Is inclisiran available in the UK (and for whom)? All you need to know.

Since 2021, both the FDA and EMA have approved Leqvio (inclisiran) as an innovative therapy for lowering LDL-C cholesterol ^2,4. This new medicine aims to help people with high levels of LDL-C cholesterol who don't respond well to statins.

In the USA and the EU, inclisiran is considered an important part of primary and secondary prevention of cardiovascular events ⁴. A big milestone for prevention, considering that 54% of adults across Europe have raised total cholesterol ³.

In the UK, the prevalence of raised cholesterol among adults is 59% ¹. So, what role can inclisiran play for you in preventing cardiovascular events?

Here's everything you need to know about inclisiran in the UK.

Is Inclisiran approved in the UK?

Leqvio (inclisiran) is approved by the MHRA. It is used to treat adults with primary hypercholesterolaemia or mixed dyslipidaemia. It is combined with a diet and:

• in patients who can't reach their LDL-C goals, a statin or combination of therapies may be used;

• it can be used alone or with other medicines for patients who can't tolerate statins or can't take them.

These are the same indications for which inclisiran is approved by the FDA and EMA. In theory, the medicine can be prescribed in the UK for patients with or without prior cardiovascular events.

There is a bit of nuance to that, however, when we look at the NICE's recommendation for inclisiran.

Is inclisiran available on the NHS?

Yes, NICE has recommended reimbursement for inclisiran in the UK. NICE and Novartis have an agreement to provide the NHS with discounted prices ⁵.

However, this recommendation only applies to secondary prevention of cardiovascular events. In other words, inclisiran is only available on the NHS for patients who have already had coronary heart disease, ischaemic stroke or another cardiovascular event.

For patients who have not had a cardiovascular event yet, inclisiran is not available on the NHS. In those cases, inclisiran is only approved for use in clinical trials ⁷.

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How can you access inclisiran in the UK for primary prevention?

If you're a patient in the UK with primary hypercholesterolaemia or mixed dyslipidaemia, and you have not had a cardiovascular event yet, you can still discuss inclisiran with your treating doctor. They can prescribe it to you, as it is approved for that indication. However, you will likely have to bear the cost of treatment yourself.

Cost of inclisiran in the UK

The official price of inclisiran as shared by the NHS is GBP 5,962 in the first year and GBP 3,975 per year afterwards ⁶. Please note that this price may vary over time.

Has your doctor prescribed inclisiran for you as primary prevention? If you're having difficulties filling a prescription for inclisiran outside of the NHS, you can buy inclisiran via the Named Patient Import regulation. This regulation allows for patients to access medicines unapproved or unavailable to them in their country.

If you need help accessing inclisiran for primary prevention in the UK, get in touch with us. We're specialized in sourcing and delivering medicines otherwise unavailable to a patient. We'd be happy to assist you, too.

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References:

1. Adults' health: Cholesterol. NHS Digital, 16 May 2023.
2. FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year. Novartis, 22 December 2021.
3. INFOGRAPHIC: Europe has the highest prevalence of high cholesterol in the world. EURACTIV.com, 2 February 2015.
4. Leqvio - 5333 - EPAR. European Medicines Agency, 15 October 2020.
5. Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia. NICE, 6 October 2021.
6. Inclisiran injection (Leqvio®) for primary hypercholesterolaemia or mixed dyslipidaemia. Pan Mersey APC, 25 May 2022.
7. NICE approves ground-breaking cholesterol-lowering drug inclisiran. NICE, 1 September 2021.