PCSK9 inhibitors have become more popular for patients with a high-risk cardiovascular disease whose low-density lipoprotein cholesterol (LDL-C) do not fall significantly even with potent statin and ezetimibe.
However, experts got into a heated debate about whether the new lipid-lowering drugs were cost-effective and should get an insurance benefit.
The discussion came at a spring cardiovascular integrated conference at BEXCO, Busan, Saturday-Sunday, where physicians argued the cost-effectiveness of PCSK9 inhibitors Repatha (evolocumab) by Amgen and Praluent (alirocumab) by Sanofi.
Kim Byung-jin, a professor of endocrinology at Samsung Medical Center, spoke on the “positioning of PCSK9 inhibitors in updated guidelines of dyslipidemia.” He argued that PCSK9 inhibitors should become reimbursable to meet the needs of lipid-lowering treatment.
Despite several treatment options, patients with atherosclerotic cardiovascular disease (ASCVD) whose LCL-C is high, those with familial hypercholesterolemia (HoFH or HeFH), and patients with resistance to statin still need a new treatment option, he added.
“Given the current domestic and international guidelines, clinical studies, and actual prescription experiences, we need a paradigm shift in lipid-lowering therapy in patients with ASCVD,” Kim said. “Until now, ‘high-dose statin’ has been the major lipid-reducing treatment. In the future, however, it should be changed to ‘high-dose lipid-lowering treatment.’”
Kim went on to say that local physicians face limitations in prescribing PCSK9 inhibitors because they are not reimbursable. If they can get an insurance benefit, it would significantly help lower cholesterol in ASCVD patients, he emphasized.
However, the floor raised a question whether patients will be able to maintain drug compliance because it has not been a long time since PCSK9 inhibitor therapy started, or because patients might need the treatment for a lifetime.
In response, Kim said an insurance coverage would address such issue easily.
“What makes the treatment difficult most is that PCSK9 inhibitors are not covered by insurance, which makes it financially burdensome for patients,” Kim said. “I have prescribed them to patients for about three to four months, and the patients did not have difficulty paying for the injections once every two weeks.”
At the “debate on new lipid guidelines,” Professor Kim Sang-hyun of Cardiology and Internal Medicine Department at SMG-SNU Seoul Boramae Hospital, said a paper showed that PCSK9 inhibitors were not cost-effective enough to prevent cardiovascular disease, citing the U.S. guidelines.
Han Ki-hoon, a professor at the Cardiology Department of Asan Medical Center, raised the need for a study on the cost-effectiveness of local PCSK 9 inhibitors because Korea has different incidence and cost from those in the U.S.
The low cost-effectiveness of PCSK9 inhibitors, evaluated in the U.S. guidelines, did not reflect the lowered prices of the drugs.
On Nov. 10 last year, the U.S. announced the guidelines for controlling cholesterol in the blood, whereas Amgen announced a 60 percent cut in Repatha’s price in late October. In February, Sanofi also reduced Praluent’s price to the level similar to Repatha.
Repatha, the only reimbursable drug among PCSK9 inhibitors in Korea, is cheaper than those sold in a 60 percent price cut in the U.S.
The lowered price of Repatha in the U.S. is $5,850 (about 6.67 million won) a year. In Korea, however, the insurance-covered Repatha in Korea for a patient with homozygous familial hypercholesterolemia (HoFH) is about 5.13 million a year.
As Repatha comes in an orphan drug category for more state support, patients can pay only 10 percent of the price. In other words, local HoFH patients get Repatha treatment by paying about 400,000 won a year.
If reimbursement expands for Repatha’s other indications, the price will go down further with an increased number of patients.