HEDS is part of the School of Health and Related Research (ScHARR) at the University of Sheffield. We undertake research, teaching, training and consultancy on all aspects of health related decision science, with a particular emphasis on health economics, HTA and evidence synthesis.

Tuesday, 11 March 2014

Only in Research recommendation by NICE for ipilimumab

Decisions from NICE are usually ‘yes’ (for the full population or sub-groups), ‘no’ or ‘minded no’ (whilst awaiting clarifications from the manufacturer).  ‘Only in research’ is very rare.  ‘Approval with research’, which is a form of ‘yes’ is even rarer.  These last two options are part of the most recent Guide to Methods – see section 6.4 for further details.  Is this a shape of things to come?

If you are interested in ipilimumab, then the following is from the NICE website:

“A skin cancer treatment should only be used by the NHS for patients in clinical trials to ensure that evidence for its clinical effectiveness continues to be collected, says the National Institute for Health and Care Excellence (NICE).

In preliminary draft guidance, NICE recommends that the drug ipilimumab (also called Yervoy and
manufactured by Bristol-Myers Squibb Pharmaceuticals Limited) is used only in the context of research as a first-line treatment for patients with advanced malignant melanoma which is either unresectable (when the full tumour cannot be removed) or metastatic (the cancer has spread to other parts of the body). The draft guidance states that people currently receiving ipilimumab as part of their NHS care should continue with the treatment until they and their doctor consider it appropriate to stop.”