How to campaign for... Access to MS medicines in England 1

Transcription

1 How to campaign for... Access to MS medicines in England 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 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 20 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 25 The MS Society and access to medicines 26 Template letters 30 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 five years represent an exciting period for people affected by MS. More MS treatments are being developed 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 NHS decides what treatments to make available. This guide is intended to make it easier to do just that. So whether you are 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. Simon Gillespie Chief Executive, MS Society 3

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 the NHS to fund prescriptions for a particular MS medicine. This guide contains useful information on how medicines are made available on the NHS, how to navigate local NHS 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. The guide is split into three parts: Part 1 looks at medicines recommended for use on the NHS by the National Institute for Health and Clinical Excellence (NICE) 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 not supported by NICE guidance 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. This guide covers the NHS in England and is for you if: 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 medicines you are entitled to By 2015, the MS Society estimates that the number of medicines available specifically for treatment of MS will have doubled from 7 to 15. 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. This looks at all the disease modifying treatments for MS in more detail. 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. 3. Weigh up the pros and cons To make an informed choice, you need to compare the risks and benefits of different treatment options. MS decisions is a website that can tell you about different disease modifying 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 drug 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 drug 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 NHS prescription the National Institute for Health and Clinical Excellence (NICE) has to approve treatments before they can be widely prescribed on the NHS. 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, 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 for prescription on the NHS Tysabri (natalizumab) Gilenya (fingolimod) 2 - Prescribed under a special Department of Health MS Risk Sharing Scheme. Copaxone (glatiramer acetate) Avonex (interferon-beta 1a) Rebif (interferon-beta 1a) Betaferon (interferon-beta 1b) Other beta-inteferon medicines are now also licensed and are not specifically listed in the scheme (Extavia). These can be prescribed in a similar way as those medicines in the MS Risk Sharing 3 - Licensed medicines for MS without NICE approval Sativex (delta-9-tetrahydrocannabinol and cannabidiol) Fampyra (fampridine-sr) Botox (botulinum toxin) 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. 7

8 Part 1: Access to MS medicines approved by NICE What does NICE do? In England and Wales the National Institute for Health and Clinical 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 it is approved for use on the NHS and they will issue guidance called a technology appraisal, which the NHS is obliged to follow. Until a licensed MS medicine is approved by NICE, its availability depends on local NHS policies or individual patients successful requests for exceptional treatment (see page 20). Know your rights It helps to know what you are entitled to and the policies which support these rights. Once a medicine is approved, the NHS across England and Wales has 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. The following policies set out your rights to access NICE approved medicines in more detail: 1. Department of Health funding directive Each technology appraisal is supported by a funding directive from the Secretary of State for Health. This is derived from Section 97 of the NHS Act 1977 as amended by the Health Act of Legally, NHS bodies are responsible for taking whatever steps are necessary to ensure the uptake of recommendations. Prescribing NICEapproved MS medicines to patients who are eligible is therefore mandatory. 2. NICE Compliance Regime The legal requirement for NHS bodies to prescribe NICE-approved medicines within three months of a technology appraisal has not always been followed through by all NHS bodies. This has led to the inconsistent application of NICE technology appraisals in which not all NICE-approved medicines are included in local NHS formularies. This has had a significant impact on patient access to medicines. 8

9 The introduction of the NICE Compliance Regime, outlined in the NHS report, Innovation, Health and Wealth seeks to reinforce the Department of Health s funding directive. It will ensure technology appraisals are quickly implemented throughout the NHS and automatically incorporated into local NHS formularies, without further local evaluation or modification of NICE appraisals. This is to ensure there are no local barriers to accessing clinically and cost-effective medicines recommended by NICE. A local NHS formulary is essentially a list of first and second choice preferred medicines approved for prescription by each NHS body, within their locality. Local NHS bodies base their formulary on medicines which have been proven as clinically effective, safe and cost-effective. This should include all those medicines issued with a NICE technology appraisal. 3. NHS Constitution The NHS Constitution states that patients have the right to medicines and treatments that have been recommended by NICE, if your doctor says they are clinically appropriate for you. So if a neurologist assesses you as eligible for an MS medicine, you can use the NHS Constitution to support your legal entitlement: to access that medicine to ensure your local NHS body puts in place support services that are needed (such as infusion units, or specialist nurses) 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 NHS 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. There are over 80 MS specialist centres across the UK. You can ask for a referral from your GP to a consultant neurologist at one of the MS specialist centres through the Choose and Book service. This national online service lets you and your GP choose the place, date and time for your referral. 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. 9

10 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. NICE guidance: technology appraisals The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE. All published technology appraisals for MS are publicly available and can be read on the NICE website. 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. 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. 10

11 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 people with MS in your area. Your local MS Society branch or support 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. Step 2: Make a formal complaint but ensure you follow local procedures Ask your hospital or trust for a copy of its complaints procedure each Primary Care Trust has its own. Remember, usually a complaint must be made within 12 months of the event you are complaining about occurring. Where is there official support on hand? Officers from the Patient Advice and Liaisons Service (PALS) are available in all hospitals. They offer confidential advice, support and information on health-related matters to patients, their families and carers. The Independent Complaints Advocacy Service (ICAS) is also a good alternative. ICAS supports people to make complaints about their NHS care or treatment. They might also help if you take your complaint to the Ombudsman (see step 6). ICAS can also be contacted through PALS. Often, a complaint is written as a letter to the Chief Executive of the trust. To make quite sure it gets logged as an official complaint copy your letter into the complaint form used by the trust. You can find a template letter and further guidance for writing to your trust on page 26 (Letter template A) A step-by-step guide on how to complain can be found on the NHS Choices website or, alternatively, more information can also be found on the Patient s Association website. 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. 11

12 Step 3: Seek local resolution Ask your primary care trust 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 and to start considering briefing the local press. Step 4: Involve your local Member of Parliament (MP) MPs 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. 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 Copy your MP 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 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 29 (template letter C) Many MPs hold surgery sessions where constituents can raise their particular local issues. There is no substitute for a face-to-face meeting with an MP 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 and let them know if your situation changes. Visiting your MP during a constituency surgery is really easy to do but if you find the experience of visiting your MP 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: Share 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 PCTs, 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: 12

13 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 PCT. Going to the media too soon may be counterproductive, 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 the Policy and Campaigns team, 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. It may be helpful to involve your local MP. 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 and press on board, and still no progress is being made, it is time to take things to the next level the Parliamentary and Health Service Ombudsman. A carer or relative can make the complaint to the Ombudsman on your behalf. The Ombudsman is independent of the NHS and government. The Ombudsman has a duty to investigate further if you can show that the NHS has not acted properly or fairly (or has not provided a good service). To get the Ombudsman to take up your case, 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: 13

14 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 Parliamentary and Health Service 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 NHS. Alternatively, it might intervene before investigating if it is considered that the evidence is so clear that the Ombudsman can seek resolution directly. 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. 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. 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? NICE decide whether medicines are cost effective for the NHS to prescribe. If an MS treatment does not receive NICE approval, it will not be automatically and widely available on the NHS. 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 drug would be effective and if the PCT is willing to pay for the treatment through an individual funding request. The exceptions to this are those medicines for MS prescribed under the special Department of Health MS Risk Sharing Scheme. The likelihood of a PCT granting access to a medicine that NICE has decided is not costeffective is seriously reduced unless individual circumstances prove to be exceptional. 14

15 Flow diagram for NICE-approved medicines 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 local SDO/branch 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 can also act on your behalf and help apply pressure on the trust. Register formal complaint with PALS, CEO of the Trust remind them of their statutory duty. Copy in your MP and to campaigns team. Arrange a meeting with the Trust and your local service development officer to seek local resolution. Complain to the Parliamentary and Health Services 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? The MS Society 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. Penny and Ruth submitted a formal complaint. 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 They were clearly paying attention to the issue. But this was now a whole year since Tysabri was approved, 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 at the time for the NHS, which has now been replaced by the Care Quality Commission). Success! In November 2008, Penny and Ruth were both offered the treatment and to date many more in the area have gained access. The Care Quality Commission (the main regulator for health and social care in England) has now replaced the Healthcare Commission. However you can no longer seek an independent review from them as Penny and Ruth did. However you can now refer similar cases to the Parliamentary and Health Service Ombudsman, who has taken over this responsibility from the Care Quality Commission (see step 6 on page 13). 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 MS Risk Sharing Scheme In 2002, NICE did not recommend Avonex, Betaferon, Rebif and Copaxone for use on the NHS. NICE had concluded that these disease modifying treatments (DMTs) would not represent a cost-effective use of NHS 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 Department of Health ruled that the four s DMTs for relapsing remitting MS should be prescribed on the NHS under an arrangement known as the MS Risk Sharing scheme. This arrangement between the Department of Health and the manufacturers ensured that the medicines would be provided on the basis that certain clinical outcomes would be met. The cost to the NHS would be adjusted on a sliding scale if outcomes differed from those agreed. 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. 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. 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. 18

19 Know your rights Every Chief Executive of NHS bodies across the UK received a Department of Health funding directive. This says that people with MS who meet the prescribing guidelines as set out by the ABN, should receive the treatment. In 2011 the Department of Health wrote to NHS bodies to remind them of their legal obligation to the MS Risk Sharing Scheme. 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 s Policy and Campaigns team know about it - campaigns@mssociety. org.uk or It is worth noting that in 2010, the MS Society publicly withdrew its support for the scheme. This should not affect access to the treatments supported by the scheme. 19

20 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 NHS-wide prescription. Without NICE approval, local primary care trusts (PCTs) 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, which decides if your case should be treated as an exception. At the moment, there are three medicines that falls into this category Sativex, Fampyra and Botox but other medicines are in the pipeline. Know your rights Compared to NICE-approved medicines, there are fewer policies that support your entitlement to licensed MS medicines that have not been approved by NICE. However, you can still make a case for your individual access to these treatments. NHS Constitution Under the NHS Constitution, patients have the right to expect that local funding decisions on medicines and treatments not approved by NICE should be made rationally, following a proper consideration of the evidence. If the local NHS decides not to fund a medicine or treatment you and your doctor feel would be right for you, they must explain that decision to you. Getting access: Know the facts Individual funding requests While the PCT is not legally obliged to provide every treatment that a patient (or a group of patients) may request, there will be procedures for individual funding requests in exceptional circumstances. There is no one definition of what an exceptional circumstance is. It is up to individual PCTs to set out a clear policy of their approach to individual funding requests and what constitutes exceptionality. The trust should explain to you how this system works, since procedures often vary locally. The NHS Confederation has produced an information booklet called Priority setting: managing individual funding requests. This explains how trusts should approach Individual funding requests and how exceptional might be defined. The document sets out best practice for procedures. This includes the requirement for trusts to make available two leaflets to explain the individual funding request process and exceptionality, one for clinicians and one for patients. 20

21 It is important to obtain copies of the leaflet from your local PCT, since the details of procedures are locally defined. The NHS Confederation has also produced a useful factsheet called Primary care trusts: an introduction, which describes the role and responsibilities of PCTs in general. 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 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 NHS? 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. This is particularly important when it is recognised that a treatment is not effective for everyone. Funding requests are not accepted directly from patients, but it may be possible for you to write to the panel in support of your case, showing how any of the points above are relevant to you. Who considers the funding request? Your request for NHS funding will usually be considered by a panel, the name of which will depend on the local procedures that are in place. For example, Harrow PCT processes requests through what is called the Individual Treatment Panel. In Derbyshire this is referred to as the Non Contract Treatment Panel. Trusts also usually have a screening process which is intended to weed out cases that are clearly not approvable or need to be considered specially (e.g. if they raise important policy issues). If this applies the trust will send out a standard letter. 21

22 Once the panel has considered the request, a letter will usually be sent to you and your doctor, containing: the panel s decision their reasons for making this decision 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 local individual funding request appeal panel. Appeals are not accepted directly from patients. However, patients can be invited to write to the panel in support of their case. There is a template for this kind of letter on page 28 (Letter Template B). Make sure you know how your PCT s appeals process works. This will vary depending on where you live. Details of the process should be available on request from the PCT the person who sent you the refusal letter should be able to help with this. The process might also be available from the PCT s website. There will be a time limit for appealing. After this, the PCT might not consider an appeal. Make sure that the decision is appealed within the specified number of days after receipt of the refusal letter otherwise the PCT has the right not to consider your appeal. The time limit should be stated clearly in the refusal letter. If no time limit is specified, it is still a good idea to check this with your PCT. 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. If you decide to write directly to the panel in support of your case, make sure you include as much information as possible about why you think the medicine concerned will be beneficial for you. You might be invited to speak to the panel to support your written statement. This can sometimes strengthen your appeal, so take the opportunity if you can. But you should not feel under any pressure to appear before the panel if you think this might cause you additional stress or anxiety. The panel might allow someone else to make the presentation on your behalf. PCTs vary in how often their appeals panels meet. For example, some meet every month, some every three months. 22

23 The appeal panel will usually be a group of people who had no involvement in your original request for the medicine. You should receive a letter shortly after the appeal, telling you: 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 your PCT 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. Firstly, try to resolve it locally by making a formal complaint to your local trust. If this does not work you may consider approaching local press and contacting your MP. If you feel that your appeal for exceptional treatment has not been handled fairly you can complain to the Parliamentary and Health Service Ombudsman. The procedure for this is described in Part 1, steps 1-6 on page 12. The MS Society s Access to Sativex a campaigns guide includes a template letter for writing to your MP as an example. Remember, if you are being denied access to an MS medicine share your story with the MS Society. 23

24 Flow diagram for accessing licensed MS medicines without NICE approval Following consultation with GP and/or Neurologist patient is recommended for treatment with a product that has not been approved by NICE Neurologist or GP submits an Individual Funding Request to the local Primary Care Trust (PCT) Individual funding request considered by local panel Refused Granted GP or Neurologist may appeal in writing to the Panel Consider if you want to write directly in support of your case Appeal Refused Appeal Granted Prescription can be issued by GP or Neurologist Get loud! If you have not succeeded even after appeal then the last resort is to apply public pressure. Write to your MP who can also act on your behalf. You can raise awareness through the local media, which may help to apply pressure on your trust. If your appeal has been unfairly handled you could complain to the Parliamentary and Health Service Ombudsman. 24

25 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 in the future The coalition government plans radical reform of the NHS. This includes changes to how services are managed, and how medicines are valued to improve patient access to effective and innovative medicines. This campaigns guide will therefore 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 have now made a commitment to update the MS clinical guideline by 2014, which is now eight 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 Policy and Campaigns team and letting us know what you think of the guide at campaigns@ 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 network. 25

26 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 PCT Address and postcode Insert your name Your address Post code Insert date Dear, [insert name of Chief Executive] Formal complaint: Access to [insert name of medicine] 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) 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 Primary 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 Secretary of State has directed that the NHS provides funding and resources for medicines and treatments recommended by NICE technology appraisals. This is reinforced by the NICE Compliance Regime which requires NICE technology appraisals to be automatically incorporated into local NHS formularies. This is further supported by the NHS Constitution which states that patients have the right to access NICE approved medicines on the NHS where a doctor believes it to be clinically appropriate. I would urge the Trust to review tools developed by NICE to help organisations implement its guidance on [insert name of medicine]. 26

27 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. 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 CC. Name and address of your PALS manager To make absolutely sure that your letter is logged as an official complaint, copy and paste your letter into an official PALS complaints form to ensure your letter is registered under the NHS formal complaints procedure. The form should be available on each PALS website to find your local PALS, enter your postcode here: Don t forget to send a copy of your letter to the policy and campaigns team by ing: campaigns@mssociety.org.uk or send a hard copy of your letter to: MS Medicines Campaign, Policy and Campaigns, MS National Centre, 372 Edgware Road, Cricklewood, London, NW2 6ND. 27

28 Template letter B To submit a letter in support of an Individual Funding Request To copy and paste this letter or to download this letter as a word document, please visit: Chair [title of local panel] Address and postcode Insert date Insert your name Your address Post code Dear, [insert name of Panel Chair] Letter in support of individual funding request for access to [insert name of drug] As a patient with multiple sclerosis I have been advised by my [neurologist/gp] that [insert name of medicine] should be prescribed for me. My doctor submitted an individual funding request for [insert name of medicine] on the [insert date]. However I have been informed that this request has been refused. I write to you in support of an appeal by my [insert neurologist or GP] against this decision. Demonstrate here how the treatment would be significantly beneficial to you over other available treatments and why your case should be treated as an exception. If you have tried other treatments which have not worked/produced side-effects mention this here. It is important to highlight the wider impact a treatment can have on your life, for example, the treatment may allow you to be more independent and reduce the need for high level care provision. Use this space to write down your concerns e.g. a lengthy delay might mean you progress beyond the point where you would likely benefit or your symptoms might have a major impact on your quality of life. I am distressed at being denied a treatment that has been advised as being suitable for me and I hope the Panel will reconsider their decision to refuse [insert name of medicine] in light of this letter of support. Yours sincerely, [Insert signature and full name] Consider copying your letter to the following key influential people who can help to resolve your case: CC. Name and address of consultant neurologist / GP CC. Name and address of your local MP CC. Name and address of your PALS manager 28

29 Template letter C Template for cover letter to your MP To copy and paste this letter or to download this letter as a word document, please visit: MP s name House of Commons London SW1A 0AA Your name Your address Your Postcode Date Dear [insert name of MP], [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. 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 29