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Transthyretin (ATTR) amyloidosis: options by country

Sourced options by country plus visit-prep questions for Transthyretin (ATTR) amyloidosis. Each line links to its regulator, HTA, or guideline source. This page maps options; it does not recommend or rank them.

Options mappedRare diseaseLast checked June 2026

What this page does

Maps options by country

It maps sourced options by country alongside diagnosis wording, stage, test results, specialists, and trial-search terms.

What it does not do

Does not choose treatment

It does not rank treatments, recommend a choice, or decide clinical fit.

Where it comes from

Built on trusted sources

Every option links to a trusted regulator, HTA, or guideline source, and the list grows as new sources pass verification.

Information to gather before the next visit

  • Is the confirmed phenotype ATTR-CM, hATTR polyneuropathy, mixed ATTR, or another amyloidosis subtype?
  • Is the ATTR hereditary/variant or wild-type, and has light-chain amyloidosis been excluded?
  • Is the option being discussed a TTR stabilizer, a TTR-lowering therapy, supportive heart-failure care, or a clinical trial?
  • Is the immediate access question EU authorisation, UK NICE funding, or national reimbursement in a specific EU country?

Trial-search terms to discuss

Transthyretin (ATTR) amyloidosis clinical trial

Options by country

Treatments by country

Regulatory and access status by country, from official sources. It shows what exists and where — not a recommendation.

United States

  • tafamidis meglumine / tafamidis (Vyndaqel / Vyndamax); acoramidis (Attruby); vutrisiran (Amvuttra); patisiran (Onpattro); eplontersen (Wainua); inotersen (Tegsedi)[1]FDA-approvedTTR amyloid deposition; hereditary TTR variant when hATTR/ATTRv is specified; wild-type ATTR-CM when no TTR mutation; Adult ATTR-CM cardiomyopathy disease-modifying therapy; adult hereditary ATTR polyneuropathy disease-modifying TTR-silencing/antisense therapy. · ATTR-CM and hATTR-PN indications are not interchangeable. Tafamidis/acoramidis are stabilizer options; vutrisiran/patisiran/eplontersen/inotersen reduce TTR production by RNA-directed mechanisms. Tegsedi label includes REMS/laboratory-monitoring caveats. Labels do not establish payer access, sequencing, or combination therapy. Confidence/conflicts: High for U.S. FDA/DailyMed indications. No sequencing, superiority, or combination claim is made.
  • tafamidis meglumine / tafamidis (Vyndaqel / Vyndamax); acoramidis (Attruby); vutrisiran (Amvuttra); patisiran (Onpattro); eplontersen (Wainua); inotersen (Tegsedi)[1]FDA-approvedTTR amyloid deposition; hereditary TTR variant when hATTR/ATTRv is specified; wild-type ATTR-CM when no TTR mutation; Adult ATTR-CM cardiomyopathy disease-modifying therapy; adult hereditary ATTR polyneuropathy disease-modifying TTR-silencing/antisense therapy. · ATTR-CM and hATTR-PN indications are not interchangeable. Tafamidis/acoramidis are stabilizer options; vutrisiran/patisiran/eplontersen/inotersen reduce TTR production by RNA-directed mechanisms. Tegsedi label includes REMS/laboratory-monitoring caveats. Labels do not establish payer access, sequencing, or combination therapy. Confidence/conflicts: High for U.S. FDA/DailyMed indications. No sequencing, superiority, or combination claim is made.
  • tafamidis meglumine / tafamidis (Vyndaqel / Vyndamax); acoramidis (Attruby); vutrisiran (Amvuttra); patisiran (Onpattro); eplontersen (Wainua); inotersen (Tegsedi)[1]FDA-approvedTTR amyloid deposition; hereditary TTR variant when hATTR/ATTRv is specified; wild-type ATTR-CM when no TTR mutation; Adult ATTR-CM cardiomyopathy disease-modifying therapy; adult hereditary ATTR polyneuropathy disease-modifying TTR-silencing/antisense therapy. · ATTR-CM and hATTR-PN indications are not interchangeable. Tafamidis/acoramidis are stabilizer options; vutrisiran/patisiran/eplontersen/inotersen reduce TTR production by RNA-directed mechanisms. Tegsedi label includes REMS/laboratory-monitoring caveats. Labels do not establish payer access, sequencing, or combination therapy. Confidence/conflicts: High for U.S. FDA/DailyMed indications. No sequencing, superiority, or combination claim is made.

European Union

  • tafamidis (Vyndaqel); acoramidis (Beyonttra); vutrisiran (Amvuttra)[2]EMA authorisedvariant/hereditary ATTR for stage 1 or 2 polyneuropathy; variant or wild-type ATTR-CM for cardiomyopathy; Adult ATTR-CM disease-modifying therapy; adult hereditary ATTR polyneuropathy stage 1 or 2 for Amvuttra/Vyndaqel contexts as stated by EMA. · EMA authorisation does not equal member-state reimbursement. NICE applies to NHS England/Wales-type commissioning contexts and includes commercial-arrangement language. Country-specific France/Germany reimbursement for Beyonttra and Amvuttra remains to verify. Confidence/conflicts: High for EMA/NICE claims. Vyndaqel EMA summary page emphasizes early-stage polyneuropathy while current product information has later updates; deeper SmPC indication parsing remains a follow-up.
  • tafamidis (Vyndaqel); acoramidis (Beyonttra); vutrisiran (Amvuttra)[2]EMA authorisedvariant/hereditary ATTR for stage 1 or 2 polyneuropathy; variant or wild-type ATTR-CM for cardiomyopathy; Adult ATTR-CM disease-modifying therapy; adult hereditary ATTR polyneuropathy stage 1 or 2 for Amvuttra/Vyndaqel contexts as stated by EMA. · EMA authorisation does not equal member-state reimbursement. NICE applies to NHS England/Wales-type commissioning contexts and includes commercial-arrangement language. Country-specific France/Germany reimbursement for Beyonttra and Amvuttra remains to verify. Confidence/conflicts: High for EMA/NICE claims. Vyndaqel EMA summary page emphasizes early-stage polyneuropathy while current product information has later updates; deeper SmPC indication parsing remains a follow-up.
  • tafamidis (Vyndaqel); acoramidis (Beyonttra); vutrisiran (Amvuttra)[2]EMA authorisedvariant/hereditary ATTR for stage 1 or 2 polyneuropathy; variant or wild-type ATTR-CM for cardiomyopathy; Adult ATTR-CM disease-modifying therapy; adult hereditary ATTR polyneuropathy stage 1 or 2 for Amvuttra/Vyndaqel contexts as stated by EMA. · EMA authorisation does not equal member-state reimbursement. NICE applies to NHS England/Wales-type commissioning contexts and includes commercial-arrangement language. Country-specific France/Germany reimbursement for Beyonttra and Amvuttra remains to verify. Confidence/conflicts: High for EMA/NICE claims. Vyndaqel EMA summary page emphasizes early-stage polyneuropathy while current product information has later updates; deeper SmPC indication parsing remains a follow-up.

Japan

  • acoramidis (Beyonttra); patisiran (Onpattro)[3]PMDA-approved (Japan)wild-type or variant ATTR-CM for acoramidis; hereditary TTR amyloidosis for patisiran; Adult ATTR-CM acoramidis stabilizer context; hATTR polyneuropathy patisiran context. · Acoramidis PMDA document is fetched regulator review material, but the exact Japan package-insert indication/reimbursement should still be checked. Onpattro Japan approval is manufacturer-announcement sourced, not a direct PMDA label in this pass. Confidence/conflicts: Medium-high for Japan acoramidis because PMDA review and manufacturer announcement align; medium for Japan patisiran until PMDA label is fetched.
  • acoramidis (Beyonttra); patisiran (Onpattro)[3]PMDA-approved (Japan)wild-type or variant ATTR-CM for acoramidis; hereditary TTR amyloidosis for patisiran; Adult ATTR-CM acoramidis stabilizer context; hATTR polyneuropathy patisiran context. · Acoramidis PMDA document is fetched regulator review material, but the exact Japan package-insert indication/reimbursement should still be checked. Onpattro Japan approval is manufacturer-announcement sourced, not a direct PMDA label in this pass. Confidence/conflicts: Medium-high for Japan acoramidis because PMDA review and manufacturer announcement align; medium for Japan patisiran until PMDA label is fetched.
  • tafamidis (Vyndamax) / tafamidis meglumine (Vyndaqel)[4]PMDA-approved (Japan)transthyretin (TTR); source refers to wild-type or hereditary transthyretin-mediated amyloidosis cardiomyopathy; adult ATTR-CM, wild-type or hereditary, with cardiovascular mortality and cardiovascular-related hospitalization endpoint language in the prescribing-information text. · The PMDA material includes non-Japanese source labeling within the review package and Japanese review context; Japanese original labeling should be checked before patient-facing reuse. This entry does not establish Japanese reimbursement, center access, cardiac diagnostic workup, or whether ATTR polyneuropathy therapy options are covered in the same pathway. Confidence/conflicts: Medium-high for Japanese PMDA source package supporting ATTR-CM tafamidis approval context; no conflict identified. Japanese final package insert/reimbursement details remain gaps.

Australia

  • tafamidis / tafamidis meglumine (Vyndamax / Vyndaqel)[5]TGA-registered (Australia)TTR amyloid; hereditary or wild-type ATTR-CM; adult wild-type or hereditary ATTR-CM in Australia. · TGA verifies registration and approved therapeutic use but does not establish PBS subsidy, diagnostic criteria, genotype testing, or specialist access rules. Confidence/conflicts: High for Australian approved indication; reimbursement/access remains source-pending. No conflict identified.
  • vutrisiran (Amvuttra)[6]TGA-registered (Australia)pathogenic TTR variant / hereditary ATTR; adult hATTR amyloidosis with stage 1 or stage 2 polyneuropathy in Australia. · The AusPAR states the indication was narrowed to patients studied in HELIOS-A, namely stage 1 or 2 polyneuropathy. These sources do not establish cardiomyopathy approval in Australia; a separate new-indication application was under evaluation in a fetched TGA page. Confidence/conflicts: High for Australia hATTR-PN approval; ATTR-CM status remains source-pending/new-indication under evaluation. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • vutrisiran (Amvuttra)[6]TGA-registered (Australia)pathogenic TTR variant / hereditary ATTR; adult hATTR amyloidosis with stage 1 or stage 2 polyneuropathy in Australia. · The AusPAR states the indication was narrowed to patients studied in HELIOS-A, namely stage 1 or 2 polyneuropathy. These sources do not establish cardiomyopathy approval in Australia; a separate new-indication application was under evaluation in a fetched TGA page. Confidence/conflicts: High for Australia hATTR-PN approval; ATTR-CM status remains source-pending/new-indication under evaluation. No conflict identified. Availability/reimbursement outside the approving regulator not established.

Thailand

  • tafamidis (Vyndamax)[7]Approvedtransthyretin (TTR); source states etiologic confirmation should exclude AL amyloidosis and characterize wild-type or hereditary ATTR with assessment tools including scintigraphy, blood/urine assessment and/or biopsy, and TTR genotyping; adult patients with wild-type or hereditary ATTR-CM; source states treatment should be initiated under supervision of a physician knowledgeable in amyloidosis or cardiomyopathy and that tafamidis should be added to standard of care. · The label states ATTR-CM should be confirmed and AL amyloidosis excluded before treatment. It notes limited clinical data in NYHA Class IV, physician discretion in more advanced amyloid-related cardiac damage such as NYHA Class III, no data for organ transplantation with discontinuation if organ transplantation occurs, and no relevant pediatric use. This entry does not establish Thai reimbursement, hospital formulary availability, or hereditary-polyneuropathy indications. Confidence/conflicts: High for Thai Vyndamax ATTR-CM label content; no conflict identified. Access/reimbursement and non-cardiomyopathy ATTR indications remain unresolved.

Canada

  • patisiran (Onpattro)[8]Health Canada approvedpathogenic TTR variant / hereditary ATTR; adult hATTR amyloidosis with polyneuropathy in Canada. · The SBD verifies the polyneuropathy indication and notes pediatric use was not authorized. It does not establish routine coverage, choice versus vutrisiran, or cardiomyopathy treatment. Confidence/conflicts: High for Canadian patisiran marketed status and approved hATTR-PN indication; reimbursement and sequencing remain source-pending. No conflict identified.
  • patisiran (Onpattro)[8]Health Canada approvedpathogenic TTR variant / hereditary ATTR; adult hATTR amyloidosis with polyneuropathy in Canada. · The SBD verifies the polyneuropathy indication and notes pediatric use was not authorized. It does not establish routine coverage, choice versus vutrisiran, or cardiomyopathy treatment. Confidence/conflicts: High for Canadian patisiran marketed status and approved hATTR-PN indication; reimbursement and sequencing remain source-pending. No conflict identified.
  • tafamidis meglumine (Vyndaqel)[9]Health Canada approvedTTR amyloid; wild-type or hereditary ATTR-CM; adult wild-type or hereditary ATTR-CM in Canada. · Health Canada has not authorized pediatric use. The sources verify label/authorization but not provincial reimbursement or sequencing versus acoramidis or vutrisiran. Confidence/conflicts: High for Canadian tafamidis ATTR-CM authorization; reimbursement not established. No conflict identified.
  • vutrisiran (Amvuttra)[10]Health Canada approvedTTR amyloid; hATTR with stage 1/2 polyneuropathy; wild-type or hereditary ATTR-CM; adult hATTR stage 1/2 polyneuropathy and adult wtATTR or hATTR cardiomyopathy in Canada. · Product portal status date reflects the original marketed product record, while the fetched current monograph includes the later cardiomyopathy indication and date of authorization 2025-12-12 in patient information. CADTH/provincial coverage for the cardiomyopathy indication remains source-pending. Confidence/conflicts: High for current Canadian monograph indications and marketed status; reimbursement and implementation remain source-pending. No conflict identified.
  • vutrisiran (Amvuttra)[10]Health Canada approvedTTR amyloid; hATTR with stage 1/2 polyneuropathy; wild-type or hereditary ATTR-CM; adult hATTR stage 1/2 polyneuropathy and adult wtATTR or hATTR cardiomyopathy in Canada. · Product portal status date reflects the original marketed product record, while the fetched current monograph includes the later cardiomyopathy indication and date of authorization 2025-12-12 in patient information. CADTH/provincial coverage for the cardiomyopathy indication remains source-pending. Confidence/conflicts: High for current Canadian monograph indications and marketed status; reimbursement and implementation remain source-pending. No conflict identified.

Sources

  1. U.S. Food and Drug Administration — official drug label · official drug label
  2. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  3. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report · regulator review report
  4. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review/application document PDF · regulator review/application document PDF
  5. Therapeutic Goods Administration (TGA) — Australian Prescription Medicine Decision Summary · Australian Prescription Medicine Decision Summary
  6. Therapeutic Goods Administration (TGA) — Australian Prescription Medicine Decision Summary · Australian Prescription Medicine Decision Summary
  7. Thai National Drug Information / Thai FDA-MOPH — local product document / regulator drug-information repository PDF · local product document / regulator drug-information repository PDF
  8. Health Canada Drug Product Database — drug product database record · drug product database record
  9. Health Canada Drug and Health Products Portal — Summary Basis of Decision · Summary Basis of Decision
  10. Health Canada Drug and Health Products Portal — drug product portal record · drug product portal record

This is official regulatory and access status only — not medical advice, not a recommendation, and not a statement about eligibility. Whether any option fits depends on your situation and your oncology team. Status changes over time; confirm the current position with the linked source. Last checked 2026-06-12.

Beyond approved care

In clinical trials & emerging options

Options that are not — or not yet — an approved standard where you live: studies, clinical trials, off-label use, and early evidence that your own oncologist may not raise. Each is labeled by how strong the evidence is. A listing here is information to research and discuss with your team; it does not mean a treatment is proven, safe for you, or available today.

In clinical trials

  • vutrisiran (Amvuttra); tafamidis; acoramidis; patisiranClinical trial · NCT04153149Clinical trialTrial only (registry)Thailand · TTR amyloidosis; trial-specific hereditary, wild-type, variant, or mixed ATTR criteria; ATTR-CM phase 3 treatment studies; non-interventional ATTR-CM/ATTRv-PN/mixed ATTR treatment observation. · Trial participation and observational registry treatment do not equal national approval, reimbursement, or current access. Thailand appears in HELIOS-B but no Thai FDA label was verified. South Korea appears in trial cells but MFDS labels were not verified. Confidence/conflicts: High for registry geography/status; low for routine Thailand/Korea/China approval status until national regulator sources are fetched. ClinicalTrials.gov — clinical-trial registry
  • vutrisiran (Amvuttra); tafamidis; acoramidis; patisiranClinical trial · NCT04153149Clinical trialTrial only (registry)Thailand · TTR amyloidosis; trial-specific hereditary, wild-type, variant, or mixed ATTR criteria; ATTR-CM phase 3 treatment studies; non-interventional ATTR-CM/ATTRv-PN/mixed ATTR treatment observation. · Trial participation and observational registry treatment do not equal national approval, reimbursement, or current access. Thailand appears in HELIOS-B but no Thai FDA label was verified. South Korea appears in trial cells but MFDS labels were not verified. Confidence/conflicts: High for registry geography/status; low for routine Thailand/Korea/China approval status until national regulator sources are fetched. ClinicalTrials.gov — clinical-trial registry
  • vutrisiran (Amvuttra); tafamidis; acoramidis; patisiranClinical trial · NCT04153149Clinical trialTrial only (registry)Thailand · TTR amyloidosis; trial-specific hereditary, wild-type, variant, or mixed ATTR criteria; ATTR-CM phase 3 treatment studies; non-interventional ATTR-CM/ATTRv-PN/mixed ATTR treatment observation. · Trial participation and observational registry treatment do not equal national approval, reimbursement, or current access. Thailand appears in HELIOS-B but no Thai FDA label was verified. South Korea appears in trial cells but MFDS labels were not verified. Confidence/conflicts: High for registry geography/status; low for routine Thailand/Korea/China approval status until national regulator sources are fetched. ClinicalTrials.gov — clinical-trial registry

A clinical-trial listing or early report shows an option is being studied — not that it works, that it is safe for any one person, or that a site is enrolling today. Whether any of these fits is a conversation for your oncology team and the trial team. Last checked 2026-06-12.