34 new global drugs, including Beleodaq, are urgently needed

Selected by KoNECT, not introduced for reasons of bridge test

Extending the system of sympathetic use and national essential medicine

A study has been released that 34 new drugs, including the peripheral T-cell lymphoma treatment Beleodaq, are urgently needed to be introduced in Korea.

 

These new drugs have not been introduced because they are judged to be insufficient in marketability due to domestic screening permits.

 

KoNECT announced that it will select 34 new drugs that are urgently needed to be introduced in Korea and release them online on the 18th for the 2022 KoNECT Brief 1.

 

KoNECT derived priorities through preliminary analysis of 244 in Korea.

 

As a result, Beleodaq (peripheral T cell lymphoma treatment), Palynziq, Zinplava (lostridium difficile recurrence reduction effect), Artesunate (severe malaria treatment), and Xerava (complex abdominal infection treatment antibiotic) were the top drugs to be reviewed.

 

Poteligeo (Fungi and Cezali Syndrome Treatment), Elzonris, Tecartus (CAR-T Cell Blood Cancer Treatment), Yescarta (CAR-T Cell Blood Cancer Treatment), Obizur (Instinctive Post-Cellular Blood Cancer Treatment), and Trumenba.

 

The third-priority drugs mentioned by the association as urgent and unmet demand diseases were BEXSERO (menopausal bacteria serum type B vaccine), Alofisel (treatment of complex anal fistula of Crohn's disease patients), and Raxibacumab (first aid drug for anthrax).

 

Top 4 drugs that need high introduction but require attention are Provenge (prostate cancer vaccine using cells from autologous choroid blood), Zanosar (treatment of malignant neoplasms of the pancreas), Cablivi (acquired thrombocytopenia), Audenz (immune cell-based influenza and anti-viral drugs), Audenz, Rukobia, Trogarzo, Krintafel, Nuplazid, and Apokyn.

 

The last drugs appeared as Steboronine (BNCT), - Scenesse (erythrocytic protorphyria), Mepsevii, Ravicti, Lamzede, Myalept, Egaten (fascioliasis parasite infection treatment), Tpoxx (natural greenhead treatment), Solosec, Voraxaze, and Idenfirix.

 

KoNECT analyzed that the main reason for the delay or non-introduction of global new drugs in Korea is to determine marketability such as whether to exempt ▲ bridge test, ▲ whether to register benefit, and ▲ product price, etc.

 

In particular, whether to be exempted from PE system in the stage of determining drug prices is also important, and it was pointed out that blind spots exist in new drugs for rare diseases that are exempted from economic evaluation.

 

For example, the MFDS' rare drugs and rare diseases of the KCDA are designated based on less than 20,000 people, but the HIRA's rare disease treatment system is limited to less than 200 people.

 

KoNECT stressed the need for a specialized institution to introduce global new drugs in Korea along with the expansion of the "Expended Access Program (EAP)" and the national essential drug system, a program that provides drugs for clinical trials that have not yet been sold on humanitarian grounds.

 

Bae Byung-joon, chairman of the National Clinical Trials Foundation, said, "Korea's drug price policy has been stingy in recognizing the innovative value of global new drugs, while generic prices are higher than the cost to protect domestic industries."