JACC: Are the JUPITER recommendations for statin use really cost effective?

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Rosuvastatin (Crestor, AstraZeneca) treatment for JUPITER-eligible patients appears to be cost effective, particularly among those with a Framingham risk score of 10 percent or greater, based on a substudy by the JUPITER researchers, which was published Feb. 15 in the Journal of the American College of Cardiology. However, the accompanying commentary questioned whether the cost associated with the millions of increased statin users, based on the JUPITER researchers' recommendations, is "the best use" of today's "healthcare dollars?"

The JUPITER trial found that rosuvastatin reduces vascular events in apparently healthy subjects with elevated high-sensitivity C-reactive protein (hs-CRP) but normal low-density lipoprotein (LDL) cholesterol levels.

Niteesh K. Choudhry, MD, PhD, from the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women's Hospital in Boston, sought to evaluate the cost-effectiveness of applying the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial results into clinical practice.

The researchers constructed a cost-effectiveness model of men at least 50 years old and women aged at least 60 years with LDL cholesterol levels of less than 130 mg/dl and no known cardiovascular disease. They compared hs-CRP testing followed by rosuvastatin treatment for patients with hs-CRP levels of at least 2.0 mg/l and usual care (i.e., no testing and no treatment).

Among patients with LDL less than 130 mg/dl and hs-CRP levels of at least 2 mg/l, Choudhry and colleagues found that rosuvastatin had an incremental cost-effectiveness of $25,198 per quality-adjusted life year (QALY) gained compared with usual care.

“If the effectiveness of rosuvastatin were 50 percent of that observed in JUPITER, the incremental cost-effectiveness ratio would increase to $50,871 per QALY,” the authors wrote. “Implementing this strategy only in patients with a Framingham risk score of at least 10 percent yielded an incremental cost-effectiveness of $14,205 per QALY.”

Among such intermediate-risk patients, a JUPITER-based strategy becomes cost-saving at a rosuvastatin price of less than $0.86 per day, the researchers concluded. “This price is similar to that of simvastatin and is more than those of pravastatin [Pravachol, Bristol-Myers Squibb] and lovastatin [Mevacor, Merck], which are both widely available in the U.S. for as little as $10 for a 90-day supply (i.e., $0.11 per day),” they wrote. “Even if other statins were less effective than rosuvastatin, our analysis suggests their use could still be cost effective, if not cost saving, because of their much lower cost.”

In the accompanying JACC editorial, Mark A. Hlatky, MD, from Stanford University School of Medicine in Stanford, Calif., wrote that the model of Choudhry et al “does not really address the cost-effectiveness of hs-CRP testing, but instead examines whether to treat with rosuvastatin after hs-CRP testing has already been done.” Therefore, according to Hlatky, they did not examine the “full array of options” needed to evaluate an hs-CRP screening program, such as the frequency of testing, the yield in different segments of the population or alternative methods to treat higher-risk subjects.

He also pointed out that Choudhry et al assumed that rosuvastatin would cut the risk of cardiac events by more than 50 percent for a full 15 years (and have some effect for up to 25 years), even though the average follow-up in JUPITER was only 1.9 years. “When they ran the model under the alternative assumption that the effect of rosuvastatin would last only five years, the cost-effectiveness ratio almost tripled, rising to $62,100/QALY from its initial value of $25,200/QALY,” Hlatky wrote.

On the cost side, he pointed out that Choudhry et al made two assumptions that reduced the net cost impact of rosuvastatin treatment: they assumed the drug price would decrease from $3.63/day to off-patent levels ($1/day) after eight years; and they omitted the added medical costs from living longer as a result of statin treatment, even though it is conventional to include such costs.

“It is essential to remember that a cost-effective therapy actually costs more money, not less. Prevention rarely saves money, despite the wishes of some that it did,” Hlatky wrote. “It has been estimated that between six million and 12 million patients might begin statin treatment based on JUPITER results … [which] implies