How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Document

    Has all of the relevant evidence been taken into account?

  • Question on Document

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

  • Question on Document

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

  • Question on Document

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?
The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

Closed for comments This consultation ended on at   Request commenting lead permission

Cost-effectiveness estimates

Committee's preferred assumptions

3.16

The exact cost-effectiveness results cannot be reported here because of confidential discounts for trifluridine–tipiracil, comparators and follow-up treatments. The company's base-case incremental cost-effectiveness ratios (ICERs) were above the range that NICE considers an acceptable use of NHS resources at a QALY weighting of 1 and 1.2, and within the standard cost-effectiveness range with a 1.7 QALY weighting. The EAG's base-case ICERs were above the range regardless of the QALY weighting applied. The committee recalled the considerable uncertainty around some of the model assumptions in the company's base case, especially in:

  • the overall survival extrapolations for trifluridine–tipiracil alone and trifluridine–tipiracil plus bevacizumab (see section 3.8)

  • the QALY shortfall calculations informing the severity modifier (see section 3.14).

Because of this uncertainty, the committee considered that further analysis that represented its preferred assumptions was needed to inform decision making. But, it noted that, with the current preferred assumptions and uncertainty, the ICERs were more than what NICE normally considers a cost-effective use of NHS resources. The committee requested the following further analyses:

  • observational data to validate overall survival for trifluridine–tipiracil alone in UK practice, and modelling of trifluridine–tipiracil plus bevacizumab overall survival by applying the SUNLIGHT overall survival hazard ratio to this data (see section 3.8)

  • data on the mean age of people having trifluridine–tipiracil alone for mCRC in current UK practice (see section 3.14)

  • updated QALY shortfall calculations for trifluridine–tipiracil alone that reflect the further analyses, particularly overall survival and mean age (see section 3.14)

  • analyses in which regorafenib survival estimates are modelled by applying hazard ratios from the NMA to the curve for trifluridine–tipiracil alone (see section 3.9)

  • analyses in which regorafenib time on treatment is modelled as a higher proportion of people in the progression-free state than in the EAG's base case (see section 3.10)

  • sensitivity analyses in which the treatment effect on survival with the intervention and comparators wanes over time (see section 3.9).