NICE Asks Genzyme for More Cost Effectiveness Data for its MS Drug

Posted 19 September 2013 | By Louise Zornoza 

The UK's cost containment agency, the National Institute for Health and Care Excellence (NICE), issued draft guidance on 18 September 2013 that requests more data from Genzyme on teriflunomide (Aubagio) as a treatment for adults with relapsing-remitting multiple sclerosis. 

The draft noted that the drug is being considered as a first-line treatment option alongside glatiramer acetate and the beta interferons, and administration of the drug would be stopped if the patient's condition converted to secondary progressive multiple sclerosis, or reached EDSS state 7.

The additional data request asks for "revised probabilistic analyses" and "pairwise comparisons for the probabilistic cost-effectiveness estimates for plausible treatment sequencing, reflecting UK clinical practice."  Genzyme must also provide: "Pairwise comparisons for the probabilistic cost-effectiveness estimates for the current active treatment (all beta interferons, 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."

Genzyme has until Tuesday, 8 October 2013 to submit this extra information to NICE. The committee will then review the extra evidence and develop further draft guidance. Final guidance on the use of teriflunomide as a treatment for relapsing-remitting multiple sclerosis is expected to be published in January 2014.

NICE Draft Guidance on Aubagio

Read all Breaking News from RegLink

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles