In December 2016, we published an Online Exclusive item reporting on the United Kingdom’s National Institute for Health and Care Excellence’s (NICE) review of two multiple myeloma drugs, based partly on source material that contained inaccurate information. We apologize for the errors and would like to thank David Bowen, MD, a NICE Appraisal Committee (AC) member, for providing an informed look at the NICE review process in the following commentary.
To the ASH Clinical News Editorial Staff:
The recent news item published on ASH Clinical News’ website contains factual inaccuracies.
First, NICE has not rejected either of these agents. Both of the agents mentioned in the article (lenalidomide and carfilzomib) are only at the Appraisal Consultation Document (ACD) stage of review; this is a major omission of fact.
The ACD is produced following a first committee meeting of the NICE AC, in which the committee assesses the clinical and cost-effectiveness evidence presented by the pharmaceutical company, and also assesses the critique from the academic Evidence Review Group. The ACD sets out the preliminary conclusions based on the evidence presented and a critique of this evidence. All stakeholders then digest the ACD and return to a second committee meeting to respond to the issues raised and to re-evaluate the evidence in a second round.
After the second committee meeting, when all stakeholders (principally the pharmaceutical company) have made their case, NICE usually issues the Final Appraisal Determination (FAD) – though sometimes more than two committee meetings are required before releasing the FAD. This is ostensibly NICE’s “final say,” but it often is appealed formally and sometimes goes on to judicial review. The UK’s National Health Service then implements the guidance in the FAD.
Second, the carfilzomib ACD judgement was not reached because “committee members also could not agree on a cost-effectiveness estimate,” as the article stated. The AC did not consider that the evidence presented by the company could be used to create a cost-effectiveness output because of disagreement with the company’s modelling and statistical methods. The AC themselves all agreed; the company model was inadequate.
–David Bowen, MD
Honorary Professor of Myeloid Leukemia Studies and Consultant Hematologist
St James’s Institute of Oncology
Leeds, United Kingdom
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