How to Get Your MS Medicine Campaigning Words Out loudly

Transcription

1 How to campaign for... Access to MS medicines in Northern Ireland 1

2 3 Foreword 4 Introduction 5 About MS medicines Reliable and independent information about MS medicines MS medicines approved for use 8 Part 1: Access to MS medicines approved by NICE and the DHSSPS Know your rights Getting access: know your facts How to get loud Inspiration from others: Penny and Ruth (Wakefield) and Neil (Kent) 18 Part 2: Access to MS medicines prescribed under the MS Risk Sharing Scheme 19 Part 3: Access to MS medicines without NICE Approval Know your rights Know the facts: Individual funding requests and exceptional circumstances Appealing decisions After an appeal getting loud if refused 23 The MS Society and access to medicines 24 Template letters 27 Useful sources and links 2

3 Foreword The MS Society believes that everyone with MS in the UK should receive the right medicine or treatment at the right time. The next few years represent an exciting period for people affected by MS. More MS treatments are being licensed and we hope the choice of treatments available to help modify the progression and symptoms of MS will increase still further. The MS Society supports people affected by MS across the UK in campaigning for access to treatments which have been proven safe and effective based on accurate and impartial information. The key to people getting the MS treatments they need is an understanding of how the Health and Social Care system decides what treatments to make available. This guide is intended to make it easier to do just that. So whether you re someone living with MS, a carer, or a friend or family member of someone with MS, I hope this guide is helpful in your efforts to get the appropriate treatment. Michelle Mitchell Chief Executive, MS Society April

4 About this guide The MS Society believes that people with MS should have access to proven medicines for their condition no matter where they live in the UK. However, not everyone with MS gets access to the right treatment at the right time, and in some cases (as you will read later in this guide) some people with MS have been denied access altogether. This even includes those treatments where there is a statutory obligation on Health and Social Care Trusts to fund prescriptions for a particular MS medicine. This guide contains useful information on how medicines are made available and how to navigate local health systems and how to get loud! We hope this guide will enable you to get access to the right medicine for you, at the right time. Whilst the MS Society does not provide individual advocacy support, your experiences are extremely valuable to our campaigning work; please consider sharing your story with us. This guide covers Health and Social Care Trusts in Northern Ireland and is for you if: The guide is split into three parts: Part 1 looks at medicines approved for use by the National Institute for Health and Care Excellence (NICE) and the Department of Health, Social Services and Public Safety (DHSSPS) Part 2 looks at disease modifying treatments prescribed under the MS Risk Sharing Scheme Part 3 looks at medicines which are licensed for MS, but are not approved by NICE for use in the Northern Ireland health system This guide has been inspired by people affected by MS who have campaigned for access to MS medicines. The MS Society and the organisations who have worked with us on this guide do not support or endorse one product over any other. The MS Society follows a strict policy when working with industry. you have not been assessed for a particular MS medicine but believe you might be eligible you have been told you are eligible for an MS medicine but you can not get the treatment, for whatever reason you have been told you are not eligible for an MS medicine and want to question this 4

5 About MS medicines The MS Society believes that everyone with MS should get the right medicine at the right time. To help make this a reality, two things need to happen: you need information about the full range of options available, so you can make an informed choice you need to know how local systems and processes work, so you can get the treatments you are entitled to By 2015, the number of medicines available specifically for treatment of MS may have increased from 8 to 14. As choice increases, it is crucial that people with MS are provided with a full and informed choice of both licensed medicines and those approved by NICE. Reliable and independent information about MS medicines If you are thinking about your treatment options, the resources below might be helpful. They are a useful starting point before you discuss things in depth with your neurologist or MS specialist nurse. 1. Get informed Read the MS Society s information booklet on Disease modifying drugs. The MS Society also produces a number of information booklets on managing MS symptoms, such as muscle spasms and stiffness, and bladder problems. 2. Keep up to date New medicines are being developed all the time - make sure you are aware of the latest approved MS treatments as well as those in the pipeline. This includes both disease modifying treatments and those to manage symptoms. The MS Society website is regularly updated with details of these new medicines. 3. Weigh up the pros and cons To make an informed choice, you need to compare the risks and benefits of different treatment options. These resources should help you to identify a range of MS medicines, including the pros and cons of each, and to understand the choice of treatments potentially available to you when talking to your consultant neurologist or MS specialist nurse. 5

6 MS medicines approved for use Before a medicine is approved for use, it goes through a long process which can take a number of years. Clinical trials after initial toxicology and pharmaceutical studies the medicine is tested in patients for efficacy, to prove that it works and for safety. Technical approval - the evidence from clinical trials is assessed by the Medicines and Healthcare products Regulatory Agency who work with the European Medicines Agency. The agencies look at all the scientific data relating to the safety, efficacy and quality of each new medicine. Licensed after their assessment the agencies grant a Product Licence or Marketing Authorisation which provides information for doctors and for the patient leaflet. This sets out the particular diseases or conditions approved for the product s use, how to use it, the dosage, the side effects, and important safety information. Approved for prescription the National Institute for Health and Care Excellence (NICE) and the DHSSPS has to approve treatments before they can be widely prescribed in Northern Ireland. NICE takes into account the cost as well as how well the medicine appears to work. 6

7 The three types of MS medicines Currently, the status of licensed medicines for MS falls into three main categories: those approved by NICE and the DHSSPS, those under the MS Risk Sharing Scheme and those without NICE approval. The medicines that come into these three categories are: 1 - Approved by NICE and the DHSSPS for prescription Tysabri (natalizumab) Gilenya (fingolimod) Aubagio (teriflunomide) However even within these categories each medicine will have its own specific eligibility criteria that you have to meet. Each category is discussed separately in the following parts. This guide does not cover medicines which are still undergoing clinical trials and have yet to be licensed for MS. Tecfidera (dimethyl fumarate) and Lemtrada (alemtuzumab) are two newly licensed medicines for MS. They are both currently undergoing NICE technology appraisals, and this guide will be updated to reflect their outcomes. Aubagio was approved in February 2014 and is expected to be fully available later in Prescribed under a special DHSSPS MS Risk Sharing Scheme Copaxone (glatiramer acetate) Avonex (interferon-beta 1a) Rebif (interferon-beta 1a) Betaferon (interferon-beta 1b) Extavia (interferon-beta 1b) is not listed in the Risk Sharing Scheme, but can be prescribed in a similar way. 3 - Licensed medicines for MS without NICE approval Sativex (delta-9-tetrahydrocannabinol and cannabidiol) Fampyra (fampridine-sr) Botox (botulinum toxin) 7

8 Part 1: Access to MS medicines approved by NICE and the DHSSPS What does NICE do? In England the National Institute for Health and Care Excellence (NICE) decides which medicines should be provided by the NHS. NICE makes these decisions based on how much the medicine will benefit patients in relation to how much it costs. If NICE decides the medicine does provide value for money and they will issue guidance called a technology appraisal. This guidance does not automatically apply in Northern Ireland. The applicability of all NICE guidance in Northern Ireland is subject to a review carried out by the DHSSPS. This review only takes into account the legal, policy and financial implications to Northern Ireland and does not attempt to reassess the clinical and cost effectiveness of the treatment. The DHSSPS reviews NICE technology appraisals within 4 weeks of final publication. As soon as the DHSSPS review is complete, endorsement decisions will be published on the Department s website under 3 categories: NICE guidance endorsed as applicable to NI; NICE guidance endorsed, or partially endorsed, as applicable to NI, including caveats (for example, to set out the equivalent NI legislation or additional local advice); NICE guidance not endorsed as applicable to NI Once the DHSSPS endorse a NICE technology appraisal, the Health and Social Care Board (HSCB) will be asked to prepare a commissioning plan for the implementation of this guidance, which the DHSSPS will need to approve. Upon approval the HSCB will issue a NICE guidance circular to local Health and Social Care Trusts (HSCT), who will be legally obliged to follow this guidance. Until a licensed MS medicine is approved by NICE and endorsed by the DHSSPS, its availability depends on local HSC organisation policies or individual patients successful requests for exceptional treatment (see page 19). Know your rights It helps to know what you are entitled to and the policies which support these rights. Once a medicine is approved local HSCTs in Northern Ireland have three months to implement the guidance. After that, patients are legally entitled to be prescribed the treatment so long as they meet the eligibility criteria. These criteria are set out in the product s technology appraisal. 8

9 The following policy sets out your rights to access NICE-approved medicines in more detail: Funding Regulations Section 7(6) of the NICE (constitutions and functions) and the HSCIC (functions) Regulations 2013 require clinical commissioning groups, NHS England and local authorities to comply with NICE technology appraisals within 3 months. Legally, the HSCB are responsible for taking whatever steps are necessary to ensure the uptake of recommendations. Prescribing NICEapproved MS medicines to those who are eligible is therefore mandatory. In 2006 the DHSSPS established a formal link with NICE. This was to ensure that the DHSSPS had independent and evidence-based information on healthcare interventions. This arrangement is set out in the Health Service Circular, which is available to read on the DHSSPS website. Getting access: know your facts As well as knowing your rights, it is important to know the facts about eligibility. How can you find out if you are likely to be eligible? Where can you go for an assessment? You will need to speak about it with your doctor i.e. your GP or neurologist. Members of your local MS Society branch may be able to help by sharing their knowledge of your local HSCT with you. Getting an assessment If you have MS and are exploring treatment options, you will need to ask for a referral to your nearest MS specialist centre to be assessed. You can ask for a referral from your GP to a consultant neurologist at one of the MS specialist centres. Make sure you know which MS specialist centre is your local centre and your GP should be able to help book a referral during your appointment. NICE guidance: technology appraisals HSC trusts are legally obliged to fund and resource medicines and treatments recommended by NICE and endorsed by the DHSSPS. All published technology appraisals for MS are publicly available and can be read on the NICE website. Checking eligibility For every medicine approved by NICE, there is a guidance document for you and a more technical version for health care professionals. Both set out the eligibility criteria for the treatment. It is worth checking this guidance before your appointment with a consultant neurologist, particularly noting the criteria you may need to meet to be considered eligible for treatment. NICE guidance can be a good prompt for questions during the consultation. You might want to ask the neurologist to clarify parts of the guidance, if you are unsure how they apply to you. Once you have had an assessment at an MS specialist centre, your consultant neurologist will tell you if they feel you are eligible for treatment. 9

10 Challenging a decision If you are not satisfied with your neurologist s decision and the reasons for this decision, you are entitled to a second opinion. You can request a second opinion through your GP, who can refer you to a consultant neurologist of your choice. To help you choose: - ask your GP s advice - approach members of your local MS Society branch, who might have valuable experience - search on the MS Society s list of specialist centres to identify a neurologist (see above) - use the Dr Foster website: Simply select neurology under speciality, type in your postcode and then hit find. Once you have chosen, your GP will write to your selected neurologist and request a second opinion on your behalf. How to get loud If you have been assessed as eligible for a NICE approved MS medicine but you can not actually get a prescription for the treatment you can challenge this by following the MS Society s 7-step plan on how to get loud. Remember that others have done this before and succeeded, so do not lose hope if a local resolution does not work. Step 1: Seek support If you have a problem accessing an MS medicine, the chances are it is also an issue for other MS patients in your area. Your local MS Society branch or support local staff team might know of people with the same problem in your area. Talk to your consultant or MS nurse about helping you and ask about any local issues. It is important to identify the particular reasons why the medicine is not available in your area, so that you can address these directly. Officers from the Patient and Client Council (PCC) are able to offer confidential advice, support and information on health-related matters to patients, their families and carers. They have local offices throughout Northern Ireland and you can also contact them on their free phone or via . 10

11 Step 2: Make a formal complaint but ensure you follow local procedures. Ask your local trust for a copy of its complaints procedure each Health and Social Care Trust has its own. Remember, usually a complaint must be made within 12 months of the event you are complaining about occurring. Often, a complaint is written as a letter to the Chief Executive of the HSCT. You can find a template letter and further guidance for writing to your HSCT on page 24 (Letter template A) Step 3: Seek local resolution Ask your HSCT to meet with you to help resolve your complaint. If they will not do this, and do not address your concerns in writing to your satisfaction, then it is time to involve your local MP/MLA and to start considering briefing the local press. Some handy tips: 1. Keep your complaint succinct only explain what is necessary. 2. You may find it helpful to detail events chronologically this might help with the structure of your complaint. 3. Attach any supporting evidence such as letters, s and any relevant notes to the end of the form. Step 4: Involve your local Member of Parliament (MP) and your Member of Local Assembly (MLA) MPs and MLAs can put pressure on the trust and on government ministers regarding your situation. With your permission, they can help promote your case in the media and raise it in the House of Commons or in the Assembly. More importantly, they might act on your behalf and speak directly to the trust about your case. Find your local MP by entering your postcode on the parliament website or call the House of Commons Information Office on You can find your local MLA by entering your postcode on the MLA website. Copy your MP or MLA into the complaint letter you send to the trust. In your cover letter, make sure you include the following details: Who you are and where you live (so that they can verify you are a constituent) Contact details A brief outline of your case and your efforts to gain access to MS medicines Copies of key documents from the trust or clinician What you would like your MP/MLA to do for you this could include asking your MP to act on your behalf There is a template for this kind of letter on page 26 (template letter B ) 11

12 Many MPs/MLAs hold surgery sessions where constituents can raise their particular local issues. There is no substitute for a face-to-face meeting with an MP/MLA no matter how brief. So if you can arrange a time to meet them, it is worth doing. Remember to keep in touch with your MP/MLA and let them know if your situation changes. Visiting your MP/MLA during a constituency surgery is really easy to do but if you find the experience of visiting your MP/ MLA in person daunting the MS Society has produced a guide on paying your MP a visit. By telling your story in the local media, you will be helping to shine the light on a situation that may well be affecting many other people. You are then in a stronger position to help change things for the better. Step 5: Sharing your story with the media Involving the media in your campaign to access MS medicines can be a good way to create greater awareness of the issue and put pressure on HSCTs, but the media spotlight might not be for everyone. Journalists will want to know your full name, age, where you live and specific details about your MS so it is important to consider this before going down this route. If you feel you may want to share your story with the media, you should consider the following guidance: Telling your story in the media should be a last resort in your campaign; your story will be stronger if you have already taken all reasonable steps to raise the issue with your medical professionals and the HSCT. Going to the media too soon may be counter-productive, but if you have taken these steps and have still been frustrated in your efforts to access an MS medicine, then approaching the media may be appropriate and can be very powerful At the MS Society, we always need strong examples of injustice to strengthen our campaigning, so we would be happy to speak to you about your story before you contact the media. In the first instance, you should contact MS Society Northern Ireland, and if appropriate, they may put you in touch with our Press Office. It may be that your story highlights a wider issue, and our Press Office may be able to support you in speaking to the media on this basis. If you decide to contact the media directly, you should think through the key points of your story before you make contact. It is usually helpful to think about the five Ws: what, when, who, where and why. It is not necessary to attempt to write a press release ; a short summarising your case should suffice, perhaps followed up by a phone call to the newsdesk of the newspaper or radio station you want to approach. Ensure you give them your full contact details so that they can call you back. Before you speak to any journalists it is a good idea to be prepared: write down what it is you want to say, the message you want to get across and stick to the main points. 12

13 It may be helpful to involve your local MP or MLA. They can help generate interest in a story and support your case in the media. Our press team is extremely skilled and experienced in dealing with the media and may be able to offer further information or advice. You can contact them by ing pressoffice@mssociety.org.uk Step 6: Take it to the next level the Ombudsman If you have sought local resolution, and got your local MP/MLA and press on board, and still no progress is being made, it is time to take things to the next level the Northern Ireland Ombudsman. Making a complaint to the Ombudsman Details of the procedure and a complaints form are available on the Ombudsman website. If you do not have access to a computer, call for further information and a hard copy of the form. A carer or relative can make the complaint to the Ombudsman on your behalf. The Ombudsman is independent of the health service and the DHSSPS. The Ombudsman has a duty to investigate further if you can show that the HSCT has not acted properly or fairly (or has not provided a good service). To get the Ombudsman to take your case on, you must have: already submitted a complaint to your local trust gone through all the appeals and local resolution opportunities the trust provides Then, you need to complete a short form. This will ask: For information on the original complaint and why you are unhappy. How you have been affected and what you would like to happen. Do not forget to attach any supporting evidence. This includes letters, s, records of meetings, and notes you have made about the situation. The Ombudsman does not have to investigate every complaint. You will need to make it clear how your complaint fits with the scope of the Ombudsman s duties. The Northern Ireland Ombudsman can investigate if: there is evidence of administration fault or service failure AND there has been injustice or hardship caused as a result If you can show how your case meets these criteria, the Ombudsman may investigate the case with the HSCT. Alternatively, it might intervene before investigating if it is considered that the evidence is so clear that the Ombudsman can seek resolution directly. 13

14 The Ombudsman is committed to keeping you informed at every stage. So call their help line ( ) if at any time you are not clear about progress in your case. Step 7: Seek judicial review A judicial review is a type of court proceeding. A judge reviews the decision or action made by a public body, in this case a primary care trust, and decides if it was lawful. A judicial review challenges the way in which a decision has been made, rather than the rights and wrongs of the conclusion reached. You can only challenge a decision in this way if it was: illegal the procedure was unfair the decision was so unreasonable that no reasonable public body could have taken it What happens if NICE reject a medicine licensed for MS? If an MS medicine does not receive NICE approval, it will not be automatically and widely available in the health service. It will only be possible for people with MS to access a treatment with a no decision from NICE if a clinician believes that the medicine would be effective and if the HSCT is willing to pay for the medicine through an individual funding request. The exceptions to this are those medicines for MS prescribed under the special MS Risk Sharing Scheme. The Health Service Circular on the process for endorsement, implementation, monitoring and assurance of NICE technology appraisals states: Where a patient has been receiving treatment with a drug which NICE has appraised and not recommended, the patient should have the option of continuing their therapy until they and their clinicians consider it appropriate to stop. Clinical judgement will continue to have precedence for individual patients to allow for people with complex underlying conditions. The likelihood of a HSCT granting access to a medicine that NICE has decided is not costeffective is seriously reduced unless individual circumstances prove to be exceptional. 14

15 Accessing NICE-approved medicines for MS Patient has conversation with consultant neurologist and is presented with a range of treatment options. Patient is assessed to determine whether they meet the eligibility criteria for the MS medicine as set out by NICE. Neurologist confirms eligibility Yes No Patient referred for treatment Patient requests second opinion via GP Treatment available locally Second opinion and assessment take place Yes No Yes No Talk to the MS Society Northern Ireland office Patient not eligible Get loud! If local resolution and letters do not work then the last resort is to apply public pressure. You can raise awareness through the local media, which may help to apply pressure on your trust. Your MP/ MLA can also act on your behalf. Write a formal complaint to the CEO of the Trust remind them of their statutory duty. Copy in your MP/MLA. Arrange a meeting with the Trust and local MS Society staff to seek local resolution. Complain to the Northern Ireland Ombudsman. If you do not receive a satisfactory answer at each level and observe no action, move to the next step in the 7-step plan on how to get loud. 15

16 Inspiration from others Penny and Ruth (Wakefield) How the campaign started Penny and Ruth run a support group for younger people with MS in Wakefield called the Pins and Needles Group. They heard from the MS Society that a treatment called Tysabri had been approved by NICE for people with highly active relapsing remitting MS. They wanted to know why the treatment was not available in their local hospital (part of the Mid Yorkshire Hospitals NHS Trust) so, in December 2007, they wrote a letter to their Patient Advice and Liaison Service. The trust wrote back to say that they were not licensed to use Tysabri and that a business case would need to be built which would take time. What happened next? Penny and Ruth submitted a formal complaint to the trust and wrote to remind the trust of its legal obligations to provide the treatment: Tysabri was approved by NICE in August Hospitals are legally obliged to provide the treatment to eligible patients within three months of approval. Unfortunately, this did not resolve the situation, so Penny and Ruth got loud. They went public with their story and appeared live on Look North, Ridings FM, Radio 5 Live and in the local newspapers including the front page of the Yorkshire Evening Post. And as a result... The formal complaint and media attention resulted in a meeting with the hospital in August A whole year since Tysabri was approved had passed and it was still not clear that the hospital was implementing the NICE guidelines. So the MS Society requested an independent investigation from the Healthcare Commission (the regulatory body in Northern Ireland is known as the the Regulation, Quality, Improvement Authority Success! In November 2008, Penny and Ruth were both offered the treatment and to date many more in the area have gained access. These case studies may be from England but it provides inspiration for those trying to access medicines across the UK. They show how persistence, determination and targeted action can influence the provision for everyone in their area. Getting loud can work! 16

17 Inspiration from others Neil (Kent) How the campaign started Neil (pictured) was told by a consultant neurologist that he was eligible for Tysabri in March However three months later, Neil had still not received any treatment. After three relapses within six months, Neil was concerned that if his MS progressed too far without treatment, he may no longer be eligible for Tysabri. What happened next? When Neil received a letter stating that his trust was having difficulty getting people with MS onto the treatment, Neil decided to write a letter of formal complaint to the Medway NHS Foundation Trust. The letter acted to remind the trust of its legal obligations to provide NICE approved medicines to those patients who are eligible, as set out in the NHS Constitution. In just over 20 working days, a formal apology was sent from the trust s Chief Executive. If you have been successful in accessing MS medicines and would like to inspire others then tell us your story. Your stories are extremely valuable to our campaigning work and show how getting your voice heard can help make a real difference. Success! Medway reviewed its MS services and opened a new Neuroscience wing with a Tysabri infusion clinic in 2011, which Neil has been attending ever since. 17

18 Part 2: Access to medicines on the Risk Sharing Scheme In 2002, NICE did not recommend Avonex, Betaferon, Rebif and Copaxone for use in the health service. NICE had concluded that these disease modifying treatments (DMTs) would not represent a cost-effective use of resources under the arrangements for purchasing medicines that existed then. The MS Society, together with many people affected by MS, campaigned for this decision to be reversed. Instead, the DHSSPS and Department of Health ruled that the four disease modifying treatments DMTs for relapsing remitting MS should be prescribed under an arrangement known as the MS Risk Sharing Scheme. This arrangement between the DHSSPS and the manufacturers ensured that the medicines would be provided on the basis that certain clinical outcomes would be met. The cost to the health service would be adjusted on a sliding scale if outcomes differed from those agreed. The medicines Avonex, Betaferon, Rebif and Copaxone were made available on prescription according to the Association of British Neurologists (ABN) prescribing guidelines, which have since been revised. The ABN guideline continues to apply across the UK. The guidelines represent a consensus of medical opinion among consultant neurologists about when people with MS should begin treatment. Similarly, they also describe when a person with MS should end treatment. Accessing MS medicines under the MS Risk Sharing scheme These four medicines can be prescribed by a neurologist at most of the MS specialist centres across the UK. You can find where your nearest centre is on the MS Society s website. If you have relapsing remitting MS but have not been offered a referral to a specialist centre, speak to your neurologist about a referral and assessment. Remember, your suitability for these treatments should be assessed and discussed alongside other treatment options. Know your rights A funding directive was issued by the DHSSPS. This says that people with MS who meet the prescribing guidelines as set out by the ABN, should receive the treatment. This funding directive (known formally as the Health Service Circular) still applies. No one with MS who fits the criteria as set out by the ABN should be denied access to these treatments. If this is happening to you please do not hesitate to let the MS Society Northern Ireland team know about it - nireception@mssociety.org.uk or The Health Service Circular (2002) is a policy document covering England, Wales, Scotland and Northern Ireland. It provides a legal assurance that: All patients with relapsing remitting MS, and those with secondary progressive MS where relapses are the dominant clinical feature, who meet the criteria developed by the ABN are eligible for treatment under the scheme. 18

19 Part 3: Access to licensed MS medicines without NICE approval There are some medicines that are licensed for MS but have not yet either been approved by NICE or considered by NICE for prescription. Without NICE approval, HSCTs are under no legal obligation to prescribe the medicine. Instead, trusts make the decision themselves, at a local level. Requests for these medicines go through a process involving an individual funding request considered by a panel, who decides if your case should be treated as an exception. At the moment, there are three medicines that falls into this category Sativex, and Fampyra and Botox but other medicines are in the pipeline. Getting access: Know the facts Individual funding requests While the HSCT is not legally obliged to provide every treatment that a patient (or a group of patients) may request, you may be able to access a treatment by submitting an individual funding request through your HSCT to the HSCB these are only accepted in exceptional circumstances. Your trust should explain to you how this process works. What is the usual process for individual funding requests? If your neurologist or GP thinks that you would benefit from a particular medicine that has not been approved by NICE, they will need to put in an individual funding request to the HSCB for the treatment on your behalf. You and your neurologist, MS nurse or GP have to show the exceptional circumstances that apply in your case, to convince the local individual funding request panel to approve the treatment for you. Examples of the kind of points that may help to convince the panel are given below: Show how you are likely to gain significantly more benefit from the medicine than might normally be expected for patients with MS. Show that you have tried other medications which have not provided adequate symptom relief or have caused intolerable side effects. Highlight alternative treatment options available are these what you would choose to have? Or are these invasive and associated with considerable costs to the health service? Illustrate lifestyle factors for example, taking a particular medicine might allow you to be more independent, and lessen the need for a high level of care provision for certain daily tasks. This is just one example; many other factors could be taken into account. Show in the request why you and your health care professional think the medicine will be effective for you and how it will improve your quality of life to a greater extent than for the general population of people with MS. 19

20 This is particularly important when it is recognised that a treatment is not effective for everyone. Funding requests are not accepted directly from patients. Who considers the funding request? Your request for individual funding will be forwarded by your local HSCT to the HSCB for consideration. The Board has a panel who meet once a week to discuss such requests. Once the panel has considered the request, a letter will usually be sent to your HSCT informing them of the: the panel s decision their reasons for making this decision Your GP or neurologist will then let you know whether your application for individual funding has been approved or not. What if your funding request is refused? If your GP or neurologist feels that there are problems with the way the decision has been made, they may appeal by writing to the HSCB appeal panel. Appeals are not accepted directly from patients. Appealing the decision Your GP or neurologist can appeal the refusal decision if: there is additional and new information OR there is evidence that that the process has not been handled appropriately If you are thinking about appealing stay positive and persevere. Good luck and do not give up! Here are some pointers to help you through the appeals process: Talk to your consultant or MS nurse about any local issues. It is important to identify the particular reasons why treatment is not available in your area, so that you can address these directly. Make sure you know how the HSCB appeals process works. Details of the process should be available on request from the HSCB. There will be a time limit for appealing. After this, the HSCB might not consider an appeal. Make sure that the decision is appealed within the specified number of days after you have been informed of the panel s refusal otherwise the HSCB has the right not to consider your appeal. The appeal panel will usually be a group of people who had no involvement in your original request for the medicine. Your HSCT should receive a letter shortly after the appeal, telling them: the panel s decision a clear explanation of how it reached its decision After an appeal: Getting loud if refused Local trusts are not under the same obligation to fund prescriptions as for a NICE-approved medicine. However there are still ways you can challenge the HSCB s decision if the answer is still no after the appeal. If you still feel that you have a strong case, then it is time to get loud. 20

21 Firstly, try to resolve it locally by making a formal complaint to the HSCB. If this does not work you may consider approaching local press and contacting your MP/MLA. If you feel that your appeal for exceptional treatment has not been handled fairly you can complain to the Northern Ireland Ombudsman. The procedure for this is described in Part 1, steps 1-6 on page 10. Remember, if you are being denied access to an MS medicine share your story with the MS Society. 21

22 Flow diagram for accessing licensed MS medicines without NICE approval Following consultation with Neurologist patient is recommended for treatment with a product that has not been approved by NICE Neurologist submits an Individual Funding Request to the Health and Social Care Trust Individual funding request considered by Health and Social Care Board Refused Granted Neurologist may appeal in writing to the panel Appeal Refused Contact the MS Society Northern Ireland office Appeal Granted Prescription can be issued by Neurologist Get loud! If you have not succeeded even after appeal then the last resort is to apply public pressure. Write to your MP/MLA who can also act on your behalf. You can raise awareness through the local media, helping to apply pressure on the trust If your appeal has been unfairly handled you could complain to the Northern Ireland Ombudsman. 22

23 What is the MS Society doing to improve access to MS medicines? The MS Society is working hard to improve local and national efforts to implement NICE technology appraisals for MS and to improve access to MS medicines across the UK. Access to medicines guide in the future This campaigns guide will be a living document that will be revised and updated regularly to reflect new treatments that may become licensed and or approved by NICE, and to reflect the changes and their implications for people with MS trying to hold their local health authority to account. Often clinical guidelines are used as a benchmark to measure the quality and performance of local services. NICE are due to update the MS clinical guideline by October 2014, which is now 11 years out of date and does not include some of the treatment options discussed in this guide. The MS Society is working hard towards ensuring the forthcoming guideline accurately reflects the significant advancement in MS treatments and care. NICE needs to make MS a priority. It is really important for us to understand whether this guide has helped you to campaign for access to MS medicines. Please help us to understand this by getting in touch with the MS Society Northern Ireland team and let us know what you think of the guide at nireception@ mssociety.org.uk or call If you would like to support our work or find out what local campaigns are happening in your area, then sign up to our campaigns community. 23

24 Template letter A To submit a formal complaint about lack of access to NICE-approved medicines To copy and paste this letter or to download this letter as a word document, please visit: Name of Chief Executive of HSCT Address and postcode Insert date Dear, [insert name of Chief Executive] Formal complaint: Access to [insert name of medicine] Insert your name Your address Post code As a patient with MS and/or as a member of the local MS Society branch, I am extremely concerned that [insert name of medicine], which is approved by the National Institute for Health and Clinical Excellence (NICE) and endorsed by the DHSSPS as a treatment for multiple sclerosis, is not being prescribed by [insert name of Trust]. I would therefore like to register this letter as a formal complaint. [insert name of medicine] is licensed for use in the UK and was approved by NICE in [insert date] for patients with [insert type of MS] MS. As you will be aware, technology appraisals (TAs) from NICE carry a three month implementation period; after this period the Health and Social Care Trust has a legal obligation to fund the approved treatment. The directions enforcing this provision derive from Section 97 of the NHS Act 1977 as amended by the Health Act of The DHSSPS has directed that the HSCT provides funding and resources for medicines and treatments recommended by NICE technology appraisals. I would urge the Trust to review tools developed by NICE to help organisations implement its guidance on [insert name of medicine]. If you have been told you are eligible for the treatment (or know of others who are eligible) and have been refused, state the reasons you have been told/have heard for the refusal e.g. lack of space within the Trust to set up an infusion unit, lack of capacity in terms of nursing staff to run an infusion unit or lack of resources. Use this as an opportunity to state clearly, in a few sentences, your concerns e.g. a lengthy delay could mean that you no longer fulfil the clinical criteria set out by NICE. If you are a branch member and know of others in your area who are being denied treatment; state this here. 24

25 I would appreciate a response detailing why the treatment has not been made available to patients with MS in [insert location] area. In the response, I would like the Trust to outline what actions it will take, how and when to resolve this situation as soon as possible. I hope this issue will be addressed as a matter of urgency. Yours sincerely, [Insert signature and full name] The MS Society recommends that you consider copying your letter to the following key influential people who can help to resolve your case: CC. Name and address of consultant neurologist CC. Name and address of your local MP/MLA Don t forget to send a copy of your letter to the MS Society Northern Ireland team by ing: nireception@mssociety.org.uk or send a hard copy of your letter to: MS Medicines Campaign, MS Society Northern Ireland, 34 Annadale Avenue, Belfast, County Antrim BT7 3JJ 25

26 Template letter B Template for cover letter to your MP/MLA To copy and paste this letter or to download this letter as a word document, please visit: Your name Your address Your Postcode MP s/mla name [Address of MP or MLA] Date Dear [insert name of MP/MLA], [Insert name of medicine] My name is [insert name] and I live [insert constituency and address]. I am writing as a person with multiple sclerosis who has recently been told that [insert name of /trust] will not prescribe me [insert name of medicine], which has been approved by the National Institute for Health and Clinical Excellence and endorsed by the DHSSPS. I have written a formal letter of complaint to the Trust and I include a copy for your reference. briefly describe what the medicine is and for what symptom/condition it has been licensed to treat briefly explain how the new treatment may benefit you and if other treatments have not worked or been appropriate for you briefly explain what steps you have taken so far to gain access to the medicine I am distressed at being denied a licensed treatment by my local trust when the efficacy and safety has been reviewed and approved by the relevant authorities. [If you are aware that the treatment has been made available to other patients in your area or in other areas, then mention this too on the basis that you feel it is potentially unfair to have treatments like this restricted on a regional basis]. In light of this and bearing in mind the problems I face I now seek your support in asking [insert name of trust] to review its decision on the provision of [insert name of medicine]. I would be very grateful if you could raise my concerns with [insert name of chief executive of trust] and I look forward to your response. Yours sincerely, Your name NB It is suggested that you keep this cover letter to just a page Remember to include copies of key documents from your Trust or Clinician 26

27 Useful Sources and Links MS Society Northern Ireland The Resource Centre 34 Annadale Avenue Belfast BT7 3JJ Tel: MS Society National Centre MS National Centre 372 Edgware Road London NW2 6ND Tel: MS Society Scotland National Office Ratho Park 88 Glasgow Road Ratho Station Newbridge EH28 8PP The Multiple Sclerosis Society MS Helpline: The MS Helpline offers emotional support and information to anyone affected by MS in the UK. MS Society documents available on the web can be requested on the MS helpline Freephone Helpline number Helpline service Open weekdays 9am-9pm (closed bank holidays) Tel: Multiple Sclerosis Society Wales/Cymru Temple Court Cathedral Road Cardiff CF11 9HA Tel:

28 MS Society Documents: Disease Modifying Drugs MS Society: MS Essentials 06 (August 2009) MS Society Research on Beta Interferon, Copaxone (glatiramer acetate) and Tysabri (natalizumab) MS Society Information on Licensed Disease Modifying Drugs MS Society Map of MS Centres around the UK MS Society Guide to Paying your MP a Visit Working with the medicines and healthcare industry Information from other organisations National Institute for Health and Care Excellence List of Published NICE Appraisals NICE Guidelines are downloaded on-line or via telephone on: NICE Clinical Guidelines on MS Dr Foster health and medical guides Web-site Northern Ireland Ombudsman Patient and Client Council 28

29 Association of British Neurologists guidelines for prescribing in multiple sclerosis Association of British Neurologists, November Cost effective provision of disease modifying therapies for people with Multiple Sclerosis Health Service Circular 2002/004 Healthservicecirculars/DH_ NICE Technology Appraisals and Clinical Guidelines New Process for Endorsement, Implementation, Monitoring and Assurance in Northern Ireland Health Service Circular 04/11 sqsd 04_11_nice_guidelines 8211 new_process.pdf Department of Health, Social Services and Public Safety Endorsed NICE guidance appraisals.htm 29

30 MS Society 34 Annadale Avenue Belfast County Antrim BT7 3JJ Helpline Multiple Sclerosis Society Registered charity numbers / SC Registered as a limited company in England and Wales