NHS Suffolk Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice)

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1 NHS Suffolk Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) This drug has been reviewed because it is a product that may be prescribed in primary care. Medicine Fingolimod (Gilenya, Novartis) for relapsing - remitting multiple sclerosis (RRMS) Document status Considered at NHS Suffolk Drug and Therapeutics Committee meeting November 2010 Date of last revision 21st November 2010 Traffic light decision DOUBLE RED - Prescribing not supported in either general practice or secondary/tertiary care ( PENDING NICE) Prescribers rating Judgement reserved-the committee postpones its judgement until better data and a more thorough evaluation of the drug are available Mechanism of action Medicine class Indication Dosage Treatment alternatives Fingolimod, a novel drug, is an oral sphingosine-1-phosphate receptor modulator (S1P-R) modulator, which is thought to act therapeutically by retaining lymphocytes in the lymph nodes. This reduces infiltration of potentially auto-aggressive lymphocytes into the CNS where they could potentially attack the protective covering around the nerve fibres. (1,2) Other- immunomodulating drugs First line treatment for RRMS One 0.5mg capsule daily orally Current MS treatment consists of both symptomatic therapies which may or may not be licensed (e.g. steroids, baclofen and anti-cholinergics) as well as treatment with disease modifying therapies (DMTs) including beta-interferon 1a, glatiramer acetate, and natalizumab. Interferon beta and glatiramer are not currently recommended by NICE (TA32), but are available in the NHS through a Risk Sharing Scheme. (1) NICE recommends natalizumab as an option for the treatment only of rapidly evolving severe RRMS (TA 127). (3) Place in therapy Future alternatives All the DMTs currently are injectable / infusion products. First line oral therapy for RRMS; may be useful in patients with needle phobia or adverse effects to existing DMTs. Laquinimod, fampridine-sr and add-on therapies (to betainterferon alfa): teriflunamide, daclizumab (1) (NB: cladribine, another oral drug in the pipeline for MS was refused a marketing authorisation by the EMEA in September 2010 on safety grounds).

2 Evidence for use Key studies: for further detail please see appendix 1. The 2 fully published pivotal phase III trials are FREEDOMS (4) (placebo controlled) and TRANSFORMS (5) (head-to head study). Participants in the trials were adult patients with RRMS, aged under 56, with Expanded Disability Status Scale (EDSS, range 0-10, 10 worst) scores 0 to 5.5, and a history of one or more relapses in the previous year or two or more in the previous two years. Head-to-head trials of subcutaneous interferon beta-1b and interferon beta-1a vs. intramuscular interferon beta-1a showed advantages of both subcutaneous regimens over the latter. The interferon - beta 1a comparator in the TRANSFORMS trial was the intra-muscular regimen. More recent trials were unable to separate the clinical efficacy of the two subcutaneously administered forms of interferon beta from that of glatiramer acetate. FREEDOMS Trial (4) 24 month double-blind RCT (N=1,272) using oral fingolimod 0.5mg or 1.25mg daily vs. placebo. Median EDSS was 2 (range 0.5-5). Interferon-beta or glatiramer acetate therapy had to have been stopped three or more months before randomisation. The primary end point was the annualised relapse rate. To constitute a confirmed relapse, symptoms must have been accompanied by an increase of at least half a point in the EDSS score, of one point in each of two EDSS functional system scores, or of two points in one EDSS functional-system score (excluding scores for the bowel bladder or cerebral functional systems). Time to disability progression was a major secondary endpoint. In terms of the primary and secondary outcomes, fingolimod was superior to placebo with no significant difference between the two doses. Time to disability progression also favored fingolimod. Both fingolimod doses were superior to placebo with regard to MRI related measures. TRANSFORMS study (5) A second 12 month study (N=1,292) compared oral fingolimod with IM interferon beta-1a. Participants were similar to those in the placebo-controlled trial, and were randomised to oral

3 fingolimod 0.5mg or 1.25mg, or IM interferon beta-1a, 30mcg weekly. A double-blind, double-dummy design was used to retain blinding. Previous recent therapy with either any type of interferon beta or glatiramer acetate was not a criterion for exclusion. As with the placebo controlled study the primary end point was the annualised relapse rate, defined as the number of confirmed relapses per year. Major secondary outcomes were disability progression and new or enlarged hyper-intense lesions on T2-weighted MRI scans at 12 months. Primary and secondary outcomes favoured fingolimod. The authors conclude that fingolimod was superior to parenteral interferon beta-1a in the treatment of relapsing-remitting MS. NNT Cautions / side effects Critical Evaluation The patients in the trial populations did not have severe MS and were all fairly well. 14.2% of the trial population discontinued the drug when placed on higher doses. The interferon used in the comparator trials was the intramuscular (IM) whereas head to head trials of subcutaneous (SC) interferon-1b and interferon 1a showed advantages for both SC regimens over the IM form. NNT = 16 (for reduction in cumulative probability of disease progression (confirmed after 3 months) for the 0.5mg dose of fingolimod vs. placebo) Adverse events associated with fingolimod included bradycardia, hypertension and macular oedema. In the FREEDOMS trial, adverse events were similar in the three study groups, and most were mild to moderate in severity. Overall incidence of infection was similar across the three groups. (4) Adverse events were mild to moderate in severity in 82% of patients receiving 0.5 mg of fingolimod, 77% of those receiving 1.25 mg of fingolimod, and 77% of those receiving placebo. Serious adverse events were reported for 10.1% of patients receiving 0.5 mg of fingolimod, 11.9% of those receiving 1.25 mg of fingolimod, and 13.4% of those receiving placebo. Adverse events that led to discontinuation of the study medication (including abnormal laboratory test results) were more common with fingolimod at a dose of 1.25 mg (occurring in 14.2% of patients) than with fingolimod at a dose of 0.5 mg (occurring in 7.5%) or with placebo (occurring in 7.7%).

4 In the TRANSFORMS study the overall adverse event rates were similar in the three study groups, however serious adverse events were most common in the 1.25mg fingolimod group with two fatal herpes-virus infections occurring in this group. (5) The most common serious adverse events were bradycardia, multiple sclerosis relapse, and basal-cell carcinoma. All other serious adverse events occurred in four or fewer patients (<1%) in any study group. Bradycardia - monitoring is required as the heart rate will usually slow down the most 6 hours after the patient takes first dose. The seven episodes of bradycardia in the two fingolimod groups (three in the 0.5mg group and four in the 1.25mg group) were reported during the monitoring period after administration of the first dose. Five of these events were asymptomatic; the patients continued to receive fingolimod and the episodes were reported as serious adverse events because the protocol-defined discharge criteria for the first-dose monitoring period were not met. Macular oedema - seven patients in the 1.25mg group developed macular oedema during treatment; in six, this resolved after discontinuation. Respiratory and hepatic impairment. Herpes - the rate of herpes infections among patients receiving the 1.25mg dose of fingolimod was 5.5%; such infections were serious in three of these patients, two of whom died. Malignant neoplasms were reported in 4 patients receiving 0.5 mg of fingolimod, 4 receiving 1.25 mg of fingolimod, and 10 receiving placebo. All 11 skin cancers (basal-cell carcinoma, malignant melanoma, or Bowen s disease) that occurred (3 cases with 1.25-mg fingolimod, 4 with 0.5-mg fingolimod, and 4 with placebo) were removed successfully. Cost within PBR tariff? Cost (prices from MIMS Oct 2010) Comparative costs of other medicines Potential number of patients and usage within NHS Suffolk Likely excluded The costs of fingolimod tablets are not yet known. Main DMT alternatives (drug costs per patient Cost - ex VAT) (28 days) Beta-interferon (no administration costs as betainterferon is self-administered) Glatiramer acetate Natalizumab (for severe disease) (administration costs are an additional 8,379 per patient) Around 100,000 people in the UK have MS. (6) It is estimated that 15% of patients diagnosed with MS are

5 Points for consideration Is it on the WHS or IHT formularies? Decisions from other bodies Comments sought from Decision review date Jan 2013 eligible for a DMT of which 86% are likely to have RRMS. (7) Of 100,000 diagnosed patients = 15,000 patients will be eligible for treatment and 12,900 patients will have RRMS. In the UK 21 patients per 100,000 population may have a diagnosis of RRMS and eligible for treatment with fingolimod. Therefore within NHS Suffolk there may be patients with RRMS technically eligible for treatment with fingolimod although many of these patients may already be receiving a DMT for their MS. Some patients with RRMS and eligible for a DMT may not be receiving a DMT because of needle phobia or adverse effects to existing DMTs. Fingolimod is likely to marketed as a new and effective treatment option in MS which offers patients a convenient alternative to frequent injections. There were some severe adverse events noted in the trials. The most common serious adverse events were bradycardia, MS relapse, and basal-cell carcinoma. The rate of herpes infections among patients receiving the 1.25mg dose of fingolimod was 5.5%; such infections were serious in three of these patients, two of whom died. The trials reported that further follow-up is needed to clarify longer-term safety, including ophthalmic and cardiovascular effects, and the potential for herpesvirus reactivation. Fingolimod is an immunosuppressive drug. The Multiple Sclerosis Resource Centre has noted that the experimental drugs have serious side effects because they interfere with the body's immune system. (Note the EMEAs refusal to grant a marketing authorisation to cladribine on the grounds of safety). West Suffolk Hospital - no Ipswich Hospital - no Cambridgeshire JPG Double Red Norfolk TAG Not considered SMC - Not considered AWMSG Not considered NICE Appraisal in progress, draft TA guidance anticipated close to launch Q Consultant neurologists and specialists in MS; Dr Brierley, Lynette Baldwin, Dr Galton, Dr Graham, Dr Manji, Chris Boyes (Ipswich Hospital). Graham Lennox, Francesca Crawley, Dr Paul Molyneux, senior MS nurse, Mary Fraser (The West Suffolk Hospital)

6 This review is based on NHS Cambridgeshire s review (1) References 1. Cambridgeshire Joint Prescribing Group Submission considered March Available via _Decision_March_2010.sflb.ashx 2. Fingolimod. New Drugs Online report. Available via 3. Natalizumab for the treatment of adults with highly active relapsing-remitting multiple sclerosis. NICE TA Kappos L, Radue E-W et al. A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis. New England Journal of Medicine 2010; 362: Cohen J, Barkhof F et al. Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis. (Editorial) New England Journal of Medicine 2010; 362: MS Society briefing on UK prevalence study issued June 2009 available via f3.pdf 7. Cost effective provision of disease modifying therapies for people with multiple sclerosis. HSC Available via statistics/lettersand circulars/healthservice circulars/dh_ Comments

7 Appendix 1 Key clinical trials Participants in the trials were adult patients with RRMS aged under 56, with Expanded disability Status Scale (EDSS, ranges 0 10, 10 worst) scores 0 to 5.5, and a history of one or more relapses in the previous year or two or more in the previous two years. Trial Study design as above Treatment Primary Endpoint Secondary Endpoints FREEDOMS (4) 24 month double-blind Total N=1,272 Time to disability progression RCT. (major secondary endpoint). Median Expanded Disability Status Scale (EDSS) was 2 (range 0-5.5). Interferon-beta or glatiramer acetate therapy had to have been stopped three or more months before randomisation. The main reasons for withdrawal were withdrawal of consent, adverse events (including abnormal laboratory tests) and lack of therapeutic effect. More patients withdrew for adverse events in the two fingolimod groups, and more for lack of effect in the placebo group. (1,033 completed the 24 months study) Oral fingolimod 0.5mg (N=425) or 1.25mg (N=429) daily vs. placebo (N=418) The primary end point was the annualised relapse rate. To constitute a confirmed relapse, symptoms must have been accompanied by an increase of at least half a point in the EDSS score, of one point in each of two EDSS functional system scores, or of two points in one EDSS functionalsystem score (excluding scores for the bowel bladder or cerebral functional systems). Fingolimod was superior to placebo with no significant difference between the two doses Annualised relapse rate was 0.18 and 0.16 with 0.5 mg and 1.25mg of fingolimod respectively, and 0.40 with placebo (p<0.001 for either dose vs. placebo). Time to disability progression favored fingolimod; for example risk of disability progression over 24 months (hazard ratio, 0.70 and 0.68, for 0.5mg and 1.25mg respectively; p=0.02 vs. placebo, for both comparisons). The cumulative probability of disability progression (confirmed after 3 months) was 17.7% with 0.5 mg of fingolimod, 16.6% with 1.25 mg of fingolimod, and 24.1% with placebo. Both fingolimod doses were superior to placebo with regard to MRI related measures (number of new or enlarged lesions on T2 - weighted images, gadoliniumenhancing lesions, and brainvolume loss; p<0.001 for all comparisons at 24 months).

8 TRANSFORMS (5) 12 months study randomised, doubleblind, double-dummy (used to retain blinding). Participants were similar to those in the placebocontrolled trial, Previous recent therapy with either any type of interferon beta or glatiramer acetate was not a criterion for exclusion. The most frequent reasons for withdrawal were adverse events and withdrawal of consent. Total N=1,292 (1,153 completed the study) oral fingolimod 0.5mg (N=431) or 1.25mg (N=426), or IM interferon beta-1a, 30 mcg (N=435) weekly. The primary end point was the annualised relapse rate, defined as the number of confirmed relapses per year. Potential relapses triggered an unscheduled visit and were confirmed by the treating neurologists on the basis of blinded examination by the examining neurologist. Relapse was defined as new, worsening, or recurrent neurological symptoms that occurred at least 30 days after the onset of a preceding relapse, that lasted at least 24 hours without fever or infection, and that were accompanied by an increase of at least half a point on the EDSS or an increase of at least one point in two functional-systems scores or of at least two points in one functional-system score (excluding changes in bowel or bladder function and cognition). Major secondary outcomes were disability progression and new or enlarged hyper-intense lesions on T2-weighted MRI scans at 12 months. Secondary outcomes also favoured fingolimod. The annualised rate of relapse was 0.20 (95% CI, 0.16 to 0.26) in the 1.25-mg group, and 0.16 (95% CI, 0.12 to 0.21) in the 0.5- mg group vs (95% CI, 0.26 to 0.42) in the interferon group (p<0.001 for both comparisons).

9 Grids used to assist the NHS Suffolk PCT Drug & Therapeutics Committee in reaching a decision about new medications For many years scientists have recognised two types of research: Primary: original studies, based on observation or experimentation on subjects. Secondary: reviews of published research, drawing together the findings of two or more primary studies. In biomedical science there is general agreement over a hierarchy: the higher up a methodology is ranked, the more robust and closer to objective truth it is assumed to be. The orthodox hierarchy looks something like this; Rank: Methodology Description 1 Systematic reviews and meta-analyses Systematic review: review of a body of data that uses explicit methods to locate primary studies, and explicit criteria to assess their quality. Meta-analysis: A statistical analysis that combines or integrates the results of several independent clinical trials considered by the analyst to be "combinable" usually to the level of re-analysing the original data, also sometimes called: pooling, quantitative synthesis. Both are sometimes called "overviews." 2 Randomised controlled trials (finer distinctions may be drawn within this group based on statistical parameters like the confidence intervals) Individuals are randomly allocated to a control group and a group who receive a specific intervention. Otherwise the two groups are identical for any significant variables. They are followed up for specific end points.

10 3 Cohort studies Groups of people are selected on the basis of their exposure to a particular agent and followed up for specific outcomes. 4 Case-control studies "Cases" with the condition are matched with "controls" without, and a retrospective analysis used to look for differences between the two groups. 5 Cross sectional surveys Survey or interview of a sample of the population of interest at one point in time 6 Case reports. A report based on a single patient or subject; sometimes collected together into a short series 7 Expert opinion A consensus of experience from the good and the great. 8 Anecdotal Something a bloke told you after a meeting or in the bar. Adapted from Systematic reviews, What are they and why are they useful? ScHARR 2008

11 To Decide if a Medication Is To Be Used In Suffolk Criterion to be measured Tends to poor 2 Medium 4 Tends to good Quality of evidence in the papers reviewed Magnitude of effect inferred from trials reviewed Low Medium High Are trial end-points surrogate markers or clinical outcomes? Clinical outcomes Clinical usefulness of trial end-points x Known Side Effect Profile High Medium Low Known Interactions High Medium Low Concern re Possible Side Effects Not Yet Uncovered High Medium Low Balance of Benefit To Harm (side effects toxicity interactions etc) Poor Medium Good NNT High Medium X Low Comparison Of Effectiveness With Other Medicines In Use For The Same Condition Poor Medium X Good

12 Severity of Condition to be Treated Trivial Medium x Severe Novel drug or member of existing class Novel Uptake (estimated proportion of people with this condition likely to be prescribed the medication under consideration maximum and minimum uptake) 60 to 70 patients Prescriber s Rating Definitions Bravo! -The drug is a major therapeutic advance in an area where previously no treatment was available. A real advance - The product is an important therapeutic innovation but has certain limitations. Offers an advantage - The product has some value but does not fundamentally change present therapeutic practice. Possibly Helpful - The product has minimal additional value, and should not change prescribing habits except in rare circumstances. Judgement reserved - The Committee postpones its judgement until better data and a more thorough evaluation of the drug are available. Nothing New - The product may be a new substance but is superfluous because it does not add to the clinical possibilities offered by previous products available. In most cases these are me-too products. Not acceptable - Product without evident benefit over others but with potential or real disadvantages. (With acknowledgement to Prescrire) To Decide Where A Medication Is To Be Used In Suffolk

13 Skills of the prescriber Criterion Red Amber Green Blue Experience Of The Condition Specific Specific Specific General Diagnosis Specific Specific Specific General Monitoring Progress Of Treatment Difficult Specific General General Therapy Patient Selection Difficult Specific Specific Easy Initiation Of Treatment Difficult Difficult Easy Easy Dose Titration Difficult Specific Easy Easy Monitoring Of Side Effects Complex Easy Easy Easy Method Of Administration Complex Normal Normal Normal Discontinuation Of Treatment Complex Complex Easy Easy References Jonsen A. Bentham in a box: Technology assessment and health care allocation. Law Med. Health Care. 1986;14: Suffolk Drug & Therapeutics Committee Responsibility for prescribing, Hospital Trust or GP Attached as Appendix 1 and Appendix 2

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