Is Keytruda covered by the SSI?

Does the SSI pay for Keytruda? Keytruda is among the cancer drugs not covered by the SSI. In order for Keytruda, which is an immunotherapy cancer drug, also called smart drug, to be covered by the SSI, patients or their lawyers representing them can file a lawsuit against the Social Security Institution with a request for precautionary measure / suspension of execution, and in these cases, the courts may decide for precautionary measure and coverage of this drug by the SSI. In our article, Keytruda SSI Reimbursement Request and Keytruda SSI Lawsuit issues are explained.

How to file a Keytruda Cancer Drug SSI Lawsuit?

Keytruda SGK Reimbursement Request: If it is stated by the specialist physician that the drug you should use according to your cancer type is Keytruda, a written application must first be made in order for the cost of this drug to be covered by the Social Security Institution. As a result of this application, which is a legal obligation, after receiving the letter stating that the request is rejected, the lawsuit phase is started.

Keytruda SSI Lawsuit: In the lawsuits filed, it is requested that the SSI refund the drug prices paid until the date of the lawsuit and that the costs of the drugs to be taken from now on be covered by the SSI. In the lawsuit filed, it is requested that this drug be provided free of charge during the trial period until the final decision is made with the request for precautionary measure or stay of execution, and in this way, it is possible to obtain the drug free of charge quickly.

Some of the documents submitted to the court during the proceedings are as follows

• Turkish Medicines and Medical Devices Agency (TİTCK) Approval for Off-label Drug Use (if required)
• TİTCK Overseas Drug Use Approval (if required)
• Drug Use Report
• Status Report
• Medicine Prescription
• Medicine Invoice
• Medicine Boxes
• Pet results and all kinds of medical reports/documents
• Scientific studies and articles demonstrating the efficacy of the drug

In cancer diseases, which are of vital importance and where even days are very important, it should be revealed that the patient does not respond to the treatments covered by the SSI or that the disease progresses further during these treatments, that the use of the smart immunotherapy drug has become necessary at the stage of treatment by the oncologist physician, that it is of “VITAL IMPORTANCE” and that there is no equivalent of the drug in terms of the patient, if possible, with a status report and a lawsuit should be filed with the evidence supporting this situation.

What are the active ingredients of Keyturda?

Active substance(s): Pembrolizumab, Pembrolizumab is a humanised, monoclonal anti-programmed cell death-1 (PD-1) antibody produced by recombinant DNA technology in Chinese hamster ovary cells.

Excipients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate-80, sucrose
and water for injection

Keytruda is authorised for the treatment of which diseases?

• A type of skin cancer called unresectable (cannot be surgically removed) or metastatic melanoma (skin cancer that has spread to other organs) that has not responded to previous treatment in adults,
• A type of lung cancer called non-small cell lung cancer and
• In the treatment of a type of cancer known as bladder cancer (urothelial carcinoma)
  is being used.

However, in terms of other cancer types and types other than these, an off-label drug use application can be made by the doctor to the Ministry of Health, Medical Drugs and Devices Agency, and after the approval of this application, it is possible to prescribe and request from the SSI.

If the Turkish Medicines and Medical Devices Agency does not approve the use of off-label medicines, a cancellation lawsuit with a stay of execution request must be filed against the decision to refuse approval for the use of off-label medicines before the SSI reimbursement lawsuit is filed. (In other words, the lawsuit to be filed in order to access the medicine increases from one to two).

Keytruda Price 2024

Current Keytruda 100 mg price for 2024 is 53.500 TL. Current Pembrolizumab Keytruda price information is given for Keytruda 100mg/4ml, and there is also a different version of the drug prepared in 50 mg form. You can learn the most up-to-date and accurate price information from hospitals and pharmacies.

Discretionary injunction in Keytruda

The current Keytruda interim injunction decision taken by our law firm is below and some personal data in the decision is hidden.

Off-label Drug Use Approval

If Keytruda smart immunotherapy cancer drug is to be used in the treatment of a cancer other than the type of cancer (indication) for which the drug is licensed in Turkey, the oncologist who will prescribe the drug must make an “off-label drug use application” to the Turkish Medicines and Medical Devices Agency. This application and approval is a legal obligation for drugs that are not authorised in Turkey or will be used outside the indication for which they are authorised.

If the Turkish Medicines and Medical Devices Agency does not approve the use of off-label medicines, a cancellation lawsuit with a stay of execution request should be filed against this decision in the administrative court. Since it will not be legally possible to request the refund of the cost of a drug that does not have off-label drug use approval from the SSI, it may cause the lawsuit to be filed against the SSI to be rejected. For this reason, it is necessary to continue the process by obtaining approval for off-label drug use.

Keytruda Drug Fee Lawsuit and Injunction

If necessary, it is necessary to first apply to the Social Security Institution with the invoice of the drug purchased from the hospital or pharmacy after the approval of off-label drug use is obtained and the drug is prescribed by the Specialist Oncolokg Doctor, and if the request is rejected, then it is necessary to file a lawsuit in the administrative court or labour court, depending on the situation.

The court is requested to refund the drug price paid and to cover the cost of the drugs to be taken from now on by the SSI.

Recovery of Drug Fees After Injunction

In the event that the court issues an interim injunction at the beginning of the process to cover the cost of medication during the treatment period, the cost of medication to be purchased after the date of the decision will be requested from the Social Security Institution by submitting the invoice. The Social Security Institution is obliged to respond positively to these requests in accordance with the injunction and to realise the refund.

Sources:

• Keytruda Instructions for Use, https://www.msd.com.tr/wp-content/uploads/sites/69/2022/04/KEYTRUDA-100-mg-4-ml-Infuzyonluk-Cozelti_KT_2022.03.17.pdf
• Keytruda Short Product Information, Turkish Medicines and Medical Devices Agency, https://titck.gov.tr/storage/Archive/2022/kubKtAttachments/temizkub_901d1bf2-3bc3-4ceb-80ff-3cbf58287289.pdf
• Prof. Dr. Mustafa ÖZDOĞAN, Medical Oncology Specialist, https://www.drozdogan.com/keytruda-pembrolizumab-immunoterapisi-nedir-ne-icin-kullanilir/

This content has been automatically translated into English from the Turkish original.