Molecular Pathology Evaluation Panel

Role, Remit, Membership 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:

To assess test submission forms:
Dr Ken Paterson, / Chair
Professor Keith Kerr, Consultant Pathologist – Grampian
Dr Craig Dick, Consultant Pathologist – GG&C / Pathology
Dr KeithGelly, Consultant Haematologist – Tayside
Dr Mark Drummond, Consultant Haematologist – GG&C / Haematology
Dr Rob Jones, Medical Oncologist, West of Scotland
Dr Allan Price, Consultant Oncologist, East of Scotland / Oncology
Dr David Baty / Scientist, Tayside Centre
Dr David Stevenson / Scientist, Grampian Centre
Kathy Walsh / Scientist, Lothian Centre
Nicola Williams / Scientist, Glasgow Centre
Supporting the panel:
Corinne Booth, Senior Health Economist, Scottish Medicines Consortium
Susan Myles, Lead Health Economist, Scottish Health Technologies Group
Dr Jan Jones, Principal Pharmacist, Scottish Medicines Consortium
NSD Programme Team providing secretariat support, including:
Dr David Stirling, Director of Healthcare Science, NHS National Services Scotland

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.


2.2 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.


4.4 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.

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)[1] 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.

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.

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[1] A Common Understanding 2012 Working together for patients: Guidance On Joint Working Between NHSScotland And The Pharmaceutical Industry, (2012) available at http://www.scotland.gov.uk/Resource/0040/00407602.pdf