Sotyktu, Starting from April 1st, reimbursement will be applied

Starting April 1st 2024, Sotyktu tablets (Ducravasitinib), a treatment for psoriasis by BMS Pharmaceuticals, will be covered by health insurance. It has been only about 8 months since receiving domestic market approval. This is the result of following the expedited listing process called the 'approval-evaluation linkage system' and skipping the drug pricing negotiation process. The maximum reimbursement price(MRP) was set at around 26.4% of the A8 adjusted average price.

According to the Ministry of Health and Welfare on the 27th, psoriasis is an immune disease characterized by rapid and excessive proliferation of keratinocytes, the cells that make up the epidermis, and affects approximately 2% of the world's population.

Treatment can be broadly classified into four stages: topical treatment, phototherapy, systemic treatment, and biological agent therapy. Biological agents show better efficacy than phototherapy and oral systemic therapies and are considered for patients who have inadequate responses to other psoriasis treatments.

Sotyktu was granted domestic market approval on August 3, 2023, for the treatment of moderate to severe plaque psoriasis in adults eligible for phototherapy or systemic therapy.

The application for insurance listing was made on July 17 of the same year. This was the result of utilizing one of the expedited listing processes, the approval-evaluation linkage system. Subsequently, the procedures of the Drug Benefit Evaluation Subcommittee on November 24 of the same year and the Drug Benefit Evaluation Committee on December 7 of the same year were swiftly completed. Negotiations with the Health Insurance Review and Assessment (HIRA) for the estimated claim amount concluded on February 26 of this year.

The Korean Dermatological Association stated, "Sotyktu is a convenient once-daily oral therapy that offers greater convenience compared to existing biological agents that require subcutaneous or intravenous injections, and it provides long-term efficacy without loss of effectiveness due to immunogenicity."

The Drug Benefit Evaluation Committee stated, "While Sotyktu is not significantly inferior to alternative agents (e.g., etanercept) in improving symptoms of psoriasis, its high cost compared to alternative agents makes it non-reimbursable."

The committee added, "However, if the company accepts a price equivalent to the weighted average price of alternative agents (20,919 KRW/tablet), reimbursement is deemed appropriate, and if it accepts a price below the drug pricing negotiation exemption criterion (100% of the weighted average price of alternative agents), the negotiation process for the MRP will be skipped."

It also explained that the weighted average price was calculated excluding drugs that were improvements over some alternative agents.

Among A8 countries, Sotyktu is registered in three countries including the United States, the United Kingdom, and Japan. The adjusted average price is 94,185 KRW, and the lowest price (in Japan) is 26,672 KRW. The Korean listing price was finally determined to be 24,919 KRW. It is set at 26.4% of the adjusted average price and is 6.5% cheaper than the lowest price.

During negotiations with the National Health Insurance Service (NHIS), an agreement was reached on an estimated claim amount of 2.98 billion KRW. This considered an annual patient count of 329. The Ministry of Health and Welfare stated, "As it is included at the level of the weighted average price of alternative agents, there is no increase in expenditure due to the listing of the applied drug."

Meanwhile, Sorcytu received rapid reimbursement recommendation in the UK just a month after receiving marketing authorization.