cost-effective in MSers with highly-active disease. Without QoL data we would not be able to prescribe natalizumab.
More on Quality of Life (QoL) Research
Re comment from anonymous and others: “Nothing annoys me more that the money wasted on quality of life type research.”
“Love it or hate it QoL research is essential, in fact vital and underpins all our work on DMTs. Take Sativex for example, the trials that got the drug licensed in the UK did not include QoL outcomes, making it impossible for NICE to assess its cost-effectiveness. Without approval by NICE the PCTs (not many of these left) and the new GP Commissioners are reluctant to fund its use. That’s fine if you don’t have severe spasticity but it makes it difficult for us neurologists’ on the firing line when MSers want and need the drug. I must point out that only ~50% of MSers respond to Sativex, so it is not a magic bullet. It helps spread the hope, something we rely on to make peoples lives more comfortable.”