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How Cardiologists Can Help to Ensure Speedy Access to New Treatments in Lipid Management

Dr Phil Jennings Discusses Guidance on Lipid Management From the Accelerated Access Collaborative, and Outlines how Cardiologists can Contribute to the Success of the Rapid Uptake Product Initiative in Meeting Cardiovascular Priorities in the NHS Long Term Plan

Due to its largely preventable nature, cardiovascular disease (CVD) is a national priority, and has been a central feature in the plans of many integrated care systems (ICS). Improving outcomes for patients with CVD is a clinical priority in the NHS Long-Term Plan,1 which aims for optimal management of patients at high risk of CVD in reducing the incidence of heart attacks or stroke. The Accelerated Access Collaborative (AAC) and Academic Health Science Networks (AHSN) Lipid Management Rapid Uptake Product (RUP) Working Group developed a NICE-endorsed clinical pathway that simplifies and summarises guidance on lipid management for the primary and secondary prevention of CVD.2 They have also produced a companion pathway for statin intolerance.

In this Q&A, Dr Phil Jennings explains how AHSNs are working to achieve the goals set out in the clinical pathway, how the programme on lipid management can help to prevent cardiovascular events, and the role of cardiologists in ensuring its success.

Guidelines in Practice (GinP): Why was there a need for the lipid management RUP programme?

Dr Phil Jennings: CVD remains the biggest cause of morbidity and mortality in the country.1 Although it has been on the radar for some time, outcomes are not improving as quickly as hoped, and, in certain communities, life expectancy is decreasing.1 Lipid management is an important part of the ABC approach (atrial fibrillation [AF], blood pressure, and cholesterol) to CVD risk reduction.1

The lipid management RUP programme enables specific innovations, diagnostics, and new products to be rapidly assessed for use in clinical settings, including CVD prevention, as well as determine whether they can provide additional benefits to care packages that are already in place. This allows for a speedier uptake and implementation on a national scale.

The assessment is performed centrally and, once an innovation or product has been selected, each AHSN is tasked with ensuring that it is adopted. AHSNs aid local systems by introducing new medical technologies, medicines, and pathways, and support them to build capacity and capability within their teams. This initiative is one of only a few examples of sponsorship at a national level, through a partnership between AHSNs and the AAC at NHS England).  

GinP: What is the aim of the lipid management RUP programme?

Dr Jennings: The RUP lipids programme uses GP medical records—which are easily accessible, of high quality, and up to date—to identify patients at high risk of CVD who could benefit from either primary or secondary prevention. These patients are assessed to see whether they need to begin a new treatment or whether existing treatment can be improved— for example, by changing the dose or combinations of current medicines, or by adding new medicines. It is hoped that this will lead to improved lipid management and reduced CV events, such as heart attacks, strokes, or other CV consequences.

GinP: What treatments are covered and how has the programme increased uptake of, and access to, different medicines?

Dr Jennings: All currently available treatments that have been approved by NICE—for example, statin therapy and medications to lower cholesterol—are included in the programme, which continues to evolve as new medicines enter the market.

For most patients, well established lipid-modifying agents, such as statins and ezetimibe, are the treatment of choice. Analysis of Quality and Outcomes Framework (QOF) data from primary care suggests that patients are often not receiving the correct molecule, dose, or combination, and simply require an alteration to existing treatment rather than a new medicine.3

In recent years, there have been several advancements in lipid therapy—including the introduction of the proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors, inclisiran,4 and bempedoic acid5—and the programme identifies patients who could benefit from these. This is supported by a clinical pathway that describes which molecule would best suit particular patients, and at what point in their treatment journey.

GinP: How can the programme help patients who remain high risk, despite receiving maximum statin dose?

Dr Jennings: In theory, maximum statin dose refers to the full dose of a high potency statin; however, in my clinical experience, many patients develop side effects long before reaching that hypothetical maximum dose, and the maximum statin dose for some patients may actually be a fairly modest dose. In addition, other patients receiving high-dose or combined therapy may not achieve their target cholesterol level.

These patients may benefit from the addition of some of the newer therapies, either by referral to specialist clinics for PCSK9 inhibitors, or through injectable therapies such as inclisiran which can be started in primary care.6 This can have a big impact on lowering cholesterol beyond the range of maximum statin doses and, hopefully, on improving outcomes for patients.7

GinP: Can the programme help to reduce health inequalities?

Dr Jennings: Health inequalities are a real challenge; some of the worst cardiovascular outcomes are concentrated in pockets of high levels of deprivation.8 In more deprived communities, the standard approach of asking people to visit a GP does not always work, so the programme is trying to reach these populations through different means, for example, by working with community champions in the voluntary sector, who often have a presence and a leading role in these communities.

There is still a lot of work to be done to engage the population and to ensure patients are receiving the appropriate treatment. By using NHS England’s Core20PLUS5 approach, AHSNs are able to identify and reach out to specific communities and, through this, to hopefully improve health inequalities.

GinP: What is the role of cardiologists?

Dr Jennings: The collaboration of cardiologists is very important for the success of the programme. Their expert advice on new medicines, or patients who are particularly tricky from a clinical point of view, is invaluable.

New medicines often come on stream in secondary care; a direct introduction into primary care occurs much less commonly. Cardiologists can provide information about these treatments, as well as support and guidance to primary care colleagues.

Acute physicians—particularly cardiologists who work in coronary care and manage patients with acute coronary syndromes—and stroke physicians are experienced at dealing with this population of high-risk patients. Recently developed pathways for acute coronary syndromes and acute stroke, such as the high sensitivity troponin pathway,9 enable these patients to be identified at the point of admission.

In addition, medicines optimisation occurs in secondary care, followed by handover to GPs. The programme must work effectively across primary and secondary care, and both sectors have an important collaborative role. 

GinP: How well is the programme working?

Dr Jennings: Every AHSN will be able to demonstrate positive results, but the patients with the greatest need remain those who are the most difficult to engage. When designing the programme, unpublished internal modelling based on QOF and public health data showed that about half of the eligible populations—those with a high prevalence of CVD coupled with deprivation and other social determinants of health— that the programme is trying to target are part of northern AHSNs.

GinP: What is the potential for the programme to move care from the hospital into the community, and could this affect adherence?

Dr Jennings: Most patients requiring lipid management are managed in the community by GPs and practice nurses. Historically, patients are referred to specialist clinics once therapy has escalated to the point where it can go no further, but often there are long waits, and there is a lack of lipid specialists in the UK.

Some new medicines, particularly inclisiran, have the potential to ease this. Although it is used in both primary and secondary care, eligible patients can be identified in primary care and treatment commenced there, without the need for attendance at a specialist clinic. This signals a new way to tackle cardiovascular health.

Inclisiran is an injectable given once every 6 months, and offers an opportunity to significantly improve adherence once therapy is established.4 In my clinical experience, many patients in this target group will already be taking between five and eight medicines a day, and may be resistant to the addition of more drugs, but a potent and effective injectable, taken twice a year, would be an attractive option for many. We are watching its impact on lipid management with great interest.

GinP: How can the RUP programme help with meeting targets on CVD in the NHS Long-Term Plan?

Dr Jennings: Apart from cancer, CVD remains the biggest national clinical challenge.1 It will take many years to catch up with European and North American colleagues, and improving outcomes for CVD remains a focus in the NHS Long-Term Plan.1

But there is a perception that we have still not made the progress that was hoped for, and clinical fatigue can set in. The clinical pathways and new drugs in this programme, along with more sophisticated ways of identifying which patients will benefit, present further opportunities to boost population health.

GinP: What impact has the programme had on hospital admissions and readmissions and the risk of heart attacks and strokes?

Dr Jennings: Lipid optimisation has the potential to make a real difference, even within a timeframe of 5 years, particularly for populations at an ICS level, which can be as many as one million patients or more. An increase in the number of people achieving target lipid optimisation from 70% to 90% over a 5-year period could prevent about 500 cardiovascular events, including heart attacks, strokes, or death from CVD.10,11 When used in conjunction with other cardiovascular interventions, such as AF screening and blood pressure optimisation, the benefits can be even greater.

GinP: What are the barriers to implementation?

Dr Jennings: In common with other innovations, the extreme pressure the NHS currently faces is a major obstacle; clearly, implementing the RUP programme involves additional clinical work and resources, much of which falls on primary care and community teams.

The ambition that treatment with novel drug therapies for eligible patients be commenced in primary care using a population health management approach, rather than waiting for them to trickle down from secondary care as occurred in the past, also creates difficulties.

This is a long-term initiative; it will be ongoing for a decade, not just for 12 or 18 months. We also require a smarter approach to the inextricable link between CVD outcomes and health inequalities, with greater investment and different ways of working. We are starting to make some progress; it will be a long process, but it is now getting the attention it deserves.

GinP: What does the future hold for the programme?

Dr Jennings: The RUP programme presents an opportunity to improve cardiovascular health in communities, particularly if we continue to use data as smartly as possible to inform a population health management approach to CVD.

There are also some exciting new developments. Many of the commonly used drugs have been around for 20 years or longer, but pharmaceutical companies have taken an innovative approach to some of the emerging drugs coming on stream, particularly in gene editing technology, with inclisiran one of the first examples of a new class of medicines. It will be exciting to track their impact over the coming years.

An ongoing dialogue and partnership between primary and secondary care physicians is a key element of success in population health initiatives, particularly when new molecules are introduced into clinical pathways. Although the bulk of prescribing will ultimately occur in primary care, sharing of knowledge and experience across sectors in the early stages can help to build the confidence of both clinicians and patients in these new treatments.

Dr Phil Jennings
Chief Executive of the Innovation Agency, one of 15 Academic Health Science Networks in England, established by NHS England in 2013. A GP by background, he is the lead for the AAC RUP programme.