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Price cut, expanded indication to prop up cholesterol-reducing PCSK9 inhibitors
  • By Kim Yun-mi
  • Published 2019.02.13 16:11
  • Updated 2019.02.14 09:09
  • comments 0

Physicians are likely to use cholesterol-lowering proprotein convertase subtilisin/kexin type 9 (PCSK 9) inhibitors more, as Amgen and Sanofi recently cut their prices, industry watchers said.

Despite PCSK 9 inhibitors’ efficacy, including cholesterol control and reduction of cardiovascular risks in patients with arteriosclerotic cardiovascular disease (ASCDV), physicians have regarded them as too expensive.

Amgen’s cholesterol fighter Repatha (left) and its rival drug Praluent by Sanofi

After Amgen slashed the price of Repatha (evolocumab) last year, Sanofi recently announced that it would follow suit for its PCSK 9 inhibitor Praluent (alirocumab) in the United States.

In Korea, Repatha is the only PSCK 9 inhibitor that won approval for insurance coverage for rare indication Homozygous Familial Hypercholesterolemia (HoFH). Amgen is now seeking reimbursement of Repatha in patients with ASCVD.

If Repatha obtains insurance coverage for ASCVD patients, physicians are likely to use PCSK 9 inhibitors more actively in Korea.

On Monday, Sanofi announced that it would lower the price of Praluent by 60 percent to $5,850 a year in the U.S. from March. The move followed that of Amgen, which cut Repatha’s price by 60 percent to $5,850 a year in October.

The new prices resulted from the issue of cost-effectiveness of PCSK 9 inhibitors.

Repatha and Praluent are indicated for hypercholesterolemia, but statin is an established treatment for hypercholesterolemia thanks to its potency in fighting cholesterol and low price. Thus, physicians found it difficult to prescribe expensive PCSK 9 inhibitors for patients outside the ultra-high-risk group.

Both Amgen and Sanofi are seeking to increase the use of PCSK 9 inhibitors in the high-risk patient group.

Amgen’s Repatha is ahead of Sanofi’s Praluent in the competition. Repatha is used for treating HoFH. Through the clinical trial FOURIER, Repatha obtained an indication for lowering cardiovascular risk in ASCVD patients, ahead of Praluent.

Praleunt proved its cardiovascular benefits in ODYSSEY OUTCOMES study but has failed to add indication so far.

Sanofi hopes to get expanded indication for Praluent in Europe next month, in the U.S. in April, and in Korea, before this year passes.

Korean patients have significantly low access to PCSK 9 inhibitors. The drugs are not only expensive, but the insurance coverage of Repatha is allowed just for very rare HoFH patients.

Before Amgen reduced Repatha’s price in the U.S., Repatha became reimbursable for the HoFH indication in Korea. The reimbursement of Repatha is smaller than the newly lowered price in the U.S. (about 6.6 million won or $5,892).

After Amgen obtained the nod for Repatha’s expanded indication for cardiovascular diseases on Aug. 31 last year, the company immediately applied for reimbursement in September.

If the health authorities grant expanded indication for Repatha in ASCVD patients, the drug price is expected to go down further because of an anticipated increase of the drug use.

Unlike HoFH patients, however, SCVD patients do not get the benefit of the special insurance policy that calls for the government to support 90-95 percent of medical costs, pushing up patients’ contribution inevitably.

In the case of Praluent, the industry expects that Sanofi will win the cardiovascular indication within this year. It will take some time for the health authorities to discuss reimbursement afterward, observers said.

“In Korea, we are preparing to discuss the reimbursement for Praluent. We will make efforts to raise the treatment access of high-risk patients with cardiovascular diseases,” Sanofi said.

Lee Cheol-whan, a professor at cardiology department of Asan Medical Center, said Repatha was an authorized treatment to lower cardiovascular risk by additionally lowering LCL-Cholesterol in ASCVD patients who could not reach the target LDL-C of 70mg/dL with conventional therapies such as a statin.

“Recurrence of ASCVD raises the chance of disability or death, which causes high social costs. The government needs to invest in medicines that proved to reduce risks through LDL-C control,” Lee said.


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