NICE Appraisal Committee has stated it cannot recommend oral MS drug Tecfidera. 

NICE initial thumbs down for oral MS drug Tecfidera(19/02/14)

Appraisal Committee's preliminary recommendations Tecfidera (dimethyl fumarate) for treating adults with relapsing–remitting multiple sclerosis.

- The Committee is minded not to recommend dimethyl fumarate within its marketing authorisation, that is, for treating adults with relapsing–remitting multiple sclerosis.

- The Committee recommends that NICE requests further clarification and analyses from the manufacturer, which should be made available for the second Appraisal Committee meeting, and should include the following:

Presentation of the results from the DEFINE and CONFIRM trials adjusted for baseline relapse rate only, for the following outcomes:

- proportion of patients with relapse at 2 years

- annualised relapse rate

- sustained disability progression confirmed for 3 months at 2 years

- sustained disability progression confirmed for 6 months at 2 years.

Revised probabilistic analyses incorporating a scenario that includes:

- revised mixed treatment comparison results adjusted for the baseline relapse rate

- revised estimates for monitoring resource use and costs as preferred by the Evidence Review Group (ERG) in its exploratory analyses

- a reduced cost of relapse estimate (£607.80) as preferred by the ERG in its exploratory analyses

- non-health costs are excluded (if non-health costs related to personal social services can be identified, these can be included), with a sensitivity analysis that includes all non-health costs, and

- pairwise comparisons and incremental analyses for the probabilistic cost-effectiveness estimates.

Pairwise comparisons for the probabilistic cost-effectiveness estimates for several plausible treatment sequences reflecting UK clinical practice. For example:

- dimethyl fumarate, beta interferon, fingolimod compared with beta interferon, glatiramer acetate, fingolimod

- dimethyl fumarate, beta interferon, glatiramer acetate compared with beta interferon, glatiramer acetate, fingolimod.

Pairwise comparisons for the probabilistic cost-effectiveness estimates for the current active treatments (all beta interferons and glatiramer acetate) compared with no disease-modifying therapy to externally validate the manufacturer’s economic model by showing how similar these cost effectiveness estimates are to those in the NHS risk-sharing scheme for multiple sclerosis.

Full Details on consultation & draft guidance.