'Anzupgo' for CHE advances in obtaining reimbursement

Received reimbursement appropriateness from the Pharmaceutical Reimbursement Evaluation Committee…drug price negotiation procedure garners attention

A new treatment option has emerged for patients experiencing limitations with topical steroids

As the new chronic hand eczema (CHE) drug Anzupgo nears National Health Insurance reimbursement, it is emerging as an option that can bridge the treatment gap between conventional topical corticosteroids and systemic therapy.

Until now, when chronic hand eczema did not achieve an adequate response to topical corticosteroids, patients had to consider systemic therapies such as phototherapy or oral alitretinoin. Because long-term non-steroidal topical options were limited, reimbursement for Anzupgo could expand access to treatment.

According to the pharmaceutical industry on the 8th, LEO Pharma's topical Janus kinase (JAK) inhibitor Anzupgo (delgocitinib) recently received reimbursement appropriateness from the Pharmaceutical Reimbursement Evaluation Committee (PREC) of the Health Insurance Review and Assessment Service (HIRA). Consequently, the drug will proceed toward National Health Insurance listing following subsequent procedures, including drug price negotiations with the National Health Insurance Service (NHIS).

Anzupgo secured reimbursement appropriateness from the PREC after demonstrating cost-effectiveness through a pharmacoeconomic evaluation.

Recurrent hand eczema…Burden of long-term treatment increases

topical Janus kinase (JAK) inhibitor 'Anzupgo'

Chronic hand eczema is a chronic inflammatory skin disease accompanied by pruritus, pain, and skin fissures. Because the hands are used continuously in daily routines and occupational activities, recurring symptoms substantially affect work performance and quality of life.

Conventional treatment has primarily followed a stepwise approach, starting with basic skin care, including moisturizers, then moving to topical corticosteroids, and finally escalating to phototherapy or oral alitretinoin.

However, long-term use of topical corticosteroids carries the burden of adverse effects such as skin atrophy, and oral alitretinoin also has limitations in continuous application across all patients due to adverse events like headache and dyslipidemia, as well as restrictions on its use in women of childbearing potential.

In clinical practice, the issue of patients who do not respond adequately to topical corticosteroids repeatedly receiving the same treatment, thereby delaying the transition to systemic therapy, has particularly been highlighted as an unmet medical need.

In fact, a study analyzing approximately 4,000 Danish patients with chronic hand eczema revealed that it took more than eight years for approximately 44% of all patients to reach their first systemic therapy.

Experts argue that rather than repeating topical corticosteroid therapy that is ineffective, clinicians need a strategy to transition to the next step of treatment based on disease severity and response.

A new option between topical therapy and systemic Treatment

Anzupgo is a non-steroidal topical pan-JAK inhibitor that inhibits JAK1, JAK2, JAK3, and TYK2. In South Korea, it was approved in September last year to treat adult patients with moderate-to-severe chronic hand eczema who have had an inadequate response to topical corticosteroids or for whom such treatments are inappropriate.

Compared with existing treatments, Anzupgo is a new topical treatment option that can be used before transitioning to systemic therapy in patients who do not respond adequately to topical corticosteroids.

In the global Phase 3 DELTA 1 and DELTA 2 studies, which served as the basis for Anzupgo's approval, administration for 16 weeks in adult patients with moderate-to-severe chronic hand eczema resulted in Hand Eczema Severity Index (HECSI) 75% or greater improvement (HECSI-75) rates of 49.2% and 49.5%, respectively.

The proportion of patients achieving an improvement of 4 points or more in itch score was also 47.1% in DELTA 1 and 47.2% in DELTA 2, outperforming the vehicle/placebo arm rates of 23.0% and 19.9%, respectively. Pain reduction was also confirmed compared to placebo, and therapeutic efficacy and safety were maintained for up to 52 weeks in the DELTA 3 extension study.

Anzupgo is currently prescribed as a non-reimbursed drug in Korea. The pharmacy acquisition price per 60 g tube is approximately KRW 690,000. The final non-reimbursed price set by healthcare institutions is around KRW 800,000.

However, the actual duration of use varies widely depending on the extent of the patient's lesions. When applied thinly twice daily to affected areas of the hands and wrists, a single 60 g tube typically lasts about two months for patients with localized lesions.

Under the current non-reimbursed status, patients may face drug expenses of hundreds of thousands of won per month, depending on individual usage. Once reimbursement is granted, the financial burden on patients requiring long-term treatment is expected to decrease.