Review of NICE Technology Appraisal Guidance No.265; Denosumab for the treatment of bone metastases from solid tumours

Proposal to complete a partial review of the guidance

As you may be aware the planned date for review of the above guidance is July 2013.

This is the date at which the Institute considers whether sufficient new evidence has emerged for the Appraisal Committee to be asked to undertake a full review appraisal.

TA265 outlines that the cost-effectiveness of denosumab is sensitive to the price of the comparator zoledronic acid. Many generic manufacturers have received marketing authorisation for zoledronic acid recently and significant reductions in price are expected with the market launch of generic versions. With zoledronic acid available at lower costs, denosumab may not be a cost-effective option for preventing skeletal related event in people with bone metastases from breast cancer and from solid tumours other than prostate. This would suggest that recommendation 1.1 ought to be reviewed.

In the prostate cancer population, denosumab is not recommended in TA265.

Consequently, we propose that TA265 recommendation 1.1 should be reviewed and updated by the Appraisal Committee and that recommendation 1.2 be moved to the static list of technology appraisals.

Topics on the static list may be transferred back to the active list for further appraisal if new evidence becomes available that is likely to have a material effect on the last guidance issued.

In order to be completely confident that this is appropriate, we are asking all relevant consultees and commentators, to inform us of any evidence which would suggest that a review would be beneficial.  Please see appendix A for a full list of the organisations we have contacted. 

July 2013