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NMOSD drug Enspryng can be prescribed at general hospitals
by Eo, Yun-Ho Mar 18, 2024 05:50am
Enspryng, a new drug for neuromyelitis optica spectrum disorder (NMOSD) is landing in general hospitals in Korea. According to industry sources, Roche Korea's Neuromyelitis Optica Spectrum Disorder (NMOSD) drug Enspryng (satralizumab) has passed the drug committees (DCs) of tertiary hospitals including Seoul National University Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, as well as medical institutions including the National Cancer Center, Chonnam National University Hospital, and Chungnam National University Hospital. In addition, the drug can be prescribed in an increasing number of medical institutions that inserted the drug code through emergency DC meetings to prescribe Enspryng. As such, the drug’s prescriptions have been increasing steadily after being granted reimbursement in December last year. Enspryng was approved in Korea in the first half of 2021, after which the company submitted an application for its reimbursement in the second half of 2022. However, due to its high price, the company faced considerable difficulties in setting its reimbursement standards and financial sharing plans. The company had first adopted the strategy of accepting the weighted average price (WAP) of its alternative, AstraZeneca’s ‘Soliris (eculizumab),’ but due to a delay in Soliris’s reimbursement listing process for NMOSD, the company turned to the pharmacoeconomic evaluation exemption track for its reimbursement. After switching to the PE exemption track, the agenda passed HIRA’s Drug Reimbursement Evaluation Committee in August and completed pricing negotiations with the NHIS in November of the same year. However, its reimbursement is currently limited to its use as a ‘fourth-line or later’ therapy. Currently, the immunosuppressant azathioprine is used as first-line maintenance therapy for NMOSD. If a patient fails treatment with azathioprine, mycophenolate, or rituximab is prescribed with reimbursement as second-line therapy. Both mycophenolate and rituximab are off-label drugs that do not have NMOSD indications. In other words, Enspryng can only be used as fourth or later-line therapy in patients who fail treatment with rituximab in the third-line. Therefore, it remains to be seen whether the company will seek to extend reimbursement for Enspryng after listing. Meanwhile, Enspryng’s efficacy was demonstrated through SAkuraStar and SAkuraSky clinical trials that were conducted on adult patients with anti-aquaporin(AQP4) antibody-positive NMOSD. In the SAkuraStar monotherapy study’s AQP4 antibody-positive subgroup, 76.5% of Enspryng-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with standard immunotherapy, 91.1% of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo.