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Idiopathic pulmonary fibrosis (IPF): 국가별 선택지

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선택지 정리됨희귀·유전 질환최종 확인 2026.06

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임상시험 검색어

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

  • nintedanib (Ofev); pirfenidone (Esbriet); nerandomilast (Jascayd)[1]FDA-approvednot biomarker-defined; adult IPF diagnosis context; Antifibrotic/PDE4B inhibitor disease-modifying therapy for adult IPF as stated in U.S. labels. · Labels do not rank therapies or determine individual eligibility. Ofev, Esbriet, and Jascayd have product-specific liver, gastrointestinal, drug-interaction, pregnancy, tolerability, and monitoring considerations. The sources do not claim cure, reversal of fibrosis, or suitability for non-IPF interstitial lung diseases unless specifically labeled. Confidence/conflicts: High for U.S. label/approval status; no conflict identified.
  • nintedanib (Ofev); pirfenidone (Esbriet); nerandomilast (Jascayd)[1]FDA-approvednot biomarker-defined; adult IPF diagnosis context; Antifibrotic/PDE4B inhibitor disease-modifying therapy for adult IPF as stated in U.S. labels. · Labels do not rank therapies or determine individual eligibility. Ofev, Esbriet, and Jascayd have product-specific liver, gastrointestinal, drug-interaction, pregnancy, tolerability, and monitoring considerations. The sources do not claim cure, reversal of fibrosis, or suitability for non-IPF interstitial lung diseases unless specifically labeled. Confidence/conflicts: High for U.S. label/approval status; no conflict identified.

European Union

  • nintedanib (Ofev); pirfenidone (Esbriet)[2]EMA authorisednot biomarker-defined; adult IPF diagnosis and FVC criteria in NICE guidance; EU authorized antifibrotic therapy for adult IPF; England NICE access/recommendation framework by FVC criteria and commercial arrangements where applicable. · EMA authorization does not automatically establish reimbursement in France/Germany or all UK nations. NICE recommendations apply to England unless adopted elsewhere and include criteria that must be checked in the current guidance. Nerandomilast/Jascayd EU/UK approval was not verified in this batch. Confidence/conflicts: High for EMA and NICE source claims; France/Germany reimbursement and EU/UK nerandomilast status remain unverified.
  • nintedanib (Ofev); pirfenidone (Esbriet)[2]EMA authorisednot biomarker-defined; adult IPF diagnosis and FVC criteria in NICE guidance; EU authorized antifibrotic therapy for adult IPF; England NICE access/recommendation framework by FVC criteria and commercial arrangements where applicable. · EMA authorization does not automatically establish reimbursement in France/Germany or all UK nations. NICE recommendations apply to England unless adopted elsewhere and include criteria that must be checked in the current guidance. Nerandomilast/Jascayd EU/UK approval was not verified in this batch. Confidence/conflicts: High for EMA and NICE source claims; France/Germany reimbursement and EU/UK nerandomilast status remain unverified.

Australia

  • antifibrotic therapy framework; supportive-care guideline context[3]Standard option (per Thoracic Society of Australia and New Zealand)not biomarker-defined; specialist-guideline framework for IPF/PPF treatment and supportive-care discussions in Australia/New Zealand. · The TSANZ page itself indexes the position statement and authorship; detailed recommendation wording should be taken from the linked full text before extracting specific treatment claims beyond the existence and scope of the guideline. This finding records guideline availability and scope, not a drug-specific approval. Confidence/conflicts: Medium-high for existence/scope of TSANZ professional guidance; specific recommendations need extraction from linked full text before finer-grained claims. No conflict identified.
  • antifibrotic therapy framework; supportive-care guideline context[3]Standard option (per Thoracic Society of Australia and New Zealand)not biomarker-defined; specialist-guideline framework for IPF/PPF treatment and supportive-care discussions in Australia/New Zealand. · The TSANZ page itself indexes the position statement and authorship; detailed recommendation wording should be taken from the linked full text before extracting specific treatment claims beyond the existence and scope of the guideline. This finding records guideline availability and scope, not a drug-specific approval. Confidence/conflicts: Medium-high for existence/scope of TSANZ professional guidance; specific recommendations need extraction from linked full text before finer-grained claims. No conflict identified.
  • nintedanib (Ofev)[4]TGA-registered (Australia)treatment of IPF in Australia, as stated by the TGA assessment. · This records regulatory indication status from the TGA AusPAR, not PBS subsidy, prescribing restrictions, pulmonary-fibrosis-center access, or individual suitability. The AusPAR also covers non-IPF ILD contexts that should not be conflated with IPF. Confidence/conflicts: High for Australian regulatory IPF indication; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • nintedanib (Ofev)[4]TGA-registered (Australia)treatment of IPF in Australia, as stated by the TGA assessment. · This records regulatory indication status from the TGA AusPAR, not PBS subsidy, prescribing restrictions, pulmonary-fibrosis-center access, or individual suitability. The AusPAR also covers non-IPF ILD contexts that should not be conflated with IPF. Confidence/conflicts: High for Australian regulatory IPF indication; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • nintedanib (Ofev); pirfenidone (Esbriet)[5]Approvednot biomarker-defined; diagnosis through multidisciplinary team per PBS access pathway; PBS-subsidised antifibrotic treatment access for IPF in Australia, subject to authority criteria. · The source is an access/authority pathway and does not rank nintedanib versus pirfenidone or determine individual suitability. Current PBS Schedule restrictions control access and may change. Confidence/conflicts: High for Australian PBS access-process claim; exact live restriction criteria remain Schedule-dependent. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • nintedanib (Ofev); pirfenidone (Esbriet)[5]Approvednot biomarker-defined; diagnosis through multidisciplinary team per PBS access pathway; PBS-subsidised antifibrotic treatment access for IPF in Australia, subject to authority criteria. · The source is an access/authority pathway and does not rank nintedanib versus pirfenidone or determine individual suitability. Current PBS Schedule restrictions control access and may change. Confidence/conflicts: High for Australian PBS access-process claim; exact live restriction criteria remain Schedule-dependent. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • pirfenidone (Esbriet)[6]TGA-registered (Australia)treatment of IPF in Australia, as stated by the TGA assessment. · The TGA committee noted modest efficacy and discussed indication breadth compared with other jurisdictions. This entry records Australian regulatory status only, not PBS criteria or individual eligibility. Confidence/conflicts: High for Australian regulatory IPF indication; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • pirfenidone (Esbriet)[6]TGA-registered (Australia)treatment of IPF in Australia, as stated by the TGA assessment. · The TGA committee noted modest efficacy and discussed indication breadth compared with other jurisdictions. This entry records Australian regulatory status only, not PBS criteria or individual eligibility. Confidence/conflicts: High for Australian regulatory IPF indication; no conflict identified. Availability/reimbursement outside the approving regulator not established.

Thailand

  • pirfenidone (Esbriet)[7]Approvedadult mild to moderate IPF. · The label includes hepatic-function monitoring, photosensitivity/rash precautions, CYP1A2 interaction cautions, contraindication with fluvoxamine, caution in moderate to severe renal impairment, and states Esbriet is not recommended in end-stage renal disease requiring dialysis, severe hepatic impairment, or end-stage liver disease. Pediatric safety and effectiveness are not established. This entry does not establish Thai reimbursement, pulmonary-fibrosis center availability, or nintedanib/Ofev indication status. Confidence/conflicts: High for Thai NDI Esbriet adult mild-to-moderate IPF indication; no conflict identified. Nintedanib/Ofev Thai registration was separately located, but the fetched registration page did not verify the IPF indication and is left as a gap.

Canada

  • nintedanib (Ofev)[8]Health Canada approvedtreatment of IPF in Canada, as stated by Health Canada sources. · The product monograph also includes SSc-ILD and progressive fibrosing ILD indications; this finding records the IPF indication only. It does not establish provincial formulary coverage or individual eligibility. Confidence/conflicts: High for Canadian label/authorization status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • nintedanib (Ofev)[8]Health Canada approvedtreatment of IPF in Canada, as stated by Health Canada sources. · The product monograph also includes SSc-ILD and progressive fibrosing ILD indications; this finding records the IPF indication only. It does not establish provincial formulary coverage or individual eligibility. Confidence/conflicts: High for Canadian label/authorization status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • nintedanib (Ofev)[9]Approvednot biomarker-defined; all other restrictive lung disease causes should be excluded per CADTH note; Canadian national reimbursement recommendation context for IPF antifibrotic therapy. · CADTH recommendation is not the same as provincial formulary listing. It also notes nintedanib should not be used in combination with pirfenidone and that other causes of restrictive lung disease should be excluded before treatment. Confidence/conflicts: High for CADTH nintedanib reimbursement recommendation; province-by-province coverage remains source-pending. No conflict identified.
  • nintedanib (Ofev)[9]Approvednot biomarker-defined; all other restrictive lung disease causes should be excluded per CADTH note; Canadian national reimbursement recommendation context for IPF antifibrotic therapy. · CADTH recommendation is not the same as provincial formulary listing. It also notes nintedanib should not be used in combination with pirfenidone and that other causes of restrictive lung disease should be excluded before treatment. Confidence/conflicts: High for CADTH nintedanib reimbursement recommendation; province-by-province coverage remains source-pending. No conflict identified.
  • pirfenidone (Esbriet)[10]Health Canada approvedadult IPF in Canada; Health Canada's SBD specifies mild to moderate IPF while the current product monograph states IPF in adults. · The Health Canada SBD and current product monograph differ in wording scope; both are recorded with attribution. This entry records regulatory status and does not establish payer coverage or suitability. Confidence/conflicts: Medium-high. The product monograph gives broader adult-IPF wording, while the Health Canada SBD records mild-to-moderate adult IPF; this scope difference should be checked against current DPD/product monograph and payer criteria. Availability/reimbursement outside the approving regulator not established.
  • pirfenidone (Esbriet)[10]Health Canada approvedadult IPF in Canada; Health Canada's SBD specifies mild to moderate IPF while the current product monograph states IPF in adults. · The Health Canada SBD and current product monograph differ in wording scope; both are recorded with attribution. This entry records regulatory status and does not establish payer coverage or suitability. Confidence/conflicts: Medium-high. The product monograph gives broader adult-IPF wording, while the Health Canada SBD records mild-to-moderate adult IPF; this scope difference should be checked against current DPD/product monograph and payer criteria. Availability/reimbursement outside the approving regulator not established.
  • pirfenidone (Esbriet); nintedanib (Ofev)[11]Approvednot biomarker-defined; Canadian provincial/territorial reimbursement navigation context for antifibrotic therapy; not a prescribing label. · CPFF is a patient-advocacy/resource organization rather than a regulator or public payer. Each linked provincial formulary or special-authorization source must be checked before recording exact eligibility or availability in that province. Confidence/conflicts: Medium. The source is useful for navigation but not authoritative for final payer eligibility; provincial source verification remains required. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • pirfenidone (Esbriet); nintedanib (Ofev)[11]Approvednot biomarker-defined; Canadian provincial/territorial reimbursement navigation context for antifibrotic therapy; not a prescribing label. · CPFF is a patient-advocacy/resource organization rather than a regulator or public payer. Each linked provincial formulary or special-authorization source must be checked before recording exact eligibility or availability in that province. Confidence/conflicts: Medium. The source is useful for navigation but not authoritative for final payer eligibility; provincial source verification remains required. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • supplemental oxygen, pulmonary rehabilitation, lung transplantation assessment, palliative/supportive care resources[12]Health Canada approvednot biomarker-defined; symptom management, functional support, and advanced-disease pathway alongside disease-directed therapy. · CPFF is a patient-advocacy education source. It does not establish eligibility for oxygen funding, rehabilitation program availability, transplant listing, or palliative-care referral in an individual province. Confidence/conflicts: Medium for Canadian supportive-care option cataloging; funding and eligibility require provincial/local verification. 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. Thoracic Society of Australia and New Zealand (TSANZ) — professional society guideline/position statement landing page · professional society guideline/position statement landing page
  4. Therapeutic Goods Administration (TGA) — Australian Public Assessment Report · Australian Public Assessment Report
  5. Services Australia — PBS complex drugs program guidance · PBS complex drugs program guidance
  6. Therapeutic Goods Administration (TGA) — Australian Public Assessment Report · Australian Public Assessment Report
  7. Thai National Drug Information / Thai FDA-MOPH — label/package-insert PDF / regulator drug-information repository · label/package-insert PDF / regulator drug-information repository
  8. Health Canada / Boehringer Ingelheim Canada product monograph — official product monograph · official product monograph
  9. CADTH / Canada's Drug Agency — CDEC final reimbursement recommendation · CDEC final reimbursement recommendation
  10. Hoffmann-La Roche Canada / Health Canada product monograph format — official product monograph · official product monograph
  11. Canadian Pulmonary Fibrosis Foundation (CPFF) — patient-advocacy coverage-resource directory · patient-advocacy coverage-resource directory
  12. Canadian Pulmonary Fibrosis Foundation (CPFF) — patient-advocacy treatment and supportive-care education · patient-advocacy treatment and supportive-care education

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.