AbbVie Korea said the Korean health insurance coverage for Rinvoq (upadacitinib), a once-daily, oral, selective and reversible JAK1 inhibitor, has been expanded to treat moderately to severely active ulcerative colitis and Crohn's disease in adults, effective from April 1. 

Rinvoq is covered by health insurance for patients with moderate to severe ulcerative colitis who have not had an adequate response to or are intolerant of conventional treatment agents such as corticosteroids, 6-mercaptopurine, or azathioprine, or for whom these agents are contraindicated. It is also indicated for patients who have not received conventional treatment (two or more agents: corticosteroids or immunosuppressive agents) and do not respond to or are intolerant of conventional therapy (two or more agents: corticosteroids or immunosuppressive agents), or who have moderate to severe active Crohn's disease (Crohn's Disease Activity Index (CDAI) of 220 or greater) for which such therapy is contraindicated.

Insurance benefits are authorized for replacement therapy with a biologic or S1P receptor modulator for ulcerative colitis and a biologic for Crohn's disease when the biologic is ineffective or cannot be continued due to adverse effects, or when there is a need to improve adherence (the replaced agent is recommended to be maintained for at least six months). Replacement therapy must be supported by a physician's report.

The health insurance coverage makes Rinvoq the first and only JAK inhibitor to be covered for moderate to severe adult Crohn's disease. 

The upper benefit limit for Rinvoq is 19,831 won ($14.67) for 15 mg and 31,628 won for 30 mg, which equates to 555,268 won and 885,584 won, respectively, based on a 28-day treatment regimen.

"Inflammatory bowel disease is a chronic condition that requires constant management and can significantly affect patients' lives with symptoms such as frequent diarrhea, bloody stools, and abdominal pain," said Kim Tae-il, a professor of gastroenterology at Severance Hospital. "If not managed properly, it can lead to an increased incidence of colon cancer and autoimmune diseases such as rheumatoid arthritis and psoriasis."

Poorly managed disease is not only associated with physical symptoms but also with psychological problems such as depression, he went on to say.

Early and aggressive treatment is crucial, and achieving mucosal healing can improve the long-term prognosis, prevent comorbidities, and reduce the necessity for surgery and hospitalization, he added. 

Kim said this coverage decision will help ease the financial burden for patients with Crohn's disease and ulcerative colitis, as the drug's clinical utility has been confirmed in multiple clinical studies. 

“We also believe that patients will benefit from the convenience of an oral formulation that is easy to administer due to the nature of inflammatory bowel disease, which often affects younger patients in their teens to 40s.”

Kang Ji-ho, Country Medical Director at AbbVie Korea, commented, "Despite the introduction of numerous therapies for inflammatory bowel disease, there remains an unmet need for achieving mucosal healing, rapid symptom improvement, and high rates of clinical remission."

"We are delighted that this coverage will expand patient access to Rinvoq treatment, which has demonstrated efficacy and safety across diverse clinical studies. Our commitment remains unwavering in providing innovative solutions to support patients in achieving optimal outcomes."