Will generics dominate the oral psoriasis treatment market?

Five drugs, including those from Dong-A ST·Daewoong, receive a conditional pass for reimbursement appropriateness

The original drug withdrew from the Korean market after the company was dissatisfied with the reimbursement decision

Dong-A ST

The global market for oral psoriasis treatment amounts to KRW 5 trillion.

 

In the Korean market, generic medicines are likely to dominate.

 

The original medicine company withdrew its drug from the Korean market due to dissatisfaction with the reimbursement decision, whereas generic medicines are likely to accept the term.

 

A new type of oral medicine is likely to be competitive because psoriasis treatments that are available in South Korea are primarily injectables.

 

The Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review held its 10th meeting for 2024 on October 10th and ruled that medicines containing apremilast would be appropriate for reimbursement coverage if the company accepted the drug price below the evaluated amount.

 

These medicines include 5 products: Otelia (Dong-A ST), Apsola (Daeowoong Pharmaceutical), Otebell (Chong Kun Dang), Otemila (Dongkoo Bio), and Psopre Tab (Hanlim Pharm).

 

The originial medicine containing apremilast is Amgen's 'Otezla.' Otezla received marketing authorization in South Korea in November 2017.

 

However, the company voluntarily withdrew approval in 2022 due to dissatisfaction with the domestic reimbursement decision.

 

Otezla is a PDE4 (phosphodiesterase 4) inhibitor used to treat psoriasis.

 

A PDE4 inhibitor blocks the activation of PDE4 enzyme that causes inflammatory responses.

 

The Korean market for psoriasis treatments is led by injectable interleukin agents.

 

These include Stelara (Janssen) and Cosentyx (Novartis).

 

Like the case of generics, Otezla also received a conditional pass during the DREC review.

 

In May 2018, the DREC review decided that Otezla is non-inferior to Enbrel inj for the treatment of psoriasis and Stelara for the treatment of psoriatic arthritis, but the drug is not cost-effective due to its high cost relevant to the treatment duration.

 

The government said it would agree on reimbursement appropriateness if the pharmaceutical company accepted the drug price below the weighted mean price of substitute medicines.

 

However, the pharmaceutical company did not accept it.

 

Although the original medicine did not accept the conditional agreement for reimbursement, generic companies are likely to wrap up the reimbursement listing process by accepting it.

 

Dong-A ST has already launched Otelia as non-reimbursable in July and began sales·marketing.

 

Generic companies have no problems launching their products after avoiding patents and reaching an agreement with Amgen.

 

When generic companies accept the DREC review decision, they will start a negotiation with the National Health Insurance Service (NHIS).

 

If a company accepts a drug price negotiation exemption criterion (90% below the weighted average price of substitute medicines), it can conclude the negotiation early by skipping the drug price negotiation and starting the estimated claim amount negotiation.

 

"Patients would have had difficulty accessing the medicine containing this active ingredient if it had not been for the Korean pharmaceutical company," pharmaceutical industry personnel said.

 

"We look forward to seeing whether generic companies with new types of oral products would take the market share in the psoriasis treatment market dominated by foreign pharmaceutical companies."