[Reporter’s View] HIRA's role in managing high-priced drugs

What role should HIRA’s new team take to manage ultra-high-priced drugs

In 2012, Soliris, a treatment for paroxysmal nocturnal hemoglobinuria (PNH), was listed for reimbursement in Korea.

 

The drug, which cost more than KRW 5 million per vial and up to KRW 500 million for a year's supply, sparked controversy over "ultra-high-priced drugs” at the time.

 

Since then, drugs more expensive than Soliris were introduced and reimbursed one after another.

 

Novartis' Kymriah and Zolgensma were two representative examples.

 

Zolgensma is listed at KRW 1.982 billion per kit, and Kymriah at KRW 360 million per treatment.

 

Although the number of doses required per drug varies, as of the end of last year, a total of 26 drugs cost more per unit than Soliris.

 

Among them, Biogen's ‘Spinraza,’ Novartis' ‘Lutathera,’ AstraZeneca's ‘Ultomiris,’ BMS' ‘Yervoy,’ Anterogen’s 'Cupistem,’ JW Pharmaceutical's ‘Hemlibra,’ Pfizer's ‘Besponsa,’ Anterogen’s ‘Remodulin,’ and Sanofi-Aventis' ‘Lemtrada’ cost more than KRW 10 million per unit.

 

Truly, the era of ultra-high-priced drugs has arrived.

 

Moreover, drugs that far exceed the price of Zolgensma are awaiting entry in Korea.

 

Lyfgenia, a treatment for sickle cell anemia that was approved by the U.S.

 

Food and Drug Administration (FDA) in December last year, has a price tag of USD 3.1 million (KRW 4.1 billion).

 

‘Casgevy’ and ‘Exa-cel,’ which were approved around the same time, cost $USD 2.2 million (around KRW 2.9 billion) each.

 

And many other drugs that cost more than USD 1 million are yet to be introduced to Korea.

 

The hemophilia B treatment ‘Hemgenix’ costs USD 3.5 million, the cerebral adrenoleukodystropha treatment ‘Skysona’ costs USD 3 million, the beta-thalassemia treatment ‘Zynteglo’ costs USD 2.8 million, the leptin deficiency treatment ‘Myalept’ costs USD 1.26 million, and Hutchinson-Gilford progeria syndrome treatment Zokinvy costs USD 1.07 million.

 

Most of these are 'one-shot drugs' that treat diseases caused by genetic abnormalities.

 

Given the development speed and recent advances in gene editing technology, industry experts say it is only a matter of time before more expensive drugs appear.

 

The annual cost of KRW 500 million, which was astronomical at the time of Soliris’s introduction, now falls in the ‘modest’ range among ultra-high-priced drugs.

 

The government is also expressing significant concerns over the issue.

 

Earlier this year, the Health Insurance Review and Assessment Service set up a ‘Pharmaceutical Performance Evaluation Department’ dedicated to the post-listing management of high-priced drugs.

 

It took over the duties of the New Drug Performance Management Division, which was established as a temporary organization under the Office of Benefits Management in September 2022.

 

For now, the office is in charge of evaluating the performance of high-priced drugs such as Kymriah and Zolgensma but will expand its responsibilities to include post-listing management of drugs that are exempt from submitting pharmacoeconomic evaluation data.

 

This seems to be a timely move in the era of ultra-high-priced drugs.

 

It's time to prepare for the next step.

 

Given that drugs even more expensive than Zolgensma are expected to be introduced into Korea in the future, one single department, however, dedicated, may not be enough to take on the responsibility of managing all of the listed high-priced drugs.

 

The changes to come call for a more fundamental reorganization of the system.

 

The number of drugs listed through tracks that do not require pharmacoeconomic evaluation, which is the basis of Korea’s health insurance reimbursement system, is increasing every year.

 

However, due to limited health insurance finances, it is impossible to blindly allow the listing of all ultra-high-priced drugs.

 

We need to prepare for the entry of another wave of ultra-high-priced drugs, including the establishment of a separate fund, which is just beginning to be discussed.

 

Korea eagerly awaits the establishment of a new system that can receive public consensus.