A Framework for Decision Making for Tests in the Scottish Molecular Pathology service. Date of issue: April 2015

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1 A Framework for Decision Making for Tests in the Scottish Molecular Pathology service Date of issue: April 2015

2 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 2 of 27 This document has been produced by the Molecular Pathology Evaluation Panel to support the evaluation of molecular pathology tests for the Scottish Molecular Pathology Consortium. The framework is based on the UK Genetic Testing Network Gene Dossier Model for the evaluation of genetic testing. Acknowledgement and thanks is given to UKGTN to allow the adaptation of the model for the introduction of molecular pathology framework. If you have any queries regarding this Framework, please contact: National Services Division, NHS National Services Scotland nss.mpep@nhs.net Further details can be found at Date of issue: April 2015 Date for review: April 2017 Framework\Papers\ Molecular Pathology Framework v2.0

3 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 3 of 27 Contents 1. Introduction Scottish Molecular Pathology Service Genetics and Molecular Pathology Molecular Genetics and Cytogenetics Molecular Pathology Types of Tests Diagnosis Prognosis Disease monitoring Treatment Stratification National Services Division A Consortium Approach Principles of Decision Making Safe Equitable Efficient Effective Person Centred Timely Process for consideration of new tests Molecular Pathology Evaluation Panel Laboratory Minimum Standards Process and Governance Structure Reporting Structure Appeals process Principles that the Panel works within Decommissioning Assays Links with SMC and test manufacturers Annex A - Test Submission Form Annex B Criteria for Decision Making Annex C Role, Remit, and ways of working Bibliography Framework\Papers\ Molecular Pathology Framework v2.0

4 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 4 of Introduction This document provides a framework for ensuring that decisions relating to the classification and declassification of molecular pathology tests in the molecular pathology service in NHS Scotland are reasonable, transparent and justifiable Scottish Molecular Pathology Service Molecular pathology services in Scotland have been established for many years, and have developed organically either within pathology, haematology or genetics services. In 2010, the Molecular Pathology Review Group made a number of recommendations on the future of pathology services in Scotland, these can be broadly summarised as follows: - Delivery of a nationally commissioned service run as a supported consortium - Molecular diagnosis should be delivered through the four Regional Centres in NHS Greater Glasgow and Clyde, NHS Lothian, NHS Tayside and NHS Grampian. - Development of robust quality assurance arrangements - Links with Scottish Cancer Taskforce, Cancer Networks, Scottish Medicines Consortium An Implementation Plan was developed outlining an approach to taking forward the recommendations. This was endorsed by the Diagnostic Steering Group in October 2011 and signed off at the first meeting of the Molecular Pathology Implementation Steering Group in May Genetics and Molecular Pathology There are different branches of genetic testing, and before trying to define molecular pathology it is important to understand these: 3.1 Molecular Genetics and Cytogenetics Molecular genetics was designated a national service in 1985 and is broadly considered as the branch of genetics that deals with the expression of genes by studying nucleic acid variation in mendelian disorders. Classification and declassification of these tests are determined by the United Kingdom Genetic Testing Network (UKGTN). Cytogenetics was designated as a national service in 2008 and is broadly considered the branch of genetics that correlates the structure, number, and behaviour of chromosomes with heredity and variation. Genetic testing is an important and increasing part of health care for many individuals. The field of genetic testing has developed rapidly, and information from genetic tests is becoming increasingly important in the assessment of non-mendelian disorders. As a result, other laboratories, including molecular pathology laboratories, some of which are distinctly separate from the designated national services have also developed expertise in molecular analysis. 3.2 Molecular Pathology In part due to the rapidly evolving nature of these specialist scientific tests, there is no universally agreed definition of molecular pathology. The earlier Review Group Report refers 1 Making Difficult Decisions in NHS Boards in Scotland (2010) Report of the Short Life Working Group, available at last accessed November 2011

5 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 5 of 27 primarily to tests undertaken for the molecular pathology of acquired disease and primarily the areas of cancer diagnosis, predictive and prognostic testing. For the Haematological malignancies the focus also included molecular assessments of Bone Marrow transplantation and minimal residual disease. A high level definition may be: The use of molecular biomarkers in the diagnosis, prognosis, disease monitoring and treatment stratification of human conditions 2. Molecular pathology is widely recognised as the study of biochemical and biophysical cellular mechanisms as the basic factors in disease. This can encompass a wide range of genes and diseases and may include DNA from humans, viruses, bacteria and microbiology. Molecular pathology for the purposes of this framework is restricted to the human genome and genetic markers or their surrogates for malignant tumours (cancer) primarily for the purpose of determining future therapies to treat or manage the cancer diagnosis. 3.3 Types of Tests A molecular pathology test is used to identify molecular biomarkers in the diagnosis, prognosis, disease monitoring and treatment stratification of human neoplastic conditions Diagnosis The test is used in the diagnosis of a neoplasm or to aid in the differential diagnosis. It may be used for exclusion purposes as well as confirmation e.g. the use of FOXO1 in the differential diagnosis of alveolar versus embryonic rhabdomyosarcoma or BIRC3-MALT1 in the diagnosis of MALT type lymphomas Prognosis The test gives an indication to the likely long term outcome for the patient and may involve the likely treatment response and/or survival on standard therapies. This is usually based on a comparison of the outcome when measured against the expected outcome for the same neoplasm with a normal genome content (as defined by current testing procedures) and often published as part of a trial report Disease monitoring The test may be used to monitor the disease status in the patient. Once an aberration has been identified, it may be possible to use this to monitor the disease status in the patient. Depending on the neoplasm, this may require a defined sequential monitoring of samples or when there is a defined clinical change in the patient (e.g. clinical relapse, disease progression). Such examples may include the monitoring of disease specific somatic mutations in the IgH gene in cases of ALL or the FISH analyses of cells from urine sediment in the case of bladder cancer Treatment Stratification The test may be used to indicate whether a particular course of treatment would be suitable for a patient or not. The test may be used both to include as well as exclude a possible therapy in a patient. Such testing would include ERBB2 testing in breast cancer to determine 2 A human neoplastic condition is abnormal mass of tissue resulting from an abnormal proliferation of cells. It usually causes a lump or tumor (but not always). Neoplasms may be benign, pre-malignant (carcinoma in situ) or malignant (cancer).

6 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 6 of 27 suitability for herceptin therapy or not, or PML-RARA testing in acute promyelocytic leukaemia to determine suitability for ATRA/arsenic therapy. Although diagnosis, prognosis, disease monitoring and treatment stratification have been listed separately, some tests could be categorised in more than one of these groupings e.g. a BCR-ABL1 positive result could be used in the diagnosis [CML, ALL or AML], disease monitoring [(RT-q) PCR for minimal residual disease], treatment stratification [imatinib or similar tyrosine kinase inhibitor (TKI)] and prognosis [a BCR-ABL1 positive individual on a TKI has a good prognosis]. 4. National Services Division National Services Division (NSD) is a division within NHS National Services Scotland (NSS). NSD receives top-sliced ring-fenced funding from the Scottish Government Health and Social Care Directorates (SGHSC) to commission and performance manage nationally designated specialist services, National Managed Clinical Networks (NMCNs) and screening programmes on behalf of NHS Scotland. NSD s primary purpose is to ensure the provision of high quality, effective, specialist health services to meet the needs of the population of Scotland, through a continued cycle of performance management. NSD works within the principles of safe, equitable, efficient, effective, person centred and timely care as defined in The Healthcare Quality Strategy for NHS Scotland 3. The Molecular Pathology Review Group recommendations and associated Implementation Plan, pave the way for the four regional laboratories to be a nationally designated services commissioned by NSD from April This will be similar to existing arrangements for Molecular Genetics and the Cytogenetics, whereby laboratories are nationally designated, funded and performance managed by NSD. In addition, the Scottish Genetics Consortium and the Heads of Laboratories Group are supported by NSD. A full list of designated services can be found at on NSD s website at 5. A Consortium Approach As well as the national commissioning of the laboratories undertaking molecular pathology testing, clinicians using the laboratory services and the heads of services come together to form a Consortium for Scotland. The overarching aims of the Consortium are to: provide a forum for collaborative discussion and decision-making on which tests will be provided in Scotland, in which laboratories and the priorities for introducing new tests. ensure that everyone in Scotland has access to the same high quality and timeliness of molecular pathology tests, regardless of geographical location. review annual activity, past trends and project forward likely future trends in activity and the quality of molecular pathology laboratory testing in Scotland; share information, audit performance, and share good practice; pursue opportunities for improving quality effectiveness and efficiency to make use of available resources. horizon scan and plan for sustainable services for the future Decision-making will be informed by the recommendations of the Molecular Pathology Evaluation Panel. 3 The Healthcare Quality Strategy for NHS Scotland (2010) The Scottish Government, available at last accessed November 2011

7 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 7 of Principles of Decision Making The Molecular Pathology Evaluation Panel identified the need for a framework outlining the decision making process to agree the commissioning of assays, which includes a Molecular Pathology Submission Form to be completed. See Annex A for details. It was agreed that: The framework will be applied retrospectively to the tests currently undertaken in Scotland Tests that are agreed for inclusion, will form part of the Consortium and be funded through NSD from April The Molecular Pathology Evaluation Panel will oversee the application of the framework (membership detailed in annex C). The NHS Healthcare Quality Strategy sets out the requirement for safe, equitable, efficient, effective, person centred and timely care. A robust national framework will help to ensure that molecular pathology services in Scotland meet these requirements. 6.1 Safe Tests undertaken as part of the Consortium are done so in laboratories that are appropriately accredited and that participate in all required external quality assurance schemes. 6.2 Equitable The Framework will provide a consistent approach across NHS Scotland that is reasonable, transparent and justifiable, bringing procedural fairness and accountability into the decision making and prioritisation process. Consideration of the resources available need to be factored into decision making, but priority must not automatically be given to tests which are not technically straightforward or are relatively inexpensive. 6.3 Efficient The Framework will ensure that tests undertaken within NHS Scotland are clinically useful thereby making best use of resources. It will provide a standardised process, which has clear points in the pathway for engagement with industry, in order to clarify roles, responsibility and expectations. 6.4 Effective All tests undertaken in Scotland as part of the national Consortium are clinically useful, and can be shown to affect patient management in particular situations. 6.5 Person Centred All patients will have access to high quality tests, supported by appropriate clinical management, regardless of where in Scotland they live and irrespective of their condition. 6.6 Timely The process for introduction of new tests will be streamlined to enable tests to be introduced to the Consortium quickly to ensure that patients can access optimal targeted treatments. Laboratories undertaking tests as part of the Consortium will be monitored to ensure that they provide a reliable service, meeting required turn around times so that treatment decisions are not delayed.

8 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 8 of Process for consideration of new tests 7.1 Molecular Pathology Evaluation Panel The Molecular Pathology Consortium will review on a rolling programme the provision and need of molecular pathology tests in collaboration with the users of the service. Molecular Pathology tests will be assessed and evaluated by the Molecular Pathology Evaluation Panel who will have responsibility for working to the confines of this framework using their knowledge in their field of expertise to assess and evaluate test submission forms ensuring that all tests undertaken are evidence based. The role and remit for Panel are outlined in Annex C. 7.2 Laboratory Minimum Standards Submissions will be accepted from Laboratories which meet the following: The Laboratory is part of the NHS Scotland Molecular Pathology Consortium The Laboratory is accredited by the Clinical Pathology Accreditation. The Laboratory participates in appropriate UK National External Quality Assurance Schemes, or European schemes for the particular tests/disorders. The testing laboratory should declare performance history, this should include participation in genotyping plus interpretation schemes where available. The Laboratory meets agreed turn around times, as dictated by relevant clinical standards The Laboratory collects data for audit, evaluation and monitoring purposes The Laboratory demonstrates that it provides a reliable service, including planning for staffing issues and technical problems The Laboratory has an active programme of research within the laboratory

9 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 9 of Process and Governance Structure

10 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 10 of Reporting Structure The Panel will report to the Molecular Pathology Consortium Steering Group through the cross membership of the Chair and secretariat and will have strong links with the existing Scottish Genetics Consortium, Scottish Medicines Consortium and the Diagnostic Steering Group. The Molecular Pathology Consortium Steering Group will consider the recommendations by the Panel and consider the resource implications associated with the test and agree which centre(s) the test should be undertaken. Recommendations from Consortium will go to the Diagnostic Steering Group for discussion and expert advice, then through NSSC to Board Chief Executives for funding decisions (if required) to be agreed. 7.5 Appeals process Feedback on the reason for a test being is not recommended will be provided to those who made the submission. Details on the appeals process can be obtained from the Panel secretariat. 7.6 Principles that the Panel works within Once the Panel has recommended a test following the evaluation of the test submission form, decisions on where it is undertaken and how many laboratories will do the test will be undertaken by the Molecular Pathology Consortium.. The molecular pathology submission outlines the reasons for undertaking the test, should additional reasons for undertaking a test be introduced following the original submission, i.e.: to inform different treatment decisions, NSD as commissioner will be informed of cost implications. If the costs are considerable, both in terms of the use of resources to undertake the test and in relation to the treatment decisions, in line with the SMC threshold, then this need for additional funds will be considered by the National Specialist Services Committee. If the Scottish Medicines Consortium accept a drug for use in Scotland which will require the development of a test to be undertaken by a laboratory in Scotland, a molecular pathology submission to the Panel will still be required to allow planning and implementation of the test. 7.7 Decommissioning Assays Laboratory activity is monitored and discussed annually with NSD. Should requests for tests cease, this will be discussed at the Molecular Pathology Consortium. If there is clinical consensus that the test is no longer required, due to different treatment pathways, laboratories will cease to offer the test. 7.8 Links with SMC and test manufacturers The Molecular Pathology Evaluation Panel will regularly liaise with SMC. The SMC horizon scanning team will provide early advice to the Panel and the Consortium of medicines that are in development that will require a companion diagnostic test. The Panel will evaluate new companion diagnostics alongside SMC assessment. SMC will confidentially share information from the manufacturer s submission of the New Product Assessment Form with members of the Panel and Consortium. Members of the Panel and the Consortium will be asked to provide expert advice on the information provided by the manufacturer eg test strategy, accuracy of test, cost of test and consumables/equipments etc and numbers of patients eligible for testing across Scotland to ensure responses reflect clinical and laboratory practice across NHS Scotland.

11 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 11 of 27 Annex A - Test Submission Form 1. ADMINISTRATIVE DETAILS 1.1. Submission date 1.2. Provider laboratory/ Laboratories 1.3. Director/head of laboratory 1.4. Laboratory address 1.5. Name and job title of person completing submission 1.6. Contact telephone number address 1.8. Name of pathologist/genetic collaborator 1.9. Contact telephone number address Name of clinical collaborator/co-applicant Contact telephone number address Declaration(s) of interest Any persons contributing to the completion of this form must declare any interests that they may have in the submission of the test in question.

12 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 12 of TEST DISEASE/CONDITION POPULATION TRIAD 2.1. Disease/condition Please provide a brief description in laymen s terms of the characteristics of the disease/condition, affected patient cohort and prognosis Proposed patient cohort for testing 2.3. Gene(s) Approved name(s) and symbol as published on HUGO database Relevance of the test Please include background information and rationale for the development of the test Technical method(s) Please provide details of the assay(s) proposed Validation process Please explain how this test has been validated for use in your laboratory Estimation of workload This will be decided as a Consortium in line with UKGTN developments in the area Mutational spectrum Please provide details of known common mutations.

13 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 13 of Are you already providing this test for this disorder? If yes, please give details of the annual activity for this test in your laboratory. How many reports are produced? No Yes Number of reports with mutation positive Number of reports with mutation negative Are you providing an alternative test for this disorder? If yes, please provide details of the test: Test name Has this test been evaluated by the Molecular Pathology Evaluation Panel? How long have you been providing this test? Is there specialised local clinical/research/laboratory level expertise for this disease? If yes, please provide details. No No Yes Yes Are you providing this test for other gene(s)/disease(s)/ condition(s)? If yes, please give details: Name(s) of gene(s)/disorder(s) that this test is provided for Has this test been evaluated by the Molecular Evaluation Panel? Current annual activity (i.e. number of tests) Performance in these and relevant EQA schemes Based on experience/data how many tests would be required annually in Scotland? Identify and reference information on which the estimate is based. No Yes

14 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 14 of How many tests will you be able to provide annually in your laboratory Does this cover the likely regional or national need for this test? If your laboratory is unable to provide the full need for Scotland, please provide information on how the national requirement may be met. This will be discussed at the Molecular Pathology Consortium

15 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 15 of EPIDEMIOLOGY 3.1. Estimated incidence/prevalence of condition in the target population to whom the test applies. The target population is the group of people that meet the minimum criteria for testing as listed in the Testing Criteria. Please provide references to data and relevant research where possible Estimated positive predictive value, clinical sensitivity and negative predictive value of test. Please identify the information on which this is based (if applicable). In molecular pathology the issue of relevance is the likelihood that a positive test result (e.g. presence of a gene mutation in tumour tissue) will confer resistance / sensitivity to the drug of interest What proportion of all relevant mutations will be detected by the proposed method? 3.4. How will the laboratory demonstrate that relevant material has been studied, and that sufficient tumour is present for exclusion of a relevant mutation? 3.5. If the mutation(s) in question are detected what is the probability of successful treatment?

16 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 16 of CLINICAL VALIDITY Please tick all the relevant purposes of testing. It is helpful when completing the Mol Path Testing Submission, to consider which of these clinical management areas the test is likely to enhance. These will be considered by the panel in the evaluation of the proposed test. If this test is required to stratify a drug treatment, please cite the relevant SMC submission Diagnosis Yes No If yes, please provide details: Can a diagnosis be made for certain by any other method? Will a molecular diagnosis remove the need to do other tests? 4.2. Treatment Yes No If yes, please give details: Will a specific molecular diagnosis affect treatment? If this test is required to stratify a drug treatment, please cite the relevant SMC submission Prognosis & management Yes No If yes, please give detail: Is there evidence in this disease that a specific molecular sub-type will affect prognosis and management to a significant extent? Will the result significantly affect the lifestyle choices of the patient or the family? Will the additional evidence on prognosis alter subsequent treatment? If so, how? 4.4. Disease monitoring Will molecular diagnosis provide a means to assess disease status in the patient Yes No 4.5. Other Yes No If yes, please give details

17 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 17 of ANALYTICAL VALIDITY 5.1. Analytical sensitivity and specificity This should be based on your own laboratory data for the specific test being applied for or the analytical sensitivity and specificity of the method/technique to be used in the case of a test yet to be set up Testing pathway for tests where more than one gene is to be tested Please include your testing strategy if more than one gene will be tested and data on the expected proportions of positive results for each part of the process. Please illustrate this with a flow diagram. 6. CLINICAL UTILITY 6.1. How will the test add to the management of the patient or alter clinical outcome? 6.2. Please provide a summary of the overall benefits of the test Is there an alternative means of diagnosis or prediction that does not involve molecular diagnosis? If so (and in particular if there is a biochemical test), please state the added advantage of the molecular test Describe any ethical, legal or social issues with this particular test.

18 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 18 of Testing criteria Are testing criteria published? Yes No If yes, please state the source. Do you agree with these testing criteria? Yes No Please explain why you think that they should be/should not be followed If you do not agree with the published testing criteria, please outline your alternative criteria below.

19 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 19 of COST EFFECTIVENESS 7.1. Costs of test The costs should reflect the resources that will be required to undertake the test e.g. staffing, consumables etc. Price per test 7.2. Intellectual property Expected national activity Number Total cost of testing for national activity Are there intellectual property issues related to this test? In particular, are there UK licensing requirements for the provision of this test met? Please provide details of any issues identified. No No Yes Yes 7.3. Savings or investment per annum in the diagnostic pathway based on national expected activity, cost of diagnostics avoided and cost of genetic test. Please provide calculations If there are cost savings, please provide these below. List the diagnostic tests/procedures/ treatments that would no longer be required with costs List any tests/procedures/interventions that will be required due to the introduction of the test. If this test is required to stratify a drug treatment, please cite the relevant SMC submission If the test is currently provided from laboratories elsewhere in the UK, please state the name of the laboratory and the cost of the test.

20 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 20 of PATHWAY OF CLINICAL CARE

21 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 21 of 27 Testing Criteria Approved name and symbol of disease/condition(s): Approved name and symbol of gene(s): OMIM number(s): OMIM number(s): Patient name: Patient postcode: Date of birth: CHI number: Name of referrer: Title/Position: Lab ID: Referrals will only be accepted from one of the following: Note for completion: please list the types of referrers for appropriate requests for testing (e.g. consultant clinical geneticists, consultant paediatric neurologists etc). Referrer Tick if this refers to you. Minimum criteria required for testing to be appropriate as stated in the Gene Dossier: Note for completion: please insert the criteria for testing e.g. list clinical symptoms and other investigations that would be expected to have been carried out prior to the DNA test and the results required to make the referral appropriate. Please specify the relationship between criteria using keywords e.g. and, or, at least N of the following. Examples to help in the completion of this are available on the UKGTN website. The boxes can be expanded and rows can be added. Criteria Tick if this patient meets criteria If the sample does not fulfil the clinical criteria or you are not one of the specified types of referrer and you still feel that testing should be performed please contact the laboratory to discuss testing of the sample.

22 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 22 of 27 Annex B Criteria for Decision Making The information and data provided in the Molecular Pathology Test Submission Forms will be reviewed and evaluated by the Molecular Pathology Evaluation Panel on the four following criteria: Analytical validity Tests need to be technical accurate and reliable of the test procedure. To what extent is: Sensitivity of test Specificity of test acceptable? Comments: Clinical Validity How clinically valid is the test in relation to: N/A Please rate from 1-5, 1 being the lowest and 5 being the highest. Diagnosis Treatment stratification Prognosis Disease monitoring N/A Comments: Clinical utility To what extent will the result be useful in making decisions in relation to: Treatment Clinical pathway of care Outcome N/A Comments: Financial implications What will be the total cost of administering the test for Scotland? What are the potential additional costs and/or savings achieved from introducing the test for NHS Scotland? Comments: Please enter cost / savings in Pounds

23 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 23 of 27 Annex C Role, Remit, and ways of working Molecular Pathology Evaluation Panel Role, Remit, and Ways of working 1. Remit The Molecular Pathology Evaluation Panel will use the Framework for Decision Making for tests in the Scottish Molecular Pathology Service to appraise the evidence on test submission forms to evaluate and assess existing and newly proposed molecular pathology tests that are being provided against the agreed criteria and make recommendations to Molecular Pathology Consortium on the clinical utility and validity of tests that should be provided on a national basis. 2. Membership The panel will consist of number members from specific disciplines of specialities to assess test submission forms purely from a scientific review perspective. The panel will be supported by pharmacist and health economist to provide advice and critical appraisal as required. NSD will provide secretariat support to the panel which include the collation of test submission forms, gathering further evidence as required and preparing papers for panel meetings. Membership: Chair Pathology Haematology Oncology Scientist, Tayside Centre Scientist, Grampian Centre Scientist, Lothian Centre Scientist, Glasgow Centre Supporting the panel: Scottish Medicines Consortium Scottish Health Technologies Group NSD /NSS Programme Team The role of each of the panel members is outlined below. 2.1 Chair The Molecular Pathology Evaluation Panel chair will lead/facilitate discussion at panel meetings to ensure that a recommendation is made on each test submission. The chair will support the panel in reaching a consensus and when the group in unable to reach a consensus the Chair will be make a recommendation based on the evidence provided and discussion of the panel.

24 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 24 of Pathology, Haematology and Oncology Pathology, Haematology and Oncology representation on the panel will provide expertise on the clinical utility of the test, advising on alternatives to the test if required. 2.3 Scientist laboratory undertaking tests/with expertise of test methodology Laboratory Scientists will provide the panel with supporting information on the efficacy of the test and cost of the test and can also advise on alternatives to the test if required. 2.4 Health Economist Health Economist will provide the panel with advice as required, scrutinising the cost and benefit of the tests. 2.5 Scottish Medicines Consortium (SMC) A representative from the SMC will be the link between the panel and the work of the SMC and provide the panel with advice on medicines that are in development that will require a molecular pathology test. The SMC representative will also liaise with the panel Secretariat in the event that expert advice is required from members of the Molecular Pathology Consortium in relation to appraising new medicines. 2.6 Secretariat to support the panel The secretariat will prepare test submissions forms for the panel to evaluate and will gather further supporting evidence as required. The secretariat will prepare agendas and papers and support the meetings of the panel. 3. Quorum The quorum for the panel is 50% plus the Chair. The 50% quorum must include one representative from each of the specialities (Pathology, Haematology Oncology and Laboratories). 4. Principles The NHS Healthcare Quality Strategy sets out the requirement for safe, equitable, efficient, effective, person centred and timely care. A robust national framework will help to ensure that molecular pathology services in Scotland meet these requirements. 4.1 Safe Tests undertaken as part of the Consortium are done so in laboratories that are appropriately accredited and that participate in all required external quality assurance schemes. 4.2 Equitable The Framework will provide a consistent approach across NHS Scotland that is reasonable, transparent and justifiable, bringing procedural fairness and accountability into the decision making and prioritisation process. Consideration of the resources available need to be factored into decision making, but priority must not automatically be given to tests which are technically straightforward or are relatively inexpensive. 4.3 Efficient The Framework will ensure that tests undertaken within NHS Scotland are clinically useful thereby making best use of resources. It will provide a standardised process, which has clear points in the pathway for engagement with industry, in order to clarify roles, responsibility and expectations.

25 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 25 of Effective All tests undertaken in Scotland as part of the national Consortium are clinically useful, and can be shown to affect patient management in particular situations. 4.5 Person Centred All patients will have access to high quality tests, supported by appropriate clinical management, regardless of where in Scotland they live and irrespective of their condition. 4.6 Timely The process for introduction of new tests will be streamlined to enable tests to be introduced to the Consortium quickly to ensure that patients can access optimal targeted treatments. Laboratories undertaking tests as part of the Consortium will be monitored to ensure that they provide a reliable service, meeting required turn around times so that treatment decisions are not delayed. 5. Accountability The panel will: Scrutinise each Molecular Pathology Test Submission Form ensuring that recommendations are made are based on the most up to date available evidence. Make decisions based on a national perspective rather than representing individual/local NHS Board/laboratory needs. Ensure that they adhere to their local NHS Board policy in relation to interacting with the Pharmaceutical and Healthcare industries and the NHS and Pharmaceutical Industry publication A Common Understanding Working together for Patients: Guidance On Joint Working Between NHSScotland And The Pharmaceutical Industry (2012) 4 that sets out three public service values which are described as being crucial for the health service - Conduct that ensures absolute standards of honesty and integrity - Accountability which stands the test of parliamentary and public scrutiny - Openness regarding activities and plans Provide reasons for not recommending a test 6. Ways of working and time commitment Panel members will be expected to individually consider test proposals against the agreed criteria using the information supplied in test submission forms and submit their considerations to the secretariat of the panel. The decisions of the panel will be arrived by consensus. The panel will meet 3-4 times in the first year and discussion will focus on test submissions that have not reached a consensus. 7. Reporting structure The Panel will report to the Molecular Pathology Consortium Steering Group through the cross membership of the Chair and secretariat. Strong links with the Scottish Genetics Consortium, Scottish Medicines Consortium and the Diagnostic Steering Group are maintained through cross membership of these groups and the Panel. 4 A Common Understanding 2012 Working together for patients: Guidance On Joint Working Between NHSScotland And The Pharmaceutical Industry, (2012) available at

26 Framework for Decision Making for Tests in the Scottish Molecular Pathology service Page 26 of 27 The Molecular Pathology Consortium Steering Group will consider the recommendations by the panel and consider the resource implications associated with the test and agree which centre(s) the test should be undertaken. Recommendations from MPCSG will go to the Diagnostic Steering Group for discussion and expert advice, then through NSSC to Board Chief Executives for funding decisions to be agreed.

27 Bibliography NHS Scotland, 2010, Making Difficult Decisions in NHS Boards in Scotland Report of the Short Life Working Group, available at, last accessed May 2012 Scottish Government, 2010, The Healthcare Quality Strategy for NHS Scotland, Scottish Government, available at last accessed May 2012 UK Genetic Testing Network, 2006, Framework for Delivering the UK Genetic Testing Network, UK Genetic Testing Network, available at K:\07 Health Support Ser\Specialist & Screening\Spec\Mol Path\Set-up\Consortium\Mol Path Framework\Papers v2.0 27