Commissioning Policy: Disease Modifying Therapies for patients with Multiple Sclerosis (MS).

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1 Commissioning Policy: Disease Modifying Therapies for patients with Multiple Sclerosis (MS). Reference No: Version: 1 Ratified by: EMSCGP029V1 EMSCG Board Date ratified: 25/09/2009 Name of originator/author: Name of responsible committee/individual: Malcolm Qualie Date issued: 25/09/2009 Review date: 01/01/2014 Target audience: Distributed via: EMSCG Clinical Priorities Advisory Group (CPAG). PCT Commissioners, Providers of Service Postmaster / Website: EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 1

2 East Midlands Specialised Commissioning Group Commissioning Policy Disease Modifying Therapies for patients with Multiple Sclerosis (MS) Version Control Sheet Draft Section/Para/ Appendix Version/Description of Amendments Date Author/Amended by 1 1 st draft October Introduction References Section 4. Policy Section 6. Review Date 2 nd Draft: Amended to include the reasons for NICE guidance not recommending beta interferon and glatiramer acetate, and the DH Risk Sharing Scheme. The addition of the DH risk sharing document, and the Association of British neurologist s guidelines. Explanation included stating that the criterions referred to in the policy for beta interferon and glatiramer acetate are based upon ABN Guidelines. Amended to include being reviewed when ABN publish new guidelines in replacement of the ones currently in use for this policy. August 2008 Malcolm Qualie EMSCG Ami Faulkner EMSCG EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 2

3 East Midlands Specialised Commissioning Group Commissioning Policy Disease modifying therapies for patients with Multiple Sclerosis (MS) Contents i. Version control sheet ii. Policy statement Section Page 1 Introduction 5 2 The rationale for this policy 5 3 Definitions 6 4 Policy 6 5 Mechanism for Funding 9 6 Review date 9 7 Glossary 10 8 References 11 Appendix 1 Equality Impact Assessment test for relevance 12 Appendix 2 Human Rights Assessment tool 16 EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 3

4 East Midlands Specialised Commissioning Group Disease Modifying Therapies for patients with Multiple Sclerosis (MS) Background Statement This policy provides guidance on the use of disease modifying therapies (notably beta interferon and glatiramer acetate) for patients with multiple sclerosis. In particular, it attempts to clarify the commencement and cessation criteria for the use of these drugs and to clarify the definitions of the terms relapse and clinically significant relapse. These terms are used in national guidance on the use of disease modifying therapies. In addition, since the National Institute for Health and Clinical Excellence issued Technology Appraisal Guidance no.127 regarding the use of Natalizumab as a disease modifying therapy, it has been necessary to clarify the term disabling relapse and to determine commencement and cessation criteria for Natalizumab. Beta interferon, glatiramer acetate and natiluzumab will be commissioned according to the starting and stopping criteria contained within this policy. Responsibilities Each primary care trust to adopt these criteria, and incorporate into Service Level Agreements and contracts with providers. Training There are no training issues. Dissemination To every member PCT in the East Midlands and Providers of the service. Resource implication There is likely to be growth year on year. However, the policy will allow commissioners to audit use of these agents against the agreed starting and stopping criteria. EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 4

5 1 Introduction 1.1 NICE produced guidance (NICE Technology Appraisal 32) for the use of beta interferon; glatiramer acetate which did not recommend them, because although it states that they work, there remains uncertainty about which patients benefit from these medicines and to what extent. So the Department of Health (DH) produced a risk sharing scheme recommending these treatments, and helping ensure that they be made cost effective for the NHS to commission. (DH Health Service Circular HSC 2002/004). Therefore, the treatments outlined within this policy for the use of beta interferon and glatiramer acetate follow the recommendations of this HSC (2002/004). 1.2 It represents a clinical consensus on the interpretation of the terms relapse, clinically significant relapse and disabling relapse and the criteria for commencement and cessation of disease modifying therapies for multiple sclerosis included in the Health Services Circular, (2002/004) namely beta interferon and glatiramer acetate. These terms are used in national guidance on the use of disease modifying therapies. 1.3 Clarification on the term disabling relapse and commencement and cessation criteria for Natalizumab follow the publication of the National Institute for Health and Clinical Excellence issued Technology Appraisal Guidance no.127 Natalizumab for the treatment of adults with highly active relapsing remitting multiple sclerosis; which is recommended as a treatment option only for rapidly-evolving severe relapsing remitting Multiple Sclerosis (RES). 1.4 This policy applies to all patients whose responsible commissioner is within the East Midlands Region. These commissioners include practice based commissioners, primary care trusts and the Specialised Commissioning Team (East Midlands). 2 The rationale for this policy Currently most PCTs commission the use of beta interferon and glatiramer acetate without prior approval. All commission on the basis of the original Health Services Circular, but without clear, written definitions of terms relating to the disease and commencement and cessation criteria. All PCTs currently commission Natalizumab, some requiring prior approval for funding. Again there are no clear, written definitions or criteria. The policy provides definitions to be adopted across the SCG which will allow beta interferon, glatiramer acetate and natalizumab to be commissioned without the need for prior approval. EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 5

6 3 Definitions 3.1 Relapse A relapse is defined as the onset of new symptoms or the worsening of pre-existing symptoms attributable to demyelinating disease lasting for more than 24 hours and preceded by improving or stable neurological status for at least 30 days from the onset of the previous relapse in the absence of infection, fever or significant metabolic disturbance. 3.2 Clinically Significant Relapse All relapses are clinically significant, but in usual practice relapses contributing to the eligibility for Disease Modifying Therapies are: 1. Any motor relapse 2. Any brainstem relapse 3. A sensory relapse if it leads to functional impairment 4. Relapse leading to sphincter dysfunction 5. Optic neuritis 6. Intrusive pain - and lasting more than 48 hours. 3.3 Disabling Relapse A disabling relapse is defined as any relapse which fulfils one or more of the following criteria: 4 Policy 1. Affects the patient s ability to work or 2. Affects the patient s activities of daily living as assessed by an appropriate method or 3. Affects motor or sensory function sufficiently to impair the capacity or reserve to care for themselves or others as assessed by an appropriate method or 4. Needs treatment/hospital admission. The following criteria must be used in conjunction with the agreed definitions of relapse, disabling relapse and clinically significant relapse described in section 3. It is important that the frequency and severity of relapses both in pre and post treatment phases are accurately and consistently recorded so as to ensure meaningful audit. (The criteria for the use of beta interferon and glatiramer acetate are based upon the criteria outlined in the Association of British Neurologists (ABN) Guidelines, which can be found in Appendix IV of the DH HSC 2002/04). EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 6

7 4.1 Beta interferon for relapsing remitting disease Commencement Criteria All of the following criteria must be met. The patient: 1. Has had at least 2 clinically significant relapses in previous 2 years 2. Is able to walk 10m or more*. 3. Is not pregnant or attempting conception 4. Is aged over 18 years 5. Has no contra-indications * for patients who can walk between 10 and 99 m (aided or unaided, EDSS 6.0 to 6.5), treatment with DMTs is permitted but recommended less strongly than for patients able to walk more than 100m unaided (EDSS 5.5 or less) Cessation Criteria Treatment should be stopped if one or more of the following criteria are met: 1. No reduction in frequency or severity of relapses compared with pre-treatment phase following a minimum 6 month period of beta interferon treatment, unless the frequency and/or severity of relapses necessitates an earlier change of therapy (e.g. Natalizumab) 2. Intolerable adverse effects of the drug 3. The patient is pregnant, breast feeding or attempting conception 4. Development of inability to walk, persistent for more than 6 months, unless unable to walk for reasons other than MS. 5. Confirmed secondary progressive disease with an observable increase in disability over a 6 month period (see beta interferon secondary progressive criteria for definitions) 4.2 Beta interferon for secondary progressive disease Commencement Criteria All of the following criteria must be met. The patient: 1. Has had at least two disabling relapses in two years 2. Is able to walk 10m or more 3. Has had minimal increase in disability due to gradual progression over the past 2 years 4. Has had disease progression by less than 2 EDSS point over last year (other than relapse-related), where the data have been recorded 5. Is not pregnant or attempting conception 6. Is aged over 18 years 7. Has no contra-indications Cessation Criteria One or more of the following criteria are met: 1. No reduction in frequency or severity of relapses compared with pre-treatment phase following a minimum 6 month period of beta interferon treatment 2. Intolerable adverse effects of the drug 3. The patient is pregnant, breast feeding or attempting conception 4. Development of inability to walk, persistent for more than 6 months, unless unable to walk for reasons other than MS. EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 7

8 4.3 Glatiramer acetate for relapsing remitting disease Commencement Criteria All of the following criteria must be met. The patient: 1. Has had at least 2 clinically significant relapses in previous 2 years 2. Is able to walk 100m or more without assistance* 3. Is not pregnant or attempting conception 4. Is aged over 18 years 5. Has no contra-indications *without assistance means that the patient is free standing and does not require walking aids Cessation Criteria One or more of the following criteria are met: 1. No reduction in frequency or severity of relapses compared with pre-treatment phase following a minimum 6 month period of glatiramer acetate 2. Intolerable adverse effects of the drug 3. The patient is pregnant, breast feeding or attempting conception 4. Development of inability to walk, persistent for more than 6 months, unless unable to walk for reasons other than MS. 5. Confirmed secondary progressive disease with an observable increase in disability over a 6 month period 4.4 Glatiramer acetate for secondary progressive disease Clinical efficacy of Glatiramer Acetate has been limited to reducing relapse rate but not preventing increase in disability. Glatiramer Acetate will not be routinely commissioned for patients with secondary progressive disease. 4.5 Natalizumab for rapidly evolving severe relapsing-remitting ms (res) Commencement Criteria All of the following criteria must be met. The patient: 1. Has had two or more disabling relapses in the past year 2. Has one or more gadolinium-enhancing lesions on MRI or increase in T2 lesion load compared with previous MRI unless comparator MRI is unavailable or assessment of gadolinium-enhancement is unreliable as the patient is treated with steroids at around the time of scan. 3. Has had no previous disease modifying therapy OR is receiving treatment with beta interferon and does not meet the agreed cessation criteria. NB: As per NICE Technology Appraisal Guidance no.127 patients with high disease activity taking beta interferon or glatiramer acetate but do not fulfil the RES criteria will not be routinely funded for natalizumab Cessation Criteria One or more of the following criteria are met: 1. No reduction in frequency or severity of relapses compared with pre-treatment phase following a minimum 3 month period of natalizumab treatment EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 8

9 2. Unacceptable adverse effects of the drug 3. The patient is pregnant, breast feeding or attempting conception 4. Development of secondary progressive disease causing inability to walk for more than 6 months 5 Mechanism for Funding Activity will be funded via PCT contributions to the Specialised Services Budget. 6 Review date Review date is 25/09/2011, or until new Association of British Neurologists (ABN) guidelines are published. EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 9

10 7 Glossary Word/Abbreviation Clinical consensus Commencement and cessation criteria Commissioning DH Efficacy Meaning General agreement on a clinical/medical subject. (In this context).the standards used to find out when a patient could start a certain treatment and stop it. Commissioning in the NHS is the process of ensuring that the health and care services provided effectively meet the needs of the population. It is a complex process with responsibilities ranging from assessing population needs, prioritising health outcomes, procuring products and services, and managing service providers. (Taken from Department of Health. The Department of Health is committed to improving the quality and convenience of care provided by the NHS and social services. Its work includes setting national standards, shaping the direction of health and social care services and promoting healthier living. Effective HTA NICE PCT Practice based commissioning (PBC). Prior approval Health Technology Appraisal National Institute for Clinical Excellence. NICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health. (NICE, 2009) Primary Care Trust. A primary care trust is responsible for buying and overseeing many of the health services for the area it covers. In the East Midlands there are 9 PCT s in total, these being Northamptonshire PCT, Bassetlaw PCT, Derby City PCT, Derby County PCT, Lincolnshire PCT, Nottingham City PCT, Nottinghamshire County PCT and Leicestershire County and Rutland PCT. They can now also be called NHS (organisational name), instead of (organisational name) PCT. This is about providing GPs and other front line clinicians more involvement in commissioning decisions in order to better meet the needs of their patients. In this context, when a certain treatment is labelled prior approval, it means that before a provider (e.g. a hospital) can give the treatment to a patient, they need to ask the PCT for their area to assess and agree to fund it. If the PCT agrees to fund it, then the treatment can be provided to the patient. EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 10

11 Risk sharing scheme Routinely commissioned Specialised Commissioning Team In this context, the Health Service Circular laid out an agreement between the Department of Health, Welsh Assembly Government, Scottish Executive and Northern Ireland Department of Health, Social Services and Public Safety with the manufacturers for the supply of certain treatments. This agreement created what is known as the 'Risk Sharing Scheme'. In this agreement the manufacturers agreed that their products would deliver certain outcomes and if these outcomes are not delivered the price that the NHS pays would fall, hence the risk sharing. (taken from Paid for without prior approval. Specialised Commissioning is the means by which Primary Care Trusts (PCTs) work together to plan, buy and manage services which treat patients with rare conditions. (Taken from For the East Midlands this is the East Midlands Specialised Commissioning Group. 8 References Association of British Neurologists (ABN) (2001) Guidelines on the use of Beta Interferons and Glatiramer Acetate in Multiple Sclerosis. Available from accessed 19/08/09. Department of Health Services Circular (HSC) 2002/004 Cost effective provision of disease modifying therapies for people with Multiple Sclerosis. NICE Clinical Guidance 32, Beta interferon and glatiramer acetate for the treatment of multiple sclerosis (2002) NICE Clinical Guidance 127, Natalizumab for the treatment of adults with highly active relapsing remitting multiple sclerosis (2004) EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 11

12 Appendix 1: Equality Impact Assessment Test for Relevance Race, Religion/Belief, Disability, Gender, Age and Sexual Orientation Name of the Service/Policy/Function: EMSCGP029V1 Commissioning policy: Disease Modifying Therapies for patients with Multiple Sclerosis (MS). 1. What you are trying to achieve in this service/policy/function (Write short notes to explain the policy/service) The overarching aim of this policy is to ensure equity of access, by providing consistency and clarity in the use of disease modifying treatments outlined within the policy for patients with Multiple Sclerosis (MS); which apply to the whole East Midlands population. The policy provides definitions of terms used relating to the treatment of Multiple Sclerosis (MS) e.g. Disabling Relapse. These definitions will be adopted across the East Midlands region through the use of this policy; therefore ensuring that the treatments for MS outlined within the policy are used consistently and equitably. 2. Which population groups the service/policy/function is intended to benefit and how? The policy is intended to benefit both current and future patients with Multiple Sclerosis (MS), by ensuring equity of access for those meeting the agreed criteria outlined within the policy throughout the East Midlands region. 3. Related policy areas that may be affected by changes in this service/policy/function There are no related policy areas that may be affected by changes in this policy. EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 12

13 Equality Impact Assessment Test for Relevance Race, Religion/Belief, Disability, Gender, Age and Sexual Orientation Name of the Service/Policy/Function: EMSCGP029V1 Commissioning policy: Disease Modifying Therapies for patients with Multiple Sclerosis (MS). Question 1 - Screening For each of the six equality categories, ask the questions in the table below: Please answer Yes or No to the following questions Question Age Disability Race Religion and Belief Gender Sexual Orientation Do different groups have different NO NO NO NO NO NO needs, experiences, issues and priorities in relation to the proposed policy service? Is there potential for or evidence NO NO NO NO NO NO that the proposed policy service will not promote good relations between different groups? Is there potential for or evidence NO NO NO NO NO NO that the proposed policy service will affect different population groups differently (including possibly discriminating against certain groups)? Is there public concern (including media, academic, voluntary or sector specific interest) in the policy area about actual, perceived or potential discrimination against a particular population group or groups? NO NO NO NO NO NO EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 13

14 Equality Impact Assessment Test for Relevance Race, Religion/Belief, Disability, Gender, Age and Sexual Orientation Name of the Service/Policy/Function: EMSCGP029V1 Commissioning policy: Disease Modifying Therapies for patients with Multiple Sclerosis (MS). Question 2 - Why have you come to these conclusions? (Write short notes to explain why you have drawn your conclusions including any evidence (of whatever type) that you have to support your assessment). The policy has been written so that anyone in the East Midlands will have access to treatment as long as they meet the criteria stated within the policy which are clinically based and not based upon any discriminatory criteria such as age, gender, sexual orientation, race, religion/beliefs or disability. Thus, none of the criteria allowing access to treatment discriminates against any person. Based on the information set out above, I have decided that an equality impact assessment is not necessary. Signed: J M Qualie.... Job title: Head of Health Policy Directorate/Service area: East Midlands Specialised Commissioning Group (EMSCG). Date 10/09/09 EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 14

15 Copy of the completed form should be sent to: 1) Director of Specialised Commissioning 2) Corporate Services Manager Specialised Commissioning 4 Smith Way, Grove Park Leicester LE19 1SS EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS) 15

16 Appendix 2: Human Rights Assessment Tool East Midlands Specialised Commissioning Group Human Rights Assessment Tool The Human Rights Act, which came into force in October 2000, incorporates into domestic law the European Convention on Human Rights to which the UK has been committed since Section 6 of the Human Rights Act makes it unlawful for a public authority to act in a way, which is incompatible with a Convention right. The underlying intention of the Act is to create a Human Rights culture in public services. To be completed and attached to any policy document when submitted to the appropriate committee for consideration and approval. Yes/No Comments 1. Will it affect a person s right to life? NO Will someone be deprived of their liberty or have their security threatened? Could this result in a person being treated in a degrading or inhuman manner? Is there a possibility that a person will be prevented from exercising their beliefs? Will anyone s private and family life be interfered with? NO NO NO NO If the answer is yes to any of the questions on the proforma can the policy be amended to avoid impacting upon Human Rights? If not, please refer it to the Director of Corporate Affairs to enable legal advice to be sought before proceeding. 16 EMSCGP029V1. Commissioning Policy: Disease modifying therapies for patients with Multiple Sclerosis (MS)

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