Biosimilar Medicines: A National Prescribing Framework. May 2015

Transcription

1 Biosimilar Medicines: A National Prescribing Framework May 2015

2 Healthcare Improvement Scotland 2015 First published May 2015 Healthcare Improvement Scotland is committed to equality and diversity. We have assessed this framework for likely impact on the nine equality protected characteristics as stated in the Equality Act 2010 and defined by age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, and sexual orientation. A copy of the impact assessment is available upon request from the Healthcare Improvement Scotland Equality and Diversity Advisor. The contents of this document may be copied or reproduced for use within NHSScotland, or for educational, personal or non commercial research purposes only. Commercial organisations must obtain written permission from Healthcare Improvement Scotland before copying or reproducing any part of this document.

3 Contents 1. Introduction 4 2. Biosimilar Medicines: A National Prescribing Framework Should biosimilar medicines be used in NHSScotland? Can patients established on a biological medicine be switched to another biological medicine, for example a biosimilar? Are different approaches to the use of biosimilar medicines required in different clinical specialties? Are there any specific efficacy or safety concerns associated with the use of biosimilar medicines? How should biological medicines, including biosimilar medicines, be monitored? How should biological and biosimilar medicines be prescribed and product details recorded? What information should be provided to patients? 16 Appendix 1 Scottish Medicines Consortium Policy Statement on Biosimilar Medicines 17 Appendix 2 Development of Biosimilar Medicines: A National Prescribing Framework 18 Appendix 3 Membership of expert advisory group 20 Appendix 4 References 23

4 1. Introduction Healthcare Improvement Scotland is supporting clinical engagement with NHS board Area Drug and Therapeutics Committees (ADTCs) to develop collaborative approaches to complex medicine governance issues. This approach aligns with the Healthcare Improvement Scotland Strategic Delivery Plan for Medicines By expenditure, eight of the top 10 drugs used in Europe are biological medicines, many of which will lose patent protection within the next five years and may face competition from biosimilar medicines. The current NHSScotland spend on biological medicines that are expected to be available as biosimilar medicines within the next five years is approximately 100m/annum (Personal communication: NHS National Services Scotland). Biological medicines are medicines that are made by or derived from a biological source, such as a bacterium, yeast or blood. They can consist of relatively simple molecules, such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies. 2 A biosimilar medicine is a biological medicine that is similar to another biological medicine which has already been granted marketing authorisation. The standard approach to licensing of a generic medicine, where the medicine must demonstrate bioequivalence (that is the bioavailability of the generic medicine must not differ significantly when given at the same dosage under similar conditions), is not sufficient for biosimilar medicines. For licensing in the European Union, the manufacturer of the biosimilar medicine must demonstrate that the medicine is: i) similar to the original reference product, and ii) does not have any meaningful differences from the original reference product in terms of quality, safety or efficacy. 2 However, if biosimilarity has been demonstrated for one indication or clinical situation, the licence may be extrapolated to a broader range of indications if appropriate scientific justification is provided. More detailed information on biosimilar medicines can be found in the European Medicines Agency questions and answers on biosimilar medicines (similar biological medicinal products) document - Page 4

5 From May 2015, the Scottish Medicines Consortium (SMC) will no longer routinely assess biosimilar medicines on the basis of a full submission. These products will be considered out of remit where the reference product has been accepted by SMC/Healthcare Improvement Scotland for the same indication(s) and in the same population or was initially licensed and available prior to 31 January Full submissions will continue to be required for indication(s)/populations where the reference product is not recommended by SMC/Healthcare Improvement Scotland. SMC will continue to horizon scan for emerging biosimilar medicines and reserves the right to request a full submission in the event that it is anticipated to have an impact on NHSScotland resources. The Scottish Medicines Consortium Policy Statement on Biosimilar Medicines is included in Appendix 1. Several small molecule biosimilar medicines (including erythropoietin, somatropin and filgrastim) have been licensed for a number of years and are in use in some NHS boards. However in 2013, infliximab, the first of the monoclonal antibodies, was licensed as a biosimilar medicine. Recognising that the availability and clinical use of biosimilar medicines in NHSScotland is growing, the NHSScotland directors of pharmacy requested that Healthcare Improvement Scotland led the development of a national prescribing framework for biosimilar medicines. As a result, Healthcare Improvement Scotland, in collaboration with NHS boards and ADTCs, convened an expert advisory group to develop the prescribing framework to inform clinical decision-making and support the safe, effective and consistent use of biosimilar medicines in NHSScotland. Details of the development process for the prescribing framework are outlined in Appendix 2. Membership of the expert advisory group is outlined in Appendix 3. The prescribing framework contains prescribing principles to: promote the safe introduction of biosimilar medicines promote prescriber confidence encourage a consistent approach across NHSScotland support National Procurement support the review of the Scottish Medicines Consortium policy on biosimilar medicines, and recognise the potential savings that can be achievable within NHSScotland by the use of biosimilar medicines. It should be noted that the prescribing framework complements the existing NHS boards governance processes for the managed introduction of new medicines. The prescribing framework aligns with the ambitions of the NHSScotland Healthcare Quality Strategy 3 which aims to ensure the most appropriate treatments, interventions, support and services will be provided at the right time to everyone who will benefit, and wasteful or harmful variation will be eradicated. The prescribing framework will be reviewed as clinical experience with the use of biosimilar medicines evolves. Page 5

6 2. Biosimilar Medicines: A National Prescribing Framework The aim of the prescribing framework is to inform clinical decision-making and support the safe, effective and consistent use of biosimilar medicines in NHSScotland. The prescribing framework is presented in the format of frequently asked questions which are summarised in Table 1 on page 7. Additional underpinning supportive detail is provided for each of the frequently asked questions. Page 6

7 Table 1: Summary of the frequently asked questions Frequently asked question 2.1 Should biosimilar medicines be used in NHSScotland? 2.2 Can patients established on a biological medicine be switched to another biological medicine, for example a biosimilar? 2.3 Are different approaches to the use of biosimilar medicines required in different clinical specialties? 2.4 Are there any specific efficacy or safety concerns associated with the use of biosimilar medicines? 2.5 How should biological medicines, including biosimilar medicines, be monitored? NHSScotland advice NHSScotland is supportive of the use of biosimilar medicines and agrees that they should be considered as a treatment option for appropriate patients for whom a biological medicine is being considered as part of their treatment pathway. Individual patients may be switched to another biological medicine, including a biosimilar medicine, as part of a clinician-led management programme which has appropriate monitoring in place. There are differing clinical characteristics within specialties which may be important to consider when using biosimilar medicines. While practice is evolving, some specialties may consider that it is most appropriate to use biosimilar medicines in new patients. There are no specific efficacy or safety concerns identified for biosimilar medicines but, as for all biological medicines, clinical experience with biosimilar medicines is still emerging to guide their use. As for all new medicines, adverse drug reactions to biosimilar medicines should be reported through the Yellow Card Scheme. Clinical outcomes for individual patients on any biological medicine should be measured using established recognised systems for monitoring disease activity and response to treatment. Clinical registries are being established for a number of biological medicines. It would be appropriate to explore the expansion of these databases to capture details of biosimilar medicines. 2.6 How should biological and biosimilar medicines be prescribed and product details recorded? 2.7 What information should be provided to patients? Biological medicines, including biosimilar medicines, should be prescribed by both generic and brand name and the brand name and batch number should be recorded on the patient s prescription, case record or other appropriate clinical system. The manufacturer s patient information leaflet should be supplied to all patients receiving any medicine, including a biosimilar medicine. Page 7

8 2.1 Should biosimilar medicines be used in NHSScotland? NHSScotland is supportive of the use of biosimilar medicines and agrees that they should be considered as a treatment option for appropriate patients for whom a biological medicine is being considered as part of their treatment pathway. Biosimilar medicines are licensed medicines which have met the regulatory requirements for quality, efficacy and safety. 2 NHSScotland recognises the benefits that increased availability of biosimilar medicines can bring. Clinicians agree that biosimilar medicines are a useful treatment option for appropriate patients for whom a biological medicine is being considered as part of their treatment pathway. The decision to prescribe a biological medicine, including a biosimilar medicine, for an individual patient is the responsibility of the prescribing clinician in consultation with the patient. The frequently asked questions which follow provide additional information to support clinical decision-making on the use of biosimilar medicines. Page 8

9 2.2 Can patients established on a biological medicine be switched to another biological medicine, for example a biosimilar? Individual patients may be switched to another biological medicine, including a biosimilar medicine, as part of a clinician-led management programme which has appropriate monitoring in place. The evidence base for the safety and efficacy of biosimilar medicines has been established through the medicines regulatory process. However, there is limited experience, as yet, of the longterm use and ease of interchangeability of biological medicines in clinical practice. Clinical experience and prescriber and patient confidence with biosimilar medicines is, therefore, still emerging. Switching to a biosimilar medicine should be managed at the discretion of the individual prescribing clinician. It is recognised that some clinical specialties (for example rheumatology and dermatology) have more experience using and switching between a range of biological medicines than others (for example gastroenterology). Some clinical specialties may, therefore, be more comfortable switching to a biosimilar medicine, particularly where there is already experience of switching between different biological medicines. Emerging evidence on switching a biological medicine to a biosimilar medicine will continue to guide decisions on interchangeability in the future. Page 9

10 2.3 Are different approaches to the use of biosimilar medicines required in different clinical specialties? There are differing clinical characteristics within specialties which may be important to consider when using biosimilar medicines. While practice is evolving, some specialties may consider that it is most appropriate to use biosimilar medicines in new patients. During the consultation process with the expert advisory group a number of issues were raised by individual clinical specialties. Gastroenterology Patients on current maintenance therapy with a biological medicine, in line with clinical guidelines, could be considered for a switch to a biosimilar medicine. All new patients being considered for biological therapy could be considered for initiation with a biosimilar medicine. Treatment choice should be at the discretion of the treating clinician. Rheumatology and dermatology Patients treated with biological medicines within these specialties are generally treated long term. If patients are being switched between biological medicines, including biosimilar medicines, there should be appropriate monitoring. Patient suitability may also influence decision-making where there is a difference in the device, preparation or formulation between the original reference product and biosimilar medicine. Treatment choice should be at the discretion of the treating clinician. Page 10

11 Oncology and haemato-oncology Patients receiving a single course of treatment with either the original reference product or a biosimilar medicine may be unsuitable for switching to an alternative biosimilar medicine because of the short-term nature of their treatment. In addition, as treatment may often be part of a combination therapy regimen which may change over time, it would be difficult to determine the effectiveness of the contribution of the biosimilar medicine to the patient response. However, experience of the use of biosimilar medicines in clinical practice is likely to influence their use in the longer term. Treatment choice should be at the discretion of the treating clinician. Diabetes Biosimilar insulins are smaller less complex molecules and clinicians describe some concerns about switching. Switching patients between any insulin has service workload implications and requires careful planning. Patient suitability may influence decisionmaking where there is a difference in the device, preparation or formulation between the original reference product and biosimilar medicines. Treatment choice should be at the discretion of the treating clinician. As insulins are predominantly managed in primary care, consideration needs to be given as to how the product details of the biosimilar medicine will be recorded (see section 2.6). Page 11

12 2.4 Are there any specific efficacy or safety concerns associated with the use of biosimilar medicines? There are no specific efficacy or safety concerns identified for biosimilar medicines but, as for all biological medicines, clinical experience with biosimilar medicines is still emerging to guide their use. As for all new medicines, adverse drug reactions to biosimilar medicines should be reported through the Yellow Card Scheme. The evidence base for the safety and efficacy of biosimilar medicines has been established through the medicines regulatory process. A biosimilar medicine is similar, but not identical, to the original reference product. A biosimilar medicine is, therefore, a different chemical product from the original reference product or another related biosimilar medicine. It is also known that small changes to the manufacturing process of biological medicines may modify the medicine. This issue is relevant to both the reference biological medicine and the biosimilar medicine. These subtle differences between the various biosimilar medicines and the original reference product may theoretically produce changes in efficacy and safety, including immunogenicity (for example neutralising antibodies and immune reactions). This could theoretically affect clinical performance of the medicine and impact on clinical outcomes for patients. As new medicines with black triangle status, adverse drug reactions to biosimilar medicines should be reported through the Medicines and Healthcare Products Regulatory Agency (MHRA) Yellow Card Scheme. When reporting adverse drug reactions to biosimilar medicines, it is important to include details of the brand name and batch number (see Section 2.5). Page 12

13 2.5 How should biological medicines, including biosimilar medicines, be monitored? Clinical outcomes for individual patients on any biological medicine should be measured using established recognised systems for monitoring disease activity and response to treatment. Clinical registries are being established for a number of biological medicines. It would be appropriate to explore the expansion of these databases to capture details of biosimilar medicines. There are two aspects to the monitoring requirements for biosimilar medicines: 1. monitoring clinical outcomes in individual patients, and 2. establishing a population-based clinical registry. Monitoring clinical outcomes in individual patients Frequent monitoring of clinical efficacy and safety outcomes is required when treatment is initiated with any biological medicine, including a biosimilar medicine. Similarly, monitoring will also be required when patients are switched between treatments. Patient response to treatment and side-effects should be measured, where possible, using established systems for monitoring disease activity and documented in case records and clinical letters. Suspected adverse drug reactions, medicines defects and significant drug interactions for biological medicines, including biosimilar medicines, should be reported through the Yellow Card Scheme in line with the criteria for reporting. Specifying the brand name and batch number, allows the specific biosimilar medicine implicated in the adverse drug reaction to be clearly identified. Page 13

14 Establishing a population-based clinical registry Some clinical specialties contribute to existing, national or international, registries for biological medicines. It is important that biosimilar medicines are included in these clinical registries as they are beneficial in gathering intelligence and building confidence over the longer term by establishing experience beyond what is already known from clinical trials or anecdotal experience. There is strong clinical support for the continuation of registries for biological medicines to monitor population outcomes. There are current challenges around the sustainability of the existing registries and supporting registries in clinical specialties where they do not currently exist. Further assessment is required of the current use and benefits of registries to inform policy and strategy for future development. Page 14

15 2.6 How should biological and biosimilar medicines be prescribed and product details recorded? Biological medicines, including biosimilar medicines, should be prescribed by both generic and brand name and the brand name and batch number should be recorded on the patient s prescription, case record or other appropriate clinical system. It is good practice to prescribe biological medicines, including biosimilar medicines, by generic and brand name. 4,5 This will ensure that patients remain on the same product unless a change in product is considered necessary. This is in line with good practice guidance from the MHRA. At the time of dispensing or administration, a biosimilar medicine should not be automatically substituted for the original reference product or another biosimilar medicine. 5 It is good practice to record the brand name and batch number of all biological medicines, including biosimilar medicines on the patient s prescription, case record or other appropriate clinical system. Should an adverse event occur, recording the brand name and batch number facilitates traceability of the medicine and post-marketing surveillance. However, the challenge of recording these details in primary care or home care is recognised and a practical solution remains to be determined. Recording may become easier with the introduction of electronic prescribing and administration systems and electronic health records. Page 15

16 2.7 What information should be provided to patients? The manufacturer s patient information leaflet should be supplied to all patients receiving any medicine, including a biosimilar medicine. As with all medicinal products, a patient information leaflet should be supplied to patients receiving a biological medicine, including a biosimilar medicine. Since 1999, it has been a legal requirement for all medicines to have a patient information leaflet. In some specialties, the manufacturer s patient information leaflet may be supplemented by locally developed information about the disease and medicines being prescribed. It would be good practice to update locally-developed information to highlight that, in some cases, patients may receive a biosimilar medicine rather than the original reference product. Patients should be kept informed about their medications and any changes to their treatment discussed with them. Patients should also be made aware that they should always receive the same brand of their biological medicine unless they are switching to another biological or biosimilar medicine as part of a managed programme. Page 16

17 Appendix 1 Scottish Medicines Consortium Policy Statement on Biosimilar Medicines Scottish Medicines Consortium (SMC) Policy Statement on Biosimilar Medicines Biological medicinal products are fundamentally different from chemically derived medicines in terms of their production, complexity of chemical structure, purity and immunogenicity. Biosimilar medicines are new biological medicinal products that have demonstrated similar efficacy and safety to an existing biological reference product. By definition, biosimilar medicines are not generic medicines (and are therefore not interchangeable), since it could be expected that there may be subtle differences between biosimilar medicines from different manufacturers or when compared with the reference product. Changes in the production site and production process (even minor) can affect the complex three-dimensional structure of a biosimilar medicine and other characteristics such as glycosylation. These variations may affect the efficacy and safety of the biosimilar medicine (e.g. increased risk of allergic reactions when compared with the reference product). The European Medicines Agency (EMA) therefore requires evidence (via pre-clinical studies and phase I and III clinical studies) that a biosimilar medicine is similar to the original reference product in terms of quality, efficacy and safety. Biosimilar medicines are usually approved via an abbreviated licensing process with a limited clinical database, hence significant post-approval commitments are required to further characterise immunogenic potential and monitor adverse drug reactions. Clinical safety of biosimilar medicines must therefore be monitored closely on an ongoing basis during the post-approval phase, including continued risk-benefit assessment. Thus in order to support pharmacovigilance monitoring, biosimilar medicines are required to be prescribed by brand name. If the specified biosimilar medicine is unavailable during dispensing, automatic substitution for the reference product is inappropriate. Substitution should only be considered if the prescribing physician gives prior consent. SMC believes that the managed introduction of biosimilar medicines into clinical practice in NHS Scotland is desirable. To facilitate this process, from May 2015 SMC will no longer routinely assess biosimilar medicines on the basis of a full submission. These products will be considered out of remit where the reference product has been accepted by SMC/HIS for the same indication(s) and in the same population or was initially licensed and available prior to 31 January Full submissions will continue to be required for indication(s)/populations where the reference product is not recommended by SMC/HIS. SMC will continue to horizon scan for emerging biosimilar medicines and reserves the right to request a full submission in the event that it is anticipated to have an impact on NHS Scotland resources. May 2015 Page 17

18 Appendix 2 Development of Biosimilar Medicines: A National Prescribing Framework Healthcare Improvement Scotland facilitated collaboration between ADTCs and an expert advisory group to develop the national biosimilar medicines prescribing framework. January May 2015 Expert advisory group The expert advisory group consisted of representation from NHS boards, NHS National Services Scotland, Healthcare Improvement Scotland and public partners. NHS board representation included doctors, nurses and pharmacists from a variety of specialties that are expected to experience the introduction of biosimilar medicines in the next few years. These include haematology, rheumatology, oncology, gastroenterology, endocrinology, dermatology and diabetes. Membership of the expert advisory group is outlined in Appendix 3. Declarations of interest were collected from members of the expert advisory group in relation to the development of the prescribing framework. Drawing on national clinical practice and experience, the expert advisory group developed the prescribing framework, outlining how biosimilar medicines should be introduced in clinical practice. January 2015 NHSScotland SurveyMonkey questionnaire Over a one-week period, January 2015, a SurveyMonkey questionnaire was distributed to NHS board formulary pharmacists and chairs of the ADTCs to identify current use of biosimilar medicines in NHS boards. The results of the nine SurveyMonkey responses received were used to provide background and context at the January 2015 meeting of the expert advisory group. Page 18

19 January 2015 Meeting of expert advisory group A national meeting, hosted by Healthcare Improvement Scotland, in Glasgow on 30 January 2015, provided a forum for members of the expert advisory group to discuss the safe and effective use of biosimilar medicines in clinical practice and gain consensus. The detail obtained from the discussions informed the content of the draft prescribing framework. February 2015 Initial consultation with expert advisory group The draft prescribing framework was distributed to the expert advisory group on 13 February Input from the consultation was used to further develop the prescribing framework. March 2015 Consultation with ADTCs The revised draft prescribing framework was distributed to the chairs of the ADTCs on 3 March 2015 for consultation within their NHS boards. The prescribing framework was then adapted, as appropriate, based on the responses obtained from the consultation. April 2015 Further consultation On 20 April 2015, the final draft of the prescribing framework was distributed to members of the expert advisory group for consultation. It was also shared with the Association of British Pharmaceutical Industry. The comments received were considered and incorporated where appropriate. May 2015 Meeting of expert advisory group The key themes from the various consultations were shared with the expert advisory group at the national meeting in Glasgow on 1 May The key themes were discussed and consensus gained on the content of the prescribing framework. Final comments were incorporated into the prescribing framework. Page 19

20 Appendix 3 Membership of expert advisory group Specialty Name Title NHS board Dermatology James Vestey Consultant Dermatologist NHS Highland Diabetes Colin Perry National Clinical Lead Diabetes Endocrinology Karen Adamson Consultant Physician General Medicine Directorate Stephen Gallacher Consultant Physician and Endocrinologist Gastroenterology Daniel R Gaya Consultant Gastroenterologist Haematooncology and Oncology Santosh Salunke John Thomson Consultant Gastroenterologist Consultant Gastroenterologist Carla Forte Principal Pharmacist Cancer Care Robert Jones Mary MacLean Jude Madeleine Pam McKay Jayaram Mohanamurali Mark Parsons Reader and Honorary Consultant in Medical Oncology Regional Cancer Care Pharmacist (West of Scotland) MacMillan Principal Pharmacist Consultant Haematologist Consultant Oncologist Principal Clinical Pharmacist Oncology NHS Greater Glasgow and Clyde NHS Lothian NHS Greater Glasgow and Clyde NHS Greater Glasgow and Clyde NHS Forth Valley NHS Grampian NHS Greater Glasgow and Clyde NHS Greater Glasgow and Clyde NHS Greater Glasgow and Clyde NHS Highland NHS Greater Glasgow and Clyde NHS Tayside NHS Tayside Page 20

21 Specialty Name Title NHS board Pharmacy Fiona Bruce Lead Pharmacist Medicines Utilisation and Education NHS Ayrshire & Arran Michele Caldwell Gary Cook Christine Gilmour Norman Lannigan Director of Pharmacy and Accountable Officer for Controlled Drugs Principal Clinical Pharmacist Chief Pharmacist Head of Pharmacy and Prescribing Support Unit and Accountable Officer NHS Ayrshire & Arran NHS Tayside NHS Lanarkshire NHS Greater Glasgow and Clyde Anne Lee Chief Pharmacist Scottish Medicines Consortium Joan MacKintosh Mandy MacKintosh Senior Clinical Pharmacist Prescribing Support Pharmacist for Acute Services NHS Highland NHS Dumfries & Galloway Lindsay McClure Pharmaceutical Adviser NHS National Services Scotland Ewan Morrison Director of Pharmacy NHS National Services Scotland Janice Watt National Clinical Lead ADTC Collaborative (Chair of Group) Healthcare Improvement Scotland Page 21

22 Specialty Name Title NHS board Rheumatology Jayne Argyle Rheumatology Clinical Nurse Specialist NHS Ayrshire & Arran Robert Campbell Sara Else Vinod Kumar Liz Murphy Ruth Richmond Rheumatology Clinical Nurse Specialist Consultant Rheumatologist Consultant Rheumatologist Consultant Rheumatologist Consultant Rheumatologist Academia Rachel Knott Molecular and Cell Biologist NHS Ayrshire & Arran NHS Forth Valley NHS Tayside NHS Lanarkshire NHS Borders Robert Gordon University School of Pharmacy and Life Sciences Public Partners Helen Cadden Public Partner Healthcare Improvement Scotland Roy Pettigrew Public Partner NHS Forth Valley Healthcare Improvement Scotland provided professional and secretariat support: Laura McIver Jill Booth Andrea Ma Chief Pharmacist Clinical Adviser (Pharmacist) ADTC Project Officer ADTC Page 22

23 Appendix 4 References 1. Healthcare Improvement Scotland (2014) Strategic delivery plan for medicines. Available at technologies_and_medicines/programme_resources/strategic_delivery_plan.aspx, accessed 3 February European Medicines Agency (2015). Biosimilar medicines. Available at europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_ listing_ jsp, accessed 12 February The Scottish Government (2010).The Healthcare Quality Strategy for NHSScotland. Available at accessed 3 February British Medical Association and Royal Pharmaceutical Society (2014).British National Formulary (number 68, September 2014 March 2015). England: National Institute for Health and Care Excellence. 5. Medicines and Healthcare products Regulatory Authority (2008). Drug safety Update: Biosimilar medicines. Available from biosimilar-products, accessed 5 February Page 23

24 Edinburgh Office: Gyle Square 1 South Gyle Crescent Edinburgh EH12 9EB Telephone: Glasgow Office: Delta House 50 West Nile Street Glasgow G1 2NP Telephone: The Healthcare Environment Inspectorate, the Scottish Health Council, the Scottish Health Technologies Group, the Scottish Intercollegiate Guidelines Network (SIGN) and the Scottish Medicines Consortium are part of our organisation. You can read and download this document from our website. We are happy to consider requests for other languages or formats. Please contact our Equality and Diversity Advisor on or contactpublicinvolvement.his@nhs.net