Turkey's Social Security Institution (SGK) published Announcement 2026/35 on September 9, 2026, amending the Bedeli Ödenecek İlaçlar Listesi (List of Reimbursable Pharmaceuticals). The legal basis is Article 12 of the İlaç Geri Ödeme Yönetmeliği (Drug Reimbursement Regulation), issued under Law No. 5510, together with articles 4.4.1 and 4.4.2 of the Sağlık Uygulama Tebliği (SUT). The amendments enter into force on September 11, 2026.
The General Health Insurance General Directorate attached a one-page Article 12 PDF and the 11.09.2026 XLSX. Six SKUs move: Tepakit 100 mg is newly listed on both EK-4/A and the mandatory hospital chemotherapy list EK-4/H; Fluarix 0.5 ml is reactivated; Atarax syrup, Tecfidera 240 mg (56 capsules), Tepharix 100 mg and Vasogus 20 IU/ml have amended EK-4/A rows. This is the next numbered batch after Announcement 2026/34 (effective September 4, 2026).
What did Announcement 2026/35 change on the reimbursable list?
It is an operative Article 12 list amendment, not guidance. Pharmacies billing Medula and hospital pharmacies procuring chemotherapy must apply the new rows from September 11, 2026. The XLSX is the control file.
| Product (kamu no) | Annex | Action | Material term |
|---|---|---|---|
| Tepakit 100 mg infusion powder (A20334, barcode 8682340179305) | EK-4/A and EK-4/H | Added | Group E1000A; price-protected; 28% public discount above TRY 151.25 wholesaler price; band tracking from September 11, 2026 |
| Tepharix 100 mg infusion powder (A20331, barcode 8699702798012) | EK-4/A | Amended | Same E1000A group; listed since September 5, 2026; distribution document due by February 5, 2027 |
| Tecfidera 240 mg enteric capsules, 56 capsules (A16055, barcode 8684907602950) | EK-4/A | Amended | Reference product (E849B/E849D); old barcode 8699783160029; 41% top-band public discount plus 13% special discount |
| Atarax 2 mg/ml syrup (A00963, barcode 8681801572181) | EK-4/A | Amended | Price-protected; old barcode 8699624570062 |
| Vasogus 20 IU/ml injection, 25 ampoules (A19640, barcode 8699844776831) | EK-4/A | Amended | Price-protected; old barcode 8699844753139; pharmacist discount 0, not the 0 to 2.5% band |
| Fluarix 0.5 ml IM prefilled syringe (A19519, barcode 8699522968930) | EK-4/A | Reactivated | Reference product; active September 11, 2026 after deactivation on July 31, 2026 |
Tepakit and Tepharix share equivalent group E1000A, so Tepakit's first listing sits next to a product that entered EK-4/A six days earlier. Fluarix's reactivation after the July 31, 2026 passivation is the seasonal influenza pattern: community pharmacies cannot bill the reimbursed rate while the row is passive.
Who has to act, and by when?
Every marketing authorisation holder (MAH) of a named SKU, plus hospital pharmacies that must stock EK-4/H chemotherapy and community pharmacies billing Medula against EK-4/A, must have the new rows live on September 11, 2026. The PDF states that date as entry into force, not a grace period.
Named exposure is concentrated: the Tepakit MAH (dual EK-4/A and EK-4/H listing), the Tepharix MAH (distribution-document clock to February 5, 2027), Biogen as originator of Tecfidera, GSK as originator of Fluarix, and the Atarax and Vasogus MAHs on barcode and discount amendments. Diff the XLSX against owned barcodes, not trade names: four of the six rows are barcode substitutions.
From September 11, 2026, hospitals that administer chemotherapy must procure Tepakit 100 mg where the protocol uses that presentation. A missing SKU is procurement non-compliance, not only a billing miss.
How do EK-4/A and EK-4/H split retail and hospital access?
EK-4/A is the reimbursable outpatient list that Medula pays against. EK-4/H is the separate list of chemotherapy products hospitals must supply. Tepakit is added to both on the same day: reimbursement and mandatory hospital procurement switch on together. TİTCK still grants the Ruhsat; the Ministry of Health Pricing Evaluation Commission still sets the price; only SGK writes these two lists. No SUT listing still means no reimbursement and no real Turkish market access.
Discount class also moves economics. Tepakit and the other price-protected rows use the 28/10/0/0 public-discount schedule. Tecfidera and Fluarix are reference products on the 41/31/23/13 schedule, and Tecfidera carries an extra 13% special discount. Vasogus is the outlier on the pharmacist discount (0 rather than 0 to 2.5%).
What should teams load before Medula applies the new rows?
Download the 11.09.2026 XLSX from the SGK duyuru page and match every owned barcode, including old-barcode columns. Confirm Tepakit is on both EK-4/A and EK-4/H, and that Fluarix is active from September 11, 2026. Push the four amended barcodes and the Vasogus pharmacist discount of 0 into pricing, hospital formulary and Medula claim tables on that date. Brief market access on Tepakit's dual listing and Tepharix's February 5, 2027 distribution-document deadline.
Continuous, per-jurisdiction real-time monitoring surfaces an Article 12 list change the moment SGK publishes it, which matters when numbered duyurus now land about a week apart.
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Verify each owned barcode against the 2026/35 XLSX, confirm the September 11, 2026 effective date with the Turkish authorised representative, and brief the market-access team on Tepakit, Fluarix and any barcode substitution in this batch. Obsidian tracks the next numbered SGK list update as it publishes.
