High-priced drugs receive reimb in the new year

Financial management of national health insurance remains an issue

Ultra-high-priced KRW 950 million Luxturna is expected to be reimbursed next month

Health authorities have set out to strengthen the management of high-priced drugs...established a post-listing evaluation system

Ultra-high-priced drugs whose costs exceed KRW 100 million are being listed for reimbursement one after another in the new year.

 

Following Koselugo’s reimbursement this month, Luxturna, which will cost KRW 1 billion, is expected to be reimbursed next month.

 

With such ultra-high-priced drugs being listed one after another, voices have been rising on the need to strengthen post-listing management to efficiently manage the financial expenditures of Korea’s national health insurance.

 

According to industry sources on the 16th, ‘Luxturna Inj,' an ultra-expensive drug that costs KRW 950 million, has completed drug pricing negotiations with the NHIS and is set to be reported to the Health Insurance Policy Deliberation Committee this month.

 

The drug is a ‘one-shot treatment’ that shows an effect after a single dose, similar to previously listed drugs like Kymriah and Zolgensma.

 

Luxturna is indicated for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

 

It is estimated that there are about 50 patients who are eligible to receive LUXTERNA in Korea.

 

The issue is its high price.

 

The drug costs about USD 710,000 per single dose in the US, which roughly translates to KRW 950 million in Korean won.

 

Feeling burdened by the high price, patients have been awaiting the drug’s reimbursement listing since it was approved by the Ministry of Food and Drug Safety in September 2021.

 

However, a sense of anxiety filled the air when Luxturna’s pricing negotiations, which began in September, failed to finish within the set deadline and extended the deadline.

 

Fortunately, the two sides quickly reached an agreement during the extended negotiation period.

 

The company and the government reportedly shared the price burden at a reasonable level through the risk-sharing agreement system.

 

Since this drug is an ultra-high-priced one-shot treatment like Kymriah and Zolgensma, it is likely to raise follow-up management issues even after listing.

 

Ultra-high-priced KRW 950 million Luxturna awaiting to be reimbursed in Korea

The neurofibromatosis treatment Koselugo Cap (selumetinib, AstraZeneca) has been reimbursed from the 1st of this month.

 

The drug has succeeded in receiving reimbursement listing for 2 years and 6 after filing an application in June 2021.

 

The expanded scope of subjects eligible for waiving submission of pharmacoeconomic evaluation data (PE exemption drugs) that was implemented in January last year played a decisive role in its reimbursement listing.

 

The company agreed upon three risk-sharing types of RSA – the refund type, expenditure cap type, and initial treatment cost refund type – with the NHIS reducing the burden of health expenditures on the government’s part.

 

With the reimbursement listing, patients only need to a copayment rate of 10% of the annual cost of KRW 200 million required for its use, reducing the burden to a KRW 10 million range.

 

The cost of new drugs being listed recently is well over KRW 100 million.

 

Zolgensma, which was listed for reimbursement in 2022, is currently the most expensive drug on the reimbursement list, at a price of KRW 1.98173 billion per kit.

 

With these high-price drugs increasing healthcare expenditures, health authorities are also focusing on the post-listing management of these high-priced drugs.

 

With the introduction of Kymriah and Zolgensma, a performance evaluation system that applies reimbursement through post-evaluations has been introduced.

 

HIRA is seeking to broaden the scope of the system to manage PE exemption drugs and has been also promoting the reevaluation of existing drugs.

 

From this year, it also established the 'Pharmaceutical Performance Evaluation Department, which will be responsible for the post-listing management of listed high-priced drugs.

 

The NHIS plans to secure the financial soundness of its system by advancing the risk-sharing agreement system.

 

To this end, it plans to minimize financial uncertainties by applying a performance-based risk-sharing system at the patient level and strengthening follow-up management of drugs using systems including the price-volume agreement system.

 

The government’s plan for managing high-priced drugs is also expected to be included in the 2nd Comprehensive National Health Insurance Plan that is expected to be announced this month.