The pharmaceutical industry is paying attention to how much the price of MSD Korea’s immunotherapy Keytruda (ingredient: pembrolizumab) will be lowered if it wins the first-line treatment status.

MSD Korea is in price negotiations with the government after applying for approval of Keytruda as the first-line therapy for non-small cell lung cancer (NSCLC). However, the talks are not making much progress, sources said.

Pharmaceutical market observers said it was clear that an expanded reimbursement on the expensive immunotherapy for NSCLC patients would weigh more financial burden on the government. Thus, it would suggest a significant price cut, which would make the negotiation harder for the drugmaker, they said.

Lung cancer experts expressed similar views.

Lee Dae-ho, a professor of oncology at Asan Medical Center, said MSD Korea would “find it difficult to avoid a large drug price cut” if Keytruda gets upgraded as the first-line therapy.

Then, why is MSD Korea seeking to obtain the nod for Keytruda as the first-line treatment despite an apparent drug price cut?

It is because Keytruda as the first-line treatment can be more widely used for patients, whereas Keytruda as the second-line treatment has to compete against Opdivo (nivolumab). Currently, Keytruda is allowed only as the second-line treatment for NSCLC.

According to data from the National Cancer Center’s cancer control institute, there were 22,000 NSCLC patients between Stage 1 and Stage 3 in Korea as of 2015.

Assuming a recurrence rate at 20-50 percent, 4,000-10,000 patients experience a recurrence of cancer a year.

About 6,700 patients are diagnosed with Stage 4 NSCLC per year. If Keytruda becomes the first-line treatment, both Stage 4 patients who did not get better by chemotherapy and Stage 1-3 patients whose symptoms worsened are subject to the administration of Keytruda.

If the number of Keytruda-treated patients rises rapidly, the government will have to consider a drastic cut in the drug price, observers said.

The Ministry of Health and Welfare said it would carry out drug price negotiations carefully.

“If Keytruda becomes the first-line treatment, it would have a significant impact on the immunotherapy market. Thus, we are carefully reviewing it,” a ministry official said.

hwz@docdocdoc.co.kr

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