[Reporter’s View] Closer look into Korea’s new drug access

“Korea has low new drug access.

 

It needs to be improved.” As much as the phrase comes to heart, we need to look more closely into the matter to correctly assess the situation.

 

Recently, the Korean Research-based Pharmaceutical Industry Association (KRPIA) recently published a report on Korea’s current new drug release status based on the ‘Global Access to New Medicines Report.’ The Global Access to New Medicines Report was published by the ‘Pharmaceutical Research and Manufacturers of America (PhRMA)’ in April.

 

The report investigated new drug release and health insurance reimbursement status in a total of 72 countries including Korea, and subdivided the investigation results by G20, OECD status, and region.

 

The results were based on a survey of a total of 460 new drugs approved for marketing in the US, Europe, and Japan over the past 10 years from 2012 to 2021.

 

According to the report, it takes longer than the Organisation for Economic Co-operation and Development (OECD) country average for new drugs to be introduced to Korea since their global launch, and Korea’s release rate and reimbursement rate were also below the OECD country average.

 

In its report, KRPIA stressed how Korea's release rate of non-reimbursed new drugs was only 5%, which is much lower than the average of 18% found in OECD countries.

 

Non-reimbursed release means the release of drugs without government support.

 

However, one can wonder how significant the comparative advantage in non-reimbursed releases is in this era of high-priced drugs.

 

The rate can be significant for patients who have the financial means to receive prescription drugs without reimbursement, but they are certainly a minority.

 

Moreover, it is also worth noting that it is individual pharmaceutical companies, not the state, that decide whether to release drugs without reimbursement.

 

The reimbursement-related numbers were also interesting.

 

According to KRPIA's data, it took a total of 46 months from the first global launch of a new drug to its reimbursement in Korea.

 

The average in other OECD countries was not that different, at 45 months.

 

However, KRPIA pointed out that compared to Japan (17 months) and France (34 months), it took 10 months to twice as long in Korea for drugs to be reimbursed in Korea.

 

Also, KRPIA stressed that the proportion of new drugs covered by health insurance in Korea was 22%, which was below the OECD average (29%).

 

This is only half that of Japan (48%) and the UK (48%).

 

In fact, my first impression of the data was that ‘the numbers are higher than expected.’ I believed that the time taken to list new drugs in Korea and the reimbursement rate would be much less than that of OECD countries.

 

However, the data showed that there was no difference in the average number of years taken to reimburse new drugs.

 

Although the report compared Korea’s numbers with Japan, unlike Korea, Japan adopts a negative list system rather than a positive list system.

 

Under the negative list system, new drugs that are approved are granted reimbursement after only conducting domestic clinical trials.

 

In addition, we should also bear the characteristics and advantages of Korea’s universal health coverage insurance system in mind.

 

The same goes for the reimbursement rate.

 

It is doubtful whether a 7% difference in reimbursement rates should be considered a significant gap considering the specificity of each country.

 

However, it is noteworthy that the reimbursement rate in the UK, whose health insurance system is most similar to Korea, is 48%.

 

Although the UK is also a reference country for many countries like Korea, its reimbursement rate was fairly high.

 

It stings a little to think that the difference in market size and the influence of NICE in the UK would have contributed to this difference, as a similar system has served as a reason for ‘passing’ Korea.

 

Korea’s reimbursement system has many advantages, but there are definitely areas for improvement.

 

There is also a clear concern that listing new drugs in the future will become increasingly difficult under the current system.

 

Therefore, it remains a regret that the association’s points were not supported by more meaningfully organized data.

 

For example, it could have been possible to elicit stronger awareness if the data presented more detailed indicators that reflect Korea’s reality, such as the listing rate of additional indications rather than the registration of a single drug itself.