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- People with familial hypercholesterolemia (FH) are at greater risk of heart disease
- 1 in 250 people in the UK are believed to have FH
- Over 260,000 people in the UK may have FH, with fewer than 10% diagnosed
- 56,000 children in the UK may have FH but only 600 of these are known
HEART UK wins for patients!
HEART UK’s campaign to allow patients greater access to PCSK9 inhibitors has been a great success.
On May 5th 2016 NICE announced that these new medicines will be available for at risk patients following HEART UK’s #Yes2PCSK9 Campaign. The recommendation will mean patients with FH and those at risk following a heart attack or stroke will be given these cholesterol lowering medicines.
Jules Payne, Chief Executive of HEART UK said: “HEART UK is delighted that common sense has prevailed and patients will now have the opportunity to use the cholesterol-lowering medication that works best for them.
“HEART UK has been working with healthcare professionals and patients and we have been lobbying NICE hard to convince them of the health benefits these new medications provide.
“Only by providing patients and healthcare professionals with the information they require to make balanced decisions can NICE ensure that the health services can make a genuine difference and help us do more to win the battle against heart disease.
“HEART UK is here first and foremost for patients. We were totally amazed when NICE first said that these lifesaving medicines won’t be available to patients on the NHS. We have worked tirelessly with both patients and health care professionals to highlight the need for these medicines and the potential they have to save many lives.”
The campaign included the support of over 100 leading health care professionals and hundreds of patients who signed HEART UK’s submission to NICE. The initial decision by NICE caused dismay amongst health care professionals who would be unable to prescribe these new medicines for patients with high cholesterol levels and at risk of a heart attack and stroke, despite maximum dosage of statins and ezetimibe.
Last year’s decision by NICE to deny access for new patients to ezetimibe was similarly met with dismay by health care professionals. HEART UK submission and campaign forced NICE again into a U-turn and continued to allow access to this cholesterol-lowering medicine.
The new draft guidance by NICE recommends PCSK9 inhibitors for patients whose LDL-C persists above levels specified by NICE despite maximal tolerated lipid-lowering therapy. NICE specifies an LDL-C level above 3.5 mmol/l where the patient has existing cardiovascular disease alongside heterozygous familial hypercholesterolaemia (HeFH) or a very high risk of further cardiovascular events without HeFH. It specifies an LDL-C level above 4.0 mmol/l for treatment of patients with cardiovascular disease who have a high risk (without HeFH); and an LDL-C level above 5.0 mmol/l for patients with HeFH who do not have cardiovascular disease.
It is expected that the Final Guidance to the NHS in England and Wales will be in June, when the NHS will have 90 days to ensure it is implemented across the health system.
More detail is available from the NICE website.
What about statins?
These medicines work differently to statins by blocking the PCSK9 protein and are suitable to be used after statin and other more cost effective therapies in patients with high LDL cholesterol despite statin therapy, genetic hypercholestrolaemia (high cholesterol) and for people who find statins too difficult to take and are truly intolerant.
Find out more about statins here.