Statin Cost Effectiveness Underscored In JAMA Study

Study by researchers at Harvard analyzes the cost-effectiveness of statins in patients at low risk of cardiovascular disease under current cholesterol guidelines.

Statins could be cost-effective in reducing the risk of cardiovascular disease in patients at even lower risk of disease than those recommended for treatment in current professional guidelines, according to a study published in the Journal of the American Medical Association July 14.

The study by Ankur Pandya, Harvard School of Public Health, et al., analyzes the cost-effectiveness of statin treatment in patents considered to be at low risk of atherosclerotic cardiovascular disease under cholesterol guidelines issued by the American College of Cardiology and the American Heart Association in 2013.

The study is likely to resolve some of the controversy over the guidelines’ recommendation to broaden the pool of patients suitable for statin therapy by including a large group of low-risk individuals (Also see "Time, And Price, Are Right To Prescribe Statins To the Masses" - Pink Sheet, 2 Dec, 2013.). It is among a number of articles in the same issue of JAMA that address cholesterol treatment and reducing the risk of cardiovascular disease, including a report on a new Medicare payment model.

The lower-risk patients recommended for treatment by the guidelines are those aged 40 to 75 without clinical atherosclerotic cardiovascular disease (ASCVD) or diabetes, but with an LDL-C level of 70 through 189 mg/dL and an estimated 10-year ASCVD risk of 7.5% or higher.

Using a hypothetical patient model including individuals with varying levels of risk, the researchers conclude “the health benefits associated with the 10-year ASCVD risk threshold of 7.5% or higher used in the ACC/AHA guidelines are worth the additional costs required to achieve these health gains.”

Interestingly, the study also suggests that “more lenient” ASCVD risk thresholds of 3% or 4% could also be considered cost-effective, using generally accepted incremental cost-effectiveness ratios.

The 7.5% or higher risk group had an incremental cost-effectiveness ratio of $37,000 per quality-adjusted life year (QALY). QALY is a measure of health improvement attributable to a medical intervention, taking into account both the quality of life and overall survival benefits.

ASCVD risk thresholds of 4% or higher and 3% or higher had incremental cost-effectiveness ratios of $81,000 per QALY and $140,000 per QALY, respectively, according to the analysis. All three levels of risk produced cost-effectiveness ratios that are below the generally accepted threshold range of $50,000 to $150,000 per QALY, though the lower the cost per QALY, the better.

Shifting from a 7.5% or higher risk level to the broader 3% or higher risk level was associated with an additional 161,560 cardiovascular disease events averted in the analysis.

The cost-effectiveness results are in part a reflection of the low pricing now available for statin therapy because of generics, the researchers point out. The study used a weighted statin cost of $68 per year based on prices for generic versions of Merck & Co. Inc.’s Zocor (simvastatin) and Pfizer Inc.’s Lipitor (atorvastatin). Assuming generic pricing only, “we projected that it would be cost effective to treat up to 61% to 67% of adults with statins,” the researchers said.

The study does not address the cost-effectiveness of newer and likely far more expensive treatments, such as the upcoming PCSK9 drugs, which are expected to be prescribed initially for high-risk patients who do not reach cholesterol goals on statins (Also see "Are PCSK9 Inhibitors Ready For “Widespread Use”?" - Pink Sheet, 15 Mar, 2015.).

In an email, Pandya observed that although price was a “key driver of the cost-effectiveness” findings, the results should not be extrapolated to the PCSK9s, which are not yet on the market. “The specific attributes of the new PCSK9 drugs with respect to health benefits, health risks, costs and patient preferences are potentially important from a cost-effectiveness standpoint. It may take some time for the evidence to accumulate for the new drugs on all of these dimensions, whereas the medical community has had 30 years of experience with statins,” he pointed out.

ACA/AHA Guidelines Accurately Identify Patient Risk

Another study published in the same issue of JAMA confirmed that the ACA/AHA guidelines improved identification of individuals who might develop a major ASCVD event in the near future and would benefit from statin treatment.

Amit Pursnani, Harvard Medical School, et al., investigated how many of a group of 2,435 statin-naïve individuals would be eligible for treatment under the 2013 guidelines versus an older clinical reference, the National Cholesterol Education Program’s 2004 Updated Third Report of the Expert Panel on Detection, Evaluation and Treatment of High Blood Pressure in Adults (ATP III) guidelines.

They found the approach taken in the ACC/AHA guidelines, known as the pooled cohort equation, led to many more people being eligible for statin therapy – 39% of the study population versus 14% under the ATP III guidelines. The pooled cohort equation includes metrics such as age, gender, blood pressure, cholesterol level and smoking status.

The researchers also conclude those patients newly eligible for statins were at a significantly higher risk for an adverse cardiovascular event and that treating a broader population would help deter health problems later in life. “Extrapolating our findings to the approximately 10 million U.S. adults who are newly eligible for statins, we estimate that between 41,000 and 63,000 incident CVD events would be prevented over a 10-year period by adopting the ACC/AHA guidelines,” they report.

In an accompanying editorial published in JAMA, Philip Greenland, Northwestern University, said that the two studies help resolve lingering questions about who should be treated for high cholesterol and what treatments they should receive.

“There is no longer any question as to whether to offer treatment with statins for patients for primary prevention, and there should now be fewer questions about how to treat and in whom,” Greenland said. “Rather, the next phase of research should be directed at better ways of applying lifestyle and drug treatments to the millions, and possibly billions, worldwide who could potentially benefit from a cost-effective approach to primary prevention of ASCVD.”

Medicare Payment Project Will Reward Risk Reduction

In a separate JAMA article, CMS officials discuss a recently announced value-based prevention payment model project that will use the ACC/AHA approach for predicting and reducing risk from cardiovascular disease in Medicare beneficiaries.

The “Million Hearts Cardiovascular Risk Reduction Model” began recruiting physician practices in June in preparation for enrolling Medicare beneficiaries beginning in early 2016. CMS aims to enroll up to 720 practices in a test of the project that will run through December 2020, the agency says in a description posted on its website.

Under the model, physicians will be eligible for additional Medicare payments when they identify individual ASCVD risk scores for their patients using the ACC/AHA pooled cohort equation.

For patients at highest risk, defined as a risk of over 30% for heart attack or stroke over 10 years, providers will also receive monthly per beneficiary care management payments to reduce their practice-wide absolute risk.

Risk reduction will be accomplished by using a range of interventions, including controlling blood pressure through exercise, taking daily aspirin or eliminating tobacco use, and will not target any specific number for blood pressure or cholesterol. Instead, “CMS will reward based solely on reduction in predicted cardiac risk,” the agency explains. The approach is expected to minimize overtreatment of individuals at low risk, because overtreatment “is not rewarded significantly.”