Lipid Regulating Drugs

Preferred list (P)

ATORVASTATIN

Total list (T)

SIMVASTATIN

ROSUVASTATIN

Total list (T)

EZETIMIBE

• Inhibits the intestinal absorption of cholesterol.
• For secondary prevention, in addition to maximum tolerated statin therapy, for those in whom LDL cholesterol is considered not adequately controlled.

Specialist initiation (S¹)

BEMPEDOIC ACID (Nilemdo^®)

• SMC Advice July 2021: For restricted use in adults, with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet.
• Restriction:for use in combination with ezetimibe in patients who are:
  • statin intolerant or for whom a statin is contra-indicated
    and
  • where ezetimibe alone does not appropriately control LDL-C
    and
  • where proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors are not appropriate.

BEMPEDOIC ACID WITH EZETIMIBE (Nustendi^®)

• SMC Advice October 2021: For restricted use in adults, with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet.
• Restriction:for use in patients who are:
  • statin intolerant or for whom a statin is contra-indicated
    and
  • where ezetimibe alone does not appropriately control LDL-C
    and
  • where proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors are not appropriate.

Specialist initiation (S¹)

BEZAFIBRATE

• Fibrates act by decreasing serum triglycerides; they have variable effect on LDL-cholesterol.
• Restriction: for severe hypertriglyceridaemia only.

Specialist use only (S²)

ALIROCUMAB

• Binds to a pro-protein involved in the regulation of LDL receptors on liver cells; receptor numbers are increased, which results in increased uptake of LDL-cholesterol from the blood.
• ALIROCUMAB (Praluent^®) is accepted for restricted use within NHS Scotland. For further details please see SMC advice August 2016.

EVOLOCUMAB

• Binds to a pro-protein involved in the regulation of LDL receptors on liver cells; receptor numbers are increased, which results in increased uptake of LDL-cholesterol from the blood.
• EVOLOCUMAB (Repatha^®) is accepted for restricted use within NHS Scotland for primary hypercholesterolaemia (heterozygous familial hypercholesterolaemia and non-familial) or mixed dyslipidaemia. For further details please see SMC advice February 2017.
• EVOLOCUMAB is not recommended for the following indication:
  • adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors. SMC advice November 2018.

INCLISIRAN

• INCLISIRAN (Leqvio^®) is accepted for restricted use within NHS Scotland for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
  • in combination with a statin or statin with other lipid lowering therapies in patients who are 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.

• SMC restriction: for specialist use only in patients at high cardiovascular risk as follows:
  -patients with heterozygous familial hypercholesterolaemia (HeFH) and LDL-C ≥5.0mmol/L, for primary prevention of cardiovascular events or,
  -patients with HeFH and LDL-C ≥3.5mmol/L, for secondary prevention of cardiovascular events or,
  -patients with high risk due to previous cardiovascular events and LDL-C ≥4.0mmol/L or,
  -patients with recurrent/polyvascular disease and LDL-C ≥3.5mmol/L.

Inclisiran (Leqvio^®) is for Health Care Professional administration and hospital supply only.