Title

Establishing a PRIME Secondary Prevention One-Stop Clinic for patients with Acute Coronary Syndrome (ACS) at King’s College Hospital NHS Foundation Trust.

Organisations Involved

Amgen Limited and King’s College Hospital NHS Foundation Trust.

Collaborative Working Project Description

• To establish a PRIME Secondary Prevention One-Stop Clinic for patients with Acute Coronary Syndromes (ACS) at King’s College Hospital NHS Foundation Trust.
• A subset of ACS patients will be reviewed and optimised in-line with NICE Guidance to reduce the patients’ risk of recurrent CVD events.
• The audit and learning from the collaborative working project will be used to produce a business case to provide recurrent NHS funding to maintain the provision of this Secondary Prevention Clinic for patients with ACS.

Expected Outcomes

• Develop a local guideline for Secondary Prevention management following ACS, based on the current NICE Guidance by the project group.
• Develop individualised LDL targets and treatment plans for patients with ACS.
• Improve efficiency of the Secondary Prevention Pathway for patients with ACS.
• Audit the number of PRIME Secondary Prevention Clinic appointments.
• Audit the number of high-risk ACS patients reviewed within the CVD Prevention Clinic.
• Audit the number of patients started on Preventative NICE-approved medicines.
• Audit the % reduction in LDL cholesterol.
• Audit improvements in blood pressure control.
• The audit will be used to produce a business case to provide recurrent NHS funding for this Secondary Prevention Clinic for all appropriate ACS patients.

Title

Implementation of Trust Lead Nurse for Lipid Optimisation Service

Organisations Involved

Liverpool University Hospitals NHS Foundation Trust (LUHFT) and Amgen Limited

Collaborative Working Project Description

• Within a 12 month pilot approach, to deliver, develop and evaluate a specialist clinical nurse service to provide a lipid optimisation service, specifically for current caseload of patients in the Trust who are at a very high risk of further CVD events and who do not have cholesterol levels at target.
• To proactively identify, implement and develop service redesign and to evaluate the implementation and risks involved with delivery of a nurse led service for the lipid modification service
• To ensure safe and effective prescribing of lipid modification therapies within the lipid modification service and that these are prescribed in accordance with national priorities, ICB and local Trust objectives and are in line with NICE recommendations and local agreements e.g. with the LMC.

Expected Outcomes

• A business case for Trust to establish a sustainable Nurse led lipid optimisation clinic service by Dec 2025.
• Enhanced cardiovascular preventative treatment in high-risk secondary prevention CVD patients.
• Reduced time to achievement of cholesterol target for high-risk secondary prevention CVD patients.
• Reduce waiting time for both new and current caseload high-risk secondary prevention CVD patients.

Title

Elective Recovery Approach Support for Manchester Royal Infirmary Lipid Service

Organisations Involved

Manchester University NHS Foundation Trust (MFT) and Amgen Limited

Collaborative Working Project Description

• This project is a 12 month task and finish project that will support Manchester Royal Infirmary (MRI) Hospital to deliver a post pandemic recovery planto reduce the current wait list for Secondary prevention CVD patients with the highest LDL-C levels waiting to be seen by applying the National Elective recovery pathway approach to managing clinic capacity
• A new clinical risk-mitigation clinic will be provided by the Lipid team over a 12 month period to enablehigh-risk secondary prevention CVD patients prioritised Patients to access care faster.
• Patients reviewed in this fast track Clinic will have lipid management optimised according to NICE Guideline 238, referencing TA394, TA393, TA385 & TA733 and European Society of Cardiology (ESC) Guidelines.

Expected Outcomes

• Enhanced cardiovascular preventative treatment in high-risk secondary prevention CVD patients.
• Reduced time to achievement of cholesterol target for high-risk secondary prevention CVD patients
• Reduce waiting time for both new and current caseload high-risk secondary prevention CVD patients

Title

Intelligent Lipids (iLipids Project) - Royal Wolverhampton NHS Trust

Organisations Involved

Amgen Limited and Royal Wolverhampton NHS Trust

Collaborative Working Project Description

The aims of this collaborative working project are to increase the identification and management of Familial Hypercholesterolaemia (FH) using the Intelligent Lipids (iLipids) test. The iLipids test is a novel tool developed in Wolverhampton that consists of a blood test together with provided patient consent and clinical data. The project aims will be achieved by:

• Implementing both retrospective and prospective approaches to identify and assess patients with potential FH using the iLipids test.
• Enhancing early cardiovascular risk assessment and preventative treatment in high-risk patients:
• Increasing referrals to the FH service and reduce time to genetic testing, FH diagnosis and initiation of lipid lowering therapy
• Developing and implementing an educational program to enhance primary care clinicians' awareness, knowledge, and confidence in utilising the iLipids test effectively.

Amgen will provide funding to support with the implementation, education and promotion of the iLipids service.

Expected Outcomes

• Increased numbers of patients with identified and managed Familial Hypercholesterolaemia.
• Enhanced early cardiovascular risk assessment and preventative treatment in high-risk patients.
• Education program will enhance primary care clinicians' awareness, knowledge, and confidence in utilising the iLipids test effectively.

Title

Pharmacist led lipid optimisation and cardiac clinic in Sheffield

Organisations Involved

Amgen Limited and Sheffield Teaching Hospitals NHS Foundation Trust

Collaborative Working Project Description

To develop and establish a sustainable Pharmacist led lipid optimisation service within ACS clinics, Catheter labs, PAD & Stroke.

To identify, manage and optimise lipids in a greater number of high-risk CVD patients from Primary and Secondary Care.

• To establish a sustainable Pharmacist led lipid optimisation and cardiac clinic service within ACS clinics, Catheter labs, PAD, Stroke and Primary Care (by Sept 2025). The proposal is to run 3 lipid clinics a week for new patients and potentially a follow up clinic.
• To identify, manage and optimise lipids in more high-risk CVD patients enabling access to all lipid lowering therapies including those that cannot be accessed in Primary Care.
• To assess, by the end of the project, the:

    - Number of CVD patients identified and optimised through the service.

    - Number of patients started on each lipid lowering therapy.

    - Number of FH patients identified and optimised.

    - Levels of LDL-Cholesterol in the number of patients who have been reviewed and placed on the pathway in line with local and NICE guidance.

Title

Service Redesign to Optimise Lipid & FH Management in Plymouth Primary Care Group

Organisations Involved

Amgen Limited and Plymouth Primary Care Group

Collaborative Working Project Description

This project is to fund a Specialist Cardiovascular Clinical Nurse to work collaboratively with Amgen to redesign the service. The project will enable the to deliver a sustainable and enhanced lipid management programme. This will be achieved by: Implementing a triage system via a Senior Pharmacist led, system audit to stratify patients according to their lipid management needs and complexity and reduce inappropriate referrals, by monitoring and improving the quality of lipid management services. Establish a robust audit and evaluation system to improve the quality and outcomes of lipid management services. Patients reviewed in the Coronary Risk Prevention Clinic will have lipid management optimised according to NICE Guideline 238, referencing TA394, TA393, TA385 & TA733 and European Society of Cardiology (ESC) Guidelines.

• Referrals into the Coronary Risk Prevention Clinic will be routed by the referrer to the appropriate clinic, thereby improving patient flow and waiting times.
• Improving efficiency of pathway, which will be mapped by the project group during the initiation phase of the project for Lipid Management patients who are clinically appropriate.
• The outputs of this Collaborative Working Project will inform the development of a Business Case to secure the additional CVD CNS resource to counter ongoing increasing demands in CVD and High-Risk Hypercholesterolemia patients.

• Develop an effective triage process which will facilitate patient signposting to the appropriate specialist clinic (Coronary Risk Prevention or FH specialist clinic in Secondary Care).
• The additional 1.0 wte CNS will enable faster triage, review and lipid optimisation of the high-risk patients currently sitting in a backlog or not identified.
• Increase the number of appropriately identified patients at high CVD risk and Hypercholesterolemia receiving lipid optimization and care plan.
• Audit the number of high-risk hypercholesterolemia patients identified including FH (Index & Cascade) case over 1 year.
• Increase the number of Injectable Lipid Lowering Therapy (LLT) appointments with approval from Chemical Pathologist. by?
• Audit patient numbers receiving Injectable LLT and on oral therapies over 1 year.
• Aim to reduce the current waiting times for patients to receive review, testing and appropriate lipid management.
• Audit number and adherence of patients maintained on injectable LLT and % reduction in LDLc over 1 year.
• Develop a Business Case highlighting the Collaborative Working Project outputs. to secure future investment to maintain this additional CNS workforce.

Title

IMPROVING THE IDENTIFICATION AND TREATMENT OF PATIENTS WITH FAMILIAL HYPERCHOLESTEROLEMIA (FH) AND THE SECONDARY PREVENTION OF PATIENTS WITH HIGH RISK CARDIOVASCULAR DISEASE IN PRIMARY CARE IN RELATION TO LIPID OPTIMISATION

Organisations Involved

Academic Health Science Network for the North East and North Cumbria (AHSN-NENC) and Amgen Ltd in collaboration with Clinical Commissioning Groups, GP Practices and CDRC (Clinical Digital Resource Collaborative)

Joint Working Project Description

The overall aims of this project are to:

• Identify patients at high risk of Familial Hypercholesterolemia (FH), evaluate medications, educate and treat patients with the sole aim of reducing excess coronary heart disease risk and premature mortality associated with Familial Hypercholesterolemia (FH).
• Increase the utilisation of the genetic screening programme across the AHSN footprint through better patient identification.
• Identify patients at high risk of CVD (>10% 10 year CV risk) and ensure appropriate treatment and management.
• Improve the patient experience by providing more specialist care within primary care and ensure better utilisation and more appropriate referrals to the specialist service base with the NHS Trust.
• To continue to refine and develop the FH service model to be adopted both regionally and nationally.

The expected outcomes from this project are as follows:

• A written document to inform the treatment of Familial Hypercholesterolemia (FH) patients in primary care including information on implementing patient identification using a Familial Hypercholesterolemia (FH) patient identification tool and clinical review at a practice level.
• A toolkit to include training materials on Familial Hypercholesterolemia (FH) and its treatment for healthcare professionals in primary care and the use of the Familial Hypercholesterolemia (FH) patient identification tool.
• Implementation of NICE CG71 and the NHS long term plan.
• To scale the programme across the NENC ICS region by:

  -   Working with the CVD programme team and wider NENC CVD stakeholders to develop strategy and operational pieces of work to deliver reduced cardiovascular disease for patients.

  -   Design and develop educational materials to enable spread and adoption across the System.

  -   Develop materials to support service transformation and lipid optimisation.

  -   Support workforce development within the lipid pathway; supporting the System to address disparities in health inequalities.

The project incorporates the principles of improved patient education, medicines optimisation and treatment close to home.

Title

Service Redesign to Optimise Lipid & FH Management at Harefield Hospital

Organisations Involved

Amgen Limited and Harefield Hospital (part of Guy’s & St Thomas’ NHS Foundation Trust)

Collaborative Working Project Description

This project is to fund a Specialist Lipid / FH Clinical Nurse to work collaboratively with Amgen to redesign the service.

The project will enable the expansion of the existing FH Service to deliver a sustainable and enhanced lipid management programme. This will be achieved by:

• Increasing access to FH genetic testing so that early detection and treatment can be initiated at the highest risk of developing cardiovascular disease.
• Patients reviewed in the FH / Coronary Risk Prevention Clinic will have lipid management optimised according to NICE Guideline 238, referencing TA394, T1393, TA385 & TA733 and European Society of Cardiology (ESC) Guidelines.
• Referrals into the FH / Coronary Risk Prevention Clinic will be triaged to ensure the first appointment is arranged within the appropriate clinic, thereby improving patient flow and waiting times.
• The outputs of this Collaborative Working Project will inform the development of a Business Case which Harefield Trust will use with both the Trust and North West London Integrated Care Board in a bid to secure additional CNS resource to counter ongoing increasing demand in CVD, Lipid and FH referrals.

• Develop an effective triage process which will facilitate patient signposting to the appropriate specialist clinic (Coronary Risk Prevention / FH). The additional 1.0 WTE CNS will enable faster triage, review and lipid optimisation of the high risk patients currently sitting in a backlog within the service. Audit of patients triaged using the tool over 1 year.
• Increase the number of FH Genetic testing appointments (Index & Cascade) offered within the service by 20%.
• Audit the number of FH patients identified (Index & Cascade) over 1 year.
• Increase the number of Injectable Lipid Lowering Therapy (LLT) appointments offered within the service by 20%. Audit patient numbers receiving Injectable LLT over 1 year.
• Aim to reduce the current waiting times for patients to receive review, testing and appropriate lipid management.
• Audit number and adherence of patients maintained on injectable LLT and % reduction in LDLc over 1 year.
• Develop a Business Case highlighting the Collaborative Working Project outputs. This will be used by Harefield Hospital to secure future investment to maintain this additional CNS workforce. 

Title

Norfolk and Waveney Lipid Hub FH & High-Risk Collaboration

Organisations Involved

Amgen Limited and NHS Norfolk and Waveney Integrated Care Board

Collaborative Working Project Description

Develop a service to identify patients with FH, enable them to have genetic testing, with a view to developing a cascade testing service to family members. Treat and manage patients effectively through primary and secondary care interventions.

Expected Outcomes

·       Develop a local guideline for identification and treatment of patients

·       Develop and evaluate an effective process for eventual cascade identification and testing of affected relatives

·       Map treatment pathway for effective treatment of these patients

Title

Denosumab for Osteoporosis: Patient Self Administration Service

Organisations Involved

Amgen Ltd and Cardiff and Vale University Health Board

Joint Working Project Description

The aim of this project is:

·       To implement a permanent Metabolic Bone Dept service model at Cardiff and Vale University Hospitals for patient self-administration of denosumab¹ within a community setting. This follows from a successful pilot project implemented in June 2018 by Professor Mike Stone.

·       This joint working partnership supports Cardiff and Vale University Health Board with funding to recruit a dedicated Self Injection Band 7 Nurse for 1 year to provide training and support for Osteoporosis patients in self-administration of their 6monthly injection of denosumab. Manage the prescribing process and onward patient journey and supporting the patient with their long-term condition.

·       Amgen will provide support for production of a Business Case which will be completed during the project to support the sustainability of the service into 2021 and beyond.

·       New and existing patients will be offered the choice of self-administering their denosumab injections after a first initial clinical consultation and denosumab injection at month 0 and a further self-administration training appointment at 6 months.

Expected Outcomes

·       Recruitment of a Band 7 Nurse in Cardiff and Value University Health Board Metabolic Bone Dept to provide capacity release from Metabolic Bone outpatients clinics.

·       Greater choice for patients in where their medicine is delivered. Patient education on Osteoporosis; including the importance of a healthy diet and exercise

·       Evaluation of the project can be made available for other NHS organisations that support management of Osteoporosis patients medicines closer to home.

·       Sustainability of the Self-Administration Service for the benefit of patients and NHS Wales

·       The project incorporates the principles of improved patient education, medicines optimisation and treatment close to home

·       The project conclusions will be published and shared with the wider NHS community.

Amgen Limited and University Hospitals Birmingham

Develop a pilot specialist service “Optimisation of LDL Cholesterol after Acute Coronary Syndromes” for LDL management post Acute Coronary Syndrome (ACS).

• Initially in a subset of ACS patients.
• Audit adherence to NICE TA394 and TA393 and European Society of Cardiology Guidelines (ESC) pre- and post-initiation of service and compare to patients that are not treated by specialist service.
• Audit will be used to produce a business case to provide NHS funding for service for all ACS patients and to expand the service to other centres.

• Develop a local guideline for LDL cholesterol management following ACS, based on the current NICE and ESC guidelines by the project group.
• Develop individualised LDL targets and treatment plans for patients, with details of available drug treatments which will be audited by the Cardiology team carrying out clinical reviews.
• Improve efficiency of pathway, which will be mapped by the project group during the initiation phase of the project for the subset of ACS patients who are clinically appropriate.
• Cardiology team carrying out clinical reviews will actively assess LDL and refer direct to specialist pharmacist who will offer the appropriate treatment intervention in line with local / NICE guidance. This approach will result in a reduction of the number of clinical touch points by at least 1-2 people compared to the standard clinical pathway.
• Improve appropriate use of PCSK9 mAb in patients in line with local guideline recommendations.
• Inpatients within the subset of patients identified in the pilot with recurrent ACS and LDL-C > 3.5 mmol/L will be referred immediately so that they can be offered PCSK9 mAb initiation if clinically appropriate (these patients are generally already receiving statin therapy and may remain at very high risk of CVD as per the NICE guidance referenced above).
• Introduce routine repeat LDL cholesterol testing at 1 month post ACS for the subset of patients identified for the pilot, with subsequent review by specialist service and referral for patient to be offered PCSK9 mAb if LDL above target NICE/ESC referenced above. This will be measured and included as part of the audit. 

Amgen

This collaborative working project seeks to bring together stakeholders from industry and NHS Wales to transform current approaches to lung cancer care in Wales by expediting the clinical implementation of diagnostic ctDNA testing early in the diagnostic pathway. The overall aim of the Project is to reduce the Time to Treatment (TTT) of targeted therapies, resulting in improved outcomes for cancer patients. 

The intended aims of the Project are to:

• Establish RWE comparing the ctDNA vs tissue biopsies
• Change the pathway to using ctDNA in its practice at one pilot center
• Scale to additional centres within lung cancer (~1,000 patients) to provide evidence for routine commissioning across Wales. This experiment can lay the foundation for expansion to other tumour types

It is anticipated that the following benefits will be achieved throughout the lifecycle of the project:

• Patients: Rapid, less invasive diagnostics that result in more appropriate treatment options, improve outcomes and avoid potentially risky repeat biopsy procedures
• NHS: More comprehensive and timely information at Multi-Disciplinary Team (MDT) that lead to more informed, rapid treatment decisions, fewer healthcare resources utilized and improved capacity and efficiency. The ability to scale nationally and best practice sharing across health boards can reduce care variation and inequalities.
• Amgen: Patients will have access to more rapid testing for appropriate biomarker-directed therapies. Collaborative working with the consortium will demonstrate value as partner of choice with national organisation creating reputational benefits and invaluable insights into national cancer pathological and genomics pathways

Amgen

Hywel Dda University Health Board

This collaborative working project seeks to bring together stakeholders from NHS Wales and Academia to develop a population health approach for population risk prediction and high intensity intervention in a controlled health system, with a key focus on targeting better outcomes.

The overall aims of the Project are to demonstrate improved outcomes as a result of a comprehensive approach to risk prediction and prevention by:

• Utilising data analytics to test, validate & improve identification of high-risk patient cohorts e.g. patients at high risk of developing CVD, patients at high risk of CVD with unaddressed risk factors, and those with established CVD not meeting guideline targets for CVD risk management
• Evaluating different service models for delivering a specific high risk CVD clinic.  Using clinical outcomes, patient reported outcomes, Value Based Healthcare Analysis and Health Economic Impact Assessment the project aims to evaluate and ensure the most effective model is sustained across NHS Wales and rolled out across other geographies

Benefits to Patients

• Improved identification of patients with and at high risk of atherosclerotic cardiovascular disease and improved treatment of lipids and other major CVD risk factors via developed service models
• Improved patient understanding of how lipids and other CVD risk factors contribute to their risk of heart attack and stroke, as well as the rationale for and nature of treatments used to address their risk through shared decision-making
• Improved patient engagement and empowerment to self-manage
• Medicines and lifestyle adherence issues identified and addressed early

Benefits to NHS

The Project aligns with the ambition set out in Welsh Government and NHS Wales ‘Quality Statement for Heart Conditions’¹, that the quality attributes of services for people with heart conditions in Wales should be:

• Effective e.g., Nationally optimised evidence-based pathways for people with heart conditions to be comprehensive and fully embedded in local service delivery.
• Efficient e.g., Detection, diagnosis, and effective management of high-risk conditions such as high blood pressure, raised cholesterol and atrial fibrillation. Utilising a national approach to informatics systems will enable greater integration of care and provide relevant, high quality, standardised data to drive service improvement.
• Person centred e.g.  Collaborative approach to person-centred care supported by a common approach to diagnosis, treatment and care provided by a multi-disciplinary care team within the community as appropriate

• Efficiency savings through service transformation to maximise outcomes, utilising new technologies and models of care
• Local reduction in avoidable CVD events
• Supporting post-COVID recovery adoptions of new models of care

Benefits for Amgen

• The Project aims to increase the identification of sub optimally treated patients at a high risk of a CVD event. Patient management could involve cholesterol lowering medicines which may include an Amgen medicine for suitable patients in line with NICE TA394 and or local / national guidelines
• Demonstrates collaborative working with the NHS to the benefit of patients and identifies scalable solutions. These may be promoted in other regions, thus raising the reputation of the Company as a partner to work with.  Disciplined experimentation to inform future approaches to collaboration and system value (health systems responding to innovative access solutions)

1. The Quality Statement for Heart Conditions https://gov.wales/quality-statement-heart-conditions-html

The overall aims of this project are to:

• Identify patients at high risk of Familial Hypercholesterolemia (FH), evaluate medications, educate and treat patients with the sole aim of reducing excess coronary heart disease risk and premature mortality associated with Familial Hypercholesterolemia (FH).
• Increase the utilisation of the genetic screening programme across the AHSN footprint through better patient identification.
• Identify patients at high risk of CVD (>10% 10 year CV risk) and ensure appropriate treatment and management.
• Improve the patient experience by providing more specialist care within primary care and ensure better utilisation and more appropriate referrals to the specialist service base with the NHS Trust.
• To continue to refine and develop the FH service model to be adopted both regionally and nationally.

The expected outcomes from this project are as follows:

• A written document to inform the treatment of Familial Hypercholesterolemia (FH) patients in primary care including information on implementing patient identification using a Familial Hypercholesterolemia (FH) patient identification tool and clinical review at a practice level.
• A toolkit to include training materials on Familial Hypercholesterolemia (FH) and its treatment for healthcare professionals in primary care and the use of the Familial Hypercholesterolemia (FH) patient identification tool.
• Implementation of NICE CG71 and the NHS long term plan.

The project incorporates the principles of improved patient education, medicines optimisation and treatment close to home.

Title

Norfolk and Waveney Lipid Hub FH & High-Risk Collaboration

Organisations Involved

Amgen Limited and NHS Norfolk and Waveney Integrated Care Board

Collaborative Working Project Description

Develop a service to identify patients with FH, enable them to have genetic testing, with a view to developing a cascade testing service to family members. Treat and manage patients effectively through primary and secondary care interventions.

Expected Outcomes

• Develop a local guideline for identification and treatment of patients
• Develop and evaluate an effective process for eventual cascade identification and testing of affected relatives
• Map treatment pathway for effective treatment pathway of these patients

Actual Outcomes

A pathway for FH has been developed.

16 PCNs have been involved in screening with 46 practices taking part.

629 patients were contacted of these patients 175 responded and 150 were screened for FH, 141 blood samples were screened.

The identification rate was 1:6

This high identification rate (nationally 1:25) was noted by Heart UK and this has secured further investment from the ICB which includes a capability to call patients directly from their GP records. The ICB have also automatically included all practices across Norfolk. A practice must actively opt out if they do not want patients screened.

The ICB have taken on the support for licencing of the Eclipse Live FH identification system which frees up resource within the Lipid Clinic. This has enabled the CNS FH to start an extra clinic within the service.

Title

Non-Small Cell Lung Cancer (NSCLC) Tissue Pathway Improvement Project

Organisations Involved

Amgen Limited and Bart’s Health NHS Trust, The Royal London Hospital on behalf of North Thames Genomics Laboratory Hub (GLH).

Collaborative Working Project Description

This collaborative working project sought to bring together a cross functional team from the GLH who in collaboration with Amgen would design and implement a ‘service optimisation project’.

The primary aim of this project was to support the optimisation of clinical pathways and outcomes, improving and standardising access and turnaround times within the NSCLC Tissue pathway.

In addition, this project also has the potential to inform and support the improvements in the National Lung Cancer Pathway through discussion and engagement with NHSE.

The expected outputs and outcomes of the project are as follows:

• The delivery of a detailed pathology pathway map for non-small cell lung cancer.
• A report identifying the key barriers and delays within the local non-small cell lung cancer pathology pathway and/or across the local network.
• The development of Optimal Tissue Management guidelines and standard operating policy to support the effective delivery of the non-small cell lung cancer tissue pathway.
• The development of a local ‘case for change’ which supports the continued improvement/ adoption and uptake of genomics testing and informs the local service model.
• An increased number of lung cancer samples are sent to the GLH vs baseline.
• An improvement in the turnaround time (TAT) from the point of tumour sampling to genomic result versus baseline.
• An increase and/or standardisation of the quality/type of samples sent for genomic analysis, resulting in the increased success rate of next generation sequencing (NGS) panel and single genome test results.
• An increased level of education and awareness of local clinical teams, who are better able to engage with the processes supporting genomic analysis of non-small cell lung cancer.

During the course of the project a continuous improvement cycle was adopted, using the learnings from the project to create business cases to secure investment into the local services. The following provides a summary of the key outputs delivered through the course of the project.

• A detailed pathology pathway map (covering receipt of specimen to publication of full genomics report) for NSCLC was created for Bart’s Health NHS Trust which identified areas of best practice and variation.
• A review of the Lung Adenocarcinoma (LUAD) biomarker testing pathway across multiple sites partnering with Bart’s Health NHS Trust was conducted via retrospective audit to understand the current operational delivery.
• Key barriers and solutions relating to the LUAD biomarker testing pathway were documented and an action plan was developed to address service issues that were impacting the delivery of National Optimal Lung Cancer Pathway (NOLCP) standards.
• Service improvements across the biomarker testing pathway were implemented spanning four key areas: specimen reception and cut up room, the main laboratory, consultant working practice and molecular pathology. These improvements will be incorporated into revised Standard Operating Procedures.
• Changes made within specimen reception and cut up room included the installation of new cut up benches, creation of a dedicated specimen reception bay with additional computer terminals and sufficient space to cater for samples from 5 hospital sites, recruitment and training for additional Medical Laboratory Assistants (MLAs) and implementation of new protocols relating to daily cutting of lung cancer resection specimens..
• Changes made within the main laboratory included the creation of dedicated cutting stations for molecular testing and the upgrading and replacement of immunostaining machines.
• Changes made in consultant working practice included IT upgrades to equipment and education and training on best practice, including audit.
• Changes made within molecular pathology included the development of a business case to expand the number of clinical scientists within the department to address current and future testing demands.
• A prospective audit was conducted to understand the impact of the changes to the pathway in terms of KPIs (TAT, DNA quality and test inadequate rates).
• Improvements were seen in TAT, DNA quality and test inadequate rates.
• Additional biomarker testing pathway improvements requiring regional and national level discussion and investment have been documented and will be shared with key stakeholders.

Amgen Ltd and Innovation Agency AHSN

The Project has been designed to support the delivery of the NHS CVD aspect of the Long-Term Plan. The focus will be to improve cholesterol management in high risk patients one of the CVD modifiable risk factors, to within parameters set by NICE guidelines with a focus on three areas:

• Support the clinical priority to reduce the number of CVD events.
• Use of population health analysis to identify cohorts of patients who are most in need of an intervention.
• Ensure where appropriate, interventions are conducted in primary care by MDT teams within a primary care network (“PCN”) footprint and not by Secondary Care.

• Standardised searches developed for Primary Care IT systems to identify high-risk CVD patient cohorts if CVD Prevent NHS tool is not available.
• Patients identified from the searches to be reviewed by Primary Care Team and improvements in lipid control monitored at 6 & 12 months by either point of care testing or blood tests.
• Implementation of revised lipid protocols and improved local pathways between Primary and Secondary Care Teams within participating practices.
• Delivery of education and quality improvement training to practices in partnership with relevant colleagues across the pathway such as secondary care teams, social prescribers, and CCG medical optimisation team to increased confidence in lipid management across the primary care workforce.
• Increased uptake of second-line therapies in line with NICE guidance.
• Completed evaluation of project.
• Using non identifiable data identified by the project, to develop a population health focused business case for sustainability and rollout of the search and optimise process across the local healthcare system.
• Share business case across NHS systems.

• Across the 2 ICS regions in the NWC, lipid and FH referral pathways and management guidance were revised and implemented to include new National NICE approved guidance as part of the project.
• Both locally designed and nationally available (UCLP Partners and CDRC) search and stratification tools used to identify patients requiring lipid review, optimisation, or referral in line with the Primary/Secondary Prevention/FH pathway national guidance, provided by the Accelerated Access Collaborative Team.
• 4 workstreams, 2 focussed on secondary prevention and 2 on Familial Hypercholesterolaemia were delivered across 8 PCNs within the NWC region.
• Positive changes such as increased use of high-intensity statins and an increase in the number of patients treated to the NICE target for LDL were observed in all of the patient cohorts.
• Increased uptake of second-line therapies in line with NICE guidance.
• Improvements were seen in FH coding, FH patient identification and management of those patients.
• A number of learnings regarding patient motivation, how to improve the % of DNA sessions in clinics and how focussing on better patient education and awareness of the effect lipids can have on CVD, were captured, and documented to support the enhancement and continuing development of local pathways and a summary is available in the final evaluation report.
• Participation in the project by a broad range of HCPs increased the competence and confidence of healthcare professionals in managing lipid-related issues, addressing statin hesitancy, and improving patient outcomes.
• Data from the project has supported local business cases for further funding in parts of the NWC but, as of yet, there is no specific tool developed across England, that can forecast a return on investment for supporting activity optimising lipids due to the variance in baseline data and incorrect coding of lipid related issues.
• The Innovation Agency commissioned an evaluation of this project. The report is available.

Amgen Ltd, Manchester University NHS Foundation Trust on behalf of North West GLH, NW Genomic Laboratory Hub, Liverpool University Hospitals NHS Foundation Trust, Salford Royal NHS Trust

This collaborative working project seeks to bring together a cross functional team from the Genomics Laboratory Hub who in collaboration with Amgen will design and implement a ‘service optimisation project’.

The primary aim of this project is to support the optimisation of clinical pathways and outcomes, improving and standardising access and turnaround times within the NSCLC Tissue pathway.

In addition, this project will also inform and support the delivery of improvements in the National Optimal Lung Cancer Pathway^3, ensuring that molecular testing is embedded and funded across local Lung Cancer pathways in all GLHs. 

The expected core outputs and outcomes of the of the project were as follows:

Outputs

• The delivery of a detailed pathology pathway map for non-small cell lung cancer
• A detailed report identifying the key barriers and delays within the local non-small cell lung cancer pathology pathway and/or across the local network
• The development of Optimal Tissue Management guidelines and standard operating policy to support the effective delivery of the non-small cell lung cancer tissue pathway
• The development of a local ‘case for change’ which supports the continued improvement/ adoption and uptake of genomics testing and informs the local service model

Pathway Outcomes

• An increased number of lung cancer samples are sent to the GLH vs baseline
• An improvement in the turnaround time (TAT) from the point of tumour sampling to genomic result v’s baseline
• An increase and/or standardisation of the quality/type of samples sent for genomic analysis, resulting in the increased success rate of next generation sequencing (NGS) panel and single genome test results

Local System Outcomes

• There is an increased level of education and awareness of local clinical teams, who are better able to engage with the processes supporting genomic analysis of non-small cell lung cancer

The actual core outputs and outcomes of the of the project were as follows:

Outputs

• The delivery of a detailed pathology pathway map for non-small cell lung cancer testing pathway for the 3 NHS structures involved in project
• A detailed report identifying the key barriers and delays within the local non-small cell lung cancer pathology pathway for the 3 NHS structures involved in the project
• Information and insights identified from the project have informed the development of Optimal Tissue Management guidelines and standard operating policy to support the effective delivery of the non-small cell lung cancer tissue pathway across the 3 regions involved in the NW wide project
• A local ‘case for change’ has been delivered via the ICB Pathology workstream in one of the NW Regions which supports the continued improvement/adoption and uptake of genomics testing and informs the local service model

Pathway Outcomes

• The number of lung cancer samples sent to the GLH vs baseline has increased across the 3 NHS structures reviewed
• An improvement in the turnaround time (TAT) from the point of tumour sampling to genomic result testing has been delivered and is effective not just in the NHS structures in the project but affecting all of the NW region. This improvement is due to the GLH testing pathway adapting and developing during the project informed by learnings and data identified during the project

Local System Outcomes

• The final report has been circulated to ensure best practice and learnings are captured and used by local clinical teams across the NW Region

Amgen Limited and Royal Devon & Exeter NHS Foundation Trust on behalf of NHS South West Genomic Medicine Service Alliance

This collaborative working project seeks to bring together a cross functional team from the Genomics Laboratory Hub (GLH) who in collaboration with Amgen will design and implement a ‘service optimisation project.’

The primary aim of this project is to support the optimisation of clinical pathways and outcomes, improving and standardising access and turnaround times within the NSCLC Tissue pathway.

In addition, this project will also inform and support the delivery of improvements in the National Optimal Lung Cancer Pathway.

The expected core outputs and outcomes of the project are as follows:

Outputs

• The delivery of a detailed pathology pathway map for non-small cell lung cancer
• A detailed report naming the key barriers and delays within the local non-small cell lung cancer pathology pathway and/or across the local network.
• The development of Optimal Tissue Management guidelines and standard operating policy to support the effective delivery of the non-small cell lung cancer tissue pathway.
• The development of a local ‘case for change’ which supports the continued improvement/ adoption and uptake of genomics testing and informs the local service model.

Pathway Outcomes

• An increased number of lung cancer samples are sent to the GLH vs baseline.
• An improvement in the turnaround time (TAT) from the point of tumour sampling to genomic result v’s baseline.
• An increase and/or standardisation of the quality/type of samples sent for genomic analysis, resulting in the increased success rate of next generation sequencing (NGS) panel and single genome test results.

Local System Outcomes

• There is an increased level of education and awareness of local clinical teams, who are better able to engage in the processes supporting genomic analysis of non-small cell lung cancer.

The actual core outputs and outcomes of the of the project were as follows:

Outputs

• Baseline Tissue pathway and timings maps delivered for each NHS site in the South West Genomic Hub region.
• Creation of “Walking Pathway” workshop “Post Analysis” workshop, gap analysis and tools to examine end to end pathways.
• Report on barriers and delays shared with local network to support pathway change and local improvements.
• Development of Optimal Tissue Management Guideline Improved delivery of the NSCLC pathway and gene panel testing embedded into Lung Cancer MDT.

Pathway Outcomes

• Significant reduction in Testing Turnaround Times from >20 days in April 2022 to <12 days for May 2023.
• An Increased uptake and standardisation of the quality and type of samples sent for centralised genomic testing.

Local System Outcomes

• Clinical Case for Change’ programme of engagement undertaken for NHS by GMS medical leads.
• Embedded Gene panel testing in Lung Cancer MDT Standards of Care. These standards of care can be shared nationally (linking to national developments in Standards of Care within Cancer services).
• Improved Genomic Medicine Service delivery for Cancer patients, speeding up diagnosis and creating efficiencies within the NHS system for genomic testing.
• Education and engagement of all local Lung Cancer MDT, Clinical Advisory Group Stakeholders to support genomic analysis of Non-Small Lung Cancer of requirements for change in guidance.
• Insights and learnings from the NSCLC Tissue Pathway Improvement Project may be used to inform future national policy and programmes of work and will support the delivery of improvements in the National Optimal Lung Cancer Pathway, ensuring that genomic testing is embedded across local Lung Cancer pathways in all Genomic Medicines Service Alliance.

South East London CCG, Guy’s & St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, The Health Innovation Network (South London AHSN)

This project was set up to assist in the delivery of the CVD ambitions relating to cholesterol outlined by NHS England / PH England in response to the NHS Long-Term Plan.

The primary aim of the project was to reengineer the local lipid pathway to ensure all patients requiring lipid management are seen by the right person, in the right setting, at the right time to optimise their care. 

The project focused on the four elements of QIPP - Quality, Innovation, Productivity, Prevention – to transform local lipid pathways across Lambeth and Southwark Boroughs to maximise outcomes for patients.

• Standardised searches will be developed for GP IT systems to identify high-risk CVD patient cohorts.
• Number of patients identified at practice level within the agreed cohorts.
• Proportion of practices who have undertaken the relevant searches.
• Implementation of revised lipid protocols within participating practices.
• Improvements in lipid control within identified cohorts above, monitored at 6, 12 and 18 months.
• Reduction in absolute numbers of patients requiring lipid intervention when standardised searches are rerun at 6, 12 and 18 months.
• Increased confidence in lipid management across the primary care workforce.
• Clear pathway for referral implemented, including triage process in primary care.
• Increased uptake of second-line therapies in line with NICE guidance.
• Integration of new technologies to improve efficiency and patient outcomes.
• Completed evaluation of project.
• Development of business case for sustainability and rollout across SEL CCG.
• Share business case across NHS systems. 

• South East London’s Lipid Management and FH Guidance was revised and implemented across the region.
• Implementation of UCLPartners AHSN Search and Stratification Tools were used to identify patients requiring lipid review, optimisation or referral in line with the Primary / Secondary Prevention pathways or FH pathway.
• 6 PCNs within South East London participated in the project, focusing on Primary Prevention, Secondary Prevention and FH patients.
• Positive changes in the use of high-intensity statin usage were observed in the Secondary Prevention patient cohorts.
• Increased uptake of second-line therapies in line with NICE guidance.
• Improvements were seen in FH coding.
• Clinicians reported a range of perceived impacts on patients, such as improved patient education and awareness leading to more informed decisions about healthcare.
• Participation in the project increased the competence and confidence of healthcare professionals in managing lipid-related issues, addressing statin hesitancy, and improving patient outcomes. The importance of a holistic approach to patient care and the need for system and workflow improvements was emphasised, highlighting the need to refine systems and processes in primary care in order to improve lipid management.The Health Innovation Network undertook an Evaluation of this project. The report is available.

University Hospitals of Leicester NHS Trust and Amgen Limited

This Project was agreed as part of the Accelerated Access Collaborative (AAC), which was formed to bring industry, government and the NHS together to remove barriers to uptake of innovation products from 7 high-potential technology areas, so that NHS patients can have faster access to certain products that can transform care.

PCSK9 inhibitors for the management of hypercholesterolemia were selected as one of the seven NICE recommended rapid uptake products to increase patient access and remove barriers across the health innovation landscape. 

Funding was made available through the Accelerated Access Collaborative Pathway Transformation Fund (PTF) to help NHS organisations integrate the rapid uptake products into everyday practice and to improve equality of access to these products. 

The PTF, in relation to PCSK9 inhibitors, combined funding from NHS England, Amgen and Sanofi for selected projects to meet the AAC objectives and increase PCSK9i uptake by addressing barriers.

19 applications relating to PCSK9 inhibitors from 12 AHSNs were submitted to the AAC for funding and 6 were selected, including University Hospitals of Leicester NHS Trust. 

The overall aim of University Hospitals of Leicester NHS Trust working in partnership with primary care and Amgen / Sanofi is to improve the identification and management of patients with familial hypercholesterolaemia (FH) and patients with cardiovascular disease and primary hypercholesterolaemia / mixed dyslipidaemia. Improved cholesterol management will reduce the cardiovascular disease risk for these patients.

UHL employed a clinical pharmacist or nurse with admin support to work on the project and to achieve the following objectives:

• Undertake a systematic search of GP records to identify patients with potential FH and patients with cardiovascular disease and primary hypercholesterolaemia / mixed dyslipidaemia.
• Clinical pharmacist / nurse led review of high-risk patients in primary care to optimise cholesterol management.
• Identification of patients with elevated LDL-C despite maximal lipid lowering medications and referral of these patients to the lipid clinic to review treatment options to improve LDL-C.

Predicted Benefits for Patients:

• Increased diagnosis rate of FH and improved management of primary hypercholesterolaemia and mixed dyslipidaemia.
• These patients can be initiated and / or treated with appropriate doses of cholesterol lowering medicines according to local guidelines which will lower their risk of cardiovascular disease / event (stroke, myocardial infarction or peripheral vascular disease).
• These patients can be educated on cholesterol, diet, exercise and the importance of a healthy lifestyle. 
  Patient empowerment and engagement in terms of their diagnosis and subsequent clinical management plan (NICE – patient participation is of importance regarding decision making in terms of drug therapy etc.).

Predicted Benefits for NHS Organisations:

• Reduce variation in identification and treatment of FH and primary hypercholesterolaemia and mixed dyslipidaemia across Leicestershire.
• Assist PCNs in identifying and managing patients with cardiovascular disease in line with the NHS Long Term Plan
• Supports implementation of NICE CG71. 
• Reduction in cardiovascular disease burden amongst Leicestershire patients will reduce associated hospital activity.

Predicted Benefits For Amgen:

• The project aims to increase the FH, hypercholesterolaemia and mixed dyslipidaemia diagnosis rates. Patients diagnosed with these conditions will be treated with cholesterol lowering medicines in line with local / national guidelines and NICE TA 394.
• Demonstrates collaborative working with the NHS to the benefit of patients and identifies scalable solutions.

The results of the project were written up to enable the learnings from the project to be shared.

Buckinghamshire Clinical Commissioning Group (CCG) and Amgen Limited

This Project was agreed as part of the Accelerated Access Collaborative (AAC), which was formed to bring industry, government and the NHS together to remove barriers to uptake of innovation products from 7 high-potential technology areas, so that NHS patients could have faster access to certain products that can transform care.

PCSK9 inhibitors for the management of hypercholesterolemia were selected as one of the seven NICE recommended rapid uptake products to increase patient access and remove barriers across the health innovation landscape. 

Funding was made available through the Accelerated Access Collaborative Pathway Transformation Fund (PTF) to help NHS organisations integrate the rapid uptake products into everyday practice. and to improve equality of access to these products. 

The PTF, in relation to PCSK9 inhibitors, combined funding from NHS England, Amgen and Sanofi for selected projects to meet the AAC objectives and increase PCSK9i uptake by addressing barriers. 

19 applications relating to PCSK9 inhibitors from 12 AHSNs were submitted to the AAC for PTF funding and 6 were selected.

Buckinghamshire CCG and Amgen were working in partnership under a joint working agreement to transform lipid management pathways in primary care by:

• The creation of a Pharmacist-Led Lipid Management Service
• Development of a clear lipid management pathway for primary care
• Establishing a “Virtual” Consultant-Led Lipid Clinic
• Improved Coding

After baselining the current quality of data and coding, a strategy to enhance the frequency and accuracy of coding was to be put in place. Outcomes data was to be captured and used to refine and optimise the service. This will be critical to support the case for sustainability beyond the pilot.

Predicted Benefit to Patients:

• Patients might expect more equitable and consistent care as well as improved and quicker access to care, better education around FH, better access to treatment options, improvement in clinical markers such as lipid levels, a clearer pathway of care with care being delivered closer to home and a better experience of the system.

Predicted Benefit to NHS:

• Decrease in numbers of patients reviewed with suboptimal lipid control in Bucks
• Increases in numbers of patients with changes to statin therapy, prescribed adjunctive ezetimibe
• Increased Patients referred, assessed and potentially initiated on PCSK9i
• Reduce numbers of patients at risk of secondary CVD

Predicted Benefit To Amgen:

• The project aims to increase the hypercholesterolaemia and mixed dyslipidaemia diagnosis rates. Patients diagnosed with these conditions will be treated with cholesterol lowering medicines which may include an Amgen medicine for suitable patients in line with NICE TA394 and or local / national guidelines.
• Greater customer understanding
• Improved reputation through partnering with the AAC initiative

The results of the project were to be written up to enable the learnings from the project to be shared.

Nottingham University Hospitals NHS Trust and Amgen Limited

This Project was agreed as part of the Accelerated Access Collaborative (AAC), which was formed to bring industry, government and the NHS together to remove barriers to uptake of innovation products from 7 high-potential technology areas, so that NHS patients can have faster access to certain products that can transform care.

PCSK9 inhibitors for the management of hypercholesterolemia were selected as one of the seven NICE recommended rapid uptake products to increase patient access and remove barriers across the health innovation landscape. 

Funding was made available through the Accelerated Access Collaborative Pathway Transformation Fund (PTF) to help NHS organisations integrate the rapid uptake products into everyday practice and to improve equality of access to these products. 

The PTF, in relation to PCSK9 inhibitors, combined funding from NHS England, Amgen and Sanofi for selected projects to meet the AAC objectives and increase PCSK9i uptake by addressing barriers. 

19 applications relating to PCSK9 inhibitors from 12 AHSNs were submitted to the AAC for PFT funding and 6 were selected, including Nottingham University Hospitals NHS Trust. 

The overall aim of Nottingham University Hospitals (NUH) working in partnership with primary care and Amgen / Sanofi was to improve the identification and management of patients with cardiovascular disease and primary hypercholesterolaemia / mixed dyslipidaemia in order to reduce the cardiovascular disease risk for these patients in Nottingham and Nottinghamshire.

NUH employed a clinical pharmacist and nurse (on a part-time basis 0.5 WTE) to work on the project to achieve the following objectives:

• Undertake a systematic search of GP records to identify patients with cardiovascular disease and primary hypercholesterolaemia / mixed dyslipidaemia.
• Project Pharmacist / Project Nurse led review of high-risk patients in primary care to optimise cholesterol management with follow-up to review treatment outcomes.
• Project nurse to deliver consultations with appropriate patients around adherence to and tolerance of lipid lowering medications.
• Identification of patients with elevated low density lipoprotein cholesterol (LDL-C) despite maximal lipid lowering medications and referral of these patients to the lipid clinic to review treatment options to improve LDL-C.

Predicted Benefits for Patients:

• Increased diagnosis rate of primary hypercholesterolaemia and mixed dyslipidaemia.
• These patients can be treated with appropriate doses of cholesterol lowering medicines according to local guidelines which will lower their risk of cardiovascular disease / event (stroke, myocardial infarction or peripheral vascular disease).
• These patients can be educated on cholesterol, diet, exercise and the importance of a healthy lifestyle.
• Patient empowerment and engagement in terms of their diagnosis and subsequent clinical management plan (NICE – patient participation is of importance regarding decision making in terms of drug therapy etc).

Predicted Benefits for NHS Organisations:

• Reduce variation in identification and treatment of primary hypercholesterolaemia and mixed dyslipidaemia across Nottingham and Nottinghamshire.
  Assist PCNs in identifying and managing patients with cardiovascular disease in line with the NHS Long Term Plan.
  Supports implementation of NICE CG71. 
  Reduction in cardiovascular disease burden amongst Nottingham and Nottinghamshire patients will reduce associated hospital activity.

Predicted Benefits for Amgen:

• The project aims to increase the hypercholesterolaemia and mixed dyslipidaemia diagnosis rates. Patients diagnosed with these conditions will be treated with cholesterol lowering medicines which may include Amgen medicine for suitable patients in line with NICE TA394 and or local / national guidelines.
• Demonstrates collaborative working with the NHS to the benefit of patients and identifies scalable solutions.

The results of the project were written up to enable the learnings from the project to be shared.