Hertfordshire Medicines Management Committee (HMMC)

Hertfordshire Medicines Management Committee (HMMC) TERMS OF REFERENCE 1. CONTEXT The following publications have been considered for the development of the HMMC Terms of Reference: The NHS Constitution for England Defining guiding principles for processes supporting local decision making about medicines Supporting rational local decision-making about medicines (and treatments) NICE Good practice guidance (GPG1) on developing and updating local formularies. 2. STATEMENT OF PURPOSE Hertfordshire Medicines Management Committee is an over-arching local decision-making group for medicines, for NHS East & North Hertfordshire Clinical Commissioning Group (ENHCCG) and NHS Herts Valleys Clinical Commissioning Group (HVCCG). The purpose of HMMC is to ensure a robust and consistent decision making process on new drugs, new uses of drugs and existing treatments commissioned by clinical commissioning groups or prescribed by NHS Trusts, general practitioners and non-medical prescribers. The committee provides a forum for GP providers, clinical commissioners and NHS Trusts to consider issues of clinical and cost effectiveness, needs of the patient and population, local priorities and affordability in the use of drugs and novel approaches to therapy (where there is a drug component) in the prevention and management of disease. HMMC will review Public Health documents where there is an impact on medicines use across Hertfordshire but ratification processes for Public Health documents lie outside of HMMC. It should therefore be noted that the purpose of HMMC in relation to Public Health documents is not to ratify but rather review and advise. 3. BUDGETARY RESPONSIBILITY NHS East & North Hertfordshire and NHS Herts Valleys Clinical Commissioning Groups (CCGs) have budgetary responsibility for treatments that fall within CCG commissioning responsibility, for their populations. CCGs have a statutory duty to break even within their allocated annual financial budget. Except where a policy in respect to a particular treatment is laid down by the National Institute for Health and Care Excellence as a technology appraisal (TA), CCGs have to set their own priorities and policies at board level in order to guide their officers as to how the CCGs resources should be allocated between conflicting demands for treatment. 4. AIM: To make recommendations to NHS ENHCCG, NHS HVCCG, East and North Hertfordshire NHS Trust (E&NHT), West Hertfordshire Hospitals NHS Trust (WHHT), Royal Free London NHS Foundation Trust (RFLFT) (Barnet and Chase Farm Hospitals (BCFH)), Hertfordshire Partnership University NHS Foundation Trust (HPFT), Hertfordshire Community NHS Trust (HCT) and Royal National Orthopaedic Hospital NHS Trust (RNOH) on policies for new drugs and new uses of drugs in the context of the overall care pathways for patient management. Where there is an overall cost pressure to the local health economy, recommendations will be prioritised by the CCG Boards or their named delegated subcommittee before being finalised. 5. OBJECTIVES 5.1 To forecast developments in healthcare which involve the use of medicines and inform each CCG on potential cost implications for the forthcoming year Page 1 of 10

5.2 To prioritise a work programme for treatments not subject to a NICE TA, in consultation with HMMC members. 5.3 To make policy recommendations on the introduction of new drugs and therapies (where there is a drug component), and new uses for existing drugs and therapies (where there is a drug component), based on local priorities. 5.4 To review and ratify clinical guidelines and protocols which identify place in therapy of treatments. 5.5 To ensure the NICE TA implementation process is adhered to, with appropriate access to treatment for the population of ENHCCG and HVCCG. 5.6 To assess the place in therapy and cost implications of the drug treatments in NICE guidelines and to make local recommendations. Commissioners are not mandated to provide funding for NICE guidelines. 5.7 To review the recommendations from provider organisations where these impact on health budgets (prescribing and activity costs) and advise providers and CCGs on the appropriateness of such recommendations. 5.8 To share final decisions with the Individual Funding Request (IFR) team. Recommendations that impact on secondary care activity to be sent to the contract leads via the Contract leads for each CCG. 5.9 To ensure robust and timely implementation processes are in place in all provider organisations. 5.10 To ensure mechanisms (including audit) are in place to monitor the implementation of decisions and their impact on the health system. 6. LINES OF ACCOUNTABILITY AND REPORTING The Committee is accountable to NHS ENHCCG and NHS HVCCG Boards. Reporting arrangements are outlined in Appendix 2. 7. MEMBERSHIP ROLES, RESPONSIBILITIES AND DEPUTISING ARRANGEMENTS Members Member Role Key Responsibility Deputising arrangement Senior public health Chair of the To facilitate and ensure effective stakeholder CCG GP Board doctor (1) group participation and give a public health overview member CCG Head of Pharmacy and Medicines Optimisation (2) Governance of process To ensure process is being followed CCG Senior/Lead pharmaceutical adviser CCG GP Board member (ENHCCG; HVCCG) (2) Chair of provider medicines decision making groups (E&NHT, WHHT) (2) (HCT, RFLFT, RNOH, HPFT may be represented by another DTC member e.g. chief/formulary pharmacist) Represent CCG Board Represent their organisation and their clinicians To provide an overall CCG perspective to the discussions; to take recommendations back to CCG. To provide an overall view from the provider perspective including view of the consultant body in the provider; To ensure that the mechanism for implementing the final recommendations from HMMC is robust, comprehensive and within defined timescale. Designated Locality GP prescribing lead. Another senior doctor (Consultant) must be identified. Page 2 of 10

Chief or formulary Pharmacist from lead provider organisation (E&NHT, WHHT, HPFT, HCT) (4) Represent their organisation To provide an overall view from the provider perspective including view of the pharmacy department and consultant body in the provider. To facilitate meetings with specialists as part of pre-meeting preparation; to circulate discussion papers to relevant clinicians within the provider organisation and to ensure comments are received from all relevant specialists prior to meeting; to oversee the governance of implementation of recommendations. Chief or formulary pharmacist or a senior pharmacist. Attendees Attendee Role Key Responsibility Deputising arrangement CCG Senior/Lead pharmaceutical adviser (2) Professional secretary of the To oversee inputs and outputs for each meeting including ensuring that papers meet CCG Senior/Lead pharmaceutical Locality prescribing leads (2: i.e. 1 from each CCG) Senior medical doctor (Registrar or above) from a lead provider organisation (1) Patient Representatives (2) Hertfordshire Local Medical Committee (1) Hertfordshire Local Pharmaceutical Committee (LPC) (1) Chief or formulary Pharmacist from lead provider organisation (RFLFT, RNOH) (2) committee Represent their locality Provide additional clinical input the need of the CCGs. To feedback GP view. To obtain engagement from GPs in their locality; to network with other GP prescribing leads within the CCG to obtain wider views. To be able to explain to locality GPs how decisions were arrived. To give a wider clinical input. adviser To make arrangements with other locality GP prescribing lead. Another senior doctor (Registrar or above) Provide a patient perspective To give the views of a patient who has user experience of the NHS and medicines. Represent GPs To give a wider view of GPs as providers. Another LMC member Represent To give a wider view of community Another LPC member community pharmacists pharmacists Represent their organisation To provide an overall view from the provider perspective including view of the pharmacy department and consultant body in the provider. To facilitate meetings with specialists as part of pre-meeting preparation; to circulate discussion papers to relevant clinicians within the provider organisation and to ensure comments are received from all relevant specialists prior to meeting; to oversee the governance of implementation of recommendations. Chief or formulary pharmacist or a senior pharmacist. Chair and secretary reserve the right to coopt other specialists (e.g. contracts/finance leads) to the committee if required. 8. ARRANGEMENTS FOR QUORACY For the committee to be quorate the following six members need to be present (or delegated deputy): One CCG GP board member or deputy from each CCG Two provider representatives (one of which must be a medical doctor [Consultant] from a lead provider organisation) Chair Professional secretary or CCG Head of Pharmacy and Medicines Optimisation. If the meeting is not quorate by up to two members, the meeting can still go ahead at the Chair s discretion but members will be contacted via correspondence to confirm endorsement of decisions prior to issue and a post-meeting record will be added to the notes. Quoracy will then be taken as Page 3 of 10

agreed. If a recommendation made during a non-quorate meeting is not endorsed by an absent member required for quoracy, then that recommendation will be brought back to the next committee meeting for discussion. If the meeting is not quorate by three or more members then Chair s action will be taken and clearly documented. 9. ATTENDING SPECIALISTS When considered appropriate, the committee will invite specialist representation for specific topics so that the views of specialists may be taken into account. The specialist may not be present during the decision making process. 10. CONFLICT OF INTEREST Any conflicts of interest (potential or actual) must be declared, recorded and a report made available for public scrutiny. In the case of committee members, if appropriate, they will be asked to leave the room during the decision making process if a conflict of interest arises. CCG policies will be adhered to under these circumstances. Committee members to complete a declaration of interests form on appointment and then reconfirm at least annually The declaration of interests to be recorded in a register maintained by ENHCCG and made publicly available on the CCG website (other organisations can link to ENHCCG website). At each meeting committee members are required to make any new declaration of interest or declaration relating to matters on the Agenda, or to reconfirm current declarations on the Register of Interests are accurate and up-to-date. Where a new declaration of interest or declaration relating to matters on the Agenda are made the following should be recorded in the minutes of the meeting: o Individual declaring the interest. o At what point the interest was declared. o The nature of the interest. o The Chair s decision and resulting action taken. o The point during the meeting at which any individuals retired from and returned to the meeting - even if an interest has not been declared. Anyone developing or commenting on papers/guidelines must declare any conflicts of interest or a nil return. When CCG Pharmacy and Medicines Optimisation Teams circulate papers for comment they are sent with a declaration of interest form for completion by anyone wishing to send comment or a request to respond with a nil return. All committee members or anyone involved with the development of papers/guidelines must adhere to their organisational policies on conflicts of interest, gifts, hospitality, commercial sponsorship, working with the pharmaceutical industry, fraud and bribery and secondary employment. Committee members will be required to make an annual declaration. Healthcare professionals must act in accordance with their profession s code of conduct. 11. PRE-MEETING PREPARATION For treatments for which policy decisions are required by CCGs, the CCG Pharmacy and Medicines Optimisation Teams will produce review documents (which include critically appraised published evidence) as prioritised within the work plan. If a local specialist applies for a treatment, a business case and up to date evidence, presented in HMMC format, to be submitted by providers to the secretary a minimum of six weeks in advance of the meeting. Provider pharmacy representatives are responsible for co-ordinating responses from relevant specialists within their Trust. The presenter of the paper should collate consultation comments and clarify points of discussion prior to the paper being finalised and circulated. Papers will be sent out to provider pharmacy representatives, to obtain views of wider specialists, at least three weeks in advance of meetings. Papers will be sent out to locality prescribing leads, to obtain views of their locality practices, at least three weeks in advance of meetings. Final papers will be sent out to members five working days in advance of meeting. Page 4 of 10

Members will read and review paperwork and bring comments to the committee for discussion. 12. METHODS FOR REACHING FINAL DECISIONS, RECORDING AND DISSEMINATING At the meeting: Committee members to give views on the evidence and specialists comments. Committee members to make assessment against the ethical framework and make a commissioning recommendation. Generally it is expected that at the committee meetings recommendations will be reached by consensus. Should this not be possible and all work on the item has been completed, the Chair will determine that a vote of members will be required. A vote could be deferred to a subsequent meeting if the committee agree that further information / evidence and stakeholder feedback needs to be obtained. The process for voting is set out below: a) Eligibility Voting Membership is as follows. Senior public health doctor, HCC (HMMC Chair) (or nominated deputy) Head of Pharmacy and Medicines Optimisation, HVCCG (or nominated deputy) GP Board member, HVCCG (or nominated deputy) Head of Pharmacy and Medicines Optimisation, ENHCCG (or nominated deputy) GP Board member, ENHCCG (or nominated deputy) Chair of provider medicines decision making group, ENHT (or nominated deputy or Chief or formulary Pharmacist) Chair of provider medicines decision making group, WHHT (or nominated deputy or Chief or formulary Pharmacist) Chief or formulary Pharmacist, HCT (or nominated deputy) Chief or formulary Pharmacist, HPFT (or nominated deputy) Under no circumstances may an absent member vote by proxy. Absence is defined as being absent at the time of the vote. A vote may only take place if the Committee meeting is quorate. b) Voting At the discretion of the Chair all questions put to the vote shall be determined by oral expression or by a show of hands, unless they direct otherwise or it is proposed, seconded and carried that a vote be taken by paper ballot. If at least one-third of members present so request, the voting on any question may be recorded to show how each member voted or did not vote except where conducted by paper ballot. c) Majority necessary to confirm a decision every question put to the vote at a meeting shall be determined by a majority of votes of members present and voting. Members receive one vote only, e.g. if a GP CCG Board member is deputising as the Chair of the meeting, they do not get a vote as the Chair and as the GP CCG Board member. d) Casting vote In the case of an equal vote, the Chair of the meeting shall have the casting vote. e) Should a vote be taken the outcome of the vote must be recorded in the minutes of the meeting. f) Abstaining from the vote Voting members can choose to abstain from the vote. The member s vote may not be transferred to another voting member. g) Concerns raised / dissenting views A record shall be made of any concerns raised / dissenting views in the minutes of the meeting. 13. POST MEETING ACTIONS Draft notes of the meeting to be agreed with the Chair. Agreed draft notes of meeting to be sent to committee members. Communication to applicants will be sent out outlining the interim position of the application and to advise on when final recommendation will be sent. Page 5 of 10

HMMC report to be made to CCG committee with authority to make financial decisions (e.g. CCG Board or designated subgroup). Treatments with a cost pressure require the aforementioned committee to approve HMMC recommendations before implementation. Final recommendations will be sent out by CCG Pharmacy and Medicines Optimisation Teams (PMOTs) to all participating organisations, and uploaded onto the CCG web-sites. Appendix 1 outlines the classification of recommendations. Final recommendations to be circulated by CCG PMOTs to GPs and uploaded onto CCG websites. Final recommendations to be circulated by CCG PMOTs to Herts Urgent Care and local community pharmacists. Process for dissemination is outlined in Flow chart for disseminating recommendations HMMC meeting notes are ratified at the next committee meeting. 14. APPEAL ARRANGEMENTS Applicants can appeal the HMMC decision where they believe the process has not been followed. The first appeal will be considered by HMMC. If applicants remain unhappy with the outcome of the first appeal, they can make a second appeal where Bedfordshire and Luton Joint Prescribing Group will review the process of decision making. Applicants can re-apply to HMMC if there is new published information, using the application process. 15. FREQUENCY OF MEETINGS A minimum of five meetings a year at approximately two to three monthly intervals. Additional meetings may be held at the discretion of the Chair. 16. ANNUAL REVIEW OF THE COMMITTEE The committee will undertake an annual self-assessment to: Review that these Terms of Reference have been complied with and whether they remain fit for purpose; Determine whether its planned activities and responsibilities for the previous year have been sufficiently discharged; and, Recommend any changes and / or actions it considers necessary, in respect of the above. Page 6 of 10

Appendix 1 - Classification of new drugs and therapies (RAG rating) DOUBLE RED Not recommended for prescribing by either Secondary or Primary care in line with ENHCCG and HVCCG policies; NOT a priority for funding. Such a treatment should only be used in exceptional cases and prescribing may be subject to challenge. Any treatment appraisals terminated by NICE will automatically be designated a double red category. RED Not recommended for prescribing in Primary Care because of clinical issues or because funding responsibility lies with NHS England, and/or in line with with ENHCCG and HVCCG policies; Prescribing may be subject to challenge. AMBER INITIATION Recommended for prescribing but only considered suitable for initial prescribing by specialists in Secondary and Tertiary care with prescribing (and monitoring, where applicable) continued by GPs. A shared care agreement is not required here but the patient s GPs must be supplied with sufficient information on the prescribed medication. Examples fitting this category are where dose stabilization is needed, or where treatments are complex but the monitoring is not great enough to require amber protocol status. AMBER PROTOCOL Recommended for prescribing but only considered suitable for initial prescribing by specialists in Secondary and Tertiary care with prescribing continued by GPs and Primary Care Clinicians in conjunction with a Shared Care Agreement or relevant equivalent or (where appropriate) with patient specific information provided by the hospital specialist. The Shared Care Agreement must follow HMMC Shared Care Principles in order for it to be accepted. These amber categories must not be confused with the Amber category in the National Enhanced Service. GREEN Recommended for prescribing and treatment considered to be suitable for initiation in Primary or Secondary care and continuation in Primary Care. Any new drug or new indication for a drug licensed after 5 April 2011 is regarded as a Double Red drug until considered by HMMC. This excludes branded generics, hybrid (generic) inhalers and biosimilars the decision to use a branded generic or hybrid (generic) inhaler lies with individual CCGs; the decision to use a biomilar lies with individual provider Trusts providing the biosimilar and implementation adheres to the standards described in the HMMC Biosimilars Position Statement and contractual agreements with the host CCG. Associated Documents 1. Business case 2. Ethical framework 3. Flow chart for disseminating recommendations Page 7 of 10

Appendix 2 - LOCAL DECISION MAKING ON MEDICINES IN HERTFORDSHIRE ENHCCG Governing Body For ratification and prioritisation (if necessary) No significant cost pressure or resource implication HVCCG Governing Body For ratification and prioritisation(if necessary) CCG Board member feedback on any issues ENHCCG Organisational Performance & Delivery Group for recommendation to Governing Body +ive NICE TAs, -ive NICE TAs, HMMC Not Recommended decisions, or cost-neutral Recommended decisions for noting & ratification. NB any implementation issues to be discussed by PCMMG Significant cost pressure or resource implication E&NH Primary Care Medicines Management Group for implementation plan New drug, or a new indication for drug, and treatment guidelines, with cost implications (including savings) Non-drug related issue in clinical guideline GB Medicines Optimisation lead to advise on process to follow. Reports to CCG Board member feedback on any issues HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (Local health economy wide committee led by Herts CCGs) Stakeholders: ENHCCG, HVCCG, ENHT, WHHT, HCT, HPFT, RFLFT, RNOH A minimum of five meetings a year ANNUAL WORKPLAN (prepared in January) informed by: Horizon scanning of new drugs & new uses of drugs, NICE guidance, individual funding requests, submissions from local providers, QIPP agenda. Workplan is shared with committee members (Stakeholders). PROCESS AS FOLLOWS: Pre-meeting 1. Workplan for the next meeting shared with stakeholders in advance at the previous meeting. 2. Papers prepared by CCG PMOTs (provider submissions via business case to include a review of evidence. This is reviewed by CCG PMOTs). Costs of whole pathway need to be provided as full costs will be considered. 3. Draft papers sent out to local specialists for views (three weeks in advance of meeting) and also to GP Prescribing leads, where treatment will impact primary care. Face to face meetings with specialists are requested in advance of next meeting. 4. Views received are summarised in final papers sent to committee members one week (minimum of five working days) before the meeting. During Meeting 1. Evidence and views received during consultation period discussed and assessed against an ethical framework that takes several factors into account and enables rationale for the decision to be explained. 2. The committee makes a commissioning recommendation. A decision is reached where there are no additional cost pressures in the treatment pathway or there are cost savings. Where an intervention will increase costs, a report is submitted to relevant CCG committees for prioritisation. Post Meeting 1. HMMC report prepared by CCG PMOT for CCG Governing Body. 2. Recommendations prepared by CCG PMOT and uploaded to CCG websites and disseminated to all stakeholders for implementation. Page 8 of 10

IMPLEMENTATION OF HMMC RECOMMENDATIONS PROCESS FOLLOWED BY CCGs Recommendations circulated to all GP practice managers, GP prescribing leads, community pharmacies and Herts Urgent Care for onward circulation. A summary of the recommendation prepared and linked to ScriptSwitch so that it appears on the GP electronic prescribing system when the drug name is entered. The evidence and decision making process are discussed with CCG pharmacy teams to enable the wider pharmacy team to understand how the decision was arrived at. Locality pharmaceutical advisers disseminate this learning to GP practices at locality prescribing leads meetings or equivalent. GP prescribing leads are asked to disseminate the rationale for the decision at wider GP practice team meetings. PROCESSES FOLLOWED BY LOCAL NHS PROVIDERS ENHT The ENHT New Drugs and Formulary (NDF) Committee is used as a sub-committee of HMMC. NDF committee meetings are scheduled roughly two weeks before each HMMC meeting. HMMC agenda is discussed at NDF meetings and relevant consultants are invited to meetings for discussion. The HMMC decision spreadsheet produced after each HMMC meeting is a standing agenda item for noting and adoption at the next NDF. Decisions are circulated to the relevant consultant who attended the NDF meeting and the clinical director of the specialities for onward circulation. Relevant consultants may be invited back to the next NDF meeting if follow up is required. The formulary is updated, a pharmacy bulletin is produced and the recommendations are displayed on the pharmacy information notice board. WHHT Pre meeting, papers are sent out to all Consultants within the Speciality for review items for HMMC then Pharmacy department receive, gather comments and submit to HMMC. HMMC notes/decisions are tabled at the Trust Medicines Use and Safety Panel (MUSP, previously D&T Committee) and sent out to all Consultants with drug names in the subject header to draw attention. Further discussions about decisions with clinical teams and Pharmacy takes places as required within the Trust. RFLFT HMMC recommendations circulated to all relevant specialists. HCT All pre-meeting papers are sent out to the relevant specialist nurses or clinicians for review. The feedback and comments are collected by pharmacy and submitted to HMMC. All HMMC decisions are circulated to the relevant HCT clinicians once published. Local decisions published on CCG websites are forwarded to relevant team for information. Any HMMC recommendations which require further discussion are tabled at HCT Medicines Management Forum which meet quarterly HPFT Relevant papers sent to specialists for comment before HMMC meetings HMMC recommendations where relevant are discussed/noted/ratified at DTC and then circulated to all prescribers. RNOH HMMC recommendations available as link on web-based formulary http://www.rnohformulary.nhs.uk Page 9 of 10

Version 5.0 Developed by HMMC August 2013: updates January 2016, September 2017, February 2018, October 2018 Date ratified Latest version October 2018 (HMMC); Ratified by HVCCG Governing Body 15/11/2018; Ratified by ENHCCG Governing Body 08/11/2018 Review date February 2019 Page 10 of 10