One-shot Luxterna may soon receive reimbursement

makes dramatic breakthrough during reimb discussions Korea

NHIS and company reached an agreement during extended negotiation period

May be listed in February next year according to HIPDC schedule

The one-shot retinal disease treatment 'Luxterna' is likely to be reimbursed soon.

 

According to industry sources, Novartis Korea completed negotiations for Luxturna (voretigene neparvovec), a treatment for inherited retinal dystrophy (IRD), with the National Health Insurance Service on the 18th.

 

Although the drug pricing negotiations did not reach an agreement by the deadline (60 days).

 

When considering the schedule of the Health Insurance Policy Review Committee, the drug will be reimbursed by February next year at the latest.

 

Luxturna passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review in July.

 

The company submitted its application for reimbursement benefits in September 2021 but made little progress for a while.

 

Then, the agenda was presented to DREC in March, but failed to set reimbursement standards and started pricing negotiations after reapplying and submitting supplementary data.

 

The government and company had then been unable to reach an agreement in Luxturna's evaluation process due to differences in opinion regarding the terms of the Risk Sharing Agreement (RSA) (refund type, etc.).

 

In this situation, Novartis has submitted supplementary data to apply again for reimbursement, and both the government and pharmaceutical companies have shown a strong will to reimburse the drug in Korea.

 

Even though the brakes were pulled during drug negotiations, the company ended up deriving good results.

 

By replacing the defective or defective RPE65 gene - one of the causes of IRD - with a normal gene, Luxturna restores the visual function of an IRD patient with a single administration.

 

In other words, the drug provides a fundamental cure for IRD.

 

In the US, the drug was granted a Breakthrough Therapy Designation by the FDA in 2014, the drug was approved as an orphan drug in 2016, then was granted Priority Review and a Fast-Track designation in 2017.

 

Meanwhile, the efficacy of Luxturna was demonstrated through a Phase III trial that was conducted on IRD patients with confirmed biallelic RPE65 mutations.

 

Study results showed that the group of patients that received Luxturna demonstrated statistically significant improvements in their functional vision compared to the control group at one year of treatment.

 

Using the mean score of the multi-luminance mobility test (MLMT), which evaluates the ability to complete the obstacle course at low light levels by recreating the daily walking environment, as the primary endpoint at one year of treatment, the MLMT score change in the Luxturna treatment group was 1.8 points, 1.6 points higher than the 0.2 points in the control group.