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1 Title: Multiple Sclerosis guidelines for the use of beta-interferon, glatiramer acetate, natalizumab, mitoxantrone and other disease Authors Name: Dr P Talbot Contact Name: Dr Paul Talbot Contact Phone : Departments/Groups This Document Applies to: Neuroscienes Scope: Trustwide Keywords: Multiple sclerosis, disease modifying drugs Classification: Clinical Guideline Replaces: MM8 (05) To be read in conjunction with the following documents: Unique Identifier: MM8(05) Review Date: March 2012 Issue Status: Approved Issue : 2 Issue Date: March 2010 Authorised by: MS Clinical Governance Group Authorisation Date: March 2010 Document for Public Display: After this document is withdrawn from use it must be kept in an archive for10 years. Archive: Date added to Archive: Officer responsible for archive: Policy Statement This guideline is intended for use by Consultant Neurologists with expertise and responsibility for prescribing disease in multiple sclerosis (MS) Page 1 of 11

2 1. Roles and Responsibilities: Consultant Neurologist - ensure patients are assessed appropriately for disease modifying drugs - ensure patients are offered treatment in accordance with guidelines - ensure patients are given appropriate information and are therefore able to give informed consent to treatment - ensure patients are monitored appropriately - ensure patients are advised to continue, switch or stop treatment in accordance with guidelines 2. Standards specific standards apply Page 2 of 11

3 3. Protocol Guideline for the use of beta-interferon, glatiramer acetate, natalizumab, mitoxantrone and other disease in multiple sclerosis Clinically isolated syndrome Relapsing remitting MS Relapsing secondary progressive MS n-relapsing secondary progressive and primary progressive MS routine treatment - consider only if major attack and MRI evidence of disease activity Routine treatment if ambulant (EDSS score <7) and at least 2 clinically significant relapses in previous 2 years - consider treatment if only a single major relapse in previous 2 years and MRI evidence of continuing disease activity Routine treatment if at least 2 clinically significant relapses in previous 1 year and MRI evidence of disease activity routine treatment - consider only if 2 disabling relapses in previous 2 years, relapses are predominant cause of increasing disability and MRI evidence of disease activity routine treatment consider only if rapid accumulation of disability and MRI evidence of disease activity Possible candidate for beta-interferon and glatiramer acetate (see notes) Probable candidate for beta-interferon and glatiramer acetate consider IVIG and azathioprine only if ineffective or poorly tolerated (see notes) Probable candidate for natalizumab - consider mitoxantrone, alemtuzumab and cyclophosphamide as alternatives only if natalizumab contraindicated (see notes) Possible candidate for beta-interferon (see notes) Possible candidate for mitoxantrone consider cyclophosphamide only if mitoxantrone contraindicated (see notes) A decision to stop or switch treatment should recognise the importance of patient choice patients should be fully informed of relevant facts and uncertainties before making a decision in discussion with their treating neurologist and MS nurse. The following are suggestive of limited benefit; Development of more aggressive relapses with increased frequency compared to pre-treatment levels, especially if MRI evidence of disease activity consider switch to natalizumab, mitoxantrone, alemtuzumab and cyclophosphamide. Relapses continue at similar frequency to pre-treatment levels - consider stopping or switching treatment. Development of high sustained levels of neutralising antibodies to beta-interferon - consider stopping or switching treatment (see local and EFNS guidelines and patient information leaflet [Neur 3 (06)]. Sorensen P.S. et al. Guidelines on the use of anti-ifn-β antibody measurements in multiple sclerosis: report of an EFNS Task Force on IFN-β antibodies in multiple sclerosis. European Journal of Neurology 2005, 12: ). Development of non-relapsing secondary progressive MS with loss of ability to ambulate (EDSS score 7 or more). This local guideline is based on the revised Association of British Neurologists (ABN) guideline for prescribing in multiple sclerosis (MS) (1). It also incorporates NICE guidance on the use of natalizumab in MS (2) and a treatment guideline concerning the use of intense immunosuppression in patients with rapidly worsening MS (3). This guideline is in accordance with the Department of Health Risk Sharing Scheme (4) and the National Clinical Guideline for diagnosis and management of MS in primary and secondary care (5). All potentially suitable candidates for treatment with a disease modifying drug who are registered with a GP in Greater Manchester should be referred by their local Neurologist or MS Specialist Nurse for assessment in the MS clinic at Salford Royal. All patients who are considered suitable candidates for treatment will be provided with information outlining issues including partial efficacy, side effect profile and potential risks. Patients will also be informed of monitoring requirements (including the need for blood testing for neutralising antibodies if appropriate see PIL [Neu 3 (06)]) and stopping/switching criteria, prior to the commencement of treatment. All patients started on a disease modifying drug will be reviewed on an annual basis in the MS clinic and reassessed with regard to the appropriateness of continuing, switching or stopping treatment. The use of disease will be audited on an annual basis (6). Page 3 of 11

4 Beta-interferon (Avonex, Betaferon/Extavia and Rebif 22/44) and glatiramer acetate (Copaxone) are indicated for those patients with MS who meet ABN Guidelines (1). All patients will be provided with a PIL [Neu 4 (06)] and advised to visit Natalizumab (Tysabri) should be considered for those patients who meet NICE criteria for rapidly evolving severe relapsing remitting MS (2) - see local treatment guidelines. All patients offered natalizumab will be provided with a PIL [TY00-PAN Feb 2009], advised to visit and informed of the specific risks of anaphylactic reaction and progressive multi-focal leucoencephalopathy (PML). Mitoxantrone should be considered for those patients with rapidly worsening MS who do not meet NICE criteria for treatment with natalizumab. All patients offered mitoxantrone will be provided with a PIL [Neu 6 (07)] and informed it is unlicensed for use in MS, of the specific risk of infection and leukaemia and that total dose is limited due to potential cardiotoxicity. Patients who respond to mitoxantrone are usually switched to glatiramer acetate (Copaxone) for long-term treatment. Alemtuzamab (PIL in development) and cyclophosphamide (PIL [Uro 4 (09)]) may be considered as an alternative to mitoxantrone in exceptional circumstances only (3). IVIG and azathioprine should only be considered for those patients with relapsing remitting MS who meet ABN Guidelines for beta-interferon and glatiramer acetate and who have not responded to or are unable to tolerate either of these medications. The routine use of disease is not recommended for patients with clinically isolated syndromes and is not indicated for patients with non-relapsing secondary progressive MS and primary progressive MS. These guidelines mayl need to be revised when new oral treatments become available including cladribine, terifluonamide and fingolimod. 4. Policy Implementation Plan Consultant Neurologists with expertise and responsibility for prescribing disease in MS will be responsible for the implementation of these guidelines. The Clinical Governance MS Subgroup will be responsible for reviewing progress in implementing this plan. 5. Monitoring and Review The implementation of these guidelines will be the subject of an annual audit to be discussed at bi-monthly Clinical Governance MS Subgroup meetings. Page 4 of 11

5 References (1) Association of British Neurologists Revised (2009) Guidelines for Prescribing in Multiple Sclerosis. (2) Natalizumab for the treatment of adults with highly active relapsing-remitting multiple sclerosis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 Aug. 21 p. (Technology appraisal guidance; no. 127). (3) Intense immunosuppression in patients with rapidly worsening multiple sclerosis: treatment guidelines for the clinician. Lancet Neurology 2008; 7: (4) Department of Health. Health Service Circular Series Number: HSC 2002/004. February 4 th (5) Clinical guideline 8. Multiple sclerosis: management of multiple sclerosis in primary and secondary care. vember (6) The Use of Disease Modifying Drugs for Multiple Sclerosis in Greater Manchester from January 1996 to 2007, 2008, 2009 & Audit ID nos 948, 1251, 1466 & Page 5 of 11

6 Endorsed by: Name of Lead Clinician/Manager or Committee Chair Jane Wainwright MS Clinical Governance Group Position of Endorser or Name of Endorsing Committee MS Clinical Governance Group Date March 2010

7 Record of Changes to Document - Issue number: 3 Changes approved in this document by - Corporate Governance and Risk Management Date: 7/7/05 Section Amendment (shown in bold Deletion Addition Reason Number italics)

8 Diversity & Equality Screening Questionnaire The Trust is legally required to ensure that all new policies and documents are assessed for their impact both positive & negative on equality target groups;, disability, ethnicity, age, religion/beliefs, gender (inc transgender) & sexual orientation. If you wish to discuss any aspect of this assessment process please contact the Equality Advisor, HR dept. Have you been trained to carryout this assessment:? YES If 'yes' continue with the assessment, if 'no' arrange to have the training first. Name of policy, document or leaflet; glatiramer acetate, natalizumab, mitoxantrone and other disease 1 Whom is this document or policy aimed? Consultant Neurologists with expertise and responsibility for prescribing disease in multiple sclerosis (MS) 2 Is this document a specific user group? if yes, why? Consultant Neurologists with expertise and responsibility for prescribing disease in multiple sclerosis (MS) How will you ensure that this policy is cascaded to the target group? It will be tabled at a Clinical Governance MS Subgroup meeting 3 Is there any evidence to suggest that different groups have different needs in relation to this policy or document (positive or negative)? 4 If you a revising a policy are any the changes to this policy likely to impact on any groups? 5 Have you undertaken any consultation/involvement with service users or other groups in relation to the new policy? If yes, what format did this take? face/face or questionnaire? Were service users who may require additional support (e.g. visually

9 impaired) involved? Have any amendments been implemented as a result of this exercise? 6 Are you aware if a request has been made for the policy to provided in alternative formats? If yes, how/was this achieved? 7 Could any individual/group be affected differently by the application of the document? 8 Does the document require any decision to be made which could result in some individuals receiving different treatment or care to other individuals? On what basis would this decision be made? Could this impact on any particular group? 8 Are you aware of any complaints from service users in relation to the application of this policy? If yes, how was the issue resolved? Page 9 of 11

10 9 Looking at the above points does this indicate that any of the groups listed below have different needs, experiences or priorities groups in relation to the document? Age Disability Gender Marital Status Racial group Religious belief Sexual orientation Transgender Low Income Yes Don t know Any additional comments If any impact have been highlighted by this assessment, you will need to ; - contact T Horrocks, Equality Advisor, HR dept - additional work may have to be undertaken ; - if necessary, gather further data to establish the level of impact - consult with relevant service users - determine if the impact of the policy is justifiable or has to be eliminated - investigate why there was an adverse impact - complete action plan outlining what action you propose to undertake to reduce or eliminate the adverse impact or justify - publication of findings Page 10 of 11

11 Page 11 of 11

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