Pemzayre, high-priced drug post-management system candidate

Reimbursement imminent

Documents evaluating treatment outcomes must be submitted…6 drugs, including Kymriah and Qarziba, are included in the system

Handok

'Pemzayre Tab,' Handok's bile duct cancer (cholangiocarcinoma) treatment, is expected to be subjected to the post-management system for high-priced drugs.

 

Pemzayre Tab is likely to be added to the reimbursement list in May.

 

Consequently, a submission system for evaluating treatment outcomes as part of the post-management evaluation will be established.

 

According to industry sources on the 7th, Pemzayre passed the Health Insurance Review and Assessment Service (HIRA's) Drug Reimbursement Evaluation Committee (DREC) in January.

 

The company is negotiating with the National Health Insurance Service (NHIS) for drug pricing negotiations.

 

Considering the 60-day drug pricing negotiations period, Pemzayre will likely to be added to the reimbursement list in May.

 

This drug is the first targeted drug in South Korea with cholangiocarcinoma indication.

 

Pemazyre is indicated for patients with locally advanced or metastatic who have FGFR2 gene fusions.

 

Pemzayre has been in used the United States, Europe, and Japan.

 

If it is reimbursed, this drug will be used in adult patients with locally advanced or metastatic cholangiocarcinoma who have FGFR2 gene fusions or rearrangements and have undergone one or more systemic therapy.

 

Based on its anatomical origin, cholangiocarcinoma is classified into intrahepatic cholangiocarcinoma (iCCA), arising from bile ducts within the liver, and extrahepatic cholangiocarcinoma, developing from bile ducts outside the liver.

 

Because this cancer is frequently diagnosed at an advanced stage with a poor prognosis, there is a critical unmet need for targeted therapies.

 

FGFR2 fusion or rearrangements are known to be found in 10-16% of patients with iCCA.

 

In recognition of this urgency, the Korean Ministry of Food and Drug Safety (MFDS) designated this as an orphan drug in November 2021.

 

The MFDS granted marketing approval via expedited review in April 2023.

 

Following approval, the drug quickly entered the reimbursement procedure.

 

After successfully establishing reimbursement criteria in August last year and passing the DREC review in January this year, its chances of inclusion in the National Health Insurance system have markedly increased.

 

However, pricing remains a significant issue.

 

The product, which contains 14 tablets per package, has a supply cost of approximately US$19,000 per product.

 

Given that the treatment course may extend for up to 42 days, its reimbursement could significantly burden health insurance expenditures.

 

Accordingly, the government is expected to manage this drug under the "High-Priced Drugs Reimbursement Management Criteria." Currently, six drugs, Kymriah, Zolgensma, Spinraza, Yescarta, Luxturna, and Tecartus, are subject to these criteria.

 

The criteria for high-priced drugs include ▲Newly listed with high prices and uncertain cost-effectiveness that require further verification ▲Incur substantial annual per capita expenditures, or generate annual health insurance claims that could severely impact the national health insurance budget ▲Expected to provide long-term benefits from a single administration, necessitating additional safety confirmation and long-term evaluation ▲Based on their impact on healthcare, deemed necessary for management.

 

Once a drug is designated as a target under the high-priced drug post-management system, a post-administration response evaluation must be conducted, and the resulting data must be submitted.

 

Based on this data, the HIRA will then perform performance evaluations and ongoing monitoring of treatment effectiveness.

 

If a drug is under patient-based performance risk-sharing agreements, the NHIS will use it to calculate drug reimbursement amounts.