The first application of NICE’s recent clarification of its own discounting guidance has produced a ‘yes’, when the previous ACD and FAD said ‘no’. So, in final draft guidance published on 7th September, NICE is recommending the use of mifamurtide (Mepact, Takeda) in combination with postoperative multi-agent chemotherapy as an option for treating high-grade resectable non-metastatic osteosarcoma (when it's made available through a patient access scheme).
The change in guidance, highlighted previously in the HEDS Blog, changes the discount rate on benefits from 3.5% to 1.5% when substantial benefits extend beyond 30 years. The effect of changing the discount rate in this instance was to reduce the manufacturer’s best-case probabilistic ICER from around £56,000 to £36,000 per QALY. Why the big effect? Well the mean age in the pivotal trial is 14 years which means a lot of future QALYs when a 60 year horizon is used.
It should also be noted that even at £36,000 per QALY this is above the range normally used to suggest that a treatment is cost-effective. However, the Committee also identified that not all relevant HRQoL effects were captured and that the drug was innovative (in its mechanism of action and its development in an area with few recent advances). Little was said about the ICERs being best case scenarios (and that other scenarios presented by the ERG increased some estimates by more than £20,000 per QALY).
The ERG for this appraisal was HEDS’ own ScHARR-TAG. The researchers were Abdullah Pandor, Patrick FitzGerald, Matt Stevenson and Diana Papaioannou.
