Title

ProActive service

Organisations Involved

Amgen limited, Oberoi Consulting limited, participating Healthcare Organisations

Collaborative Working Project Description

This collaborative working project seeks to support participating healthcare organisations to identify patients prescribed denosumab who may have missed or are due their injection and/or pre-injection blood tests.

This will be achieved through the deployment of a suite of searches and alerts onto participating healthcare organisations IT systems.

• Predicted Benefits to Patients:
• ProActive ensures patients that are prescribed denosumab do not miss their 6-monthly injection.
• Predicted Benefits to the NHS:
• An easy and integrated recall system within a GP system that ensures patients do not miss their 6-monthly injection and/or their pre injection blood tests.
• Supports primary care in identifying patients prescribed denosumab who have missed or are due their next dose and/or pre injection blood tests, which is of mutual interest.
• Deployment of a suite of searches and alerts (ProActive Searches) to Identify patients due or who have missed their next denosumab Injection
• Healthcare organisation will be offered training (after initial deployment of the searches and alerts) to optimise use of the ProActive service.
• Oberoi Consulting will inform the healthcare organisation of the number of patients who have been identified through the searches.
• Searches will be re-run 3 months after initial deployment to compare with baseline. After searches have been run, at both time points, it is then a clinical decision within the healthcare organisation to decide upon the appropriate recall for each identified patient. 

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.

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.

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

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.

The 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 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