September 2023
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QOF Update 2023 / 24 : The ‘ need to knows ’ of lipid management
This advertorial has been initiated and funded by Novartis Pharmaceuticals UK Ltd and is intended for UK healthcare professionals only . Novartis have reviewed the contents for technical accuracy and compliance with relevant regulatory requirements .
Prescribing information can be found at the end of this advertorial .
LEQVIO ( inclisiran ) is indicated in adults with primary hypercholesterolaemia ( heterozygous familial and non-familial ) or mixed dyslipidaemia , as an adjunct to diet : 1
• In combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin , or
• Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant , or for whom a statin is contraindicated .
The Quality and Outcomes Framework ( QOF ) rewards general practices financially for delivering interventions and achieving patient outcomes using evidence-based indicators developed by the National Institute for Health and Care Excellence ( NICE ). 2 The 2023 / 24 QOF includes two new cholesterol indicators ( worth 30 points and £ 36 million ). 3
There are 6.4 million people currently living with cardiovascular disease ( CVD ) in England , making it a priority for improvement as outlined in the NHS Long Term Plan . 4 , 5 Heart and circulatory diseases are responsible for 25 % of all deaths in England , which is equivalent to one death every four minutes . 4
Hypercholesterolaemia is a key risk factor for CVD . 6 Worryingly , in England , only 23.7 % of CVD patients are reaching their cholesterol targets of non-high-density lipoprotein cholesterol ( non-HDL-C ) less than 2.5mmol / L or LDL-C less than 1.8mmol / L . † 7
Cholesterol Control and Lipid Management ( CHOL ) indicators : 8
For patients on the QOF Coronary Heart Disease , Peripheral Arterial Disease , Stroke / Transient Ischaemic Attack ( TIA ) or Chronic Kidney Disease Register , the following indicators have been confirmed for 2023 / 24 : 8
1 . 70 % to 95 % should be prescribed a statin or , where a statin is declined or clinically unsuitable , another lipid-lowering therapy
2 . 20 % to 35 % of patients should have a recording of non-HDL cholesterol in the preceding 12 months that is lower than 2.5mmol / L or , where non-HDL cholesterol is not recorded , a recording of LDL-C in the preceding 12 months that is lower than 1.8 mmol / L
Reducing LDL-C greatly reduces the risk of a first major cardiovascular event ( MACE ). 9 In fact , a 21 % risk reduction of a first MACE is achieved for every 1mmol / L LDL-C reduction in the first year of statin therapy ; in each subsequent year , this increases to a 24 % risk reduction . * 9 , 10 In this way , QOF LDL-C targets support the delivery of the NHS Long Term Plan . 5 , 8
* The effect of LEQVIO ® on cardiovascular morbidity and mortality has not yet been determined 10
Helping your patients reach their LDL-C targets
Statin monotherapy is insufficient to reach LDL-C goals in many patients 11
Although statins have proven to be an efficacious LDL-C lowering medication , they may not be sufficient or appropriate for every patient need . 11 For example , in a study of patients with coronary heart disease or atherosclerotic CVD ( ASCVD ), 28.3 % to 34.8 % of patients taking atorvastatin had LDL-C levels < 1.8mmol / L , regardless of dose measured between 3 months and 1 year following the first prescription . 12 Some patients may benefit from additional or alternative approaches for LDL-C lowering . 11
In instances where patients are unable to reach their LDL-C goals with statins alone , LEQVIO can be used in combination with a maximally tolerated statin to help your secondary prevention patients reach their LDL-C targets . 1 , 13
How does LEQVIO prescribing fit with the new QOF indicators ?
In ORION-10 ( n = 1,561 ), LEQVIO reduced LDL-C by 52 % at month 17 , as compared with baseline , in patients with ASCVD on a maximally tolerated statin ( 95 % CI : -55.7 to -48.8 ; P < 0.001 ; percentage change in LDL-C of 1.0 % with placebo and -51 % with LEQVIO ). ‡ 1 , 13 LEQVIO delivered a time-adjusted LDL-C reduction of 54 % from baseline after day 90 and up to day 540 ( 95 % CI : -56.2 to -51.3 ; P < 0.001 ; time-adjusted change in LDL-C of 2.5 % with placebo and -51.3 % with LEQVIO ). ‡ 1 , 13
In ORION-11 ( n = 1,617 ), LEQVIO reduced LDL-C by 50 % as compared with baseline at month 17 ( 95 % CI : -53.1 to -46.6 ; P < 0.001 ; percentage change in LDL-C of 4.0 % with placebo and -46 % with LEQVIO ). The time-adjusted LDL-C reduction was 49 % after day 90 and up to day 540 ( 95 % CI : -51.6 to -46.8 ; P < 0.001 ; time-adjusted change in LDL-C of 3.4 % with placebo and -45.8 % with LEQVIO ). ‡ 1 , 13
At day 510 of the ORION-10 and ORION-11 studies , in patients with LDL-levels of < 100mg / dL , 83.4 % and 49.6 % attained the LDL-C target with LEQVIO and placebo , respectively . 14
LEQVIO ® was generally well tolerated , with a safety profile similar to placebo apart from injection-site reactions . 1 , 15 Equally , no new safety signals have been observed with almost
§ 16 , 17
10,000 patient-years of exposure and 20,000 injections .
Looking forward : getting started with LEQVIO
LEQVIO ® offers your patients effective and sustained LDL-C reductions in combination with a maximally tolerated statin ( up to 18 months ) with two maintenance doses a year . 1 , 13 After an initial dose , inclisiran is administered again at 3 months , followed by every 6 months . 1 , 13
Following release of guidance from the National Institute of Health and Care Excellence ( NICE ) on LEQVIO in 2021 , an agreement