NICE Guidance Expected To Add 1.4 Million To Roster Of Statin Users

An additional 1.4 million patients in England and Wales are expected to begin using statins as a result of guidance directing doctors to identify patients at high-risk for cardiovascular disease.

Noting that the lipid modification guidelines from the National Institute for Health and Clinical Excellence provide "treatment based on overall cardiovascular risk rather than on isolated lipid levels," NICE Deputy Chief Executive Gillian Leng says it should "reduce the current variation in prescribing lipid modifying drugs in primary care."

The guidance, issued May 28 to the National Health Service in England and Wales, also discusses lifestyle changes affecting weight, smoking, alcohol consumption and physical activity that can decrease CVD risk.

In the U.S., the National Heart Lung and Blood Institute has launched an effort to develop a single clinical guideline for cardiovascular risk reduction. It is directed at primary care practitioners and includes directives for controlling high blood pressure and obesity, as well as cholesterol (see ¹ ).

Cost of Statin Therapy

NICE estimates that its guidance could increase spending on statins in England and Wales by £110 million ($217.8 million) once fully implemented. These outlays would be offset by £51 million ($101 million) in savings from avoided cardiovascular disease events, the agency calculates.

When Pfizer's Lipitor (atorvastatin) loses exclusivity in 2011, drug expenditures under the guidance would decrease by £24.1 million ($47.5 million) if generics cut the cost for an 80 mg/day dosage in half, NICE says.

The guidelines, developed by the National Collaborating Centre for Primary Care, call on National Health Service doctors to identify people aged 40 to 74 with a high risk of CVD and to take action to modify their lipid levels. The guidelines also address patients with established CVD.

Statin therapy is recommended as part of a management strategy for preventing CVD in adults with a 20 percent or greater risk of developing CVD within 10 years.

After modifiable risk factors are optimized, statin treatment should be initiated with simvastatin 40 mg, unless contraindicated, or there are potential drug interactions. As an alternative, NICE suggests a lower dose of simvastatin or a drug such as pravastatin (Bristol-Myers Squibb's Pravachol and generics). The agency does not set a target for total or LDL cholesterol for these patients and says repeat lipid measurement is unnecessary.

Current U.S. cholesterol guidelines, which were last updated in 2004, set a target LDL-C reduction of 30 to 40 percent in individuals with high and moderately high risk for having a heart attack. (² (Also see "Merck/Schering Vytorin Launch Could Be Aided By New Cholesterol Guidelines" - Pink Sheet, 19 Jul, 2004.), p. 31).

The threshold for initiating drug therapy in high-risk patients - those with coronary heart disease, blood vessel disease or diabetes, or two or more risk factors that give them a 20 percent chance of having a heart attack in 10 years - is an LDL-C level of 100 mg/dL or higher. The treatment goal is LDL-C of <100 mg/dL. For moderately high-risk individuals, it is <130 mg/dL, with a therapeutic option of <100 mg/dL.

The NICE guidance says that, for adults with clinical evidence of CVD, treatment can begin immediately with simvastatin 40 mg. In this case, if a total cholesterol of <4 mmol/lit or an LDL cholesterol of <2 mmol/lit is not attained, consideration should be given to increasing simvastatin to 80 mg, or using a drug of similar efficacy and acquisition cost.

People with acute coronary syndrome should be treated with a higher intensity statin, NICE adds.

U.S. guidelines consider patients with cardiodiovascular disease and multiple or poorly controlled risk factors or metabolic syndrome as "very high risk." For these patients, an LDL goal of <70 mg/dL is considered a reasonable clinical strategy.

NICE estimates the cost for NHS to identify patients at high-risk for CVD as £14.4 million ($28.4 million). This is considered part of the cost of an NHS initiative announced in April to identify vulnerability to vascular diseases - heart disease, stroke, diabetes and kidney disease.

- Cathy Dombrowski ([email protected])