Is Opdivo covered by the SSI?

Opdivo is unfortunately among the cancer drugs that are not covered by the SSI. In order for Opdivo, an immunotherapy cancer drug, also called smart drug, to be covered by the SSI, patients or their lawyers can file a lawsuit against the Social Security Institution with a precautionary injunction request, and in these cases, the court may decide on precautionary injunction and coverage of the drug by the SSI. Opdivo SGK Reimbursement Request and Opdivo SGK Lawsuit issues are discussed in our article.

How to Open an Opdivo Cancer Drug SSI Lawsuit?

If your specialist doctor has recommended you to use Opdivo medication specific to your cancer type, you will need to file a lawsuit in order for the cost of this medication to be covered by the Social Security Institution. In the lawsuits filed, it is requested that the SSI reimburse the drug costs paid until the date of the lawsuit and that the SSI cover the drug costs from now on.

Opdivo SGK Reimbursement Request: It is a legal obligation to apply to the SSI before the lawsuit. After the SSI’s response, the lawsuit phase is started.

Opdivo SSI Lawsuit: During the litigation process, until the final judgement is given, a precautionary injunction is requested from the court to provide the drug free of charge, and in this way, free access to these drugs can be provided while the trial is ongoing. It can be proved with all kinds of evidence that the patient cannot be cured with the current treatment methods covered by the SSI, that the use of Opdivo smart drug is medically necessary as of the point reached in the treatment and that there is no equivalent of the drug.

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

What are Opdivo Active Ingredients?

The generic Opdivo is available in two different dosage forms: 40 mg / 4 mL Vial Containing Solution for Infusion Concentrate and 100 MG / 10ML IV INF. COZ. CONS. ICEREN 1 FLACON is available in two different doses. The active substance of Opdivo generic name drugs is nivolumab.

Nivolumab

Opdivo active substance: The active substance is nivolumab.

Each 1 mL of solution for infusion concentrate contains 10 mg nivolumab. Each vial contains 40 mg nivolumab (in 4 mL). Nivolumab is a fully human-specific anti-PD-1 monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology (IgG4), a type of protein normally produced by the immune system that helps the body defend against infections and cancer.

Excipients: Sodium citrate dihydrate, sodium chloride (see section 2), mannitol
(E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and hydrochloric acid for injection
is water.

Opdivo is authorised for the treatment of which diseases?

• Melanoma (skin cancer) after complete resection (surgical removal) in adults
  cancer) (post-surgical treatment as adjuvant therapy
  called).
• It is used for the treatment of advanced melanoma (skin cancer) in adults. OPDIVO alone or in combination with ipilimumab is used to treat advanced melanoma (melanoma (skin cancer) that cannot be surgically removed or has spread to other organs) in adults. It is used for the treatment of advanced renal cell carcinoma (advanced kidney cancer) in adults.
• It is used for the treatment of advanced renal cell carcinoma (advanced kidney cancer) in adults. Patients must have a Karnofsky performance status of at least 70. They must have been previously treated with one or two lines of antiangiogenic drugs that reduce and destroy the vascularity of cancer cells and have received a maximum of 3 lines of systemic therapy and the disease must have progressed. OPDIVO is used in combination with ipilimumab in the first-line treatment of adult patients aged 65 years and younger with intermediate/poor risk advanced renal cell carcinoma. Patients must have a Karnofsky performance status of 70 and above.
• Autologous stem cell transplantation (transplantation of your own blood-producing stem cells) in adults
  transplantation to yourself) and brentuximab vedotin, or for the treatment of recurrent or progressive classical Hodgkin’s lymphoma after at least 3 lines of systemic therapy, including autologous stem cell transplantation.
• It is used in the treatment of locally advanced or metastatic (spread to other organs), Non-Small Cell Lung Cancer (NSCLC) in adults until progression again in the treatment of patients who have progressed after the use of one step chemotherapy, who are in good general condition and/or who have not spread to the brain. (No other OPDIVO-like drug can be used in the treatment of patients before or after treatment).
• In adults, inoperable, local, advanced, after chemoradiotherapy
  It is used in the treatment of patients with head and neck (oral cavity, pharynx, larynx) cancer that develops again or spreads to other organs in the first 6 months after chemotherapy, until the disease progresses.
• Alone in adults, treatment with a fluoropyrimidine, oxaliplatin and irinotecan
  for the treatment of patients with colorectal (colon) cancer (CRC) that has spread to other organs with subsequent disease progression, high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).
• It can be used alone after prior fluoropyrimidine and platinum-based multiple chemotherapy in the treatment of adult patients with locally advanced oesophageal squamous cell carcinoma that is metastatic (has spread to other organs) or is not amenable to curative treatment (surgery is not possible).

Opdivo Price 2024

Opdivo (Nivolumab) immunotherapy is administered at 14-day intervals. A total of 240 mg is used in each course, which includes 2 doses of 100 mg and 1 dose of 40 mg. The current Nivolumab Optivo price is as follows:

• In 2024, the price of Opdivo 100 MG is 30,808.70 TL.
• In 2024, the price of Opdivo 40 MG is 12,322.69 TL.

Caution: The Opdivo price mentioned above is the suggested retail price for pharmacies and may vary or be out of date.

Off-label Drug Use Approval

If the smart immunotherapy cancer drug Opdivo is to be used in the treatment of a cancer other than the type of cancer (indication) for which it is authorised in Turkey, the oncologist must submit an “off-label drug use application” to the Turkish Medicines and Medical Devices Agency in order for the drug to be prescribed. This application and approval process 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. Because it is not legally possible to claim the cost of a drug that has not been approved for off-label use from the SSI, the lawsuit to be filed against the SSI may be rejected. Therefore, it is important to obtain approval for off-label drug use in order to continue the process.

Opdivo Drug Fee Lawsuit and Injunction

If necessary, it is necessary to apply to the Social Security Institution first 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 Oncologist, 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.

Sources:

• Opdivo Instructions for Use, Turkish Medicines and Medical Devices Agency , https://titck.gov.tr/storage/Archive/2022/kubKtAttachments/TTCKOnaylKTOPDIVO40MG_360f4db8-28f9-414e-8197-4bbb031793a7.pdf
• Opdivo Short Product Information, Turkish Medicines and Medical Devices Agency, https://titck.gov.tr/storage/Archive/2019/kubKtAttachments/ONAYLIK%C3%9CB100.pdf_fcb02d05-5ff3-40b2-b02d-a16017ab72ca.pdf
• Drug information, ilacabak .com, https://www.ilacabak.com/opdivo-100-mg-10ml-iv-inf-coz-kons-iceren-1-flakon-19782

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