The Department of Health (DoH) has published a document that details the National Policy on Statins. Before discussing the pros and cons of statin administration, it would be helpful to look at the current UK policy on statin prescribing. This insight will assist the reader to understand the background information that was used to inform the current policy. It is a given that the National Institute for Clinical Excellence (NICE) and National Service Frameworks (NSF) will play a large part in determining and implementing health policies for the UK.
The policy document is entitled “Statins: National Policy”. It was authored by Dr Stephen Green and was produced by the DoH Vascular Team. The document opens and immediately deals with “Importance of this issue”[1] The document states, among other things, “Statins key role to play in achieving further improvements in mortality, morbidity & need for interventions (Lancet 2005 - Sept 2005).”[2]
It also states “Statin prescribing needs to be increased to meet primary prevention guidance issued by NICE (TA094).”[3]
The policy document shows a graph that delineates the increase of individual statin prescriptions between the years 2002 ~ 2005.[4] What is clearly seen on the graph is that the prescribing of statins has climbed sharply from just under 8,000,000 prescribed items in 2002 to almost 16,000,000 prescribed items in 2005. Within the duration of four years, the total number of prescribed items (statins) has more than doubled.
Next are some pages that look at the % of low cost statins being prescribed (when the particular preparation is out of patent) and compare those figures with national prescribing trends. For now, these trends need not concern us greatly because the central issue is why prescribe statins to us all in the first instance.
The next page is entitled the CHD NSF [5] and refers to two interventional steps that are recommended. Next to the subheading (Standard 4) It states that “General practitioners and primary health care teams should identify all people at significant risk of cardiovascular disease but who have not developed symptoms and offer them appropriate advice and treatment to reduce their risks”.
The first step intervention is for people with diagnosed CHD, which is assumed to mean coronary heart disease. The recommended intervention follows... Statins and dietary advice to lower serum cholesterol concentrations EITHER to less than 5 mmol/l (LDL-C to below 3 mmol/l) OR by 30% (whichever is greater)
The second step intervention is for people without diagnosed CHD or other occlusive arterial disease with a CHD risk greater than 30% over ten years. The recommended intervention follows... Add statins to lower serum cholesterol EITHER to less than 5 mmol/l (LDL-C to below 3 mmol/l) OR by 30% (whichever is greater)
A box underneath this steps denotes a change in the policy that was brought about by the NICE technical appraisal (TA094)[6] The change required by the NICE technical appraisal was that the risk would be changed from a 30% ten year risk to a 20% ten year risk.
Following on is a page that is headed ‘NICE - Lipids & Statins’ which details what NICE has already reported on. The main conclusions of the technical appraisal known as ‘Report - Statins for the Prevention of cardiovascular events are listed (this report is TA094).[7] The list of 4 bullet points follows...
1. Statin therapy recommended for the prevention of CVD for adults with 20% or greater 10 year risk of developing CVD
2. Level of CVD should be estimated using a risk calculator
3. Decision to initiate based on informed doctor/patient discussion
4. When decision made to prescribe - recommended therapy should be initiated with a drug with low cost
The following page details the cost of NICE guidance.[8] This is £78.1 million and the savings are listed as £69.6 million. The net cost is £8.5 million. It is worth pointing out that the £69.6 million savings is an estimate of potential savings. The table provided shows which event will be avoided, how much each event costs, the number of events that will be avoided and the projected annual cost saving.
The following page confirms that NICE has been asked by the Department of Health and the Welsh Assembly to review the management of lipid disorders.
The text of the requests[9] follows and it is reproduced below...
1. To prepare a clinical guideline for the NHS in England and Wales for the identification of patients with lipid disorders as part of the wider risk assessment of CVD.
2.This should include those with existing CHD or other vascular disease, as well as those at higher risk of developing these conditions.
3. The guideline will include best practice advice on the management of lipid disorders, placing treatment in the context of other potential actions, to reduce risk including diet, exercise and smoking. Advice on the level of reduction of cholesterol with lipid lowering drugs will be given, taking into account the cost effectiveness of such reductions.
4. This guideline will have the effect of updating the advice given in the NSF for Coronary Heart Disease and will be informed by a NICE technology appraisal to determine the level of risk at which to intervene with cholesterol-lowering drug therapy.
NICE states that it will report in December 2007
(note: The bold and underlined text are shown like this in the original text)
The Quality and Outcomes Framework is mentioned[10] and the current and future indicators (re: Cholesterol) are detailed. These are the points that allow the family practitioner to receive additional money.
The policy document underlines the importance of the role of NICE and NSFs. It also notes that performance will be assessed on more than national targets and mentions delivery of high quality standards including NSFs and emphasises NICE guidance.[11]
The next page refers to ‘Core Standard (C5) about NICE Technical Appraisals’.[12] These core standards mention that “C5 Health care organisations ensure that a) they conform to NICE technology appraisals and, where it is available, take into account nationally agreed guidance when planning and delivering treatment and care;”
The next page refers to JBS2.[13] This document carries the unwieldy full name.... Joint British Societies’ guidelines on the prevention of cardiovascular disease in clinical practice (Dec 2005) The societies comprise: British Cardiac Society, Diabetes UK, HEART UK, Primary Care Cardiovascular Society and The Stroke Association.
The page[14] notes that JBS1 (published in 1998) recommendations were very influential in determining the content of the relevant NSF. The aim of JBS2 is listed as... “to promote a consistent multidisciplinary approach to the management of people with established atherosclerotic cardiovascular disease (CVD) and those at high risk of developing symptomatic atherosclerotic disease.”
Further points made are...
“The new guidelines recommend a healthy lifestyle, thresholds for initiating treatments and treatment targets, including the use of cardioprotective drug therapies.
The new JBS2 cardiovascular risk prediction charts developed for these guidelines are also published in the British National Formulary[15] and are available to all clinicians.”
Two further pages of the National policy document on statins are used to display bullet points of the recommendations. The points are listed below...
We recommend that CVD prevention in clinical practice should focus equally on:
(i) people with established atherosclerotic CVD
(ii) people with diabetes, and
(iii) apparently healthy individuals at high risk (CVD risk of >20% over 10 years) of developing symptomatic atherosclerotic disease.
This is because they are all people at high risk of CVD
This can be achieved through lifestyle and risk factor interventions and appropriate drug therapies.
In all high risk people rigorous control of blood cholesterol is recommended with the following treatment targets:
“The optimal total cholesterol target is, 4.0 mmol/l and low density lipoprotein (LDL) cholesterol, 2.0 mmol/l or A 25% reduction in total cholesterol and a 30% reduction reduction in LDL cholesterol, whichever gets the person to the lowest absolute value”
“An “audit standard” for total cholesterol of 5 mmol/l (or a 25% reduction in total cholesterol) and for LDL cholesterol of 3 mmol/l (or a 30% reduction in LDL cholesterol), whichever gets the person to the lowest absolute level, is also recommended. This audit standard is considered to be the minimum standard of care for all high risk people.”
The following page shows a table that is entitled ‘Guidance on CVD & CHD Risks and Cholesterol.’[16] The table shows the guidance standard falling from a 40% ten year risk of CVD to a 20% ten year risk of CVD in the years from 1998 until 2006 (with 2007 still to be announced). The same period for the ten year CHD risk shows a fall from 30% to 15%. The total cholesterol has fallen from < 5 mmol/l to < 4 mmol/l during the same time span and the LDL cholesterol figure has fallen from < 3 mmol/l to < 2 mmol/l during the same 8 year period.
The next page is headed ‘Cardiac Networks’[17] and states that cardiac networks have an important part to play in the move to lower cost statins and in the achievement of TA094.
The final page of the policy document is headed ‘Summary’ and it describes the future.[18] It states: “Future changes in prescribing statins will be set by NICE”.
It also states: “There is a lot of work to be done to increase prescribing rates to meet the guidance in TA094”
Another important statement follows...
“When NICE report on risks and cholesterol targets - their guidance will become the national standard to be achieved”.
That completes this brief look at the English National Policy on Statins. The links to the document are all to the same place. Each separate page does not have a unique web-site address. The numbers in square brackets [1] within the text of this web page are referred to as 'Text ref:' and can be found in the line above each each link. The numbers within the round brackets, next to the 'Link page ref:, gives the relevant page numbers within the linked document.
Text ref: [1, 4, 5, 7, 8, 9, 10, 11, 12, 14, 16, 17 & 18]
Link page ref: (page - 3, 4, 9, 10, 11, 13, 15, 16, 17, 18, 21, 22 & 23)
National Statin Policy
Text ref: [3 & 6]
Link page ref: (page - 4 & clause 1.2)
NICE Technical Appraisal TA094
Text ref: [13]
Joint British Societies' Guidelines on the Prevention of Cardiovascular Disease in Clinical Practice (JBS2)
Text ref: [15]
British National Formulary
Text ref: [2]
The Lancet reference is not supplied but it will be added when it becomes available.
