Korean patients pay ₩10.5M for ₩300M Luxturna

with reimbursement approval

Expected to be used by around 9 adults per year...is applied 3 RSA types

Novartis

Luxturna (voretigene neparvovec-rzyl, Novartis), the first gene therapy for Inherited Retinal Dystrophy (IRD), is set to be reimbursed from the 1st of next month and is expected to significantly reduce the burden of those suffering from IRD in Korea.

 

Although the price limit for Luxturna had been set at KRW 325.8 million per vial, the out-of-pocket cost borne by each patient is expected to be about KRW 10.5 million with the insurance reimbursement.

 

According to industry sources on the 22nd, Luxturna will be listed for reimbursement under the risk-sharing system with a price cap of KRW 325.8 million per vial from next month.

 

Novartis has signed 3 types of risk-sharing agreements with the National Health Insurance Service, including the refund type, expenditure cap type, and performance-based refund type RSA.

 

The drug is used for adult and pediatric patients who have sufficient viable retinal cells but have lost vision due to IRD caused by a mutation in the RPE65 gene.

 

The number of affected by IRD is estimated to be around 9 per year.

 

Novartis’s Luxturna is a one-shot treatment that can treat a disease with a single administration, and the third among one-shot treatments to receive reimbursement approval in Korea, following Kymriah and Zolgensma.

 

Currently, Luxturna is listed in 6 of the A8 countries – the US, France, Japan, Italy, Switzerland, and the UK.

 

The A8 adjusted average price is KRW 875.11 million for both eyes.

 

In Korea, Luxturna will be listed at a lower price of KRW 652 million.

 

If used on one eye, the total cost is KRW 325.8 million.

 

If you apply the 10% copayment rate, the cost is KRW 32.58 million, but if you apply the out-of-pocket maximum system, the cost borne by the patient drops to KRW 10.5 million.

 

The estimated claims amount for the drug in the first year is about KRW 5.86 billion based on the list price, but the NHIS expects the actual financial expenditure to be less than this, considering the risk-sharing agreement signed for the drug.

 

In addition, to ensure cost-effectiveness, Novartis needs to submit long-term follow-up data from Phase III clinical studies.

 

The data will be evaluated at the end of the risk-sharing agreement period.

 

Luxterna applied for reimbursement upon its approval in September 2021 and received insurance reimbursement in 2 years and 4 months.

 

Meanwhile, Novartis decided to lower the price of its chronic heart failure treatment ‘Entresto Film Coated Tab’ from KRW 1,690 to KRW 1,683 per tablet upon Luxturna’s reimbursement.