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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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    Are the recommendations sound and a suitable basis for guidance to the NHS?

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1 Recommendations

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Severity

3.14

The committee considered the severity of the condition (the future health lost by people living with the condition and having standard care in NHS). The committee may apply a greater weight (a severity modifier) to quality-adjusted life years (QALYs) if technologies are indicated for conditions with a high degree of severity. The company and EAG agreed that the QALYs generated from the company's and EAG's models implied:

  • a 1.2 QALY weighting for the comparison with trifluridine–tipiracil alone

  • a 1.7 QALY weighting for the comparison with regorafenib.

The company also pointed out that the data from NICE's technology appraisal guidance on trifluridine–tipiracil alone for previously treated mCRC gave a 1.7 weighting when used to calculate QALY shortfall. The committee recalled that the clinical experts considered overall survival extrapolations may have underestimated the clinical effectiveness (and therefore overall survival) of trifluridine–tipiracil alone (see section 3.8). They considered that the size of the QALY shortfall calculated for the trifluridine–tipiracil alone may have been overestimated if that were the case. The committee also thought that the model starting age of 62 years (informed by the mean age in SUNLIGHT) used to calculate QALY shortfall may not reflect average age of people with mCRC in NHS practice. The patient experts explained that the number of younger people with mCRC has increased over time. The clinical experts stated that there has also been an increase in the number of older people with mCRC suitable for active treatment. They thought that the average age of people having treatment is higher in clinical practice than it was in the clinical trial, likely between 65 and 70 years. The committee considered that it would like further data on the mean age of people having trifluridine–tipiracil alone for mCRC in current NHS practice. Also, it would like to see more data on survival with trifluridine–tipiracil alone. The committee concluded that some uncertainty with the decision on which QALY weighting was most appropriate for people with mCRC in the comparison with trifluridine–tipiracil alone could be resolved through:

  • observational data on the mean age of people starting treatment with trifluridine–tipiracil alone

  • overall survival estimates for people with mCRC taking trifluridine tipiracil alone.