That would make a NICE change….

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NICE are currently undergoing what appears to be quite a wide re-evaluation of their HTA process. As part of this process, they have recently released a white paper for comment, entitled “The NICE methods of health technology evaluation: the case for change”.

I've picked out some (mostly statistical) highlights:

  1. End-of-life patient status and needs to be captured as part of a disease severity ‘modifier’.
  2. New methodological guidance to be released around RWE.
  3. Less weight placed on extrapolated data.
  4. Challenges associated with treatment switching better acknowledged.
  5. More emphasis on subgroups, including greater freedom to not recommend reimbursement in a subgroup when the overall population shows benefit.
  6. The ‘exploration’ of multiple methods of obtaining comparative effectiveness where no head-to-head evidence exists.
  7. Discount rates to be lowered, i.e. more emphasis placed on longer term data (but see point 3 above!)
  8. Use of cure-proportion modelling, especially with advanced therapy medicinal products.
  9. Potential value of Bayesian hierarchical models in histology-independent cancer drugs/basket trials. Additional guidance will be released on a whole plethora of topics:
  • population adjustment
  • bias adjustment
  • ordered category data and trials involving both discontinuation and efficacy outcomes
  • joint synthesis of structurally related outcomes
  • using prior distributions (including informative priors)
  • the proportional hazards assumption and associated methods when it is and is not met synthesising diagnostic accuracy evidence.

Overall, NICE appear to be headed in the right direction and obviously want to get ahead of the curve with regard to current industry trends, such as the increased use of RWD. However, I would strike a cautionary note around the topic of subgroups. I certainly hope they won’t be adopting the approaches that some other European reimbursement agencies’ take on this issue.