Draft guidance from NICE asks for more information on multiple sclerosis treatment
The National Institute for Health and Care Excellence (NICE) is calling on Genzyme to provide more information on its multiple sclerosis drug, teriflunomide (also called Aubagio). In draft guidance published for consultation, NICE has requested a series of clarifications on the evidence submitted by the manufacturer.
This draft guidance has now been issued for consultation: NICE has not yet published final guidance to the NHS.
NICE is appraising teriflunomide as a treatment for adults with relapsing-remitting multiple sclerosis. This is a chronic, disabling, neurological condition that, as it progresses, can be life altering and have a substantial negative impact on quality of life and activities of daily living. The independent Appraisal Committee, which develops the guidance on behalf of NICE, considered evidence from the manufacturer, clinical experts, patient representatives and an independent critique of the manufacturer's submission.
Sir Andrew Dillon, NICE Chief Executive, said: "When reviewing the evidence for teriflunomide, the Appraisal Committee concluded that there were still questions to be answered about the effectiveness of the drug for adults with relapsing-remitting multiple sclerosis. This is why we have requested more details from the manufacturer; we want to ensure that we have as much information as possible to make an informed final recommendation."
The manufacturer 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 The committee will then review the extra evidence and develop further draft guidance.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. Until then, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
The draft guideline (appraisal consultation document/ACD) can be found from 00:01hrs on Wednesday 18 September on the NICE website.
Embargoed copies are available on request from the press office.
1. Teriflunomide would be considered as a first-line treatment option alongside glatiramer acetate and the beta interferons, and would be used in line with the Association for British Neurologists' guidelines, and that it would be stopped if the person's condition converted to secondary progressive multiple sclerosis, or reached EDSS state 7.
2. The Committee acknowledged that the most plausible ICER was very uncertain, but may lie in the range of £6000 to £107,000 per QALY gained compared with glatiramer. Therefore the Committee was minded not to recommend teriflunomide for treating adults with relapsing-remitting multiple sclerosis as a cost-effective use of NHS resources, and requests more analyses.
3. The manufacturer has estimated that, based on the list price, the annual cost of teriflunomide to be £13,529 per patient per year.
4. The manufacturer of teriflunomide has agreed a patient access scheme with the Department of Health. This is a simple discount scheme, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence.
5. NICE requests further clarification from the manufacturer, which should include the following:
Revised probabilistic analyses that:
use 'all years' mixed treatment comparison data adjusted for baseline annualised relapse rates
incorporate the inputs used in the Evidence Review Group's (ERG's) preferred scenario
include waning of treatment effect, with 75% treatment effect after 2 years and 50% treatment effect after 5 years
present probabilistic incremental cost-effectiveness ratios (ICERs) in a fully incremental analysis and as pairwise comparisons
Include pairwise comparisons for the probabilistic cost-effectiveness estimates for plausible treatment sequencing, reflecting UK clinical practice. For example:
teriflunomide, Rebif-44 (interferon beta-1a, 44 micrograms) and fingolimod compared with Rebif-44, fingolimod and no disease-modifying therapy teriflunomide, Rebif-44 and glatiramer acetate compared with Rebif-44, glatiramer acetate and no disease-modifying therapy
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.
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