Reducing cholesterol using Inclisiran
Health Innovation NENC were chosen as the lead organisation to support the rollout of Inclisiran, a Novartis therapy, that aims to reduce cholesterol produced to aid cholesterol reduction. This complex project involved a tripartite agreement between Health Innovation Networks (previously AHSNs), Novartis and the NHS. Implementation was novel and used a population health management approach and targeted primary care where the greatest benefit would be realised.
Inclisiran is proven to reduce cholesterol production in the liver up to 50%, although some patients have seen a higher reduction. It can be used alongside existing drugs such as statins and Ezetimibe to further reduce CVD risk.
Despite early challenges and more recent barriers in the system to adoption, HI NENC achieved regional support and adoption across both primary and secondary care.
Contact Details
- Nikki Holdsworth - Programme Manager
- Health Innovation NENC
- [email protected]
Project Dates
Project Start 02/12/2021
Project End Ongoing
Programmes
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‘We have seen substantial decreases in LDL-c in secondary prevention patients, thus reducing their risk of a cardiac event in those who have had an Inclisiran injection. We are delighted the NHS and NICE have approved such an innovative drug in such an innovative manner by allowing deployment to primary and secondary care in tandem. This will ensure it is reached by those most in need.'
Previously to manage lipids in Primary Care in addition to lifestyle advise there were two options available for patients – statins or Ezetimibe. Both had suffered from bad and often exaggerated press such as suggestions they cause cancer and could cause unpleasant side effects for the patient such as muscle pain and general tolerance to the drugs. If cholesterol was not controlled by these two drugs, patients were at increased risk of a CVD event, such as a heart attack or stroke. The efficacy of these two drugs currently prescribed was to reduce cholesterol, statins by 40 – 50% and Ezetimibe a further 11 – 15%, depending on dose. However, some patients will not reach their cholesterol target on these therapies alone.
The innovation within this project is twofold –
Inclisiran is a brand-new world first drug made by Novartis which works differently to the drugs currently prescribed. It works within the liver cell where cholesterol is broken down. The cholesterol reduction potential is up to 50% (source – https://www.nejm.org/doi/full/10.1056/NEJMoa1912387), however, local clinicians have seen reductions in LDL-c of up to 77%.
Secondly, the collaborative approach used for distribution is new to the healthcare system. Historically a new drug is distributed through secondary care first where confidence and momentum is gained. If possible, it may then be adopted by primary care. This new collaboration between the pharmaceutical company Novartis, the NHS and the former Academic Health Science Network (AHSN) (now Health Innovation Networks) meant access was given to primary care and secondary care in tandem. This is giving equitable access, taking a population health management approach and reducing the time taken for the majority of eligible patients to access the drug.
- The National Institute for Clinical Excellence (NICE) approved on 1/9/21
- It was then on the 90 day wait list to appear on formularies
- In Dec 2021 – Inclisiran guidelines (produced by NICE) and a pathway (produced by the Accelerated Access Collaborative) were published. The drug was available from this point.
There was initial resistance from primary care due to conflicting priorities as they had recently been advised about assisting with the rolling out of COVID-19 vaccinations.
The RCGP and BMA – two key bodies for primary care, issued a statement stating they did not support the Inclisiran rollout due to no long-term outcome trial data. There was nervousness around the roll out within primary care alongside the usual route of secondary care.
The 15 regional HINs covering England were tasked with roll out in their locality. The following actions were taken –
- Face to face education sessions
- Online webinars
- These initiatives identified clinical champions in primary care who were keen to support the adoption and roll out of Inclisiran
- These champions established a relationship with other healthcare professionals and worked to identify barriers and offer support where required (resources and funding).
From the start primary care were offered the drug at a subsidised rate, they were also offered an additional £10 per item ordered to cover nurse time to administer the drug.
Initially secondary care was not offered the subsidised rate nor the additional £10 imbursement. This resulted in a renegotiation of the contract between the NHS and Novartis arrangement so secondary care could access the drug at the same cost as primary care. This stimulated demand and usage increased.
Throughout 2022 there was increased confidence by healthcare professionals (HCP) and they can see the improvement in results when checking patients cholesterol.
In 23/24, the responsibility for adoption and uptake of Inclisiran in Primary Care was devolved to the regional ICBs.
Inclisiran is available in primary and secondary care with varying uptake levels.
In the North East and North Cumbria each month numbers of patients on Inclisiran increase. This is being seen across a wider spread of primary care networks. Some areas are proactively case finding eligible patients, initiating patients on Inclisrian, which is significantly reducing cholesterol levels and ultimately the risk of CVD events.
Almost 3,000 units of Inclisiran had been ordered across NENC by Q1 2024.
This project forged relationships between primary and secondary care staff as there was increased information sharing. It is unusual for pharmacists from each to meet and collaborate.
Patient
- Reduction in risk of CVD event which feeds into NHS England long term plan goals
- Less side effects – Inclisiran has no reported side effects
- Inclisiran is administered once every 6 months by injection negating the need for patients to regularly visit the practice, receive a prescription and remember to take the medication
As the drug is delivered by an HCP, there is no reliance on the patient to remember to take it so it is always delivered as intended.
Inclisiran is easy for primary care to handle – it has no drug interactions, no cold storage is required, no blood monitoring is required and there are no dose adjustments as it is in a pre-filled syringe.
There will be a cost saving to the system through reduction of CVD events and improved CVD health as well as helping more patients reach their cholesterol target, thus supporting achievement of cholesterol QOF targets.
Administering Inclisiran will result in a reduction in polypharmacy – there will be less journeys to the GP practice and less pharmacy visits.
Less product and packaging as Inclisiran is administered via one syringe every six months as opposed to monthly prescription for tablets requiring collection or delivery.
The HINs are a key partner in this unique three way collaboration with Novartis, the NHS and the HIN.
HI NENC are the lead HIN for roll out of Inclisiran throughout England.
Programme manager support has been provided throughout by Nikki Holdworth (HI NENC) who will go into healthcare settings to provide support. The following have also been produced the by HI NENC to aid delivery:
- Training, webinars, searches and resources for implementation and delivery
- Podcast – see link below
- YouTube videos –
‘Introducing Inclisiran into the Lipid Management Pathway’
https://www.youtube.com/watch?v=5Lgw37mzY-0&t=2s
‘Inclisiran – Optimising Lipid Management’
https://www.youtube.com/watch?v=raN_z_6LQVU
- A standard operating procedure
- A process map
- An excel template for ongoing patient management.
Funding has also been sourced for primary care and some secondary care trusts, to assist with roll out where necessary.
As a NICE recommended treatment option and its inclusion in the Secondary Prevention Treatment Pathway, https://thehealthinnovationnetwork.co.uk//wp-content/uploads/2024/06/Lipid-optimisation-pathway-for-secondary-prevention-in-primary-care-and-the-community.pdf the team will continue to support HCPs in primary care with the aim of increasing spread and adoption. As increasing numbers of patients benefit from Inclisiran, along with confidence from healthcare professionals, it is hoped there will be a cascade approach and a reduction in Cardiovascular events.
Despite the early issues around Inclisiran and the more recent barriers in the system to adoption, HI NENC achieved regional support and adoption across both primary and secondary care.
A series of videos can be found here in relation to introducing and optimising Inclisiran:
A series of podcasts can found here in relation to this work:
https://healthinnovationnenc.org.uk/news-and-events/podcasts/