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 Formulary Chapter 2: Cardiovascular system - Full Chapter
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02.12  Expand sub section  Lipid-regulating drugs
Alirocumab
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Formulary
Red
High Cost Medicine
  • Only approved for use in accordance with NICE guidance.
 
Link  NICE TA393: Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia
 
Evolocumab
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Formulary
Red
High Cost Medicine
  • Approved for use in accordance with NICE guidance for treating primary hypercholesterolaemia.
  • Approved for the treatment of homozygous familial hypercholesterolaemia in line with NHS England Commissioning policy.
 
Link  NICE TA394: Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia
 
Icosapent ethyl (Vazkepa®)
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Formulary
Green plus
  • 998mg capsules
  • Icosapent ethyl is recommended as an option for reducing the risk of cardiovascular events in adults. It is recommended if they have a high risk of cardiovascular events and raised fasting triglycerides (1.7 mmol/litre or above) and are taking statins, but only if they have:
    • established cardiovascular disease (secondary prevention), defined as a history of any of the following:
      • acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation)
      • coronary or other arterial revascularisation procedures
      • coronary heart disease
      • ischaemic stroke
      • peripheral arterial disease, and
    • low-density lipoprotein cholesterol (LDL‑C) levels above 1.04 mmol/litre and below or equal to 2.60 mmol/litre
 
Link  NICE TA805: Icosapent ethyl with statin therapy for reducing the risk of cardiovascular events in people with raised triglycerides
 
Inclisiran (Leqvio®)
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Formulary
Green

  • 284mg/1.5ml solution for injection pre-filled syringes

    • Approved for the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet in adults in line with NICE. 




 
Link  NICE TA 733 - Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia
 
02.12  Expand sub section  Bile acid sequestrants
Colestyramine
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Formulary
Green plus
  • For initiation in lipid clinic only in patients with familial hypercholesterolaemia and/or those with substantial cardiovascular risk and who are unable to tolerate existing treatments.
  • Also approved for the treatment of leflunomide toxicity Red Traffic Light.
 
 
Colesevelam
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Formulary
Green plus
  • For initiation in lipid clinic only in patients with familial hypercholesterolaemia and/or those with substantial cardiovascular risk and who are unable to tolerate existing treatments.
 
 
02.12  Expand sub section  Ezetimibe
Bempedoic acid (Nilemdo®)
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Formulary
Green
  • 180mg tablets
  • Approved for the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in adults in line with NICE and following the statin intensification pathway outlined in NEELI

 

 
Link  NICE TA694 - Bempedoic acid with ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia
 
Bempedoic acid with ezetimibe  (Nustendi®)
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Formulary
Green
  • Bempedoic acid 180mg & ezetimibe 10mg tablets
  • Approved for the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in adults in line with NICE and following the statin intensification pathway outlined in NEELI

 

 
Link  NICE TA694 - Bempedoic acid with ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia
 
Ezetimibe
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Formulary
Green
  • Only approved for use in accordance with NICE guidance.
  • For further information refer to NEELI

 

 
Link  NICE TA385: Ezetimibe for treating primary heterozygous-familial and non-familial hypercholesterolaemia
 
02.12  Expand sub section  Fibrates
 note 

For initiation in lipid clinic only in patients with familial hypercholesterolaemia and/or those with substantial cardiovascular risk and who are unable to tolerate existing treatments.

Fenofibrate
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First Choice
Green

For initiation in lipid clinic only in patients with combined hyperlipidaemias and severe hypertriglycerideamia.

 
Bezafibrate
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Formulary
Green
 
Link  MHRA Drug Safety Update (Dec 2010): Fibrates: first-line treatment not recommended
 
02.12  Expand sub section  Statins to top
Atorvastatin
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First Choice
Green
  • 10mg, 20mg, 40mg & 80mg tablets
 
Rosuvastatin
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Formulary
Green
  •  5mg, 10mg, 20mg & 40mg tablets
    • May be used as an alternative to atorvastatin for primary or secondary prevention in line with NEELI guidance 

 

 
 
Simvastatin
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Alternatives
Green

  • 10mg, 20mg. 40mg & 80mg tablets

 
Link  MHRA Drug Safety Update (Dec 2014): Simvastatin: dose limitations with concomitant amlodipine or diltiazem
 
Atorvastatin Chewable
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Alternatives
Green
  • 10mg and 20mg chewable tablets
  • Note: atorvastatin 10mg and 20mg chewable tablets should be used instead of simvastatin suspension where solid dosage forms cannot be used. 

 

 
 
Pravastatin
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Alternatives
Green

  • 10mg, 20mg & 40mg tablets

 
 
02.12  Expand sub section  Nicotinic acid group
02.12  Expand sub section  Omega-3 fatty acid compounds
02.12  Expand sub section  PCSK9 inhibitors
02.12  Expand sub section  Other lipid modifying agents
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.  

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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