Amvuttra access in Turkey: the TITCK named-patient pathway
How patients in the Republic of Turkiye legally obtain Amvuttra (vutrisiran) when the locally registered indication, stocked presentation, or payer coverage does not match what the prescribing physician has written.
Last reviewed 2026-05-12 by Reserve Meds clinical and regulatory team.
Quick orientation
Patients in Turkey access Amvuttra (vutrisiran) for polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults and cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalisation through the TITCK named-patient pathway, a the Turkish Medicines and Medical Devices Agency (Turkiye Ilac ve Tibbi Cihaz Kurumu)-administered mechanism that allows a Turkish-licensed physician at a registered facility to import the FDA-labelled product for a specific named patient. This page details the documentation, approval timeline, and real cost in TRY.
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How Amvuttra reaches patients in Turkey
Amvuttra (vutrisiran, a GalNAc-conjugated small interfering RNA targeting hepatic TTR mRNA for quarterly subcutaneous administration, FDA-approved June 2022 for polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and expanded March 2025 for cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalisation; marketed by Alnylam Pharmaceuticals) is not currently visible on the TITCK registered-product list at titck.gov.tr/dinamikmodul/43 as of 2026-05-31. Turkish patients access Amvuttra through the Yurt Dışından İlaç Temini (Provision of Medicines from Abroad) named-patient programme statutorily anchored in Additional Article 7 of Law No. 1262 (Ek Madde 7) and operationally codified in TITCK's Yurt Dışından İlaç Temini ve Kullanımı Kılavuzu Revision 14 dated 29 August 2024, accessible at portal.aifd.org.tr TITCK Kılavuzu Rev. 14. The application is submitted by the treating physician to the TITCK Commission for Evaluation of Medicines in Personal Treatment (Şahsi Tedavide Kullanılacak İlaçların Değerlendirilmesi Komisyonu). The Amvuttra-specific clinical justification must document confirmed hATTR or ATTR-CM by TTR genotyping and DPD scintigraphy or biopsy (the polyneuropathy indication requires hATTR documentation; the cardiomyopathy indication accepts wild-type or hereditary), prior tafamidis or patisiran exposure where applicable, and the prescribing physician's documentation of insufficiency of existing licensed options. Clinical-approval turnaround is typically 1 to several weeks; dispensing follows within days through TEB at teb.org.tr Yurt Dışından İlaç Temini or USHAŞ at ushas.com.tr.
Where Amvuttra is administered in Turkey
Amvuttra is a subcutaneous chronic therapy administered quarterly at 25 mg per dose in adult neurology (for hATTR polyneuropathy) or cardiology (for ATTR-CM) outpatient settings. Turkish tertiary nodes with structured amyloidosis services include Hacettepe University Faculty of Medicine Department of Neurology and Department of Cardiology in Ankara at hastane.hacettepe.edu.tr, which runs Turkey's longest-standing inherited-amyloidosis clinical and genetic-counselling service; Ankara University İbni Sina Hospital Department of Neurology and Department of Cardiology in Ankara; Istanbul University Cerrahpaşa Medical Faculty Hospital Department of Neurology and Department of Cardiology in Istanbul; Istanbul University Çapa Faculty of Medicine Hospital Department of Cardiology; Marmara University Pendik Training and Research Hospital Department of Cardiology in Istanbul; Acıbadem Maslak Hospital Department of Cardiology in Istanbul (private tertiary); Anadolu Medical Center (Anadolu Sağlık Merkezi, affiliated with Johns Hopkins) Department of Cardiology in Kocaeli; Memorial Şişli Hospital Department of Cardiology in Istanbul; and Medipol Mega University Hospital Department of Cardiology in Istanbul. Hacettepe University publishes faculty rosters and runs Turkey's inherited-amyloidosis registry; it is the most-likely Amvuttra reference centre for both polyneuropathy and cardiomyopathy indications, with the genetic-counselling support critical to hATTR diagnosis.
What Amvuttra costs in Turkey
The US reference WAC for Amvuttra is approximately USD 119,000 per 25 mg single-dose pre-filled syringe per Alnylam disclosures and Drugs@FDA at accessdata.fda.gov/scripts/cder/daf. The quarterly dosing schedule (4 doses per year) drives an annual US WAC of approximately USD 475,000 to USD 480,000. Under Turkey's SGK named-patient reimbursement framework administered through the Social Security Institution at sgk.gov.tr Yurt Dışından İlaç Temini, prices are exempt from international reference pricing and mandatory discounts; SGK reimburses at the foreign-sourced price for approved named-patient cases, typically lower than US WAC because the source is European wholesale rather than US WAC. No public TRY benchmark for Amvuttra is published on the SGK or TITCK pages as of 2026-05-31 because pricing is set per import transaction. Do not estimate a single TRY figure. Price snapshot: 2026-05-31. The TRY/USD spot rate from the Central Bank of Türkiye on the date of any final quote should be footnoted, given TRY volatility (multiple devaluations 2021 to 2024). Cost layers for SGK-insured patients: drug cost mostly absorbed by SGK; out-of-pocket co-payments and administrative fees; the dispensing TEB or USHAŞ logistics; and Reserve Meds concierge fee where the patient prefers US-sourced product or the SGK route is delayed.
Funding and access barriers for Amvuttra in Turkey
Turkey's SGK reimbursement of named-patient imports is one of the most favourable in the region. For SGK-insured patients (the vast majority of Turkish residents), full reimbursement is generally available for approved hATTR or ATTR-CM cases under the SGK Sağlık Uygulama Tebliği SUT §4.3 named-patient framework, at prices exempt from international reference pricing. Insured patients face limited direct cost on the drug itself; co-payments and administrative costs are the main OOP exposure. The dispensing channel is TEB (Turkish Pharmacists' Association) at teb.org.tr or USHAŞ (Uluslararası Sağlık Hizmetleri A.Ş.) at ushas.com.tr; patient-facing content must direct readers to the TITCK Commission for Evaluation of Medicines in Personal Treatment, not the local eczane. For Turkish patients without SGK coverage (small share of the population, predominantly Turkish residents on private-only health insurance and foreign residents not enrolled in SGK), private health insurance through Acıbadem Sigorta, Anadolu Sigorta, AXA Sigorta, Allianz Sigorta, Mapfre Sigorta, Generali, or Türk Nippon Sigorta is supplementary; covering Amvuttra subject to policy terms. Alnylam compassionate-access programmes operate case-by-case for hATTR and ATTR-CM globally. The 2024 İTS (İlaç Takip Sistemi) drug-tracking-system requirement adds a track-and-trace step for named-patient imports of rare-disease drugs.
Recent regulatory and access news for Amvuttra
FDA expanded the Amvuttra label on 20 March 2025 to ATTR-CM (transthyretin amyloid cardiomyopathy) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalisation based on the HELIOS-B phase 3 trial; this is a major label expansion broadening the eligible population from polyneuropathy-only to encompass cardiomyopathy patients including wild-type ATTR-CM (the larger amyloidosis population). The FDA approval letter is at accessdata.fda.gov/scripts/cder/daf. EMA mirrors the ATTR-CM expansion via the EPAR at ema.europa.eu/medicines/Amvuttra. TITCK published Revision 14 of the Yurt Dışından İlaç Temini ve Kullanımı Kılavuzu on 29 August 2024, the operative reference for Turkish named-patient applications. Turkish authorities introduced a Resmî Gazete regulation requiring İTS registration of foreign-sourced medicines per Anadolu Ajansı.
Where Reserve Meds fits in Amvuttra cases
Reserve Meds is a US-based concierge coordinator. We do not replace your treating physician, we do not replace TITCK, and we do not replace your dispensing pharmacy. For Amvuttra specifically, we orchestrate the US-side sourcing through a DSCSA-compliant specialty channel, build the documentation packet your physician submits, coordinate validated logistics (cold-chain with continuous temperature logging where the FDA label requires it) into Turkey, and assign a single named coordinator through the case. Standard named-patient coordination under our specialty playbook applies. Presentation selection, dose-band confirmation, and patient onboarding for self-administration where applicable are the recurring operational fundamentals we expect for this drug.
Operationally, a typical Amvuttra case runs across four parallel tracks. The clinical track is the physician's: justification letter, dosing plan, monitoring schedule, and the next patient-facing follow-up. The regulatory track is the TITCK application packaged by the importer; we provide the documentation template, the dispensing facility license check, and the chain-of-custody attestation. The logistics track is the US-side sourcing and the validated international shipment with continuous temperature logging and customs broker coordination. The patient-experience track is the named coordinator who keeps everyone aligned on dates, addresses dispensing-pharmacy questions, and confirms the medicine has been received and stored correctly. The four tracks are run in parallel rather than in series; that is the operational difference between a 3-week and a 9-week case.
Turkish specialty care concentrates at the Acibadem, American Hospital, and Memorial chains in Istanbul, with Hacettepe University Hospital in Ankara serving as the principal academic referral centre; the TITCK named-patient supply pathway is routed through the Turkish Pharmacists Association (TEB) foreign medicines channel.
Next step
If your Turkish physician has prescribed Amvuttra and you are weighing the cross-border route, the next step is a short intake. We confirm eligibility within 24 to 48 hours and send a documentation kit to your physician.
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