Peer Approved Clinical System Tier 2 (PACS2)

Transcription

1 Peer Approved Clinical System Tier 2 (PACS2) Purpose of this procedure: This procedure is to support the policy issued by the Scottish Government on the implementation of Peer Approved Clinical System (PACS) Tier 2. The Procedure: 1.0 Introduction The Chief Medical Officer and the Chief Pharmaceutical Officer wrote to boards on 29 March 2018 [Appendix 1] to provide guidance on the implementation of the Peer Approved Clinical System (PACS) Tier Two, also known as PACS2, which replaces some of the processes previously covered by the Individual Patient Treatment Request (IPTR) policy. There is a main Patient Treatment Request (PTR) panel and a separate cancer medicines management committee (for adult patients). The main PTR panel will have 3 parts to the meeting; PACS1 applications, PACS2 applications and other PTR applications. All PACS1 and PACS2 application are to come to the main panel. Other PTR applications for cancer medicines in adult patients can go to the cancer medicines management committee, PTR requests from other specialities should be submitted to the main panel. The NHS Lothian PTR Panel is also responsible for oversight of the following NHS Lothian procedures: Peer Approved Clinical System (PACS) Tier One, also known as PACS1 For ultra-orphan medicines. Procedures for SMC Non Submissions To be further defined. In the interim, refer to IPTR policy Procedures for Surgical Procedures Not Recommended by NHS Policy To be further defined. In the interim, refer to IPTR policy 1.1 Aim of the Policy The aim of the Scottish Government policy is to enhance the consistency of approach across all NHS Boards when considering medicines that have not been accepted for routine use in NHS Scotland. A patient treatment request can only be sought where the clinician fully supports the request. The clinician is defined as the hospital consultant or General Practitioner with overall clinical responsibility for the patient. Decisions on medicines, including those not recommended by the SMC and therefore not routinely available in NHS Lothian, are published on the Lothian Joint Formulary website at Document owner: Lead Pharmacist, MMT on behalf of ADTC, Review date: August 2020

2 Page 2 of 7, PACS2 1.2 Procedure Objectives This procedure and its supporting appendices will address the following items: Circumstances under which PACS2 will be considered Referral Criteria Generic core composition of the PTR panel Evidence Timescales for decisions Appeals 1.3 Scope There are no clinicians (including non-medical prescribers) exempt from this policy when a medicine meeting the appropriate criteria for PACS2 is considered for use in a patient. This policy is applicable to patients being treated within primary care and secondary care across NHS Lothian. The process will apply to new patients. Submissions to the PTR Panel will not be required for patients who have already been initiated on a medicine through the NHS, although there is an opportunity to monitor and review patients. PACS2 process is designed to provide an opportunity on a case by case basis to request the use of a licensed medicine that - is a medicine for an indication that has been considered and not recommended for use in NHS Scotland by the Scottish Medicines Consortium (SMC); or - is a medicine accepted for restricted use by SMC but the intended use is out with SMC restrictions; or - is a medicine which has been submitted to and is awaiting/undergoing evaluation by the SMC. 2.0 Philosophy, Principles and Objectives Scottish Government guidance seeks to ensure a consistency of approach in relation to the introduction and availability of newly licensed medicines across NHS Scotland. This is to ensure that all patients across NHS Scotland, regardless of health board, have equal access or opportunity to be considered for treatment with a medicine even if not recommended by the SMC. The paperwork is included as Appendix 2 Policy statements are included as Appendix 3 Decision checklist included as Appendix 4 Non-approved medicines process flowchart [DRAFT] Appendix 5 Patient Information Leaflet is included as Appendix 6 Document owner: Lead Pharmacist, MMT on behalf of ADTC, Review date: August 2020

3 Page 3 of 7, PACS2 3.0 Roles and Responsibilities 3.1 Patients, Relatives and Carers Information for patients and the public (Appendix 6) has been developed by the Area Drug and Therapeutics (ADTC) Collaborative, hosted by Healthcare Improvement Scotland. The ADTC Collaborative team worked with healthcare professionals, public partners, public involvement groups and patient and carer support groups across NHS Scotland to develop the medicines factsheet. The clinician will explain the application process and the appeal process to the patient. The responsibility of the patient is to ask if they do not understand what they are being told. Relatives and carers are integral to supporting their family member. The clinician will explain the application process and the appeal process to relatives and/or carers. 3.2 NHS Lothian Staff Clinicians Clinicians (both the clinician applying for their patient as well as the clinician providing peer support) responsibilities are included in Appendix 3, National PACS2 policy statements. Applying clinicians should include any service implications that may arise as a result of this treatment being approved under the any additional information section of the PACS 2 form. Applying clinicians should liaise with pharmacy to gain support for the application when relevant (see below), and to ensure that the pharmacy implications of the medicine being approved for use can be taken into consideration Clinical Directors and Associate Medical Directors (secondary care only) There is no formal requirement for the CD and the AMD, to sign-off the application. It would be considered best practice for all applications to be discussed with the management team prior to the application being made Clinical Management Team (CMT) Director of Operations or CH(C)P Clinical Director There is no formal requirement for the Director of Operation or CH(C)P Clinical Director, to sign-off the application. It would be considered best practice for all applications to be discussed with the management team prior to the application being made. Document owner: Lead Pharmacist, MMT on behalf of ADTC, Review date: August 2020

4 Page 4 of 7, PACS Hospital Clinical Pharmacist or Primary Care Pharmacist Hospital Clinical Pharmacists or Primary Care Pharmacists will be responsible for advising their respective clinicians on any PACS2 application. These duties might include: - Check the medicine and indication for treatment being considered and the patient s circumstances and advise on whether it should be a PACS1, PACS2 or PTR request (refer to flow chart in Appendix 5). - Support the clinician in preparing the evidenced-based case for the individual patient. Guidance on the nature of evidence to be presented is included in section 4 of Appendix 3. - Consider the requirements for the introduction of a new medicine, this might include; timely ordering and supply of the medicine, protocol development, aseptic worksheets, team education. - Consider the service implications for delivery of the medicine Medicines Information The Lothian Medicines Information Service (LMIS) has access to other evidence briefing templates prepared across Scotland via the Association of Scottish Medicines Information Pharmacists. LMIS will be responsible for checking if a prior evidence briefing template meeting the medicine/indication being considered has been prepared. If available an electronic copy will be supplied. This may be useful in completing the application form NHS Lothian PTR Administrator The PTR Administrator will be responsible for the receipt and logging of requests and appeals. The PTR Administrator will capture all relevant information from the Panel discussion on the decision record (Appendix 2) and the panel decision checklist (Appendix 4.) Feedback to the clinician will be provided (Appendix 2) by the PTR Administrator within 5 working days of the Panel meeting. NHS Boards are asked to maintain accurate and up to date information on decisions, appeals and their outcomes in order that information can be provided on request. The PTR Administrator will perform these duties. In addition, the PTR Administrator will be responsible for providing hospital/community pharmacies with information on individuals approved to receive a medicine via PTR approval on an ad hoc basis if required prior to medicine being dispensed. Document owner: Lead Pharmacist, MMT on behalf of ADTC, Review date: August 2020

5 Page 5 of 7, PACS NHS Lothian PACS2 Panel The panel is responsible for ensuring that the governance processes are transparent and can withstand scrutiny. The Panel will consider the national guidance for PACS2 guidance (Appendix 3) when making its decisions. Panel members should refer to the decision making grid when discussing PACS2 applications (Appendix 4). This grid will also inform the panel meeting note and the decision record. The membership of the PTR panel may include: Medical Director (Chair) [or nominated deputy] Chair of Cancer Medicines Management Committee [or nominated deputy] Director of Pharmacy [or nominated deputy] Nurse Director [or senior nurse deputising] Chief Operating Officer [or nominated deputy] CH(C)P General Manager or director [or nominated deputy] Director of Strategic Planning [or nominated deputy] General Practitioner Chair of Formulary Committee [or nominated deputy] Public Health representative Finance representative Medical Director, Acute Services Medicines Management Pharmacist Associate Medical Director, Primary Care [or nominated deputy] Chair of cancer medicines management committee (or nominated deputy) Co-opted members can be present as required (e.g. independent clinical specialist and/or pharmacist specialist for indication for treatment; primary care pharmacist). The NHS Lothian PTR Panel will meet on a monthly basis unless an emergency case arises. Where an urgent decision is required, the Medical Director would be the point of contact. The Medical Director will assume responsibility for approval; and may use telephone or an of relevant PTR Panel members to reach decision. The final decision of the PTR Panel will be communicated to requesting clinician within 5 working days of the meeting. It will be the clinician s responsibility to communicate to the patient within 1 working day of receiving reply. Document owner: Lead Pharmacist, MMT on behalf of ADTC, Review date: August 2020

6 Page 6 of 7, PACS2 4.0 Appeals The National Review Panel is a function within Healthcare Improvement Scotland (HIS) who will facilitate support to the Panel. HIS will be responsible for its governance and will provide all the necessary support to the Panel. HIS personnel will not be part of the review process. In the event where a requesting clinician and patient feel they have grounds for a review of a local PACS Tier Two decision, a National Review Panel will be established to independently review and make recommendations to the relevant NHS Board on their original decision. This replaces each NHS Board s own local appeal process. HIS will ensure that the National Review Panel will be clinician-led and include appropriate senior medical and pharmacist perspectives. The individuals involved in the Panel should be fully conversant with the National Review Panel policies. HIS will give due consideration to any training required for Panel members. The review process will accommodate reviews on either of the following grounds: - the NHS Board has failed to follow due process and the situation cannot be resolved locally; and/or - the NHS Board has reached a decision which could be deemed unreasonable in light of the evidence submitted. See Appendix 1 Annex B for further information. Document owner: Lead Pharmacist, MMT on behalf of ADTC, Review date: August 2020

7 Page 7 of 7, PACS2 Associated materials/references: Appendices Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 Scottish Government letter and guidance Scottish Government template application form National NHS Board Policy statements Panel decision checklist Non-approved medicine process flowchart [DRAFT] PACS Tier 2 Patient Information Leaflet Document owner: Lead Pharmacist, MMT on behalf of ADTC, Review date: August 2020

8 Directorate for Chief Medical Officer Chief Medical Officer Chief Pharmaceutical Officer Dear Colleague GUIDANCE ON THE IMPLEMENTATION OF THE PEER APPROVED CLINICAL SYSTEM (PACS) TIER TWO Introduction I am writing to inform you about the implementation of PACS Tier Two to replace your current Individual Patient Treatment Request (IPTR) processes. Purpose The key purpose of this guidance is to provide a revised framework to support NHS Boards in the development of local policies to enhance the consistency of approach across all NHS Boards when considering medicines that have not been accepted for routine use in NHSScotland. Overview PACS Tier Two introduces refreshed decision making criteria, clearer accompanying guidance and the establishment of a National Review Panel to enhance consistency in decision making processes across the country. It also retains key elements of the original IPTR process. The PACS Tier Two process is designed to provide an opportunity for clinicians, on a case by case basis for individual patients, to request the use of a licensed medicine (other than an ultra-orphan medicine) that: is a medicine for an indication that has been considered and not recommended for use in NHS Scotland by the Scottish Medicines Consortium (SMC); or is a medicine accepted for restricted use by SMC but the intended use is out with SMC restrictions; or is a medicine which has been submitted to and is awaiting/undergoing evaluation by the SMC. Access to ultra-orphan medicines, unlicensed medicines, use for indications outside of the marketing authorisation (off-label) and medicines which are non-submissions or have not yet been submitted to SMC are not covered by PACS Tier Two. 29 March 2018 Addresses For action Chief Executives, NHS Boards Medical Directors, NHS Boards Directors of Pharmacy, NHS Boards Directors of Finance, NHS Boards For information Chairs, NHS Boards Directors of Public Health, NHS Boards Chair, Scottish Medicines Consortium Chief Executive, Healthcare Improvement Scotland Area Clinical Forum Chairs Enquiries to: Martyn McDonald St Andrew s House Regent Road Edinburgh EH1 3DG Tel: martyn.mcdonald@gov.scot Irene Fazakerley St Andrew s House Regent Road Edinburgh EH1 3DG Tel: Irene.fazakerley@gov.scot 1

9 Applications to access ultra-orphan medicines not recommended by SMC should continue to be considered using the PACS Tier One process. This is currently being piloted nationally and will be reviewed in due course. We are also progressing work on the Review of Access to New Medicines recommendation in relation to the Scottish Model of Value. Guidance Attached to this letter is guidance and PACS Tier Two paperwork which seeks to set out the key components of the process that NHS Boards should, as a matter of good practice, seek to apply in accordance with local circumstances. The Area Drug and Therapeutics Committee (ADTC) Collaborative will ensure the ongoing review and development of the PACS Tier Two paperwork and provide relevant best practice statements as appropriate. This includes ensuring that there is a consistent process across all NHS Boards to consider medicines which are non-submissions or have not yet been submitted to SMC. A six and twelve month review, which will take account of the impact of the guidance including the National Review Panel, will be undertaken in partnership with NHS Boards. There will also be an ongoing scrutiny component established to support the implementation in order to ensure that enhanced consistency of approach is achieved. This guidance replaces all previous guidance on IPTRs as the PACS Tier Two process will replace the IPTR process. Actions for NHS Boards Decisions regarding the provision of NHS Services remain matters for NHS Boards; and clinicians remain responsible for clinical decisions regarding the care of individual patients. NHS Boards are asked to ensure their local policies are aligned to this guidance from 1 June 2018 subject to local governance processes. NHS Boards are further asked to confirm, by Friday 18 th May 2018, that they have robust systems in place to collate core data, as set out in Annex A, in relation to PACS Tier Two, including the requirement to be able to produce high level management in confidence information for the Scottish Government on request. The guidance comprises three annexes: Annex A sets out the specific guidance for PACS Tier Two applications 2

10 Annex B sets out the specific guidance on the operation of the National Review Panel Annex C sets out the new PACS Tier Two paperwork to be used for all applications. Yours sincerely Dr Catherine Calderwood Chief Medical Officer Dr Rose Marie Parr Chief Pharmaceutical Officer 3

11 Guidance for PACS Tier Two Applications ANNEX A PACS Tier Two Process The PACS Tier Two process provides an opportunity for clinicians, on a case by case basis for individual patients, to request the use of a licensed medicine (other than an ultraorphan medicine) that: is a medicine for an indication that has been considered and not recommended for use in NHS Scotland by the Scottish Medicines Consortium (SMC); or is a medicine accepted for restricted use by SMC but the intended use is out with SMC restrictions; or is a medicine which has been submitted to and is awaiting/undergoing evaluation by the SMC. Access to ultra-orphan medicines, unlicensed medicines, use for indications outside of the marketing authorisation (off-label) and medicines which are non-submissions or have not yet been submitted to SMC are not covered by PACS Tier Two. Applications to access ultra-orphan medicines not recommended by SMC should continue to be considered using the PACS Tier One process. The ADTC Collaborative will work with NHS Boards to ensure that there is a consistent process to address requests for use of a medicine which has either been a non-submission or has still to be submitted to SMC. Standardised PACS Tier Two paperwork has been developed and must be used by all NHS Boards. Please see Annex C for further detail. Decision Making Criteria for PACS Tier Two Requests The responsibility for making a request through the PACS Tier Two process rests with the clinician who wishes to prescribe the requested medicine. The requesting clinician is required to demonstrate the clinical case for the patient to be prescribed the medicine within its licensed indication(s) where the following criteria apply: (i) The clinician can demonstrate that a reasonable attempt, or appropriate consideration, has been made to treat the patient in the first instance with medicines currently accepted by the SMC for routine use in NHS Scotland for this condition and for the patient in question that these medicines are deemed unsuitable or have been found to be ineffective; And (ii) The clinician can present an evidence-based case to demonstrate the potential that the patient will achieve a measurable clinical benefit at least comparable to if not better than that experienced by the population considered by SMC. 4

12 PACS Tier Two Decisions PACS Tier Two decisions are clinical decisions. As was the case with the previous IPTR process, the cost of the medicine must not be part of the decision making process. A PACS Tier Two Panel will consider the clinician s request for use of the medicine and whether the evidence and information presented by the requesting clinician and the peer review statement supports the case that the individual patient is likely to achieve measurable clinical benefit that is at least comparable to if not exceeding that which is normally expected of that medicine compared to the population considered by SMC in its assessment. The Panel will also consider the wider benefit to the NHS. If the PACS Tier Two Panel agrees the decision making criteria have been met and that prescribing the medicine is considered of benefit to both the patient and the NHS then the request should be approved. If the Panel feels the decision making criteria have not been met and/or the medicine is not considered of benefit to the patient and the NHS then the request should not be approved and the clinician should be informed of the rationale for this decision, for onward communication to the patient. PACS Tier Two Evidence and Information That Will Be Considered It is the responsibility of the requesting clinician to provide an evidence-based case detailing all the relevant information on the reasons why their patient would receive measurable clinical benefit from the requested medicine that is at least comparable to if not exceeding that which is normally expected of that medicine compared to the population considered by SMC. This includes explaining why an SMC accepted medicine would not be suitable. PACS Tier Two decisions should be based on a range of evidence and information including: (i) SMC advice (unless assessment is in progress); (ii) any new evidence that has emerged since an SMC decision; (iii) the decision making criteria; and (iv) the PACS Tier Two request case report from the requesting clinician which details the evidence base for the request in the standard case report documentation (Parts A-C of the paperwork attached at Annex C) which should be used by all NHS Boards for this purpose. Appropriate evidence includes published, peer reviewed evidence, new emerging evidence still to be published and expert opinion. Patient factors include examples such as intolerable side effects and specific genetic sub-types where clinical evidence is stronger. Whilst equity of access across other parts of the UK is not one of the decision making criteria both the requesting clinician and the Panel should consider whether availability elsewhere in the UK is driven by new evidence that has emerged since an SMC decision was published which is of relevance to the individual patient. 5

13 Support for Clinicians in Advance of Making a PACS Tier Two Request It is the responsibility of the requesting clinician to provide full and appropriate detail in the request using the PACS Tier Two paperwork, and paying particular attention to meeting the decision making criteria. In order to support this, NHS Boards should put in place appropriate mechanisms for clinicians in advance of making an application to ensure applications are submitted as effectively and efficiently as possible and to manage expectations. This includes advice regarding appropriate evidence and completion of the paperwork. Making a PACS Tier Two Application Support from Peers/Multidisciplinary Teams As part of best practice and in order to strengthen the case being made, the requesting clinician must seek peer review for their application from another NHS clinician with suitable experience in treating the condition for which the medicine is being requested. The reviewing clinician may be from within the same NHS Board, but if there are no other clinicians with suitable expertise locally, then experts within the NHS from elsewhere in Scotland or the UK can provide the peer review. In providing a peer review of the information presented for the patient, the reviewing clinician is considering that (a) any alternative accepted medicines have been considered and excluded as being unsuitable treatment options and (b) the patient characteristics detailed and the clinical evidence presented imply that the response to treatment will be at least comparable to, if not increased, compared to the population considered by SMC. Part C of the PACS Tier Two paperwork must be completed by the reviewing clinician. Similarly, where the patient is under the care of a multi-disciplinary team, clinicians must take the opportunity to discuss and gain the support of the team for the PACS Tier Two application and indicate their support in Part A of the paperwork. Composition of a PACS Tier Two Panel In establishing a PACS Tier Two Panel NHS Boards should ensure that the Panel will be clinically composed and include appropriate senior medical and pharmacist perspectives. The individuals involved in the PACS Tier Two Panel should be fully conversant with the NHS Board policies on PACS Tier Two. Boards should give due consideration to any training required for Panel members. NHS Boards should also ensure that the members of the PACS Tier Two Panel are aware of their responsibilities in relation to declarations of any interests which could potentially impact on their impartiality in decision-making. Timescales for PACS Tier Two Decisions NHS Boards should undertake preliminary examination of the request and ensure due consideration is given to the urgency of the request given the patient s clinical condition and manage timescales accordingly. The requesting clinician will be responsible for outlining any time sensitive factors the panel ought to be aware of in their case report documentation. 6

14 Information for the Public and Patients about the PACS Tier Two Process NHS Boards should make available to clinicians and the public information on their PACS Tier Two arrangements in accordance with relevant legislation including Equalities legislation. This includes listing the information in the Board s formal scheme of publications. In doing so, NHS Boards should, as a matter of good practice, ensure that such information is fully accessible in an easy read version and is available in different formats. The content could include: clarification around what constitutes a PACS Tier Two request; how, when and by whom, a PACS Tier Two request can be initiated; details of sources of local advice in relation to the PACS Tier Two process; a description of who will consider PACS Tier Two requests; clarity on the basis on which PACS Tier Two decisions will be reached, and how, when and by whom supporting evidence/information can be submitted; the timescales of decision making for PACS Tier Two requests; the timescales and methods for communicating decisions to patients/carers/patient advocates for whom a PACS Tier Two request has been made; information about the options open to patients when PACS Tier Two decisions have been reached, including information about the grounds on which a request for a national review can be made, how this is done, and by whom, and where local advice on the national review process can be sought. When patients are going through the PACS Tier Two process they should be signposted to a named individual appointed by the NHS Board to provide advice and support. NHS Boards may decide, with input from the patient, whether this is the clinician responsible for the patient s care or another named person. Patient and Public Involvement in PACS Tier Two Requests In line with previous guidance on IPTRs, NHS Boards should secure patient and public involvement in the development of their PACS Tier Two policies and processes through their patient focus and public involvement arrangements. Patient Involvement in the PACS Tier Two Process In addressing patient involvement in the PACS Tier Two process, NHS Boards and requesting clinicians should undertake the following: the requesting clinician should provide the patient with the PACS Tier Two national patient information sheet as soon as a decision has been taken to make a request through PACS Tier Two. the requesting clinician will present the case to the Panel for the medicine on behalf of the patient (or patient s representative) using the PACS Tier Two paperwork. In doing 7

15 so, they will have ensured that the patient understands the application which is being submitted on their behalf and has consented to its submission; verbal and written statements by patients must not be submitted to the panel; where appropriate, the clinician should provide the contact details of suitably trained personnel within the NHS Board who can provide further advice and support to the patient/patient representative, including any other patient information and support mechanisms available. Communicating PACS Tier Two Decisions On reaching a decision, the record of the PACS Tier Two decision must be documented in Part D of the original PACS Tier Two paperwork and should be ed to the requesting clinician within 5 working days, or if possible on the same day if clinical urgency demands this. The record should include the rationale for the decision, including where possible a detailed breakdown of the panel s assessment of the application against the decision making criteria and should be as comprehensive as possible to aid understanding of the decision. PACS Tier Two decisions should be communicated to the patient/patient representative by the requesting clinician responsible for their care within a timescale previously agreed with the patient/patient representative. The requesting clinician should discuss the outcome of the PACS Tier Two request in detail, and clarify the options open to the patient for their future treatment. If felt appropriate, the clinician can make an application for a national review of the PACS Tier Two decision via the National Review Panel (see Annex B for information on the review application process). In addition to the national review process, if a patient is not satisfied with the way the PACS Tier Two process was handled, they can progress their concerns via the NHS complaints process. Maintaining Accurate Records NHS Boards are expected to maintain accurate and up to date information on PACS Tier Two requests and their outcomes. These arrangements should facilitate requests from Scottish Ministers for high level summary information in relation to medicines requested and whether or not these were made available. Data Capture NHS Boards are expected to capture and share the following data as retrospective in confidence summary management reports in line with General Data Protection Regulation (GDPR) principles with the Scottish Government as part of the PACS Tier Two process on a quarterly basis. PACS Tier Two NHS Board output Medicine, strength and formulation Status (orphan, end of life etc. according to SMC classification) Indication Decision (supported/not supported /deferred for further information) Grounds for the decision (not supported/deferral) 8

16 PACS Tier Two National Review panel output (NHS Board) Medicine, strength and formulation Indication National Review Panel findings (review required/not required) Confirmation of advice implementation, decision and date (if appropriate) The Scottish Government will share this collated data with all NHS Boards quarterly to allow for comparison. 9

17 ANNEX B Guidance on the Operation of the National Review Panel PACS Tier Two Review Process In the event where a requesting clinician and patient feel they have grounds for a review of a local PACS Tier Two decision, a National Review Panel will be established to independently review and make recommendations to the relevant NHS Board on their original decision. This replaces each NHS Board s own local IPTR appeal process. Composition of a PACS Tier Two Panel HIS will ensure that the National Review Panel will be clinician-led and include appropriate senior medical and pharmacist perspectives. The individuals involved in the Panel should be fully conversant with the National Review Panel policies. HIS will give due consideration to any training required for Panel members. The review process will accommodate reviews on either of the following grounds: the NHS Board has failed to follow due process and the situation cannot be resolved locally; and/or the NHS Board has reached a decision which could be deemed unreasonable in light of the evidence submitted. The Panel will undertake a review of the evidence presented and will consider whether due process had been correctly followed and/or that the decision reached was reasonable on the basis of the evidence presented. National Review Panels will be convened on a monthly basis. Meetings can be held electronically (by WebEx/video and teleconferencing) to support the rapid turnaround of applications. However, ad-hoc meetings of the National Review Panel will be convened when the clinical urgency of the case dictates that this is necessary. The National Review Panel is a function within Healthcare Improvement Scotland (HIS) who will facilitate support to the Panel. HIS will be responsible for its governance and will provide all the necessary support to the Panel. HIS personnel will not be part of the review process. It is the responsibility of the requesting clinician, with the patient s consent, to submit an application to the National Review Panel by completing Appendix 1 of the original PACS Tier Two paperwork submitted to the Board s PACS Tier Two Panel. The requesting clinician should provide a robust case for the review, including any substantiation of procedural impropriety and/or that the decision could not have been made reasonably on the basis of the evidence presented. In the event that the clinician is requesting a review because the NHS Board failed to follow due process then the clinician should also send the Board s PACS Tier Two process. Paperwork that is incomplete or has been completed incorrectly will be returned to the requesting clinician and will not be considered by the National Review Panel. 10

18 As with a PACS Tier Two request, NHS Boards should put in place appropriate mechanisms for clinicians in advance of making a request for a national review to ensure applications are submitted as effectively and efficiently as possible. This includes advice regarding appropriate evidence and completion of the paperwork. PACS Tier Two Review Applications An application to the National Review Panel must be made by the requesting clinician, through a secure NHS Scotland address. The clinician should also redact information relating to patient identifiable information in advance of it being submitted to the National Review Panel (via HIS), in line with data protection requirements. The information which should be redacted should be as follows: Part A: Request Details Patient s CHI No Patient postcode Part B: Case for Prescribing Any person identifiable references to the patient Part C: Peer Support Any personal identifiable references to the patient Part D: PACS Tier 2 Decision record Any named references to the patient HIS will notify the Chief Executive, Medical Director and Director of Pharmacy in the relevant NHS Board that an application for a PACS Tier Two review has been made. PACS Tier Two Review Requests A request for a national review will not be accepted solely because the clinician and/or patient do not agree with the views or conclusions reached by the local PACS Tier Two Panel. Where a review is requested because a clinician and patient consider that the conclusion reached by the local Board s PACS Tier Two Panel was not reasonable on the basis of the evidence presented, it will be for the clinician requesting the national review to provide justification for this in their application. The National Review Panel will review the original NHS Board s PACS Tier Two decision on this basis. Where a review is requested because the clinician and patient consider that the NHS Board has failed to follow due process then the National Review Panel will only accommodate a review in the event where this cannot be resolved locally. The National Review Panel will not accept applications where new evidence for the medicine emerges or if the original decision was based on a factual inaccuracy. The requesting clinician should pursue a resubmission through the NHS Board PACS Tier Two process. 11

19 PACS Tier Two National Review Panel No new evidence will be considered by the National Review Panel. The National Review Panel will refer to the decision making criteria used by the local NHS Board PACS Tier Two Panel which is laid out in this guidance. Evidence to be submitted at the time of request and that will be considered by the National Review Panel includes: the original request submitted to the Board s PACS Tier Two Panel (Parts A-D of the paperwork); appendix 1 of the paperwork completed by the requesting clinician making the case for procedural impropriety or that the decision could not have been made reasonably on the basis of the evidence presented; any additional note of the meeting or evidence relating to the case by the NHS Board; and the NHS Board s PACS Tier Two process and procedures. Both the NHS Board and the requesting clinician will be invited to attend and present at the National Review Panel. Outcome of the Review Process The purpose of the review is to consider the reasonableness of a local PACS Tier Two Panel s decision and/or whether due process has been followed. As regards reasonableness this is in the context of whether the decision in question would be deemed reasonable on the basis of the evidence presented. The review process will therefore establish if the ground(s) for review is/are or is not/are not established. The National Review Panel will either make a finding: that a decision, with reference to the information and/or evidence on which that decision is based, is or is not reasonable; or on whether or not due process has or hasn t been followed. In the event that the Panel make a finding that the review ground(s) is/are not established then the NHS Board will not be expected to revisit the original decision. If the ground(s) of review is/are established then the case will be redirected back to the NHS Board who will be expected to convene a new PACS Tier Two Panel in order to revisit their original decision, taking into account the National Review Panel reasoning as to why it considered either the original decision unreasonable in light of the evidence submitted and/or that due process had not been followed. The National Review Panel will issue its findings and recommendations, using Appendix 2 of the paperwork at Annex C, to the relevant NHS Board Chief Executive, Medical Director and Director of Pharmacy, ideally within one working day of the panel meeting. The NHS Board must inform the requesting clinician, as soon as practicable taking into consideration any clinical urgency, of the National Review Panel s decision and recommendations. 12

20 Final decision The final decision is for the NHS Board to determine. The NHS Board should convene a new PACS Tier Two Panel to consider the request and ensure that the final PACS Tier Two decision is communicated within a timescale that takes into account any associated clinical urgency and/or the patient s clinical needs. It is the responsibility of the requesting clinician to inform the patient of the final decision. There will be no further right to appeal. 13

21 ANNEX C Paperwork to be used for all PACS Tier Two and Review Applications The PACS Tier Two paperwork replaces all existing NHS Board local paperwork and should be used for PACS Tier Two and National Review applications from the 1 June 2018 subject to local governance processes. The paperwork comprises a national set of PACS Tier Two forms which aims to enhance the consistency of approach across all NHS Boards in Scotland. The ADTC Collaborative will ensure the ongoing review and development of the PACS Tier Two paperwork and provide any relevant best practice statements as appropriate. All Boards are required to use the same PACS Tier Two paperwork to ensure consistency of approach. The PACS Tier Two paperwork should be completed, saved and submitted electronically. Paper copies should not be accepted unless in exceptional circumstances. Please see separate attachment for forms. 14

22 Peer Approved Clinical System PEER APPROVED CLINICAL SYSTEM (PACS) TIER TWO REQUEST FORM AND DECISION RECORD Please note: This form is only to be used to request access to a licensed medicine that; is a medicine for an indication that has been considered and not recommended for use in NHS Scotland by the Scottish Medicines Consortium (SMC); or is a medicine accepted for restricted use by SMC but the intended use is out with SMC restrictions; or is a medicine which has been submitted and is awaiting/undergoing evaluation by the SMC. Access to ultra-orphan medicines, unlicensed medicines, use for indications outside of the marketing authorisation (off-label) and medicines which are non-submissions or have not yet been submitted to SMC are not covered by PACS Tier Two. Notes for electronic completion: This document can be completed by adding text to the grey text fields and by checking the tick boxes or selecting from drop-down boxes where applicable. It should be completed, saved and submitted electronically. Paper copies will not be accepted unless in exceptional circumstances. The form is partitioned into 4 parts and 2 appendices: Parts A - C are to be completed prior to submission to the PACS Tier Two Panel. Part D is to be completed by the PACS Tier Two Panel only. Appendix 1 is to be completed when referring a decision to the National Review Panel. Appendix 2 is for completion by the National Review Panel only. Before submitting: 1. The requesting clinician completes parts A and B. 2. Part C is completed by another NHS clinician who is experienced in treating the condition for which the medicine is being requested. 3. Part D is completed by the PACS Tier Two Panel. 4. Appendix 1 is completed by the clinician in the event of referral to the National Review Panel. 5. Appendix 2 is completed by the National Review Panel. Please note that paperwork that is incomplete or has been completed incorrectly will be returned to the requesting clinician and will not be considered by the National Review Panel. How to submit the request: This section may be edited at board level to accommodate local processes. On reaching a decision: 1. The record of the PACS Tier Two decision must be documented in Part D of this form. The Chair of the PACS Tier Two panel should inform the requesting clinician of the decision by ing a completed copy of Part D of this form within 5 working days, or if possible on the same day if clinical urgency demands this. 2. The Chair of the PACS Tier Two panel should ensure that a copy of the completed PACS Tier Two form and decision is ed to the (insert local contact details). 3. Decisions should be communicated to the patient/patient representative by the requesting clinician responsible for their care within a timescale previously agreed with the patient/patient representative. 4. The responsible clinician should discuss the outcome in detail, clarify future treatment options and discuss grounds for review, if appropriate, with the patient/patient s representative. 5. The patient s clinician should file a copy of the PACS Tier Two form and decision in the patient s case notes and retain a copy for future outcome reporting. (This paperwork will be required in the event of a referral to the National Review Panel or information requests from Scottish Ministers). PAGE 1 of 11

23 Peer Approved Clinical System PART A: PACS TIER TWO REQUEST DETAILS To be completed for all requests made by the requesting clinician Patient s CHI Number: NHS board conducting PACS Tier Two: (Please select from the drop-down list) Patient s NHS board (if different from above): (Please select from the drop-down list) Hospital/site where treatment is to be delivered/initiated: NHS NHS Ayrshire and Arran Patient Postcode: Requesting Clinician: Position held: address: Telephone/pager: Acute Services Division: Medicine and formulation: (Include strength and dosage, refrain from using abbreviations. Please also include the SMC ID where known) Intended indication: (Also include any relevant positioning) Clinical urgency: (Please select from the drop-down list) Routine - response required within 4 weeks Please give an explanation for your response regarding clinical urgency: How does this request relate to the SMC status of this medicine: (Has the medicine not been recommended by SMC or is it awaiting/undergoing evaluation by the SMC, or is the intention to use the medicine outside of the restrictions on use imposed by SMC advice? Please select from the drop-down list) Medicine not recommended for use by SMC Under which process(es) was medicine considered by SMC (This is the status of the medicine according to the SMC classification. Tick all options which apply) Orphan End-of-life None PAGE 2 of 11

24 The patient understands the process: (The clinician should explain the process to the patient (including the process for review) and ensure that the patient is content that the clincian will represent all of their clinical interests. Tools to support this may include using the national patient leaflet etc. Multidisciplinary team support: (If the patient is under the care of the multidisciplinary team the clinician has discussed the request and gained their agreement and support). Peer Approved Clinical System Tick here to confirm Tick here to confirm In accordance with the Code of Conduct of NHS (insert local Health Board) you are required to declare all interests you have in the pharmaceutical company which markets the medicine you are requesting on this form. It is possible that these may be checked against the national ABPI Interests database. Declared Interests do not directly impact on the process or decision, but are required to be noted to ensure transparency of process. Declaration of interests: No interests to declare (Please select from the drop-down list) Personal interests may be payments/fees/resources etc that you have received personally from the company Non-personal interests may include payments/fees/resources etc. that your department has received from the company Specific interests are those that relate directly to the medicine you are requesting Non-specific interests are those that relate to the company, but not directly to the medicine you are requesting Details of any declared interests: (Where applicable) By ticking this box I confirm that I am the clinician named above in charge of the patient s care: Date: PAGE 3 of 11

25 Peer Approved Clinical System PART B: PACS TIER TWO CASE FOR PRESCRIBING To be completed for all requests The responsibility for a request through the PACS Tier Two process rests with the clinician who supports prescribing the requested medicine. It is the requesting clinician who is expected to demonstrate the clinical case for the patient to be prescribed the medicine within its licensed indication(s) where the following criteria apply: 1. The clinician can demonstrate that a reasonable attempt, or appropriate consideration, has been made to treat the patient in the first instance with medicines currently accepted by the SMC for routine use in NHS Scotland for this condition and for the patient in question that these medicines are deemed unsuitable or have been found to be ineffective; and 2. The clinician can present an evidence-based case to demonstrate the potential that the patient will achieve a measurable clinical benefit at least comparable to if not better than that experienced by the population considered by SMC. PLEASE NOTE: Only the information detailed on this form will be used to inform the panel s decision (and the review panel should that be required) and you will not have any further opportunity to clarify or provide further information. It should be noted that a lack of relevant detail relating to the patient may result in the panel not having sufficient information to ascertain that the request meets the referral criteria noted above. Information directly relating to referral criteria: Please provide information to demonstrate that a reasonable attempt, or appropriate consideration, has been made to treat the patient with routinely available medicines normally of similar or better efficacy, including why they are deemed unsuitable for the patient or have been found to be ineffective. PAGE 4 of 11

26 Considering any existing SMC advice (if available), please demonstrate the likelihood that the patient will achieve measurable clinical benefit (You should include all relevant factors such as performance status, previous response to other medicines and individual clinical characteristics that suggest that the patient will derive increased benefit. Please provide full citations for any clinical papers referred to) Peer Approved Clinical System Further information relating to patient: Previous treatment received by patient for this indication where available and why this is not being continued (Including approximate durations) Are there any supportive treatments, diagnostic tests or monitoring needed for this treatment? (provide detail, including whether the tests etc are routinely available) What are the potential adverse effects of the medicine requested? What outcome(s) would you propose to measure to ascertain a response to treatment? Detail the outcomes you would measure and how you would determine response (e.g. a response may be either an improvement in an outcome, or determined to be stabilisation) Under what circumstances would the requested treatment be reviewed or discontinued? Considering the outcomes that are proposed to be monitored, how would these be used to determine stopping criteria? PAGE 5 of 11

27 Information directly relating to the medicine: Relevant NICE advice (available from If the medicine has been accepted for use by NICE, please provide a reference (e.g. NICE TA number) and brief summary of guidance on use Relevant All Wales Medicines Strategy Group (AWMSG) (available from If the medicine has been accepted for use by AWMSG, please provide the reference number and brief summary of guidance on use Any other information: Peer Approved Clinical System PAGE 6 of 11

28 PART C: PEER REVIEW Peer Approved Clinical System As part of best practice and in order to strengthen the case being made, the requesting clinician must seek peer review for their application from another NHS clinician with suitable experience in treating the condition for which the medicine is being requested. This clinician may be from within the same NHS board, but if there are no other clinicians with suitable expertise locally, then an expert within the NHS from elsewhere in Scotland or the UK can provide the peer review. In providing a peer review of the information presented for the patient, the reviewing clinician is considering that (a) any alternative accepted medicines have been considered and excluded as unsuitable treatment options and (b) the patient characteristics detailed and the clinical evidence presented imply that the response to treatment will be at least comparable, if not increased, compared to the population considered by SMC. Name and position: NHS board/ Employing authority Peer review statement: The clinician should state his/her opinion relating to the request for this medicine for this condition, indicating whether they are supportive of the request and why. NHS Ayrshire and Arran In accordance with the Code of Conduct of NHS (insert local Health Board) you are required to declare all interests you have in the pharmaceutical company who market the medicine you are requesting on this form. It is possible that these may be checked against the national ABPI Interests database. Declared Interests do not directly impact on the process or decision, but are required to be noted to ensure transparency of process. Declaration of interests: No interests to declare (Please select from the drop-down list) Personal interests may be payments/fees/resources etc that you have received personally from the company Non-personal interests may include payments/fees/resources etc. that your department has received from the company Specific interests are those that relate directly to the medicine you are requesting Non-specific interests are those that relate to the company, but not directly to the medicine you are requesting Details of any declared interests: (Where applicable) By ticking this box I confirm that I am the clinician named above: Date: PAGE 7 of 11

29 Peer Approved Clinical System PART D: PACS TIER TWO DECISION RECORD PLEASE NOTE: TO BE COMPLETED BY THE PACS TIER TWO PANEL ONLY PACS TIER TWO PANEL MEMBERSHIP: In accordance with Code of Conduct of NHS (insert local Health Board) each panel member is required to declare all interests they have in the pharmaceutical company who market the medicine you are requesting on this form. Panel Chair (Typically a senior clinician) Panel member and position held: Name and position: Declaration of interests: Non-personal, non-specific interests declared No interests to declare Panel member and position held: No interests to declare Panel member and position held: Panel member and position held: PACS TIER TWO PANEL DISCUSSION: Date request received: How panel discussion was conducted: (Please select from the drop-down list) Main discussion points of panel: (Include how evidence and peer perspective were weighted) Meeting DECISION OF REQUEST AND RATIONALE: PACS TIER TWO PANEL DECISION: (Please select from the drop-down list) Terms and conditions of acceptance (optional): E.g. duration of treatment after which efficacy must be reviewed, monitoring schedule or stopping criteria. Where applicable, these terms should be clearly conveyed to the patient prior to commencing treatment. Rationale for submission not supported: Where a request has been rejected, the reasoning MUST be clearly stipulated in this section to allow the patient and clinician to be able to understand the rationale for the decision made. Not Supported No interests to declare No interests to declare Date of discussion: PAGE 8 of 11

30 Feedback to requesting clinician: Where the request has been rejected, and there is scope for further review (e.g. there was insufficient information given to allow the panel to make a decision, please indicate what the clinician may do) Peer Approved Clinical System By ticking this box I confirm that I am the PACS TIER TWO Panel Chair as detailed above: Please provide further detail and resubmit as new request Other (provide additional comment in text box below) Date: This form should be ed to the requesting clinican within 5 working days of the panel decision, or if possible on the same day if clinical urgency demands this. PAGE 9 of 11

31 Peer Approved Clinical System APPENDIX 1: APPLICATION TO NATIONAL REVIEW PANEL Date of original application: Basis for review request: (NOTE: a review will not be accepted on the grounds that the patient or clinician does not agree with the views or conclusions reached) Date of PACS TIER TWO Panel advice: reached a decision which was not reasonable Case for review request: The requesting clinician should provide a robust case for the review, including any substantiation of procedural impropriety and/or that the decision could not have been made reasonably on the basis of the evidence presented. By ticking this box I confirm that I am the clinician in charge of the patient s care and that the patient supports the decision to request a review: Date: PAGE 10 of 11

32 Peer Approved Clinical System APPENDIX 2: NATIONAL REVIEW PANEL ADVICE Please note: to be completed by the national review panel only NATIONAL REVIEW PANEL MEMBERSHIP: In accordance with the Code of Conduct of NHS (insert local Health Board) each panel member is required to declare all interests they have in the pharmaceutical company who market the medicine you are requesting on this form. Panel Chair and position held Name: Declaration of interests: Non-personal, non-specific interests declared Panel Member and position held: Panel Member and position held: Panel Member and position held: NATIONAL REVIEW PANEL DISCUSSION: Date request received: How review panel discussion was conducted: (Please select from the drop-down list) Meeting No interests to declare No interests to declare No interests to declare Date of discussion: Basis for review request: (NOTE: a review will not be accepted on the grounds that the patient or clinician does not agree with the views or conclusions reached) Main discussion points of review panel: reached a decision which was not reasonable OUTCOME AND RATIONALE: NATIONAL REVIEW PANEL FINDING (Please select from the drop-down list) Rationale: (state why the panel feels a review is or is not necessary based on original evidence submitted) Then original decision was reasonable By ticking this box I confirm that I am the Review Panel Chair as detailed above: Date: PAGE 11 of 11

33 PEER APPROVED CLINICALSYSTEM TIER 2 (PACS 2) POLICY STATEMENTS INTRODUCTION These policy statements provide Health Boards with guidance to promote consistency of application of the Peer Approved Clinical System Tier 2 (PACS 2) across NHS Scotland. These policy statements have been developed to reflect Scottish Government guidance noted in Guidance on the Implementation of the Peer Approved Clinical System (PACS) Tier Two issued 29 March GENERAL POLICY STATEMENT 1.1. SMC advice for a particular medicine and indication is made on the basis of an evaluation of the comparative clinical evidence and cost effectiveness compared with standard clinical practice in Scotland. The PACS 2 process is not intended to overturn the SMC advice, but provides an opportunity for senior clinicians, on a case-by-case basis for individual patients, to request use of a licensed medicine as outlined below. The PACS 2 process takes into consideration the application of set decision making criteria and the wider benefit of the request to the NHS (see section 6). 2. APPLICABILITY AND SUBMISSION 2.1. The PACS 2 process is applicable to requests for access to a licensed indication where: The SMC has considered a submission for a medicine and has issued not recommended advice; or The request relates to use of the medicine out-with a SMC restriction; or Where a medicine has been submitted but the SMC has yet to issue advice on the medicine where the clinician responsible believes a delay in treatment until publication of SMC advice would result in a significant adverse outcome for the patient The PACS 2 process is open to senior clinicians who are directly responsible for a patient s care. This may be a Consultant, GP or Lead Non-Medical Prescriber in a specialist area It is the responsibility of the clinician to make the case for prescribing the medicine using the PACS 2 request form. Only the information contained in this form will be used to inform the Panel s decision (and any subsequent review of the decision should that be sought). It should therefore be noted that a lack of relevant detail relating to the patient may result in the Panel making a negative decision The requesting clinician should brief the patient (or their representative) on treatment options and likely benefits, associated risks, monitoring of outcomes, review of benefit and criteria for discontinuation. PACS 2 DOPs Implementation Task and Finish Group May 2018 PAGE 1 OF 5

34 PEER APPROVED CLINICALSYSTEM TIER 2 (PACS 2) 3. PEER SUPPORT 3.1. The requesting clinician must seek peer support for their application from another clinician. Peer Support should be completed by another clinician with experience in treating the condition for which the medicine is being requested. Part C of the PACS 2 request form should be completed independently by the designated reviewing clinician In providing a peer review of the information presented for the patient, the reviewing clinician is stating that: any alternative SMC accepted medicines have been considered and excluded as suitable treatment options and the patient characteristics detailed and the clinical evidence presented demonstrate the potential that the patient will achieve a measurable clinical benefit at least comparable to if not better than that experienced by the population considered by SMC The reviewing clinician may be from within the health board where the request is being made. If there are no other appropriate clinicians locally, then experts within the NHS from elsewhere in Scotland or the UK can provide the peer review statement Where the care of the patient in question is under the care of a multi-disciplinary team, clinicians should seek their support for the PACS 2 application and indicate this in Part A of the request form. Please note Part C: PEER REVIEW section of the form still requires to be completed 4. NATURE OF EVIDENCE 4.1. The Board s PACS 2 Panel will consider the information submitted by the clinician on the PACS 2 request form. Evidence and information from clinicians to demonstrate the fulfilment of the decision making criteria and that prescribing the medicine is of benefit to the patient and to the NHS may include: SMC advice (where available) Any new evidence that has emerged since an SMC decision Peer reviewed evidence, e.g. a medicines summary information Expert opinion Rationale for why alternative SMC accepted medicines are unsuitable, for example, intolerable side effects, contraindications or other treatments being ineffective The balance between benefit and risk (for example side effects or contraindications) Individual characteristics which have been shown to have a positive influence on response e.g. specific genetic sub-types where clinical evidence is stronger Other UK guidance or formal health technology assessment with new evidence that has emerged since The SMC advice was published which is of relevance to the individual patient Impact of the requested treatment on healthcare, e.g. cost effectiveness and the balance of benefit and risk in the context of what is the wider benefit to the NHS PACS 2 DOPs Implementation Task and Finish Group May 2018 PAGE 2 OF 5

35 PEER APPROVED CLINICALSYSTEM TIER 2 (PACS 2) 5. PACS 2 PANEL MEMBERSHIP 5.1. The Panel for reviewing a request via PACS 2 will be clinically composed and will typically include: Senior physician (e.g. Chief of Medicine, Clinical Director, Medical Director) or nominated deputy Senior pharmacist Other relevant healthcare professionals as appropriate 5.2. An appropriate person to comment on service requirements and implications (such as a General Manager or Service Manager) may be sought to join the Panel where required 5.3. Local arrangements should be in place for managing PACS 2 request for patients from other health boards. 6. PANEL CONSIDERATIONS FOR DECISION MAKING 6.1. The Panel will initially consider whether the request has clearly demonstrated that the patient s individual clinical circumstances meet the following decision making criteria: i. The clinician has demonstrated that a reasonable attempt, or appropriate consideration, has been made to treat the patient in the first instance with medicines currently accepted by the SMC for routine use in NHS Scotland for this condition and for the patient in question that these medicines are deemed unsuitable or have been found to be ineffective; AND ii. The clinician has presented an evidence-based case to demonstrate the potential that the patient will achieve a measurable clinical benefit at least comparable to if not better than that experienced by the population considered by SMC The Panel will, in addition, consider the wider benefit of the request to the NHS. Evidence and decision making should focus on the clinical merit of the application for the individual patient. Consideration should be given to the wider benefit to the NHS, the Panel may consider aspects such as the level of health gain in the context of NHS resource consumed and the balance of benefit and risk The Panel should also consider whether availability elsewhere in the UK is driven by new evidence that has emerged since an SMC decision was published which is of relevance to the individual patient If the Panel agree the decision making criteria have been met and that prescribing the medicine is considered of benefit to both the patient and the NHS then the request should be supported. If the Panel feels the decision making criteria have not been met and/or the medicine is not considered of benefit to the patient and the NHS then the request should not be supported Appendix 1 provides Panels with a decision checklist tool to assist in the consideration of request and to help promote consistency in approach. PACS 2 DOPs Implementation Task and Finish Group May 2018 PAGE 3 OF 5

36 PEER APPROVED CLINICALSYSTEM TIER 2 (PACS 2) 7. TIMESCALE FOR DECISION 7.1. Timescales for the decision-making process will be established in accordance with the patient s clinical needs and be communicated to the patient by the clinician responsible for the patient s care, following discussion with the Panel Chair. The clinician will be responsible for outlining any time dependent factors. 8. DOCUMENTATION AND COMMUNICATION OF DECISION 8.1. The decision of the Panel will be recorded in full by the chair of the Panel in the part D of the PACS 2 request form. The rationale for the decision should be as helpful and comprehensive as possible. The rationale should specifically relate to the decision making criteria for acceptance and the wider benefit to the NHS A completed decision checklist (appendix 1) should form the basis of the content recorded in the Main discussion points of Panel section in the Part D of the PACS 2 request form 8.3. The chair of the Panel will then inform the requesting clinician of the decision in writing or via by providing a copy of the fully completed PACS 2 request form including the decision and rationale within 5 working days, or within the same day for cases deemed to be an emergency In some cases, follow-up discussions between the chair of the PACS 2 Panel and the requesting clinician may be helpful to clarify the discussion The decision should be communicated to the patient/patient representative by the clinician responsible for their care within one working day and there should also be discussion with the patient around the decision, future treatment options and consideration of application to the National Review Panel if relevant It is good practice to file a copy of the completed PACS 2 request form in the patient s medical notes Where the patient is not satisfied with the way the PACS 2 request was handled, this could include progressing their concerns via the NHS complaints process. Complaints and national reviews about the PACS 2 process can be progressed simultaneously and will not impact on each other Once clinical agreement has been reached by the Panel the financial consequences of this decision needs to be sent to the appropriate management team so that this can be accounted for within financial planning and budgetary processes. Boards will need to consider local requirements and processes to ensure that PACS 2 decisions are compliant with SFIs PACS 2 DOPs Implementation Task and Finish Group May 2018 PAGE 4 OF 5

37 PEER APPROVED CLINICALSYSTEM TIER 2 (PACS 2) 9. SUPPORT FOR THE PATIENT 9.1. The patient is supported and guided through the PACS 2 process primarily by his/her clinician, who will outline the terms on which a PACS 2 request can be submitted and the basis of the case in addition to answering any specific questions the patient may have The patient will also have access to other persons within the health board who can offer support regarding the PACS 2 process (via the patient s clinician) Each patient should be given a patient information leaflet which will provide information relating to the PACS 2 process including an overview of the process, sources for further advice, timescales and the reviews process. 10. DECLARATION OF INTERESTS Relevant declarations of interest of all persons involved in the process should be captured using the PACS 2 request form. PACS 2 DOPs Implementation Task and Finish Group May 2018 PAGE 5 OF 5

38 APPENDIX 1 DECISION CHECKLIST To be used when considering requests for medicines for individual patient use whether licensed. PACS 2 reference 35T (Where there are options Y/N please delete as appropriate, additional text space is provided to include information which is not contained on the request form) The panel should consider and note: 1. Clinical effectiveness a) Has the clinician demonstrated that a reasonable attempt, or appropriate consideration, has been made to treat the patient in the first instance with medicines currently accepted by the SMC for routine use in NHS Scotland for this condition and for the patient in question that these medicines are deemed unsuitable or have been found to be ineffective? N (if negative the process should not continue) Y 35T b) Has the clinician presented an evidence-based case to demonstrate the potential that the patient will achieve a measurable clinical benefit at least comparable to if not better than that experienced by the population considered by the SMC N (if negative the process should not continue) Y 35T c) Is the patient expected to achieve a clinical benefit better than experienced by the population or sub populations, considered by the SMC e.g. are there any individual patient characteristics for example genetic sub-types where the clinical evidence is stronger? N Uncertain Y 35T d) The strength of the available evidence (tick those that apply) SMC DAD Clinical Trials Additional case studies etc. 35T Additional relevant information e.g. briefing from MI 35T e) Nature of the benefit, when will occur and duration of benefit? 35T f) Likely response rate and/or attributable risk reduction and how this differs from the population reviewed by SMC (if applicable)? 35T PACS 2 DOPs Implementation Task and Finish Group May 2018 Page 1 of 3

39 2. Risk Benefit a) Are there any safety considerations in using this medicine in this individual case that would affect the risk benefit e.g. side effects/ health risks and likelihood of occurrence? 35T 3. Equity a) Has this medicine been approved for use in the same or similar circumstances within your NHS Board? N Y 35T b) Has this medicine been approved for use in the same or similar circumstances within UK? N Y 35T 4. Operational Impact a) Service Impact for example chair time, clinic capacity etc. 35T b) Other considerations e.g. administration, regimen, travel etc. 35T c) Nursing impact training/ expertise/ capacity 35T d) Pharmacy impact is it in stock/ used before/ protocols in place? Impact on aseptic services/ capacity? 35T e) Other factors space, equipment, diagnostics, etc. 35T f) Does this contribute to any NHS priorities e.g. care closer to home, waiting time reduction etc. 35T 5. Assessment of benefit to the NHS - health gain versus resource consumed Impact of the requested treatment on healthcare e.g. Cost effectiveness and affordability, and the balance of benefit and risk in the context of what is the wider benefit to the NHS? 35T PACS 2 DOPs Implementation Task and Finish Group May 2018 Page 2 of 3

40 Note of meeting taken by 35T Signed 35T Date 35T PACS 2 DOPs Implementation Task and Finish Group May 2018 Page 3 of 3

41 1st step Check the Lothian Joint Formulary Can be prescribed without additional paperwork Yes Is the medicine included for the proposed indication? Complete Non-formulary request form and give to relevant pharmacist. 1 Follow "PTR" policy and procedures No Yes No Is medicine licensed for proposed indication? Yes Is there advice from SMC for the proposed indication? No Is the medicine and proposed indication out-side the remit of SMC? No Has the medicine been submitted to SMC for the proposed indication, and advice is awaited? No Yes Refer to Unlicensed Medicines Policy Is the proposed indication approved for use by the SMC? No Was the medicine assessed under the ultra-orphan process? 2 Yes Follow PACS tier 2 policy and procedures Complete Non-formulary request form and give to relevant pharmacist. 1 An unlicensed medicine request form may need to be completed; liaise with your pharmacist. Yes Yes No Complete Non-formulary request form and give to relevant pharmacist. 1 Follow PACS tier 1 policy and procedures Follow PACS tier 2 policy and procedures Version 1 (May 2018) Written by N Murray, Pharmacy Department, Royal Infirmary of Edinburgh Footnotes: 1 - If there is likely to be a patient group who would benefit from the medicine for the indication, formulary application requests can be made; refer to the Lothian Joint Formulary website for details. 2 - Assessment by SMC under the ultra-orphan process is noted within the Detailed Advice Document published by SMC.