Luxturna can be prescribed at general hospitals

Medical institutions such as Seoul National University Hospital passed DC

Attention is focused on drug price negotiations after passing the Pharmaceutical Evaluation Committee in September

Luxturna, a one-shot retina treatment, can be prescribed at general hospitals.

 

According to related industries, Luxturna, a treatment for Inherited Retinal Dystrophy, has passed the drug committee of medical institutions such as Seoul National University Hospital.

 

Luxturna is currently in the process of registering for insurance benefits and is beginning to create a prescription environment.

 

This drug passed HIRA on the 7th and is about to negotiate the price with NHIS.

 

Discussions on reimbursement for Luxturna, which is an expensive drug and targets a very small number of patients, were difficult.

 

An application for benefits was submitted in September 2021, but there has been no significant progress in the registration process and only recently produced results.

 

Although it has passed the evaluation committee, it remains to be seen whether drug price negotiations can be concluded smoothly.

 

Luxturna restores the function of the deficient or defective RPE65 gene, which is one of the causes of IRD, by replacing it with a normal gene with just one administration.

 

This means that fundamental treatment of the disease is possible.

 

This drug was designated by the U.S.

 

FDA as a Breakthrough Therapy in 2014, an Orphan Drug in 2016, and a Priority Review in 2017, and it also obtained expedited approval in 2017.

 

Meanwhile, Luxturna proved its effectiveness through a phase 3 clinical trial conducted on patients with hereditary retinal disease in whom biallelic mutations in the RPE65 gene were confirmed.

 

Clinical results showed that at one year of treatment, functional vision treated with Luxturna was statistically significantly improved compared to the control group that did not receive treatment.

 

As a result of evaluating the average score of the Multi-Luminance Mobility Test as the primary endpoint at a year of treatment, the score change in the Luxturna treatment group was 1.8 points, which was 1.6 points higher than the control group's score change of 0.2 points.