PCSK9 inhibitors and modulators (Formulary)

Important: Formulation and dosage details

Formulation:

Solution for injection pre-filled pen 75mg/mL, 150mg/mL (specialist use only)

Dosage:

As per SMC 1147/16: 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 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 at 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.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

 

Important: Formulation and dosage details

Formulation:

Solution for injection pre-filled pen 140mg/mL (specialist use only)

Dosage:

By subcutaneous injection, 140mg every 2 weeks, alternatively 420mg every month, administered into the thigh, abdomen or upper arm.

As per SMC 1148/16: in adults with primary hypercholesterolaemia (heterozygous familial hypercholesterolaemia 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 unable to reach low density lipoprotein-cholesterol (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, when administered at a dose of 140mg every two weeks, 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 at 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.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Important: Formulation and dosage details

Formulation:

Solution for injection in pre-filled syringe 284mg (hospital use only)

Dosage:

For patients under lipid clinic who are eligible for PCSK9 inhibitors but who have failed treatment with them due to side effects.

As per SMC 2358: 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.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot