Olumiant receives reimbursement for severe alopecia areata

Reimbursed for adults with severe alopecia areata after failing conventional therapy…up to 2 years

Phase III studies demonstrated scalp, eyebrow, and eyelash regrowth

Marks a milestone in expanding access to treatment for an autoimmune disease, beyond cosmetic care

For the first time, patients with severe alopecia areata have gained access to an evidence-based targeted therapy reimbursed by Korea's National Health Insurance system.

With reimbursement now granted for Eli Lilly Korea's Janus kinase (JAK) inhibitor Olumiant (baricitinib), the treatment landscape is expected to shift away from reliance on conventional immunosuppressants and non-reimbursed therapies.

However, given the chronic, relapsing nature of alopecia areata, several issues remain unresolved, including the two-year reimbursement limit, reimbursement eligibility requirements for patients previously using non-reimbursed treatments, and coverage for adolescents.

Lilly Korea held a press conference on the 5th to mark the reimbursed launch of Olumiant for adults with severe alopecia areata. The drug was granted National Health Insurance reimbursement from July 1 for severe alopecia areata.

(from the left) Chang Hoon Huh (Dermatology, Seoul National University Bundang Hospital); Sang Seok Kim (Dermatology, Kangdong Sacred Heart Hospital); Yong Hyun Jang (Dermatology, Kyungpook National University Hospital)

Alopecia areata is an autoimmune disease, not a cosmetic condition… marks first step for reimbursement of targeted therapies

Alopecia areata is an autoimmune disease in which immune privilege around hair follicles collapses, allowing immune cells to attack the follicles. The disease follows an unpredictable course, with repeated cycles of relapse and remission.

In severe cases, patients may lose not only scalp hair but also eyebrows, eyelashes and body hair. The resulting changes in appearance often lead to reduced self-esteem, social withdrawal and difficulties in daily life.

Chang Hoon Huh, Professor of Dermatology at Seoul National University Bundang Hospital (President of Korean Hair Research Society), said, "Reimbursement for alopecia areata treatment has been one of the Korean Hair Research Society's key priorities for many years. Olumiant’s reimbursement marks an important first step."

Sang Seok Kim, Professor of Dermatology at Kangdong Sacred Heart Hospital (Secretary General, KHRS), also highlighted the limitations of existing treatments. Systemic corticosteroids and cyclosporine, which have long been used for severe cases, lack robust large-scale clinical evidence specifically in alopecia areata and are associated with significant safety concerns during long-term use.

JAK inhibitors are targeted therapies that block intracellular signaling pathways involved in the pathogenesis of alopecia areata. Professor Kim said, "The introduction of JAK inhibitors is changing the treatment paradigm for severe alopecia areata. Olumiant’s reimbursement opened an opportunity for patients to reduce financial burden."

Under the reimbursement criteria, coverage is available for patients whose Severity of Alopecia Tool (SALT) score has not improved by at least 30% after three months or more of treatment with systemic corticosteroids or cyclosporine, or for those unable to continue treatment because of adverse events.

Eligible patients generally include those with SALT scores of 50 or higher, indicating at least 50% scalp hair loss. Patients with SALT scores between 20 and 50 may also qualify if they show eyebrow or eyelash loss, or obvious interruption of hair growth.

Yong Hyun Jang, Professor of Dermatology at Kyungpook National University Hospital, said, “In most countries, reimbursement is limited to patients with SALT scores of 50 or above. Korea's decision to include patients with SALT scores between 20 and 50 who also have eyebrow or eyelash loss is particularly meaningful," he added.

Clinical benefits continue beyond 36 weeks… support long-term treatment

The clinical evidence supporting Olumiant comes from the Phase III BRAVE-AA1 and BRAVE-AA2 trials in adults with severe alopecia areata.

More than half of participants had lost over 95% of their scalp hair. The mean SALT score was 96, and the average disease duration was approximately 12 years, indicating that most participants had long-standing, severe disease.

At Week 36, the proportion of patients achieving SALT 20 or lower, corresponding to no more than 20% scalp hair loss, was 38.8% in BRAVE-AA1 and 35.9% in BRAVE-AA2 among patients receiving Olumiant 4 mg. Hair regrowth was also observed in the eyebrows and eyelashes.

Treatment responses continued to improve beyond Week 36. While some patients responded early, others experienced gradual improvement or showed meaningful responses after Week 36.

Professor Jang said, "Because hair regrowth takes time, some patients show better outcomes at Week 52 than at Week 36. We need reimbursement criteria that allow both early and late responders to continue receiving treatment."

Reimbursement is only the beginning, not the end… 2-year limit and progress rules remain challenges

Several challenges remain following reimbursement approval. To maintain reimbursement, patients must achieve a SALT score of 20 or below at Week 36. Treatment response is then reassessed every 6 months, and reimbursement is currently limited to a maximum of 2 years.

The concern is that alopecia areata is a chronic disease characterized by repeated relapses and remissions. Even after successful hair regrowth, discontinuing treatment may lead to renewed hair loss, meaning some patients could require therapy beyond the current reimbursement period of 2 years.

Professor Jang argued that extending reimbursement for patients who continue to respond is unlikely to place a substantial additional burden on the healthcare budget, given that treatment effectiveness is already reassessed every 6 months. He said a formal pathway is needed to allow continued reimbursement beyond 2 years for patients who maintain treatment benefit.

The transition rules for patients already using non-reimbursed Olumiant were also identified as an issue. To receive reimbursement, these patients must objectively demonstrate through historical medical records, photographs, and SALT assessments that they met the current reimbursement criteria when treatment began. Patients treated for more than 36 weeks must also submit their Week 36 evaluation results.

However, before reimbursement criteria existed, neither physicians nor patients had any reason to collect or preserve such documentation. Patients who have already responded to treatment may find it difficult to prove the severity of their previous condition based on their current clinical status, while those who changed hospitals may struggle to obtain earlier records.

Professor Jang said, "Applying today's reimbursement criteria to treatment that began before those criteria existed and requiring historical documentation is problematic. The evidentiary requirements should be relaxed, and a separate pathway must be established to ensure that patients who have already improved are not excluded from coverage."

Expanding reimbursement to adolescents also remains an outstanding issue. Although Olumiant's indication was recently extended to include patients aged 12 years and older with severe alopecia areata, reimbursement currently applies only to adults. Experts also noted that as additional JAK inhibitors enter the alopecia areata market, reimbursement criteria should allow physicians to switch therapies based on individual patient response and safety profiles.

Professor Jang said, "Reimbursement for Olumiant should not be the final improvement; rather, it should be the starting point for improving treatment in alopecia areata. Future efforts should focus on enabling continued treatment beyond 2 years, extending reimbursement to adolescents, improving transition rules for existing patients and providing greater flexibility in treatment selection."