An Institute for Clinical and Economic Review (ICER) analysis found that the price that best represents the benefits of newly FDA-approved proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors should be approximately two-thirds lower than the wholesale acquisition cost (WAC) of the medications.
ICER, a nonprofit healthcare research organization, released the draft report on Sept. 8. The report is open to public comment until Sept. 22, and a revised report will be posted on Oct. 6. Members of the New England Comparative Effectiveness Public Advisory Council will review and debate the revised report on Oct. 27 in Boston in a meeting that is free and open to the public.
The annual WAC is $14,600 for alirocumab and $14,100 for evolocumab. Both drugs are injectable medications that lower low-density lipoprotein (LDL) cholesterol by 55 percent to 60 percent in patients who are receiving statins or cannot take statins.
Researchers from ICER said the price should be between $3,615 and $4,811 per year based on their overall benefits, although they did not take budgetary concerns into consideration. They estimated between 3.5 million and 15 million Americans may be eligible to receive PCSK9 inhibitors.
“Even if these drugs were used in just over 25 percent of eligible patients, then employers, insurers, and patients would need to spend on average more than $20 billion a year for these drugs, a cost that would continue on into the future,” ICER founder and president Steven D. Pearson, MD, said in a news release.
When taking budgetary concerns into consideration, the researchers suggested an annual drug cost of $2,177 would be more appropriate, which suggests a discount of 85 percent off of the WAC.
“Our draft report therefore suggests that $2,177 is the price that should serve as an alarm bell – if the cost is more than $2,177 a year, drug companies, doctors, insurers, and other parties may need to work together to determine ways to limit the use of these drugs, find savings in other parts of the health care system, or adopt other measures to help make these drugs more affordable,” Pearson said.
In the ICER review, researchers evaluated 25 clinical trials and two systematic reviews and meta-analyses. They noted that approximately one-third of American adults have cardiovascular disease, which is the leading cause of death in the U.S. Although research has indicated statins LDL cholesterol and reduce the risk of MI, stroke and death from cardiovascular disease, other drugs that lower LDL cholesterol such as hormone therapy, niacin and torcetrapib do not decrease cardiovascular disease events.
The researchers mentioned that alirocumab and evolocumab had similar reductions in LDL cholesterol and that differences in patients enrolled in clinical trials could explain the small differences in LDL cholesterol.
“The evidence therefore strongly suggests that the two drugs have very similar effects, and the lack of head to head randomized trials makes it impossible to determine whether one of the PCSK9 inhibitors lowers cholesterol more than the other,” they wrote.
Although current studies have not determined if the PCSK9 inhibitors lower mortality or cardiovascular disease adverse events, the researchers estimated they could reduce all-cause and cardiovascular mortality by approximately 50 percent. However, they noted the confidence intervals were wide and the number of events was low.