Keytruda may make ₩300 billion with 1st-line reimb

Reimbursement expanded to first-line lung cancer and second-line Hodgkin’s lymphoma from March

4,000 additional patients to receive benefits… simple calculation shows a gain of ₩72 million won per patient

First exceeded ₩200 billion in annual sales for the first time last year… is expected to be the first to make ₩300 billion among pharamceuticals

The reimbursement expansion approval of Keytruda is expected to add wings to the sales growth of an already leading product in the domestic pharmaceutical market.

 

It is expected that the company may achieve ₩300 billion in sales with its reimbursement expansion to the first-line, which has more patients, from the ₩200 billion sold last year.

 

According to industry sources, the insurance benefit for MSD’s PD-1 inhibitor Keytruda (pembrolizumab) will be expanded to first-line treatment of NSCLC.

 

This is the first time an immunotherapy drug was granted reimbursement for the first-line treatment of cancer.

 

Also, a new reimbursement category was prepared for the drug’s use as second or higher-line monotherapy in Hodgkin’s lymphoma.

 

Patient groups that will be newly benefitting from the reimbursement expansion are ▲ Patients with advanced (Stage IV) NSCLC (PD-L1 positive (TPS≥50%) without EGFR or ALK mutations, ▲ patients with metastatic non-squamous NSCLC without EGFR or ALK mutations (in combination with chemotherapy) ▲ metastatic non-squamous cell lung cancer without EGFR or ALK mutation (in combination with chemotherapy) ▲ adult and ages 2 or older patients who have relapsed/refractory typical Hodgkin’s lymphoma and have failed two or more therapies and failed or cannot receive autologous stem cell transplants (ASCT).

 

The reimbursement expansion this time is expected to become a ‘catalyst’ for the explosive growth of Keytruda’s sales.

 

Based on IQVIA, Ketyruda’s sales had surpassed ₩200 billion for the first time last year.

 

This is a 28.5% increase from the ₩155.7 billion made in the previous year.

 

The drug has topped the ranks with its sales for the second consecutive year.

 

With its reimbursement expanded to first-line treatment, an area with relatively more patients, Keytruda is expected to be the first to exceed ₩300 billion in annual sales.

 

The health authorities believe 4,000 additional metastatic NSCLC and Hodgkin lymphoma patients will receive insurance benefits with the expanded reimbursement.

 

Simple calculation of once every three weeks (2 vials) administration at the discounted price (₩2,107,642) will bring around ₩72 million in annual sales per patient.

 

In other words, even if only half of these potential patients are treated with Keytruda, this will bring in ₩140 billion in sales.

 

Quarterly sales of Keytruda (Source=IQVIA)

Keytruda's sales had surged when it was initially approved for reimbursement.

 

Its sales, which stayed at ₩10 billion after its release in Korea in 2015, skyrocketed to ₩70.4 billion after it started being reimbursed as a second-line treatment for NSCLC in August 2017.

 

In 2019, its sales exceeded ₩100 billion.

 

It has been analyzed that the reimbursement approval played a big part in Keytruda's sales exceeding ₩200 billion only 6 years since its release.

 

Less than 10 products including Lipitor, Avastin, Tagrisso, and Humira, had made over ₩100 billion in annual sales in the domestic prescription drug market.

 

Among the products, Keytruday was the only product that recorded over ₩200 billion in sales as a single product.

 

If patients start using Keytruda for first-line treatment, its annual sales may easily reach ₩400 billion.

 

Of course, due to the expenditure-cap type RSA that was agreed upon for the reimbursement, the company’s profit may not be proportional to the increased sales.

 

This is because the company and the authorities agreed to increase the company's share of the cost burden after undergoing 9 deliberations by the Cancer Disease Deliberation Committee.

 

The reimbursement extension was also good news for the patients.

 

The immune checkpoint inhibitor Keytruda treats cancer with a different mechanism of action than other existing anticancer drugs.

 

It inhibits PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activating the immune system to treat cancer.

 

The introduction of Keytruda had changed the treatment paradigm for NSCLC, which was untreatable using targeted therapies.

 

However, its high cost had acted as a high barrier in its access.

 

Until now, the non-reimbursed use of Keytruda had cost nearly ₩100 million, an amount difficult to come up with unless you have private medical indemnity insurance or go to hospitals that are applied the new DRG system.

 

However, with the reimbursement expansion, its price had fallen 25.6%, and patients will now only need to bear 5% of the cost as a copayment, which is around ₩3.5 million a year.