The only non-reimbursed Evrysdi struggle in the market

Will it be reimbursed this year?

SMA market in Q1 recorded KRW 20 billion in sales... Evrysdi posts sales of KRW 300 million

Ranks No.2 in global sales, the leading product in the US and Japan

Its non-reimbursement remains a barrier in Korea for over 2 years...will be deliberated at DREC in June

(From the left) Spinraza, Evrysdi, Zolgensma

It has been 1 year and 6 months since the only oral spinal muscular atrophy (SMA) treatment, ‘Evrysdi (risdiplam),’ has been released in the Korean market.

 

However, the company is having trouble posting sales in Korea.

 

This is in stark contrast to how the same product exceeded the sales of 'Zolgensma' and is comparable to the sales of 'Spinraza.’ The fact that the reimbursement application was not even discussed for nearly 2 years and its reimbursement was blocked acted as a barrier in Korea.

 

However, the Health Insurance Review and Assessment Service plan to review Evrysdi at its Drug Reimbursement Evaluation Committee (DREC) soon.

 

According to the market research institution IQVIA on the 31st, the SMA treatment market in Korea had reached KRW 20 billion in Q1, up 15% YoY.

 

Three SMA treatments are currently available in Korea: ▲Biogen’s ‘Spinraza (nusinersen)’ ▲Roche’s ‘Evrysdi (risdiplam,’ and ▲Novartis’s ‘Zolgensma (onasemnogene abeparvovec).

 

Data: IQVIA

Among the 3, the drug that posted the highest sales was Spinraza, which posted KRW 14.3 billion in sales in Q1 this year.

 

When it was the only drug available in the market, it once exceeded KRW 20 billion in quarterly sales, but it recently showed a decline in sales due to the emergence of its competitors.

 

In Q1 this year, its sales fell 18% YoY.

 

Zolgensma, the “one-shot treatment” that only needs to be administered once in a lifetime, came in second with KRW 5.4 billion.

 

On the other hand, Evrysdi, the only oral drug, recorded only KRW 300 million in quarterly sales.

 

This is in stark contrast with the global market trend.

 

In the global market, Evrysdi’s sales exceeded Zolgensma's and are even threatening Spinraza’s sales.

 

In its Q1 earnings report, Roche announced that Evrysdi's global sales recorded CHF 363 million (approximately KRW 530 billion).

 

During the same period, Zolgensma posted sales of USD 309 million (approximately 409 billion).

 

Evrysdi’s global sales followed up to the bottom of Spinraza’s sales, which posted USD 443 million (approximately KRW 586 billion).

 

SMA is a rare condition in which the SMN1 gene is innately deficient or mutated to result in progressive muscle atrophy.

 

Globally, SMA occurs in about 1 in 10,000 newborns, and in Korea, it is known that about 30 patients (based on 300,000 newborns) occur each year.

 

The severity of the condition is closely related to the number of the “backup” SMN2 genes.

 

The SMN2 gene can produce up to 10% of the SMN protein that SMN1 cannot produce.

 

In the case of SMA Type 1, the most common and severe form of SMA, if left untreated, over 95% of the motor neurons are damaged within 6 months, and 90% die before the age of 2.

 

Although the condition is rare, the number of treatment options had increased to three at once with the recent development of new drugs.

 

Starting with Spinraza in December 2017, Evrysdi in November 2020, and Zolgensma in May 2021 each drug received approval from the Ministry of Food and Drug Safety.

 

The 3 drugs have different characteristics.

 

Spinraza has the strength of being the first treatment.

 

Evrysdi is an oral drug that is easy to administer and relatively inexpensive.

 

Zolgensma is the most expensive drug in Korea, but it is a gene therapy that can fundamentally treat the disease with one single injection.

 

The market prospects are more favorable to Evrysdi.

 

U.S.

 

analysts have predicted that Evrysdi would post the highest sales in 2026.

 

They expect that the more affordable oral drug strategy will work for the benefit.

 

Evrysdi, which has risen to the forefront in major countries such as the United States and Japan, is struggling only in Korea.

 

Roche released the drug into the domestic market and applied for its reimbursement about a year after approval.

 

Its sales were recorded only since Q3 2022, 1 year after its launch.

 

However, unlike the other two drugs that are approved for reimbursement, the non-reimbursed Evrysdi posted less than KRW 500 million in quarterly sales.

 

Roche applied for the reimbursement of Evrysdi to HIRA in mid-2021, but HIRA delayed discussing Evrysdi’s reimbursement for nearly two years.

 

The biggest reason was the extension of Spinraza's reimbursement standards.

 

As the two drugs target the same disease, the authorities planned to discuss the reimbursement of Evrysdi after revising the reimbursement standards for Spinraza, but the discussion on Spinraza took longer than expected, not allowing Evrysdi to even be submitted for review by DREC.

 

With discussion making way recently, Spinraza and Evrysdi’s reimbursement applications recently passed Drug Reimbursement Standard Subcommittee.

 

The 2 drugs are scheduled to be presented for review to DREC for the meeting on the 1st of next month.

 

Expectations are high that the agendas will easily pass the DREC review as they have been discussed for a long time.

 

As the price is cheaper than its comparators, the drug pricing negotiations are also expected to be completed without difficulty.

 

If reimbursed, Evrysdi’s sales are expected to expand significantly.

 

However, since the reimbursement standards are also being extended for Spinraza, it will be difficult for the latecomer Eversdi to compete in the Korean market.

 

Whether or not the reimbursement for switching will be recognized is also expected to be a variable that determines the extent of Evrysdi’s sales growth.