Prescribing Policy: Lipid Modification - Primary Prevention Policy Statement: Date of Approval: 11 th February 2010 This policy defines the decision made by the NHS Western Cheshire Clinical Commissioning and Strategy Committee Lipid-modifying agents should only be prescribed in accordance with NICE guidance for primary prevention. Simvastatin 40mg is first line therapy, a lower dose of simvastatin or pravastatin 40mg should be prescribed if simvastatin is not tolerated. High intensity statins should NOT be prescribed for primary prevention There are no targets for lipid lowering in primary prevention. Note: Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed at the PCT Bespoke Care Panel upon receipt of a completed application form from the Patient s GP, Consultant or Clinician. Applications can not be considered from patients personally. Version 1.0 Approved by (committee) Clinical Commissioning and Strategy Committee Date Approved 11 th February 2010 Date of implementation 1 st May 2010 Produced by Prescribing policy development group Review Date Earliest of either amended NICE guidance or five years from issue
Further information about this document: Document name Prescribing Policy: Lipid modification primary prevention Category of Document in The Policy Schedule Commissioning Policy Author(s) Contact(s) for further information about this document This document should be read in conjunction with Published by Copies of this document are available from Prescribing policy development group Telephone: 01244 650316 Email: barbara.perry@wcheshirepct.nhs.uk Prioritisation framework NHS Western Cheshire 1829 Building Countess of Chester Health Park Liverpool Road Chester, CH2 1HJ Main Telephone Number: 0800 132 966 (Freephone) Main Email Address: feedback@wcheshirepct.nhs.uk Website: www.wcheshirepct.nhs.uk Copyright NHS Western Cheshire, 2007. All Rights Reserved Version Control: Version History: Version Number Reviewing Committee / Officer 0.1 Prescribing policy development group December 2009 0.2 Area Prescribing Committee January 2010 0.2 Clinical Commissioning and Strategy Committee February 2010 Date
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Contents 1. Background 2. Evidence 3. Conclusions 4. Responsibility for implementation 5. References 6. Route for policy development and ratification Appendix 1 Flowchart for lipid modification in primary prevention of CVD The following terms are used in this document CHD CVD LDL-C NICE PCT TC Coronary heart disease Cardiovascular disease Low density lipoprotein cholesterol National Institute for Health and Clinical Excellence Primary Care Trust Total cholesterol
1. Background 1.1 Blood cholesterol is a key modifiable risk factor for coronary heart disease. Other modifiable risks include smoking, alcohol consumption, blood pressure and weight. Management of these risk factors should be optimised before offering lipid modification therapy. Statins lower the risk of CHD by reducing cholesterol levels. 1.2 NICE clinical guideline 67 recommends the risk assessment of patients aged 40 to 74 years and treatment with statins if their 10 year risk of developing CVD is 20% or more. Patients aged 75 years and over may be considered at increased risk of CVD and likely to benefit from statin treatment. 1.3 There are no target cholesterol levels for primary prevention. 1.4 Patients with confirmed vascular disease, diabetes or familial hypercholesterolaemia should not be treated as primary prevention. 1.5 National Better Care Better Value indicators include the prescribing of low cost statins. Western Cheshire Primary Care Trust does not perform well in this area, being ranked 131 out of 152. Potential savings of almost 800,000 were identified in quarter 1 of 2008, if the PCT performance moved into the national top quartile. 2. Evidence 2.1 NICE reviewed the evidence to support lipid lowering in primary prevention of CVD and concluded that the use of low cost acquisition statins was a cost-effective intervention. There is less evidence to support the prescribing of fibrates. 3. Conclusions 3.1 For patients with a 10 year risk of CVD of 20% or over, treatment with a statin should be considered. Modifiable risk factors should be optimised prior to initiating lipid modifying therapy. 3.2 First line treatment should be simvastatin 40mg. If this is not tolerated or there are contraindications or potential drug-drug interactions, a lower dose of simvastatin or pravastatin 40mg should be used. Patients taking warfarin should have their INR monitored more frequently until stable. Prescribing Policy Lipid modification primary prevention Version: 1.0
3.3 Higher intensity statins and nicotinic acid should NOT be used for primary prevention, nor should the combination of a fibrate, fish oil supplement or an anion exchange resin with a statin. 3.4 If statins are not tolerated, fibrates, anion exchange resins or ezetimibe (NICE TA132) may be considered. 3.5 Monitoring of cholesterol levels is not necessary as there are no targets for primary prevention. 3.6 Compliance with therapy and lifestyle interventions should be checked at every review. 3.7 Liver function should be checked within 3 months of initiation of statin therapy and at 12 months, but not again unless clinically indicated. 4. Responsibility for implementation 4.1 Responsibility for implementation lies with the Practice Based Commissioning Consortium and the Area Prescribing Committee. 5. References 5.1 NICE CG67 Lipid modification 5.2 NICE TA132 Ezetimibe for the treatment of primary (heterozygousfamilial and non-familial) hypercholesterolaemia. Prescribing Policy Lipid modification primary prevention Version: 1.0
6. ROUTE FOR POLICY DEVELOPMENT AND RATIFICATION Evidence researched by Public Health Specialist Evidence reviewed by Task & Finish Group and draft policy developed Draft policy reviewed and agreed by Area Prescribing Committee Draft policy finalised and ratified by Clinical Commissioning and Strategy Committee Policy distributed to relevant stakeholders and uploaded on the PCT extranet and website Prescribing Policy Lipid modification primary prevention Version: 1.0
Appendix 1 Flowchart for lipid modification in primary prevention of CVD Primary prevention Identify patients aged 40-74 who have a 20% 10 year risk of developing CVD using an appropriate assessment tool. Exclude patients with Established vascular disease Diabetes Thyroid disease N.B. Patients aged 75 years or over may be considered to be at increased risk of CVD and likely to benefit from statin treatment Patients of south Asian origin have an increased risk, so should be offered treatment if 10 year CVD risk >14% Patients with one first degree relative with early onset CVD* should be offered treatment if 10 year CVD risk is.13% Patients with two first degree relatives with early onset CVD* should be offered treatment if 10 year CVD risk is >10% * male<55 years, female<65 years Offer treatment with simvastatin 40mg If this is not tolerated or there are contraindications or potential drug-drug interactions, a lower dose of simvastatin or pravastatin 40mg should be used. Higher intensity statins or nicotinic acid should not be used Do not offer the combination of an anion exchange resin, fibrate or fish oil supplement with a statin If statins are not tolerated, consider fibrates, ezetimibe or anion exchange resins Monitoring of lipid levels is not necessary as there are no target levels for primary prevention. Measure liver function within 3 months of starting statin therapy and at 12 months, but not again unless clinically indicated. Check compliance with therapy and lifestyle changes at every review. If initiating simvastatin in patients taking warfarin, monitor INR frequently until stable. Prescribing Policy Lipid modification primary prevention Version: 1.0