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First patients in Yorkshire and Humber receive new cholesterol lowering drug Inclisiran

Written by: Adele Bunch - 25th January 2022

In this second blog, programme lead Adele Bunch showcases initial prescribing of Inclisiran in the region, within Affinity Care in Bradford, as part of the first population health management agreement between pharma and the NHS.

The introduction of the new injectable therapy, Inclisiran has shone a light on lipid-management pathways used to help lower the level of harmful cholesterol in patients at higher risk of having a heart attack or stroke. Affinity Care Primary Care Network (PCN) are leading the way in the region having this week become the first PCN to prescribe the drug to some of their eligible patients.

Despite the significant pressure placed on primary care to deliver the COVID-19 vaccination booster programme, Affinity Care has made excellent headway in revising their local lipid-management pathway and identifying suitable patients – a real credit to their commitment to continue to meet local cardiovascular challenges and drive down health inequalities.

As we know, cardiovascular disease (CVD) has been identified in the Long Term Plan as the single biggest area where the NHS can save lives over the next decade. CVD has a huge impact on people’s lives, but early detection and treatment can help patients live longer healthier lives. Risk factors such as high cholesterol can be prevented and treated to help reduce the risk of heart attacks or strokes. Inclisiran bridges a gap in the lipid-management pathway, offering an alternative to the use of drugs such as statins, ezetimibe or PCSK9 inhibitors.

Introduced into the NHS in September 2022 having been endorsed by the National Institute for Health and Care Excellence (NICE), Inclisiran is designed to treat patients with CVD whose cholesterol cannot be lowered with maximally tolerated statins alone or ezetimibe. In December, the revised national NICE endorsed pathway was published, enabling local leaders to revise local lipid pathways.

So how did Affinity Care manage to make such significant progress? I caught up with Dr Matthew Fay, Clinical Chief Executive at Affinity Care and Mahmoud Khodadi, Chief Pharmacist and Partner who advised:

Although there are clear priorities for the NHS in protecting people from Sars-cov-19 with the vaccination programme, Affinity Care PCN was concerned that we cannot restrict our view and we need to continue the prevention agenda in other areas as well.

“Our PCN population in Bradford carry significant cardiovascular risk and of course that risk is very high in those with established disease. For many years, the only evidence-based intervention for lipids in this setting was limited and the implementation of the PCSK9-inhibitors locally had been stymied by Sars-cov-19, so the NICE recommendation around Inclisiran to be implemented by primary care gave an additional intervention for our patients to reduce their risk.”

Identifying other clinical pathways to support patients with high cholesterol is vital if we want to reduce the risk of CVD. Inclisiran is just one part of the lipid-management pathway. It will not be applicable to all patients with high cholesterol and can only be prescribed if someone has had a CVD event.

However, in line with NICE guidance, for those patients where other treatments are not working, Inclisiran provides a new option and can reduce cholesterol levels by 50%.

The work that Affinity Care is doing to help their patients better control their cholesterol levels is a good example of how to use the tools offered by the national Lipid Management and Familial Hypercholesterolaemia Prescribing Pathway programme to help identify and treat patients with a higher risk of CVD.

The team at Affinity Care reviewed their cholesterol and lipid pathway early in 2021 to prepare for the release of Inclisiran. They wanted to ensure they were starting to check against LDL-C – often referred to as ‘bad cholesterol’ which, if too high, can be associated with a build-up of fatty deposits inside the arteries – as well as Non-HDL-C (‘good cholesterol) in people with known CVD or Type 2 diabetes. This allowed them to ensure they could identify those people who may require further intervention.

Dr Fay and Mahmoud Khodadi added: “The pathway already had comprehensive guidance on how to determine who could not receive statin therapy, rather than those who did not take statins through personal choice. This preparation has meant that data searches could be used to identify the potential candidates for a more intensive intervention.

“Affinity Care PCN has a very comprehensive pharmacy team who are involved in much more than just medicine reconciliation and are a core part of the Long Term Conditions management multidisciplinary team. Armed with the new lipid protocol and data searches they were ready to support the intensification of lipid management, in addition to other modifiable risk factors for our local population.

“Due to this preparation, we have now started to use Inclisiran in North Bradford”.

I continue to engage with the system to discuss local formularies (list of medicines approved for prescription across various settings) and system readiness for prescribing. I’m pleased to say six of our 21 formularies are now green which means primary care prescribers would normally take full responsibility for prescribing and monitoring.  Work continues with local area prescribing committees to discuss the status of those yet to be reviewed or currently  in amber/grey status. Green status of local formulary allows prescribing by GPs and independent prescribers in the primary care team, crucial to the integration of Inclisiran into lipid-management pathways.

Please do reach out to me at if you have any questions about this programme or wish to share early adopter best practice.