In the appraisal consultation document published on the NICE website, the appraisal committee's preliminary recommendation states:
Daclizumab is not recommended within its marketing authorisation for treating relapsing forms of multiple sclerosis in adults.
The committee was critical of the analysis submitted by the manufacturer of the cost effectiveness of daclizumab compared with other disease modifying treatments. The MS Trust is reviewing the appraisal documents from NICE and we will respond to the consultation process.
Anyone wishing to comment on the draft recommendations has until 21 October 2016 to do so. The NICE appraisal committee will meet again on 2 November to review the comments received and further evidence from the manufacturer. NICE expects to publish its final guidance for the NHS in 2017.
Daclizumab is an experimental drug treatment being developed for relapsing remitting MS. It is taken as an injection under the skin, once a month. In clinical trials, daclizumab reduced relapse rates by approximately 50% compared to placebo and by 45% compared to beta interferon. The drug was licensed in Europe in July 2016.
Serious infections, serious skin reactions and impaired liver function occurred more frequently in people treated with daclizumab than in other treatment groups.
We remain hopeful that NICE will reconsider its draft guidance, but it is very frustrating that, yet again, access to an effective new treatment will be further delayed by the NICE appraisal process.
Amy Bowen, Director of Service Development, MS Trust