MOHW to expand ‘approval-assessment-negotiation’ project

Which drug will benefit?

Health authorities select additional targets for 2H following Qarziba and Bylvay

Novartis’s ‘Pluvicto’ and Sanofi’s ‘Cablivi’ considered strong candidates

With the pilot project for the parallel operation of the ‘approval-assessment-negotiation linkage’ system that was implemented to shorten the drug reimbursement process in full swing, additional drugs are expected to be selected for the project in 2H this year.

 

This is because the health authorities started a demand survey to select additional candidates for the pilot project in the second half of the year.

 

Therefore, industry interest is rising on which items will additionally benefit.

 

Pic.

 

MOHW, HIRA, and NHIS have been operating the pilot project for the parallel operation of the ‘approval-assessment-negotiation linkage’ system this year

According to industry sources on the 3rd, the Ministry of Health and Welfare, Health Insurance Review and Assessment Service, and National Health Insurance Service are planning to expand the operation of the ‘approval-assessment-negotiation linkage’ pilot project in 2H this year.

 

The health authorities have been promoting a pilot project that included the parallel operation of the approval, benefit evaluation, and drug price negotiation system.

 

The system was implemented to address the issue of how long and complicated the process for the reimbursement of high-priced rare diseases is.

 

The authorities prepared a system that simultaneously operates the whole approval to reimbursement and drug price negotiation process.

 

President Suk-Yeol Yoon had pledged to expedite the listing of ultra-high-priced drugs and expand reimbursement during his presidential campaign.

 

Accordingly, the health authorities recently selected the neuroblastoma treatment Qarziba Inj (dinutuximab, Recordati) and the progressive familial intrahepatic cholestasis treatment advanced Bylvay (odevixibat, Ipsen) as priority candidates for its pilot project.

 

Qarziba Inj, which is manufactured by the Italian pharmaceutical company Recordati, is being supplied by the Korea Orphan & Essential Drug Center in Korea.

 

The drug is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above.

 

Bylvay is indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis.

 

The drug received FDA approval in 2021.

 

In Europe, the drug was approved to treat patients from the age of 6 months with progressive familial intrahepatic cholestasis.

 

The French pharmaceutical company Ipsen had acquired Albiero which owns Bylvay earlier this year.

 

The health authorities are now planning to select additional candidates for the project through a demand survey in 2H this year.

 

The drug currently being discussed is 'Pluvicto (lutetium (177Lu) vipivotide tetraxetan), Novartis' prostate cancer drug.

 

Also, Cablivi (caplacizumab), Sanofi's acquired thrombotic thrombocytopenic purpura (aTTP) treatment, is also being considered as a candidate.

 

An industry official who requested anonymity, said, “The pilot project will be conducted in 2H 2023 to minimize the registration period for drugs that have proven superior treatment effects for patients with no appropriate treatment and a life expectancy of less than 1 year.

 

The authorities will select candidates for the pilot project in 1H and carry out the project in 2H.” He added, “A demand survey may be conducted for Novartis’s ‘Pluvicto’ and Sanofi’s ‘Cablivi’ in 2H this year.

 

The drugs subject to the project need to go through the MFDS’s Global Innovative products on Fast Track (GIFT), so the GIFT system is also being extended.”