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Tuberous sclerosis complex (TSC): 국가별 선택지

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선택지 정리됨희귀·유전 질환최종 확인 2026.06

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임상시험 검색어

Tuberous sclerosis complex (TSC) 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.

European Union

  • everolimus (Votubia); cannabidiol (Epidyolex)[1]EMA authorisedTSC1/TSC2 pathway condition; option selection is manifestation-defined in the fetched sources; EMA Votubia settings are manifestation-specific: renal angiomyolipoma, SEGA, and add-on treatment for refractory TSC-related partial-onset seizures. Wales cannabidiol source is a commissioning policy for seizures caused by TSC in people aged 2 years and above. · EMA authorization does not itself establish access or reimbursement in every EU member state. The Wales policy is jurisdiction-specific within the UK and does not automatically establish England, Scotland, or Northern Ireland access. The Wales document also describes other seizure-related options such as added anti-seizure medicines, ketogenic diet, vagus nerve stimulation, and surgical resection as context rather than universal recommendations. Confidence/conflicts: High for EU Votubia authorization and Wales cannabidiol commissioning; medium for broader UK because England/Scotland/Northern Ireland source cells need separate verification.
  • everolimus (Votubia); cannabidiol (Epidyolex)[1]EMA authorisedTSC1/TSC2 pathway condition; option selection is manifestation-defined in the fetched sources; EMA Votubia settings are manifestation-specific: renal angiomyolipoma, SEGA, and add-on treatment for refractory TSC-related partial-onset seizures. Wales cannabidiol source is a commissioning policy for seizures caused by TSC in people aged 2 years and above. · EMA authorization does not itself establish access or reimbursement in every EU member state. The Wales policy is jurisdiction-specific within the UK and does not automatically establish England, Scotland, or Northern Ireland access. The Wales document also describes other seizure-related options such as added anti-seizure medicines, ketogenic diet, vagus nerve stimulation, and surgical resection as context rather than universal recommendations. Confidence/conflicts: High for EU Votubia authorization and Wales cannabidiol commissioning; medium for broader UK because England/Scotland/Northern Ireland source cells need separate verification.

Australia

  • everolimus (Afinitor)[2]TGA-registered (Australia)TSC clinical/genetic disorder context; manifestation-defined treatment; Australian patient-advocacy access summary for everolimus across SEGA, renal angiomyolipoma, and refractory seizures. · This is a patient-advocacy source, not the live PBS Schedule. Exact subsidy criteria, formulations, prescriber rules, and authority requirements need direct PBS/TGA confirmation before use as a final access claim. Confidence/conflicts: Medium. Source is disease-advocacy and consistent with earlier fetched TGA label context, but live PBS authority criteria remain source-pending. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • everolimus (Afinitor)[2]TGA-registered (Australia)TSC clinical/genetic disorder context; manifestation-defined treatment; Australian patient-advocacy access summary for everolimus across SEGA, renal angiomyolipoma, and refractory seizures. · This is a patient-advocacy source, not the live PBS Schedule. Exact subsidy criteria, formulations, prescriber rules, and authority requirements need direct PBS/TGA confirmation before use as a final access claim. Confidence/conflicts: Medium. Source is disease-advocacy and consistent with earlier fetched TGA label context, but live PBS authority criteria remain source-pending. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • everolimus (Afinitor; Afinitor dispersible tablets)[3]TGA-registered (Australia)TSC clinical/genetic disorder context; no TSC1/TSC2-specific restriction stated in the fetched Australian product information; TSC-associated SEGA requiring intervention, TSC renal angiomyolipoma not requiring immediate surgery, and adjunctive treatment for TSC-associated refractory seizures, as stated by the Australian sources. · The Australian product information distinguishes tablet and dispersible-tablet use; it states tablets are not recommended for TSC refractory seizures while dispersible tablets may be used for SEGA and refractory seizures with therapeutic drug monitoring. This entry records label status, not PBS subsidy or individual eligibility. Confidence/conflicts: High for Australian everolimus TSC label contexts; no conflict identified. confirm current TGA ARTG registration status Availability/reimbursement outside the approving regulator not established.
  • everolimus (Afinitor; Afinitor dispersible tablets)[3]TGA-registered (Australia)TSC clinical/genetic disorder context; no TSC1/TSC2-specific restriction stated in the fetched Australian product information; TSC-associated SEGA requiring intervention, TSC renal angiomyolipoma not requiring immediate surgery, and adjunctive treatment for TSC-associated refractory seizures, as stated by the Australian sources. · The Australian product information distinguishes tablet and dispersible-tablet use; it states tablets are not recommended for TSC refractory seizures while dispersible tablets may be used for SEGA and refractory seizures with therapeutic drug monitoring. This entry records label status, not PBS subsidy or individual eligibility. Confidence/conflicts: High for Australian everolimus TSC label contexts; no conflict identified. confirm current TGA ARTG registration status Availability/reimbursement outside the approving regulator not established.
  • multidisciplinary pregnancy planning; everolimus medication review; renal and neurologic monitoring[4]Standard option (per Tuberous Sclerosis Australia)TSC clinical/genetic disorder context; preconception/pregnancy supportive-care planning in Australian TSC education context. · This is an educational resource, not individual pregnancy advice. Medication changes, fetal medicine referral, nephrology, neurology, and obstetric planning require specialist review. Confidence/conflicts: Medium-high for supportive-care planning context; not a drug-label or payer source. No conflict identified.

Canada

  • cannabidiol oral solution (Epidiolex)[5]Health Canada approvedTSC clinical/genetic disorder context; adjunctive therapy for TSC-associated seizures in patients aged 2 years and older, as stated by the Canadian product monograph. · This is antiseizure treatment for TSC-associated seizures, not a disease-modifying therapy for the underlying TSC process. This entry records label status, not public-drug-plan coverage or individual suitability. Confidence/conflicts: High for Canadian label status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • cannabidiol oral solution (Epidiolex)[5]Health Canada approvedTSC clinical/genetic disorder context; adjunctive therapy for TSC-associated seizures in patients aged 2 years and older, as stated by the Canadian product monograph. · This is antiseizure treatment for TSC-associated seizures, not a disease-modifying therapy for the underlying TSC process. This entry records label status, not public-drug-plan coverage or individual suitability. Confidence/conflicts: High for Canadian label status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • cannabidiol oral solution (Epidiolex), plus contextual antiseizure and nonpharmacologic options described by CADTH[6]Health Canada approvedTSC clinical/genetic disorder context; Canadian reimbursement-review and supportive-care context for TSC-associated seizures. · CADTH is a reimbursement/evidence body and does not replace the product monograph. CADTH clinical experts noted cannabidiol does not address the underlying disease process more than conventional antiseizure medicines; it is framed here as an option to discuss for seizure control, not a cure or superior option. Confidence/conflicts: Medium-high for CADTH reimbursement and supportive-care context; no conflict with the Canadian product monograph identified.
  • cannabidiol oral solution (Epidiolex), plus contextual antiseizure and nonpharmacologic options described by CADTH[6]Health Canada approvedTSC clinical/genetic disorder context; Canadian reimbursement-review and supportive-care context for TSC-associated seizures. · CADTH is a reimbursement/evidence body and does not replace the product monograph. CADTH clinical experts noted cannabidiol does not address the underlying disease process more than conventional antiseizure medicines; it is framed here as an option to discuss for seizure control, not a cure or superior option. Confidence/conflicts: Medium-high for CADTH reimbursement and supportive-care context; no conflict with the Canadian product monograph identified.
  • everolimus (Afinitor or generic everolimus protocol context)[7]ApprovedTSC clinical/genetic disorder context; British Columbia protocol context for everolimus in TSC-associated high-risk renal angiomyolipoma. · BC Cancer protocol is a professional consensus/protocol document and states clinicians must use independent medical judgment. It is provincial and should not be generalized to all Canadian jurisdictions without local verification. Confidence/conflicts: High for BC protocol existence and eligibility summary; other provinces remain source-pending. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • everolimus (Afinitor or generic everolimus protocol context)[7]ApprovedTSC clinical/genetic disorder context; British Columbia protocol context for everolimus in TSC-associated high-risk renal angiomyolipoma. · BC Cancer protocol is a professional consensus/protocol document and states clinicians must use independent medical judgment. It is provincial and should not be generalized to all Canadian jurisdictions without local verification. Confidence/conflicts: High for BC protocol existence and eligibility summary; other provinces remain source-pending. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • everolimus (Afinitor); sirolimus comparator context[8]Health Canada approvedTSC clinical/genetic disorder context; Canadian Health Canada authorization and national HTA/evidence review context for TSC-associated renal angiomyolipoma. · CDA-AMC review is not a final universal provincial coverage decision. Pediatric renal angiomyolipoma coverage/indication, sirolimus off-label comparator use, imaging access, and provincial implementation remain uncertain. Confidence/conflicts: Medium-high for Canadian regulatory/HTA context; provincial reimbursement remains variable and source-pending. No conflict identified.
  • everolimus (Afinitor); sirolimus comparator context[8]Health Canada approvedTSC clinical/genetic disorder context; Canadian Health Canada authorization and national HTA/evidence review context for TSC-associated renal angiomyolipoma. · CDA-AMC review is not a final universal provincial coverage decision. Pediatric renal angiomyolipoma coverage/indication, sirolimus off-label comparator use, imaging access, and provincial implementation remain uncertain. Confidence/conflicts: Medium-high for Canadian regulatory/HTA context; provincial reimbursement remains variable and source-pending. No conflict identified.
  • everolimus (Afinitor; Afinitor Disperz)[9]ApprovedTSC clinical/genetic disorder context; no TSC1/TSC2-specific restriction stated in the fetched Canadian product monograph; Canada label contexts for TSC renal angiomyolipoma, TSC-associated SEGA, and adjunctive treatment of TSC-associated seizures not satisfactorily controlled with current therapies. · The Canadian monograph states surgical resection can be curative for SEGA while everolimus has been shown only to reduce SEGA volume. It also specifies formulation limits for seizure treatment and notes that pediatric renal angiomyolipoma use is not authorized. Confidence/conflicts: High for Canadian monograph status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • everolimus (Afinitor; Afinitor Disperz)[9]ApprovedTSC clinical/genetic disorder context; no TSC1/TSC2-specific restriction stated in the fetched Canadian product monograph; Canada label contexts for TSC renal angiomyolipoma, TSC-associated SEGA, and adjunctive treatment of TSC-associated seizures not satisfactorily controlled with current therapies. · The Canadian monograph states surgical resection can be curative for SEGA while everolimus has been shown only to reduce SEGA volume. It also specifies formulation limits for seizure treatment and notes that pediatric renal angiomyolipoma use is not authorized. Confidence/conflicts: High for Canadian monograph status; no conflict identified. Availability/reimbursement outside the approving regulator not established.

Multiple

  • vigabatrin; ACTH/prednisolone fallback; mTOR inhibitor; embolization; kidney-sparing therapy[10]Standard option (per TSC Alliance)TSC clinical/genetic disorder context; International consensus supportive/disease-management context for TSC infantile spasms and renal angiomyolipoma. · This is international guidance, not proof of approval or availability in any one country. Vigabatrin, ACTH/steroid, mTOR inhibitor, embolization, and kidney-sparing options must be checked against local approvals, access, and specialist pathways. Confidence/conflicts: High for consensus-guideline statements; country-specific access remains source-pending. No conflict identified.
  • vigabatrin; ACTH/prednisolone fallback; mTOR inhibitor; embolization; kidney-sparing therapy[10]Standard option (per TSC Alliance)TSC clinical/genetic disorder context; International consensus supportive/disease-management context for TSC infantile spasms and renal angiomyolipoma. · This is international guidance, not proof of approval or availability in any one country. Vigabatrin, ACTH/steroid, mTOR inhibitor, embolization, and kidney-sparing options must be checked against local approvals, access, and specialist pathways. Confidence/conflicts: High for consensus-guideline statements; country-specific access remains source-pending. No conflict identified.

출처

  1. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  2. Tuberous Sclerosis Australia — patient-advocacy treatment/access education · patient-advocacy treatment/access education
  3. Therapeutic Goods Administration (TGA) — Australian Public Assessment Report · Australian Public Assessment Report
  4. Tuberous Sclerosis Australia — GP educational resource · GP educational resource
  5. Health Canada Drug and Health Product Portal — regulator product portal · regulator product portal
  6. CADTH via NCBI Bookshelf — reimbursement recommendation / health technology review · reimbursement recommendation / health technology review
  7. BC Cancer — provincial treatment protocol · provincial treatment protocol
  8. Canada's Drug Agency / CDA-AMC — reimbursement review · reimbursement review
  9. Novartis Canada / Health Canada product monograph format — official product monograph · official product monograph
  10. TSC Alliance — international consensus surveillance and management guideline summary · international consensus surveillance and management guideline summary

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.