Sales of EGFR anticancer drug Tagrisso have been put on hold

EGFR-TKI's 5 types of sales in 1st quarter are ₩35.5 billion (↓3% compared to last year)

Tagrisso's sales have been falling for two consecutive quarters

The market for EGFR lung cancer drugs has been put on hold.

 

Sales of Tagrisso, a third-generation drug, have declined since its benefit.

 

As new products emerge one after another, the market is expected to change within this year.

 

According to IQVIA, a pharmaceutical research institute, the size of Korea's market for EGFR tyrosine kinase inhibitors (TKI) in the first quarter of last year was ₩35.5 billion, down 2.9% from ₩36.5 billion a year earlier.

 

South Korea's EGFR-TKI market increased to ₩38.9 billion in sales in third quarter of last year as it continued to grow since first quarter of 2017, but fell for second consecutive quarter.

 

EGFR-TKI is a targeted anti-cancer drug prescribed to patients with metastatic non-small cell lung cancer (NSCLC) accompanied by EGFR mutations.

 

EGFR mutations are a very common mutant type observed in 30–40% of non-small cell lung cancers that account for 80–85% of lung cancer, occurring between exon 18 and exon 21.

 

It is known that Asian markets, including Korea, China, and Japan, are larger because they are more popular than Westerners.

 

EGFR-TKI, which is currently on the market in South Korea, includes first-generation drugs Iressa (Gefitinib), Tarceva (Erlotinib), second-generation Giotrif (Afatinib), and third-generation Tagrisso (Osimertinib).

 

Among the five products, the total size of the market tends to depend on the sales of Tagrisso.

 

Tagrisso's first-quarter sales rose 3.1% year-on-year to ₩24.4 billion.

 

As of first quarter, Tagrisso accounts for 68.9% of all markets.

 

It is maintaining a four-fold gap with Giotrif, the second-largest item in sales.

 

AstraZeneca's Tagrisso was approved by the MFDS in May 2016 for "local progressive or metastatic non-small cell lung cancer patients with EGFR-T790M mutations confirmed after EGFR-TKI administration." It is prescribed as a secondary treatment for non-small cell lung cancer patients who have developed resistance after administration of the existing first and second generations of EGFR-TKI.

 

Tagrisso's sales soared in December 2017 when it was covered by health insurance benefits as a secondary treatment.

 

Tagrisso's sales, which started at ₩2.3 billion in the first year of release and stayed at ₩10.3 billion in 2017, jumped 5.8 times to ₩59.4 billion in 2018.

 

Although it continued to grow rapidly with ₩79.2 billion in 2019 and ₩106.5 billion in 2020, it is not as good as it used to be recently.

 

After setting its own record of ₩27.9 billion in sales in third quarter of last year, it continued to decline for two consecutive quarters.

 

The decline in Tagrisso sales varies.

 

Tagrisso was added to the primary therapy indication in Korea in December 2018, and the reimbursement process has been stalled for more than two years.

 

Tagrisso, which is not covered by insurance, costs ₩217,782 per 80mg, more than ₩6 million a month.

 

Even if it meets the standards, there are many patients who cannot be treated because of the cost burden.The release of generics also seems to have had some impact.

 

Since last year, global clinical subjects have been actively recruiting third-generation EGFR-TKI Leclaza (Lazertinib) therapy developed by Yuhan.

 

Pfizer's Vizimpro (Dacomitinib), a small but second-generation drug, also began to be prescribed late last year after being listed on the benefit.

 

Sales of Giotrif in the first quarter of last year were ₩5.2 billion, up 10.1% year-on-year.

 

This is its biggest sales since its launch in South Korea.

 

The remaining EGFR-TKI sales are sluggish.

 

First quarter sale of Iressa by AZ were ₩4.2 billion, down 29.9% from a year earlier.

 

During the same period, Roche's Tarceva recorded ₩1.5 billion in sales, down 29.6%.

 

Vizimpro's sales in fourth quarter of last year and first quarter of this year are still insignificant.

 

Industries are predicting that changes in EGFR-TKI markets will also accelerate during second half of this year.

 

It is observed that competition between the 3rd generation EGFR-TKI will intensify after the launch of the domestic new drug Leclaza (Lazertinib).

 

Leclaza was approved by the MFDS in January as a treatment for patients with EGFR T790M mutations that had previously been treated with EGFR-TKI.

 

The HIRA's Cancer Drugs Benefit Application Committee, which was held in February, has been properly assessed and negotiated between the Pharmaceutical Benefits Advisory Committee and the NHIS.

 

It is predicted that sales will begin in earnest from the second half of this year after completing the registration process quickly.