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Neuromyelitis optica spectrum disorder (NMOSD): 국가별 선택지

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선택지 정리됨희귀·유전 질환최종 확인 2026.06

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임상시험 검색어

Neuromyelitis optica spectrum disorder (NMOSD) clinical trial

국가별 선택지

국가별 치료 선택지

공식 규제·평가 기관 출처를 바탕으로 한 국가별 승인·접근 상태입니다. 무엇이 어디에 존재하는지를 보여줄 뿐, 추천이 아닙니다.

United States

  • eculizumab (Soliris); ravulizumab-cwvz (Ultomiris); inebilizumab-cdon (Uplizna); satralizumab-mwge (Enspryng)[1]FDA-approvedanti-aquaporin-4 (AQP4) antibody positive; Relapse-prevention / disease-modifying biologic therapy for AQP4-positive adult NMOSD as stated in U.S. labels. · Labels do not rank these therapies or define individualized eligibility. Complement inhibitors require meningococcal vaccination/prophylaxis and REMS-related steps. Uplizna requires infection, hepatitis B, tuberculosis, and immunoglobulin considerations. Enspryng requires infection, hepatitis B/tuberculosis/liver-transaminase screening and vaccination planning. Pediatric NMOSD access is not established by these adult labels. Confidence/conflicts: High for U.S. adult AQP4-positive NMOSD label claims; no conflict identified.
  • eculizumab (Soliris); ravulizumab-cwvz (Ultomiris); inebilizumab-cdon (Uplizna); satralizumab-mwge (Enspryng)[1]FDA-approvedanti-aquaporin-4 (AQP4) antibody positive; Relapse-prevention / disease-modifying biologic therapy for AQP4-positive adult NMOSD as stated in U.S. labels. · Labels do not rank these therapies or define individualized eligibility. Complement inhibitors require meningococcal vaccination/prophylaxis and REMS-related steps. Uplizna requires infection, hepatitis B, tuberculosis, and immunoglobulin considerations. Enspryng requires infection, hepatitis B/tuberculosis/liver-transaminase screening and vaccination planning. Pediatric NMOSD access is not established by these adult labels. Confidence/conflicts: High for U.S. adult AQP4-positive NMOSD label claims; no conflict identified.

European Union

  • eculizumab (Soliris); ravulizumab (Ultomiris); inebilizumab (Uplizna); satralizumab (Enspryng)[2]EMA authorisedAQP4 antibody / AQP4-IgG seropositive, depending on product source; EU-authorized biologic relapse-prevention/disease-modifying therapy for AQP4-positive NMOSD populations; Germany HTA context for Uplizna. · EMA authorization does not equal reimbursement in Germany, France, or the UK. The G-BA resolution is a benefit-assessment/access-policy source and is legally governed by the German version. UK access remains source-pending in this batch. Confidence/conflicts: High for EU authorization claims; medium for country access because UK and France reimbursement are not verified and the German G-BA source is a courtesy translation.
  • eculizumab (Soliris); ravulizumab (Ultomiris); inebilizumab (Uplizna); satralizumab (Enspryng)[2]EMA authorisedAQP4 antibody / AQP4-IgG seropositive, depending on product source; EU-authorized biologic relapse-prevention/disease-modifying therapy for AQP4-positive NMOSD populations; Germany HTA context for Uplizna. · EMA authorization does not equal reimbursement in Germany, France, or the UK. The G-BA resolution is a benefit-assessment/access-policy source and is legally governed by the German version. UK access remains source-pending in this batch. Confidence/conflicts: High for EU authorization claims; medium for country access because UK and France reimbursement are not verified and the German G-BA source is a courtesy translation.

Japan

  • satralizumab (Enspryng); ravulizumab (Ultomiris); rituximab (Rituxan); eculizumab (Soliris)[3]EMA authorisedAQP4 antibody positive / AQP4-IgG seropositive where stated; Relapse prevention / disease-modifying therapy for AQP4-positive NMOSD contexts as stated by Japan/China manufacturer and PMDA sources. · Japan/China product claims rely partly on manufacturer announcements and one PMDA review context rather than a complete current label set. China Soliris source is manufacturer-sourced, not direct NMPA label. Rituximab Japan details need product-specific label/reimbursement follow-up before recording as a broad option outside the PMDA review context. Confidence/conflicts: Medium for Japan/China country availability because direct current labels were not fully fetched; high for the specific manufacturer/PMDA statements recorded. No conflict identified.
  • satralizumab (Enspryng); ravulizumab (Ultomiris); rituximab (Rituxan); eculizumab (Soliris)[3]EMA authorisedAQP4 antibody positive / AQP4-IgG seropositive where stated; Relapse prevention / disease-modifying therapy for AQP4-positive NMOSD contexts as stated by Japan/China manufacturer and PMDA sources. · Japan/China product claims rely partly on manufacturer announcements and one PMDA review context rather than a complete current label set. China Soliris source is manufacturer-sourced, not direct NMPA label. Rituximab Japan details need product-specific label/reimbursement follow-up before recording as a broad option outside the PMDA review context. Confidence/conflicts: Medium for Japan/China country availability because direct current labels were not fully fetched; high for the specific manufacturer/PMDA statements recorded. No conflict identified.

Australia

  • inebilizumab (Uplizna)[4]TGA-registered (Australia)anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive; adult AQP4-IgG-seropositive NMOSD monotherapy in Australia, as stated by the TGA assessment. · The entry records regulatory indication status only. It does not establish PBS coverage, specialist-center availability, acute-relapse use, or use in AQP4-negative disease. Confidence/conflicts: High for Australian inebilizumab regulatory status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • inebilizumab (Uplizna)[4]TGA-registered (Australia)anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive; adult AQP4-IgG-seropositive NMOSD monotherapy in Australia, as stated by the TGA assessment. · The entry records regulatory indication status only. It does not establish PBS coverage, specialist-center availability, acute-relapse use, or use in AQP4-negative disease. Confidence/conflicts: High for Australian inebilizumab regulatory status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • ravulizumab (Ultomiris)[5]TGA-registered (Australia)anti-aquaporin-4 (AQP4) antibody positive; relapse-prevention / maintenance disease-modifying treatment for adult anti-AQP4-positive NMOSD in Australia. · The AusPAR wording is adult anti-AQP4-positive NMOSD and explicitly excludes acute relapse treatment. Complement-inhibitor infection precautions and current product information should be reviewed locally. Confidence/conflicts: High for Australian regulatory indication; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • ravulizumab (Ultomiris)[6]ApprovedNMOSD; PBS restriction details require checking the current Schedule item; PBS-subsidised NMOSD treatment pathway in Australia, subject to PBS restrictions. · This is a payer/access cell, not a clinical recommendation. The Schedule restrictions and authority application process control subsidised access and may change. Confidence/conflicts: High for Australian PBS listing/access-process existence; detailed restriction text should be checked on the live PBS Schedule. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • ravulizumab (Ultomiris)[6]ApprovedNMOSD; PBS restriction details require checking the current Schedule item; PBS-subsidised NMOSD treatment pathway in Australia, subject to PBS restrictions. · This is a payer/access cell, not a clinical recommendation. The Schedule restrictions and authority application process control subsidised access and may change. Confidence/conflicts: High for Australian PBS listing/access-process existence; detailed restriction text should be checked on the live PBS Schedule. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • satralizumab (Enspryng)[7]TGA-registered (Australia)anti-aquaporin-4 immunoglobulin G (AQP4-IgG) positive; relapse-prevention/maintenance treatment context for adult AQP4-IgG-positive NMOSD, as stated by the TGA assessment. · The Australian final wording is narrower than the sponsor-proposed adult/adolescent wording described earlier in the AusPAR. This entry records the TGA final Australian adult indication, not acute relapse treatment or PBS access. Confidence/conflicts: High for Australian adult AQP4-positive indication; no conflict identified when final Australian wording is used. Availability/reimbursement outside the approving regulator not established.
  • satralizumab (Enspryng)[7]TGA-registered (Australia)anti-aquaporin-4 immunoglobulin G (AQP4-IgG) positive; relapse-prevention/maintenance treatment context for adult AQP4-IgG-positive NMOSD, as stated by the TGA assessment. · The Australian final wording is narrower than the sponsor-proposed adult/adolescent wording described earlier in the AusPAR. This entry records the TGA final Australian adult indication, not acute relapse treatment or PBS access. Confidence/conflicts: High for Australian adult AQP4-positive indication; no conflict identified when final Australian wording is used. Availability/reimbursement outside the approving regulator not established.

Thailand

  • ravulizumab (Ultomiris)[8]Approvedanti-aquaporin 4 (AQP4) antibody-positive; adult anti-AQP4-antibody-positive NMOSD; chronic-administration setting per source. · Ravulizumab must be administered by a healthcare professional under supervision of a physician experienced in neuroinflammatory disorders. The label states treatment in adult NMOSD has only been studied in chronic administration, that pediatric NMOSD safety and efficacy have not been established, and that ravulizumab has not been studied for acute treatment of NMOSD relapses. This entry does not establish Thai reimbursement, center availability, or use in anti-AQP4-negative/MOG-associated disease. Confidence/conflicts: High for Thai NDI Ultomiris anti-AQP4-positive adult NMOSD label content; no conflict identified. Reimbursement/access and other NMOSD biologics remain unresolved.

Canada

  • eculizumab (Soliris)[9]Approvedanti-aquaporin-4 (AQP4) antibody positive; adult anti-AQP4-positive NMOSD treatment in Canada; not acute relapse treatment. · The monograph states safety and effectiveness for NMOSD in pediatric patients under 18 have not been established. Complement inhibitor warnings and meningococcal-risk precautions are part of the product-monograph context. Confidence/conflicts: High for Canadian label indication; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • inebilizumab (Uplizna)[10]Health Canada approvedanti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive; Canadian adult AQP4-IgG-seropositive NMOSD monotherapy context. · The current Canadian product monograph also includes other disease indications; this finding records only the NMOSD indication. It does not establish payer coverage or use in pediatric or AQP4-negative NMOSD. Confidence/conflicts: High for Canadian inebilizumab NMOSD label status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • inebilizumab (Uplizna)[10]Health Canada approvedanti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive; Canadian adult AQP4-IgG-seropositive NMOSD monotherapy context. · The current Canadian product monograph also includes other disease indications; this finding records only the NMOSD indication. It does not establish payer coverage or use in pediatric or AQP4-negative NMOSD. Confidence/conflicts: High for Canadian inebilizumab NMOSD label status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • inebilizumab (Uplizna), with comparative/reimbursement context including satralizumab, eculizumab, rituximab, azathioprine, and mycophenolate references in CADTH material[11]Health Canada approvedanti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive; Canadian reimbursement/evidence-review context for adult AQP4-IgG-seropositive NMOSD relapse prevention. · CADTH review material is not a prescribing label and includes comparative/economic analysis, not individual access. References to rituximab, azathioprine, and mycophenolate in the CADTH review should be treated as comparator/context references, not proof of Canadian label approval for NMOSD. Confidence/conflicts: Medium-high for CADTH reimbursement/comparator context; no conflict with Canadian label sources identified.
  • inebilizumab (Uplizna), with comparative/reimbursement context including satralizumab, eculizumab, rituximab, azathioprine, and mycophenolate references in CADTH material[11]Health Canada approvedanti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive; Canadian reimbursement/evidence-review context for adult AQP4-IgG-seropositive NMOSD relapse prevention. · CADTH review material is not a prescribing label and includes comparative/economic analysis, not individual access. References to rituximab, azathioprine, and mycophenolate in the CADTH review should be treated as comparator/context references, not proof of Canadian label approval for NMOSD. Confidence/conflicts: Medium-high for CADTH reimbursement/comparator context; no conflict with Canadian label sources identified.
  • ravulizumab (Ultomiris)[12]Approvedanti-aquaporin-4 (AQP4) antibody positive; adult anti-AQP4-positive NMOSD treatment in Canada. · This label finding does not establish public reimbursement. It excludes pediatric NMOSD based on the monograph and requires complement-inhibitor infection precautions. Confidence/conflicts: High for Canadian label indication; no conflict identified.
  • ravulizumab (Ultomiris)[13]Approvedanti-aquaporin-4 (AQP4) antibody positive; Canadian public-drug-plan reimbursement-with-conditions context for adult anti-AQP4-positive NMOSD. · CDA-AMC recommendation is not the same as provincial listing. It sets reimbursement conditions and should not be read as individual eligibility or treatment sequencing advice. Confidence/conflicts: Medium-high for Canadian national HTA/reimbursement criteria; provincial implementation remains source-pending. No conflict identified.
  • ravulizumab (Ultomiris)[13]Approvedanti-aquaporin-4 (AQP4) antibody positive; Canadian public-drug-plan reimbursement-with-conditions context for adult anti-AQP4-positive NMOSD. · CDA-AMC recommendation is not the same as provincial listing. It sets reimbursement conditions and should not be read as individual eligibility or treatment sequencing advice. Confidence/conflicts: Medium-high for Canadian national HTA/reimbursement criteria; provincial implementation remains source-pending. No conflict identified.
  • satralizumab (Enspryng)[14]Health Canada approvedanti-aquaporin-4 (AQP4) seropositive; Canadian maintenance/relapse-risk-reduction context for adult and adolescent AQP4-seropositive NMOSD. · The product monograph patient section states Enspryng reduces relapse/attack risk; this entry does not claim acute-relapse treatment, superiority, or individual eligibility. Confidence/conflicts: High for Canadian satralizumab label status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • satralizumab (Enspryng)[14]Health Canada approvedanti-aquaporin-4 (AQP4) seropositive; Canadian maintenance/relapse-risk-reduction context for adult and adolescent AQP4-seropositive NMOSD. · The product monograph patient section states Enspryng reduces relapse/attack risk; this entry does not claim acute-relapse treatment, superiority, or individual eligibility. Confidence/conflicts: High for Canadian satralizumab label status; no conflict identified. Availability/reimbursement outside the approving regulator not established.

출처

  1. U.S. Food and Drug Administration — official drug label · official drug label
  2. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  3. Roche — manufacturer regulatory approval announcement · manufacturer regulatory approval announcement
  4. Therapeutic Goods Administration (TGA) — Australian Public Assessment Report · Australian Public Assessment Report
  5. Therapeutic Goods Administration (TGA) — Australian Public Assessment Report · Australian Public Assessment Report
  6. Services Australia — PBS complex drugs program guidance · PBS complex drugs program guidance
  7. Therapeutic Goods Administration (TGA) — Australian Public Assessment Report · Australian Public Assessment Report
  8. Thai National Drug Information / Thai FDA-MOPH — SmPC PDF / regulator drug-information repository · SmPC PDF / regulator drug-information repository
  9. Health Canada product monograph repository / Alexion — official product monograph · official product monograph
  10. Amgen Canada / Health Canada product monograph format — official product monograph · official product monograph
  11. CADTH / Canada's Drug Agency — reimbursement review · reimbursement review
  12. Alexion Canada / Health Canada product monograph — official product monograph · official product monograph
  13. NCBI Bookshelf / CADTH-CDA-AMC — reimbursement recommendation hosted by NCBI · reimbursement recommendation hosted by NCBI
  14. Health Canada / Hoffmann-La Roche product monograph — official product monograph · official product monograph

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니고, 적격성을 판단하지도 않습니다. 어떤 선택지가 적합한지는 환자의 상황과 종양내과 팀에 달려 있습니다. 규제 상태는 바뀔 수 있으니 표시된 출처에서 확인하세요. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026-06-12.