During the cancer treatment process, patients and their families face various challenges. Among these challenges, cancer medications not covered by the Social Security Institution (SSI) are at the forefront.

The financing of necessary medications for cancer patients is shaped according to the criteria set by SSI. SSI's regulations regarding healthcare services are addressed under the Health Implementation Communiqué, which clearly defines which medications are covered by reimbursement.

According to Article 4.1.9 – Medications to be Paid for (APPENDIX-4/A) of the Health Implementation Communiqué, medications to be covered by SSI are listed in the "List of Medications to be Paid for (APPENDIX-4/A)" published on the Institution's official website. As clearly stated in the Communiqué, medications that do not have a commercial name and barcode/QR code number in this list will not be reimbursed by SSI under any circumstances. However, it is noted that special regulations regarding medications obtained from abroad are excluded from this scope.

This regulation emphasizes SSI's authority to determine which medications are covered under reimbursement, while also causing significant issues for patients.

In particular, the immunotherapy and chemotherapy medications not covered by SSI create a significant financial burden for patients. This situation leads some patients to seek legal avenues to demand that the state covers the cost of the medications. In this article, we will provide detailed information on the legal processes and steps involved in filing a lawsuit to access cancer medications that are not covered by the state.

1. Doctor's Application

Firstly, your doctor needs to submit an application to the Turkish Medicines and Medical Devices Agency under the Ministry of Health. The application should include convincing statements such as the unavailability of an equivalent medication, the life-threatening nature of the condition, and the necessity of the medication for maintaining the patient's quality of life.

2. Written Petition to the Social Security Institution (SSI)

For immunotherapy and smart drugs, which are proposed for the treatment of cancer and are not covered by SSI, the patient, the patient's family members, or their representative must first submit a petition to the Health Social Security Center of the SSI Provincial Directorate to request that the medication be covered by SSI and to seek reimbursement for the paid medication costs.

At this stage, it is important to express your request in a way that covers the entire treatment process without interruption when applying to SSI. Otherwise, if you wish to expand your request later, you may need to apply again.

The application to SSI is a prerequisite for both the Labor Court and the Administrative Court. It is not possible to file a lawsuit regarding cancer medications without completing this procedure. Therefore, to initiate the legal process, an application to the administration must be made first.

The written application must include the name of your cancer, information about the hospitals where you have been examined and tested, and the name of the cancer medication you wish to be covered. The petition must be accompanied by documents such as the diagnosis report for the illness, the official certified version of the medication usage report, and the original certified version of the prescription issued by the doctor, including the doctor's stamp and protocol number.

Documents That Must Be Included in the Initial Application to SSI:

  1. The original certified version of the prescription
  2. The original certified version of the medication usage report
  3. The approval for Off-Label Drug Use issued by the Ministry of Health's Medical Devices and Pharmaceuticals Agency, submitted by your doctor
    • Before applying to SSI for cancer medications not covered by SSI, your doctor must first obtain approval from the Turkish Medicines and Medical Devices Agency for off-label drug use. While this approval can sometimes be granted easily, it may be rejected in exceptional cases. In such a situation, before filing a lawsuit for cancer medications not covered by SSI, an annulment lawsuit must be filed at the administrative court against the rejection of the off-label drug use approval.

Your application will be rejected based on the Health Implementation Communiqué of the Social Security Institution,4.1.9 Bedeli Ödenecek İlaçlar” başlıklı maddenin 1.bendinde yer alan ““Article 4.1.9 – Medications to be Paid for, which states in section 1: "Medications to be paid for by the Institution are listed in the 'List of Medications to be Paid for' (APPENDIX-4/A) published on the official website of the Institution. Medications not listed with their commercial names and barcode/QR codes will not be reimbursed under any circumstances." düzenlemesine dayanılarak reddedilecektir.

3. Filing a Lawsuit Against the Social Security Institution (SSI)

You can file a lawsuit against SSI after your application is rejected or if the legal response period of 60 days has passed (Article 4, Labor Courts Law No. 7036). A lawsuit for reimbursement of medication costs from SSI can only be filed after a rejection decision or if no response is provided within 60 days, starting from the 60th day after the application. Otherwise, the lawsuit will be dismissed due to the absence of the required procedural condition.

According to Article 101 of the Social Insurance Law No. 5510, in cases where there is no contrary provision, disputes arising from this law fall under the jurisdiction of the labor courts. A similar provision is also found in Article 5 of the Labor Courts Law No. 7036. Therefore, the competent court for lawsuits seeking reimbursement of cancer medications is, in principle, the Labor Court.The competent court is the one located in the area of the SSI Provincial Directorate to which the patient is registered.

It is worth mentioning an exception regarding the competent court for civil servants and public employees. According to the decisions of the Court of Cassation (10th Civil Chamber, E. 2017/2735, K. 2019/5127, 18.06.2019) and the Dispute Court (Dispute Court, E. 2020/530, K. 2020/634, 26.10.2020), those who worked as civil servants or public employees before the enactment of the Social Insurance and General Health Insurance Law No. 5510 will continue to be subject to the provisions of the Law No. 5434, and the actions taken by SSI will remain classified as "administrative actions." Lawsuits filed to annul such actions should be resolved in the administrative courts. 5434 Sayılı Türkiye Cumhuriyeti Emekli Sandığı Kanunu hükümlerine tabi olmaya devam edeceğinden Sosyal Güvenlik Kurumunca tesis edilen işlem ve yapacağı muamelelerin “idari işlem” ve “idari eylem” niteliğini korumaya devam edecektir. Söz konusu işlem veya eylemin iptali için açılan davaların çözüm yerinin idari yargı yeri olduğu istikrarla ifade edilmiştir.

In summary, civil servants and public employees who worked before the enforcement date of Law No. 5510 (June 16, 2006) will remain subject to the provisions of Law No. 5434, and administrative courts will have jurisdiction. However, civil servants and public employees who started their duties after the enactment of Law No. 5510 will be considered insured under Article 4/c of Law No. 5510 and will be subject to the provisions of this law. Therefore, disputes related to these individuals will be resolved in judicial courts.

  • Filing a Request for a Provisional Injunction Against the Social Security Institution (SSI)

When a claim is made for the reimbursement of cancer treatment drugs, such as immunotherapy and smart drugs, that should be covered by SSI during the course of treatment, and when the institution's decision to reject the request is contested, the petition to the competent court should be accompanied by a request for a provisional injunction. olmalıdır.

Provisional injunctions are governed under Articles 389 and following of the Civil Procedure Code No. 6100 (HMK). Article 389, titled "Conditions for Provisional Injunction," states: “İhtiyati Tedbirin Şartları” başlıklı 389. maddesi; “"A provisional injunction may be granted when there is concern that a change in the current situation may significantly hinder or completely make it impossible to obtain the right, or that a delay could result in harm or danger." kararı verilebilirThe law sets out the conditions for granting a provisional injunction. It recognizes situations where a change may make obtaining the right substantially more difficult or impossible, where there is a concern that delay will result in a harm or serious damage, or where urgency is required. In claims involving the reimbursement of imported cancer drugs, in addition to the urgency, it is necessary to demonstrate a probable cause of the claim, as per Article 390/3 of the HMK. imkânsız hale geleceği veya gecikmesinde sakınca bulunması yahut ciddi bir zararın ortaya çıkacağı endişesi bulunan hallerThis means the plaintiff must show, through a prima facie case, that the refusal to grant the provisional injunction could pose a life-threatening situation for the patient. To demonstrate the merits of the claim (probable cause), the following evidence should be provided in the case file:

Evidence Required for a Successful Claim

Submitting a complete set of documents when applying to SGK is crucial for the smooth and timely progression of the process. Below are the required documents for the application and details regarding each:

  1. Rejection Letter by the SSI The application letter made for the reimbursement of the mentioned drug by SSI or the refund of the amount paid for the drug, along with the rejection decision given by the institution, must be included in the lawsuit file.
  2. Pathology Report: The pathology report, which includes all diagnostic, diagnostic, treatment, and examination documents, images, films, and similar records related to the patient, must be included in the lawsuit file. All radiological examinations (including PET/CT scans) and radiology reports, as well as imaging tests like tomography and MR, must also be included. If available, the report of imaging tests showing the response after the patient has been treated with the drug should also be included (it is generally requested to be sent in DICOM format, i.e., on a CD).
  3. Discharge Summary Report:The discharge summary is a report type that begins to be prepared when the patient presents to the healthcare facility. This report includes the drugs used for the patient, the tests performed, the diagnosis made, the results of the treatment, and, if surgery was performed, all examinations conducted in the order of the operation. The discharge summary report must contain: i) all the doctor’s discharge summary reports related to the disease in question, and ii) the doctor's discharge reports showing the chemotherapy/radiotherapy treatments applied. i) söz konusu hastalık nedeniyle düzenlenen tüm doktor epikriz raporlarını ve ii) uygulanan kemoterapi/radyoterapi tedavilerini gösterir doktora epikriz raporlarını içermesi gerekir.
  4. Tumor Tissue Reports: All studies related to the tumor tissues taken from the patient (biopsy reports, genetic analysis reports, etc.) must be included.
  5. Doctor’s Report Certifying the Condition: A health board report is required, explaining the patient's health condition and the necessity of using chemotherapy or immunotherapy drugs not covered by SSI. This report should explain the benefits of the drugs on the patient's health and how their health condition will be negatively affected if these drugs are not used.
  6. Off-Label Approval Report:: Any use of a drug outside its approved indication and the dosage described in the brief product information requires off-label drug use approval from the"Turkish Medicines and Medical Devices Agency,"which is affiliated with the Ministry of Health. The patient's doctor submits an application to the institution, which evaluates and makes a decision. If the Turkish Medicines and Medical Devices Agency does not approve the off-label use of the drug, the decision made by the institution is considered an administrative act. Therefore, a Cancellation Case with a Request for a Stay of Execution must be filed with the Administrative Court within 30 DAYS to annul the administrative decision made by the institution. tesis ettiği idari işlemin iptali için 30 GÜN içinde yürütmeyi durdurma talepli İPTAL DAVASI açılması gerekmektedir.
  7. İPrescription:All prescriptions issued by doctors for immunotherapy or smart drugs to be used in cancer treatment must be included in the lawsuit file.
  8. Drug Use Report:A drug use report issued by the doctor regarding immunotherapy or smart drugs to be used in cancer treatment must be included in the lawsuit file.
  9. Invoice:If payment has been made for immunotherapy or smart drugs required for cancer treatment, the payment slip and invoice for this payment must be included in the lawsuit file.
  10. Doctor’s Report on the Use of the Drug and Disease Progression: A report from the patient’s own doctor should be submitted during the lawsuit process regarding the use of the drug and its effect on the disease progression, within the scope of the provisional injunction granted by the court.

Some drugs used in immunotherapy and smart drug treatment are not covered by SSI. Below is a list showing whether some commonly used drugs in treatment are covered by SSI:

Drug Name Active Ingredient Status
Keytruda Pembrolizumab Not Reimbursed
Opdivo Nivolumab Covered Since 2018
Altuzan Bevacizumab Covered
Cyramza Ramucirumab Not Reimbursed
Imfinzi Durvalumab Not Reimbursed
Lynparza Olaparib Covered Since 2021
Perjeta Pertuzumab Covered Since 2016
Reampla Palbosiklib Covered Since 2020
Tagrisso Osimertinib Covered Since 2018
Valamor Ribosiklib Covered Since 2020
Bavencio Avelumab Covered Since 2024
Besponsa İnotuzumab Covered Since 2021
Rozlytrek Entrectinib Not Reimbursed
Verzenios Abemasiklib Not Reimbursed

 

If you encounter legal issues during your cancer treatment process or need assistance regarding the reimbursement coverage by SSI, Bayrak Law Office is here to support you. Contact us immediately, and let's evaluate legal solutions together to manage the process in the best possible way.

 

Att. Polen Bayrak