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Legal Processes for SGK Coverage of Trastuzumab Deruxtecan (Enhertu)

An academic review of the legal avenues available to obtain SGK coverage for trastuzumab deruxtecan (Enhertu) and other off-label targeted cancer therapies in Turkey.

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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.

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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:

1. Administrative Application to SGK

2. Action for Annulment before the Administrative Court

3. Application for Interim Injunction

Conclusion

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