NICE Single Technology Appraisal Guidance No 254
Fingolimod for the treatment of highly active
relapsing–remitting multiple sclerosis
This NICE guidance was published on25 April
2012. The web reference for the appraisal and other related
documents is: www.nice.org.uk/TA254
NHSScotland should note
that:
1. Recommendations of NICE Single Technology
Appraisals (STAs) have no status in NHSScotland.
2. NHS boards should adhere to the Scottish
Medicines Consortium (SMC) advice.
SMC published a Statement of Advice (763/12) on
this medication for this indication in September 2012. This stated
that:
fingolimod (Gilenya®) is
accepted for restricted use within NHS Scotland.
Indication under review:
As single disease modifying therapy in highly
active relapsing remitting multiple sclerosis (RRMS) for the
following adult patient groups:
- Patients with high disease activity despite
treatment with a beta-interferon.
These patients may be defined as those who
have failed to respond to a full and adequate course (normally at
least one year of treatment) of beta-interferon. Patients
should have had at least one relapse in the previous year while on
therapy, and have at least nine T2-hyperintense lesions in cranial
magnetic resonance imaging (MRI) or at least one
gadolinium-enhancing lesion.
A “non-responder” could also be defined as a
patient with an unchanged or increased relapse rate or ongoing
severe relapses, as compared to the previous year.
or
- Patients with rapidly evolving severe RRMS
defined by two or more disabling relapses in one year, and with one
or more gadolinium enhancing lesions on brain MRI or a significant
increase in T2 lesion load as compared to a previous recent
MRI.
SMC restriction: restricted
to use as single disease modifying therapy in highly active RRMS in
adult patients with high disease activity despite treatment with a
beta-interferon with an unchanged or increased relapse rate or
ongoing severe relapses, as compared to the previous
year.
This SMC advice takes account of the benefits of
a Patient Access Scheme (PAS) that improves the cost-effectiveness
of fingolimod. This SMC advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland.
Access the advice of SMC
3. There is no material difference between the
recommendations of the NICE STA and SMC. NICE has recommended the
medication as an option for the treatment of highly active
relapsing remitting patients with an unchanged or increased relapse
rate or those experiencing ongoing severe relapses compared with
the previous year despite treatment with beta interferon. The NICE
STA advice is based upon the application of a Department of Health
agreed Patient Access Scheme
If you need further assistance, please contact
Eleanor Brownlee in the first
instance tel - 0141 225 6873
Published Date: 25 April 2012
