Para 27. Can NICE share a more detailed breakdown of current costs for each appraisal type?
Para 14. What is the rationale for preferring full cost recovery, rather than other models of fee for service?
We did go through an option appraisal process to choose the preferred model. We considered:
A subscription model – did not seem equitable
The Canadian model – we are required by Treasury rules to recover full cost
PPRS – top slicing would not free us from rigidity of current fiscal framework plus complications since current PPRS has some time to run also not all companies participate in PPRS.
Para 14. Will there be a process for reviewing the cost structure to ensure that full cost is proportionate for each appraisal type and that total costs flex when efficiencies are implemented?
It will be kept under review and the accounting for it will be ring fenced so this will make it transparent. Over the longer run efficiencies should be reflected in prices as they are adjusted
Para 16. NICE are currently looking for efficiencies in the appraisal process. If efficiencies are identified will appraisal costs be recalculated?
Para 14. Charging for appraisals opens the door for NICE to further expand on methods and process which would in turn further increase costs for appraisal. How will industry be consulted on any potential future increase in costs of appraisals?
We don’t envisage ‘expansion’ on methods and processes. In fact more likely that some will be slimmed down where appropriate in which case there will be separate costing/pricing for this which is likely to be lower. Any consultation will be in line with current arrangements for consultation on methods. We are not formally consulting on costs.
Para 16. Additional implementation tools and resources are also proposed to be included. Will the value of these tools/resources be reviewed prior to finalising costings?
Assume this refers to the existing approach to the production of such additional resources and the costs of the production of these is built into the standard pricing model
Para 17. What is the rationale for including DSU costs? Which aspects of DSU costs will be included?
This is a cost incurred directly by NICE whilst the ERG costs are incurred by NIHR. The total value of the contract is £180k and it is all included.
Para 21. What is the rationale for companies paying 100% upfront?
It eliminates the risk of companies refusing to pay if they don’t like the outcome. The MHRA charges 100% upfront.
Para 23. Will different costing solutions be considered for rarer conditions?
The challenge is not so much small company vs large company but one of the value seeking a NICE recommendation for a small patient population.
This is not currently being considered
Para 27. We assume the rapid review includes the CDF at the end of the 2yr data collection period? Or will CDF medicines be charged as two STAs?
Yes the rapid review will normally apply to CDF drugs at end of 2 year data collection period unless the work involved amounts to an STA
Para 30. How can industry signal very early that an appraisal should not go ahead, so no costs are incurred for horizon scanning or topic routing?
The costs of horizon scanning and topic routing for topics that don’t proceed are included in the model.
Para 33. What is the rationale for charging companies for NICE’s involvement in developing a MAA or CAA? If NICE is paid for their role in agreeing commercial agreements it may be viewed as inappropriate and conflicted?
We do not think there is a conflict here
Para 34. What language will appear on NICE website when an appraisal is terminated or not started due to non-payment?
As we currently do, but with an explanation that the company has decided not to take part in the appraisal because they do not wish to incur a charge.