Abstract
This article examines the administrative and judicial avenues available when the Social Security Institution (SGK) declines to cover the biologic drug Enhertu (trastuzumab deruxtecan). It provides an evaluation of interim injunctions, case law on off-label drug reimbursement, and the current regulatory framework.
This article is pending migration from the original platform. The excerpt below is a placeholder — the full article text should be added here.
This content awaits migration of the full article text.
Introduction
Trastuzumab deruxtecan (INN) is a biologic agent of the antibody-drug conjugate (ADC) class used in the treatment of HER2-positive breast cancer and other solid tumours with HER2 expression. Registered in Turkey under the trade name "Enhertu", the drug had not been included in the SGK Health Implementation Communiqué (SUT) reimbursement lists as of 2023 and its cost is not covered by SGK.
Legal Process
The legal avenues for seeking SGK coverage of such drugs include:
- Administrative Application to SGK
- Action for Annulment before the Administrative Court
- Application for Interim Injunction
Conclusion
Original article content to be migrated here. This section is reserved for legal analysis of the reimbursement process.
Frequently Searched Questions
How Should a Petition for an Enhertu (Trastuzumab Deruxtecan) SGK Application Be Prepared?
The petition should include a health board report documenting the patient's HER2 status and prior treatment history, any TİTCK off-label use approval, and the written pre-litigation application to SGK together with its refusal or implied refusal. Given the urgency of treatment, a request for an interim injunction should also be included.
Where Is the Cost of Enhertu Obtained From?
Since Enhertu is not on SUT's Annex 4/A list, it cannot be obtained through a standard hospital-pharmacy prescription; the drug is generally imported and supplied to the patient through TİTCK's foreign drug procurement mechanism or through specialised pharmacies.
Can the Amount Paid for Enhertu Be Reclaimed?
Yes. If the drug cost was initially paid by the patient, a case can be filed to reclaim it after applying to SGK with invoices and medical documents and receiving a refusal; under Article 97 of Law No. 5510, this claim is subject to a 5-year limitation period.
Why Does SGK Refuse Enhertu Requests?
The most common ground is that the drug is not listed at all on SUT's Reimbursable Drugs List (Annex 4/A). The absence of TİTCK approval and a health board report that does not adequately document HER2 positivity or prior treatment failure are also common grounds for refusal.
Which Court Hears an Enhertu Case?
Insured persons under SSK or Bağ-Kur file their case before the labour court, while civil servants and retired civil servants within the scope of Article 4/c of Law No. 5510 file before the administrative court.
Precedent Decisions
- Mide Kanseri - ENHERTU (Trastuzumab Deruxtecan) Hakkında Verilen Yürütmenin Durdurulması Kararı
- Meme Kanseri - ENHERTU (Trastuzumab Deruxtecan) İçin Kazandığımız Davanın Sonucu (İş Mahkemesi)
- Adenoid Kistik Karsinom - ENHERTU (Trastuzumab Deruxtecan) Hakkında Verilen İhtiyati Tedbir Kararı
- Meme Kanseri - ENHERTU (Trastuzumab Deruxtecan) Hakkında Verilen İhtiyati Tedbir Kararı
Av. Barış Ürün
Avukat — Ankara Barosu