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1 Version History Policy Title Drugs for MS.Drug facts box fingolimod Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required by local organisations) Previous Versions Version Date Changes 1

2 Drugs for multiple sclerosis Summaries of key information and evidence for efficacy and safety January 2013 Drug Facts Box for Fingolimod What is this drug for? 1 To improve the symptoms of highly active relapsing remitting multiple sclerosis (as a disease-modifying therapy) Who is this drug for? 1 Adults with high disease activity despite treatment with a beta-interferon Adults with rapidly evolving severe relapsing remitting multiple sclerosis Patients under age 18 Who should not be taking this drug? 1 Patients with severe hepatic impairment Patients with high risk of infections or active infections, or malignancies 2

3 How is this drug administered? 1 Orally as a capsule What dose of this One 0.5 mg tablet drug is administered? 1 How often is this drug Once daily administered? 1 What is the cost of One 28-tablet pack, sufficient for one patient for one month, costs 1,470 this drug? What are the adverse Most commonly: influenza viral infections, headache, cough, diarrhoea, back reactions associated pain, raised alanine transaminase with this drug? 1 Licensing timeline Launched in the UK in March 2011 Other information: Treatment with fingolimod should be initiated and supervised by a physician experienced in multiple sclerosis 1 NICE has published a Technology Appraisal (TA254, 2012) recommending fingolimod as an option only if the patient has an unchanged or increased relapse rate or ongoing severe relapses compared with the previous year despite treatment with beta interferon, and the manufacturer provides fingolimod with the discount agreed as part of the patient access scheme. 2 The MHRA has published new advice not to use fingolimod in patients at high risk of cardiovascular adverse events, and updating monitoring advice after the first dose. 3 Studies Summary of methods Two multi-centre, double-blind, placebo-controlled, RCTs evaluated the efficacy of fingolimod as a disease-modifying treatment for patients with relapsing-remitting MS. 4,5 The trials were very similar in design. Included patients were adults with a diagnosis of relapsing, remitting multiple sclerosis (n = 1,292 and 1,564 in the two trials). One trial compared the efficacy of fingolimod at two doses (0.5 mg or 1.25 mg daily) with placebo; the other compared the same doses of fingolimod with interferon beta-1a given intramuscularly (30 µg weekly). The duration of treatment was 12 months in one study and 24 months in the second. The primary outcome was the annualised confirmed relapse rate. Secondary outcomes included the probability of disease progression, scores on the EDSS and MSFC (scales of disability in MS), and the number of new or enlarged lesions on MRI scans. 3

4 Quality of the trials The design of the trials was fairly good, being double-blind, randomised and controlled. Both trials were sponsored by the manufacturer of fingolimod. Main results The relapse rate was significantly lower with both doses of fingolimod than with the control treatment at the end of the study period in both trials. The probability of disability progression was reported to be consistent with the primary results in one trial and significantly lower than placebo in the second. Disability scores showed significantly less worsening with fingolimod than with placebo after 24 months. The results of the MRI scans showed a significant improvement in the fingolimod treated group compared with placebo, but not with interferon beta-1a. Adverse events Serious adverse events and those leading to discontinuation of treatment were most frequent in the group taking fingolimod 1.25mg. The most common serious events with fingolimod were bradycardia and atrioventricular block. Adverse events that occurred in over 10% of patients were infections, headache, and fatigue, which were reported in all treatment groups, including controls. References 1. Gilenya 0.5 mg hard capsules Summary of Product Characteristics. Novartis <accessed 6/2012> 2. TA254 Multiple sclerosis (relapsing-remitting) - fingolimod: guidance. NICE <accessed 6/2012> 3. MHRA Safety Update May Fingolimod: not recommended for patients at known risk of cardiovascular adverse events. New advice for extended early monitoring for those with significant bradycardia or heart block after the first dose. MHRA <accessed 6/2012> 4. Cohen JA, Barkhof F, Comi G et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010;362: Kappos L, Radue EW, O'Connor P et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010;362:

5 Table 1. Fingolimod: study design and results Study (n randomised) TRANSFORMS (Cohen et al., ) Double-blind RCT Multicentre n = 1,292 Jadad score: 3 Sponsored by the manufacturer Novartis FREEDOMS (Kappos et al., ) Double-blind RCT Multicentre n = 1,564 Jadad score: 3 Sponsored by the manufacturer Novartis Inclusion criteria Exclusion criteria Treatment arms (n) Duration of study Aged 18 to 55 Diagnosis of MS with relapsing, remitting course 1 documented relapse during previous year or 2 in previous 2 years Score of 0 to 5.5 on EDSS scale Aged 18 to 55 Diagnosis of MS with relapsing, remitting course 1 documented relapse during previous year or 2 in previous 2 years Score of 0 to 5.5 on EDSS scale relapse within 30 days active infection, macular edema, immunosuppression, clinically significant coexisting systemic disease relapse or corticosteroid treatment within 30 days active infection, macular edema, diabetes mellitus, immunosuppression, clinically significant coexisting systemic Fingolimod 0.5 mg daily (431) Fingolimod 1.25 mg daily (426) Interferon beta-1a 30 µg IM weekly(435) Duration of study: 12 months Fingolimod 0.5 mg daily (425) Fingolimod 1.25 mg daily (429) Placebo (418) Duration of study: 24 months Main outcomes Primary Secondary Annualised confirmed relapse rate fingolimod 0.5 mg: 0.16 (95% CI 0.12 to 0.21) fingolimod 1.25 mg: 0.20 (95% CI 0.16 to 0.26) interferon beta-1a: 0.33 (95% CI 0.26 to 0.42) Confirmed progression of disability that lasted 3 months : findings supported primary results Number of new or enlarged lesions on MRI scans at 12 months: no difference among study groups Annualised confirmed relapse rate fingolimod 0.5 mg: 0.18 (95% CI 0.15 to 0.22) fingolimod 1.25 mg: 0.16 (95% CI 0.13 to 0.19) placebo: 0.40 (95% CI 0.34 to 0.47) Probability of disability progression (1 point on EDSS score) that lasted 3 months : 17.7% *, 16.6% *, 24.1% respectively 5

6 disease treatment with interferon-beta or glatiramer within 3 months Mean EDSS and MSFC z scores at 24 months: worsened significantly less with fingolimod Number of new or enlarged lesions on MRI scans at 24 months: significantly fewer with fingolimod MS, multiple sclerosis; RCT, randomised controlled trial; IM, intramuscular; MRI, magnetic resonance imaging; EDSS, Expanded Disability Status Scale; MSFC, MS Functional Composite; * p < 0.01; p < vs. control; CI, confidence interval 6

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