SMA tx Evrysdi has been applied for insurance benefits

Starting reimbursement procedures early this month, eight months after approval

Zolgensma applies for the reimbursement around the same time

Roche's Evrysdi, the second treatment for spinal muscular atrophy (SMA) in Korea, began the process of registering insurance benefits eight months after approval.

 

According to the pharmaceutical industry on the 15th, Roche Korea applied to the HIRA earlier this month for the registration of the oral SMA treatment Evrysdi(Risdiplam).

 

Evrysdi is the second domestically licensed treatment for spinal muscular dystrophy after Biogen's Spinraza.

 

Although it was approved in November of last year, it has not been officially released in markets yet.

 

A third treatment for spinal muscular dystrophy, Novartis' Zolgensma, has been approved.

 

Novartis completed the application last month using the evaluation linkage system.

 

Evrysdi was approved first, but Zolgensma's reimbursement was faster.

 

Evrysdi is expected to be easy to register because it is cheaper than the previously listed Spinraza.

 

Zolgensma are most expensive, so there are many concerns about which pay model to apply.

 

Spinraza was also not easy to register at a high cost of nearly ₩100 million per vial at the time of the process.

 

It took months before it was presented to the Pharmaceutical Benefits Advisory Committee.

 

The final price of Spinraza is ₩9,2359,131.

 

It costs ₩554.15 million per person in the first year, and ₩277.07 million from the following year.

 

Patient's copayment is 10% of the total cost.

 

Since Spinraza, which is already more expensive, has been reimbursed, it is not difficult to register if Evrysdi's drug price negotiation goes well.

 

Evrysdi is also likely to follow the Expenditure Cap (RSA) applied to Spinraza.

 

Zolgensma is a "one-shot treatment" that is only taken once in a lifetime, but the price is about ₩2.5 billion (based on the U.S.), the most expensive drug in Korea.

 

The government and the company are considering ways to reduce the financial burden of health insurance.

 

The company proposed a value-based RSA.

 

The government are reviewing the Amortized Payment model.

 

However, the only drug listed as Value-based RSA is "Evoltra," an acute lymphocytic leukemia treatment, and the Amortized Payment model is a new model that is attempted for the first time.

 

It is expected to take some time to set detailed items such as standards and evaluation methods.

 

Meanwhile, Evrysdi met the criteria for 'sitting without help' in BSID-III 12 months after treatment in the FIREFISH clinical trial of 41 infants from 2.2 to 6.9 months of age.

 

88% of patients on Evrysdi over two years survived without respirators for two years.

 

In addition, the SUNFISH study of 180 patients aged 2-25 demonstrated improvement in motor function evaluation scale MFM-32 of Evrysdi in the 12th month of treatment.