Will SGK public coverage with Allianz Sigorta, Anadolu Sigorta, and Acibadem Sigorta employer plans cover this?

Each insurer assesses named-patient imports case by case. Some reimburse fully when Aqneursa is on their formulary even if not currently stocked, some reimburse a percentage subject to copay, and many require pre-authorisation. We supply the documentation set that allows your insurer to assess the case; the claim itself sits with you or your hospital.

Is the FDA-approved indication recognised by TITCK?

The TITCK named-patient pathway exists precisely to permit access when the local registration or stocking lags the FDA label. The application documents the FDA indication, the reference-authority approval, and the local gap; TITCK review focuses on the clinical justification rather than re-litigating the FDA decision.

My physician is licensed in one emirate / state / province and the hospital is in another. Is that fine?

Any Turkish-licensed physician practicing in good standing in the jurisdiction of the dispensing facility has signing authority on the clinical justification letter. The Turkish Medical Association (TTB) and the Ministry of Health licensing directorate verifies the active license; the TITCK application records both the prescribing physician and the dispensing facility.

Can I receive Aqneursa at home?

The dispensing facility must be Turkish-licensed. The hospital outpatient or specialty pharmacy releases the medicine to you after final verification, and you then administer or self-administer at home where the FDA label permits, after the dispensing pharmacy's training. The cold-chain or controlled-storage handoff ends at the dispensing pharmacy; home storage and any handling protocol are part of your patient onboarding kit.

What about competitors or alternative therapies in the same class?

Choice of therapy depends on the patient's full phenotype, prior therapy, and the prescriber's judgment. Reserve Meds coordinates whichever medicine the physician has prescribed; we do not substitute, advise on substitution, or promote one brand over another.

Indicative drug-only band: USD 14,000 to 18,000 per month. Delivered quote within 24h.Get my quote

Aqneursa access in Turkey: the TITCK named-patient pathway

How patients in the Republic of Turkiye legally obtain Aqneursa (levacetylleucine) 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 Aqneursa (levacetylleucine) for neurologic manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients weighing 15 kg or more 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 Aqneursa reaches patients in Turkey

Aqneursa (levacetylleucine, an oral N-acetyl-L-leucine for neurologic manifestations of Niemann-Pick disease type C from IntraBio, FDA-approved 24 September 2024 for the treatment of neurological manifestations of Niemann-Pick disease type C in adults and paediatric patients weighing 15 kg and above) is not currently listed on the TITCK registered-product database at titck.gov.tr/dinamikmodul/43 as of 2026-06-01. Access is administered under Additional Article 7 of Law No. 1262 on Pharmaceutical and Medical Preparations through the personal-treatment pathway codified in TITCK's Yurt Disindan Ilac Temini ve Kullanimi Kilavuzu (Guideline on Provision and Use of Medicines from Abroad), Revision 14 dated 29 August 2024, available at portal.aifd.org.tr. The treating paediatric neurologist or adult neurologist with inborn-error-of-metabolism expertise files the epicrisis, scientific justification, and prescription with the TITCK Sahsi Tedavide Kullanilacak Ilaclarin Degerlendirilmesi Komisyonu (Commission for Evaluation of Medicines in Personal Treatment). For Aqneursa specifically, the file must reference biochemically or genetically confirmed Niemann-Pick disease type C (NPC1 or NPC2 pathogenic variants, filipin staining of cultured fibroblasts, or plasma cholestane-3-beta,5-alpha,6-beta-triol elevation), patient weight at or above 15 kg per the FDA Aqneursa label, the modified-Scale-for-the-Assessment-and-Rating-of-Ataxia (mSARA) baseline score, the planned weight-banded dosing regimen (one to three sachets three times daily per the label table), and the IB1001-301 phase 3 trial evidence base (NCT05163288). On clinical approval the dossier routes to USHAS at ushas.com.tr or to the Turkish Pharmacists Association (TEB) at teb.org.tr as the named-patient import channel. Foreign-sourced product registration on the National Drug Tracking System (Ilac Takip Sistemi, ITS) was made mandatory by Resmi Gazete regulation as reported at aa.com.tr, adding a track-and-trace step at receipt.

Where Aqneursa is dispensed in Turkey

Aqneursa is a room-temperature oral granular sachet supplied for once-, twice-, or three-times-daily dosing weight-banded per the FDA label, with chronic indefinite administration mixed with food or non-acidic liquid. No cold chain, no reconstitution by trained staff, and no infusion infrastructure are required; the dispensing site must, however, sit within a paediatric or adult neurology service experienced with Niemann-Pick disease type C and the associated metabolic, neuro-ophthalmic, and motor disease course. The Turkish institutions with paediatric neurology, adult neurology, or inherited metabolic disorder capability appropriate to Niemann-Pick C management include the Hacettepe University Ihsan Dogramaci Children's Hospital in Ankara with paediatric neurology, paediatric metabolism, and genetic and metabolic disorders at hastane.hacettepe.edu.tr; the Behcet Uz Children's Hospital in Izmir with paediatric tertiary subspecialties; Ankara University Cebeci Hospital Department of Paediatric Neurology and Metabolism; Istanbul University Istanbul Faculty of Medicine Cerrahpasa Paediatric Neurology and Metabolism; and Marmara University Pendik Training and Research Hospital Department of Paediatric Neurology in Istanbul. The Ankara Bilkent City Hospital and Basaksehir Cam ve Sakura City Hospital provide multi-specialty tertiary cover for adolescents and adults transitioning out of paediatric NPC care. Hacettepe Ihsan Dogramaci is the centre most frequently cited in Turkish paediatric inherited-metabolic-disorder reporting for academic-led lysosomal storage disease workflows.

What Aqneursa costs in Turkey

The US wholesale acquisition cost for Aqneursa at launch is approximately USD 18,000 to USD 25,000 per 30-day supply at the FDA-labelled adult dosing band (three sachets three times daily for patients above 25 kg, totalling approximately USD 220,000 to USD 300,000 per year before weight-band adjustments) per IntraBio launch communications and Drugs@FDA at accessdata.fda.gov/scripts/cder/daf. No public Turkish Lira benchmark for Aqneursa on the TITCK pricing tables or in SGK reimbursement publications has been observed as of 2026-06-01; do not estimate. Price snapshot: 2026-06-01. Cost layers above the drug cost include ambient-temperature logistics from the IntraBio supplier through the TEB or USHAS channel into Turkey (a stable oral granule does not require cold chain or active loggers, low to mid four-figure USD range per shipment), the outpatient pharmacy dispensing fee, the paediatric neurology surveillance fee (mSARA scoring, neuropsychology assessment, neuro-ophthalmology where indicated), and the Reserve Meds concierge fee itemised separately on every firm quote. IntraBio US patient services do not extend to Turkish residents. The Central Bank of Turkey TRY/USD spot rate on the snapshot date should be footnoted by the patient's financial controller at the time of any TRY quote conversion; TRY has been volatile across 2021-2024 per Central Bank of Turkey rate history at tcmb.gov.tr.

Funding and access barriers for Aqneursa in Turkey

Turkey's Social Security Institution (Sosyal Guvenlik Kurumu, SGK) is the dominant payer for almost all Turkish residents and reimburses named-patient imports under the Saglik Uygulama Tebligi (SUT) section 4.3 framework documented at sgk.gov.tr. Under named-patient personal-treatment use, SGK reimbursement of foreign-sourced medicines is generally available at prices exempt from international reference pricing and mandatory discounts, a posture documented in the Cambridge International Journal of Technology Assessment in Health Care analysis at cambridge.org. For Aqneursa, the practical sequence is paediatric neurology or inherited-metabolic-disorder approval at a designated centre, TITCK personal-treatment permit referencing biochemical or genetic NPC confirmation, and SGK reimbursement decision tied to the diagnosis dossier. Private supplementary insurers active in this profile include Acibadem Sigorta, Anadolu Sigorta, Allianz Sigorta, AXA Sigorta, Mapfre Sigorta, and Generali; these typically cover patient out-of-pocket exposure at private facilities and are coverage-tier dependent for ultra-rare-disease imports. Niemann-Pick disease type C has historically been associated with miglustat (off-label substrate-reduction therapy) and supportive neuroprotection; Aqneursa is the first FDA-approved drug specifically for NPC neurological manifestations, so the personal-treatment permit framing references the lack of any locally registered NPC-specific therapy. IntraBio US patient assistance programmes do not extend to Turkish residents.

Recent regulatory and access news for Aqneursa

TITCK issued Revision 14 of the Yurt Disindan Ilac Temini ve Kullanimi Kilavuzu on 29 August 2024, the operative reference for any current Aqneursa personal-treatment file; consolidated PDF at portal.aifd.org.tr. The Anatolian Agency reported the Resmi Gazete regulation making registration of foreign-sourced medicines on the Ilac Takip Sistemi (ITS) mandatory at aa.com.tr, applicable to ultra-rare-disease oral therapies sourced from US manufacturers. TITCK published a clarification statement on Yurt Disindan Ilac Temini following supply and pricing controversies at aa.com.tr. On the manufacturer side, the EU Commission granted marketing authorisation for Aqneursa (levacetylleucine, IntraBio EU brand Aqneursa) in February 2025 for NPC neurological manifestations, providing reference-authority approval frequently cited in TITCK personal-treatment files for Turkish patients. No drug-specific TITCK or SGK bulletin for Aqneursa over the last 12 months has been observed as of 2026-06-01.

Where Reserve Meds fits in Aqneursa 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 Aqneursa 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 Aqneursa 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 Aqneursa 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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