Sotyktu, Adtralza set for reimbursement listing

Soliris receives expanded reimbursement

Sotyktu and Adtralza concluded negotiations with the NHIS and will soon be reported to the Health Insurance Policy Review Committee

Soliris price will be reduced, with the expansion of reimbursement for neuromyelitis optica

Sotyktu.

Two drugs, plaque psoriasis drug 'Sotyktu (deucravacitinib)' and atopic dermatitis drug 'Adtralza (tralokinumab)' have completed the negotiation with the National Health Insurance Service (NHIS) and may soon be listed for reimbursement.

 

Additionally, the upper price limit of Soliris (eculizumab) is expected to be reduced following the expansion of reimbursement for neuromyelitis optica.

 

According to industry sources on the 15th, Sotyktu and Adtralza concluded negotiations with the NHIS to receive reimbursement.

 

Sotyktu is the first TYK2 inhibitor to be approved in South Korea for treating adult patients with moderate to severe plaque psoriasis.

 

It is administered orally once a day for convenience.

 

The drug was approved by the Ministry of Food and Drug Safety (MFDS) last August and cleared the review by the Drug Reimbursement Committee of the Health Insurance Review and Assessment Service (HIRA) in December.

 

BMS Pharmaceutical, the company for Sotyktu, agreed to the evaluation price suggested by the Drug Reimbursement Committee.

 

Notably, the company accepted an amount below the standard for negotiation exemption, solely negotiating for the anticipated claim amount.

 

BMS Pharmaceutical and Yuhan recently made a joint promotion agreement for Sotyktu.

 

When the drug gets listed on reimbursement next month, Sotyktu will likely be distributed through the marketing network of Yuhan-BMS.

 

Adtralza.

LEO Pharma’s 'Adtralza' is a treatment for atopic dermatitis with an underlying mechanism of neutralizing interleukin-13 (IL-13).

 

Adtralza approval is expected to expand the treatment options for atopic dermatitis as Dupixent (dupilumab) is the only biologic available for treating the disease.

 

Like Sotyktu, Adtralza is expected to be listed for reimbursement after one year of approval.

 

It was approved last August and cleared for review by the Drug Reimbursement Committee in November Adtralza began negotiations with the NHIS in last November and it has recently come to an agreement.

 

Currently reimbursed for atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH), Soliris is expected to receive approval for additional reimbursement for neuromyelitis optica spectrum disorder (NMOSD).

 

Soliris is under pre-review by the HIRA.

 

It is reported to be a high-priced new drug, valued at approximately KRW 500 million.

 

Since 2015, the financial burden of the drug has been mitigated through Risk Sharing Agreements (RSA) but transitioned to regular listing in October 2019.

 

Soliris.

The company submitted the request for expanding Soliris’ reimbursement to neuromyelitis optica in 2021, but it took some time to be listed for reimbursement.

 

After concluding negotiations with the NHIS, the coverage by reimbursement is expected to begin next month.

 

With the reimbursement expansion, the current upper price limit of KRW 5,130,000 is expected to be reduced.