About 70% of new anticancer drugs are listed

Expenditure on drug costs such as increased use of expensive drugs, management plan required

The period of use of advanced general hospitals for new drugs listed has been reduced from 97 to 28 days

The average listed rate for new drugs approved in Korea was 67.2%.

 

Looking at the rate of chemotherapy drug listed alone, it was 70.2%, which is higher than all new drugs.

 

Korea Institute for Health and Social Affairs This data was shown on the 8th through the 'Health and Welfare ISSUE&FOCUS (Silvia Park, Korea Institute for Pharmaceutical Policy Affairs, Solyip Ha, Social Budget Research Group)' published by the Korea Institute for Health and Social Affairs.

 

As a result of analyzing 570 new drugs approved in Korea from 2007 to 2018 by the Korea Institute for Health and Social Affairs, Trends in new drug properties seen in the global market have recently been observed, such as increased treatment for severe diseases, higher costs, and uncertainty in the basis for decision making.

 

As a result of analyzing the database of the MFDS, the annual average of 47.5 new drugs has been approved over the past 12 years.

 

Of these, 141 new anticancer drugs accounted for 24.7% of all new drugs, and since 2007, the proportion has increased gradually, accounting for about 39% in 2016 and 2017.

 

As a result of comparing the health insurance drug price file and claim data based on the MFDS, as of May 2019, 383 items, 67.2% of the 570 new drugs approved, were listed on the reimbursement list.

 

Anti-cancer drugs, 99 items (70.2%) out of the total 141 items were listed, showing a higher listing rate than all new drugs.

 

Anticancer drugs that were approved in 2013~2015 have a very high guarantee rate of about 90%, and the incidence rate of approved anticancer drugs after 2016 is likely to increase further.

 

Among the new drugs for anticancer drugs, 45.5% of them were listed as risk-sharing agents (RSA).

 

In particular, the ratio of RSA to reimbursement was more than 90% in the case of licensed anticancer drugs from 2016 to 2017, after the policy to strengthen the guarantee in 2014.

 

In the United States or the European Union, the percentage of drugs approved for sale under conditional approval was the highest in RSA-listed new drugs at 66.7%, with 46.8% for anticancer drugs and 15.4% for all new drugs.

 

The expenditure on health insurance drug for new drugs increased from ₩392.5 billion in 2012 to ₩1.89 trillion in 2017, while the expenditure of new drugs for anticancer drugs increased from ₩20 billion in 2012 to ₩209.6 billion in 2017, and the share of new drug costs increased by about four times from 5.1% in 2012 to 19.2% in 2017.

 

Among the new drugs in 2014, the RSA drug cost was ₩20.9 billion, accounting for 2.9% of the total new drug cost, while in 2017, the value rose to ₩76.8 billion and 7.1%, respectively.

 

The cost of RSA in anti-cancer drugs increased rapidly from 3.3% of total anti-cancer drug drugs to ₩2.7 billion in 2014, to ₩75.6 billion in 2017 and 36.1%, respectively.

 

If the new drug listed in 2012 took 97 days to be used for the first time in advanced general hospitals, it was shortened to 28 days in 2017.

 

The percentage of total drug expenditures for new drugs that are less than 6 years old are listed as 3.48% in 2013 from 4.68% in 2017.

 

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As a new drug for anticancer drugs, the proportion of total drug expenditures for products with less than 6 years of entry into the drug increased from 0.35% in 2013 to 0.91% in 2017, and also increased annually.

 

"The proportion of anticancer drugs in the number of new drugs and the expenditure of new drugs is increasing, and new drugs registered as RSA are increasing," said the Korea Institute for Health and Social Affairs.

 

The institute said, "We need a policy to secure financial continuity by strengthening the clinical efficacy evaluation structure of new drugs in our decision to manage uncertainty in new drugs and secure access to innovative new drugs."