5 Cancer Drugs, Including Immunotherapy Opdivo, Added to Reimbursement!

Amendments to the Social Security Institution Health Implementation Communiqué, published and effective in the Official Gazette dated 21.03.2018, brought 5 cancer drugs into reimbursement:

1. Opdivo: Active ingredient nivolumab. A new-generation immunotherapy drug, Opdivo entered reimbursement for renal cell cancer (kidney cancer), malignant melanoma and classical Hodgkin lymphoma.
   • Opdivo in malignant melanoma: Used alone until progression in patients with good performance (ECOG 0-1), progression after first-line chemotherapy, no previous PD-1 and PD-L1 inhibitor treatment, and unresectable locally advanced or metastatic malignant melanoma. Reimbursement requires prescription by medical oncologists based on a 6-month medical board report stating these conditions and the treatment protocol, including at least one medical oncology specialist. Continued treatment reports must state no progression. Sequential or combined use with the ipilimumab immunotherapy Yervoy is not reimbursed.
   • Opdivo in classical Hodgkin lymphoma: Based on individual off-label approval from the Ministry of Health, for classical Hodgkin lymphoma , in patients progressing or relapsing on brentuximab after autologous stem cell transplantation . Reimbursement requires a prescription by medical oncology or hematology specialists based on a 6-month board report stating these conditions and protocol, with at least one medical oncologist or hematologist.
   • Opdivo in kidney cancer: For good-performance patients previously treated with at least one cytokine line (interferon or interleukin), followed by a line of antiangiogenic therapy, as line 3 or 4 for advanced clear-cell renal cancer until progression. Reimbursement requires a medical oncologist's prescription based on a 6-month board report documenting conditions and protocol, including at least one medical oncology specialist. Continued treatment reports must state no progression.
2. Altuzan: Active ingredient bevacizumab. Previously approved in metastatic large bowel (colorectal) cancer, Altuzan, an antiangiogenic drug, newly received approval for cervical cancer and glioblastoma.
   • Cervical cancer symptoms and treatment
   • Xgeva: Active ingredient denosumab. It received approval for giant cell tumor of bone and, in prostate, breast and lung cancers, bone metastases treatment.
   • Xgeva mechanism, use in giant cell tumor of bone and side effects (detailed)
   • Xgeva conditions of use (indications): Until bone metastasis progression in patients without previous zoledronic acid use, with breast cancer, hormone-resistant prostate cancer or non-small-cell lung cancer metastatic to bones at high fracture or compression risk. Also for unresectable giant cell tumor of bone, or high surgical morbidity risk, in adults and skeletally mature adolescents. Reimbursement requires at least 1 medical oncology specialist in a 6-month board report and prescription by medical oncology specialists.
3. Mozopil: Active ingredient plerixafor. Leukemia, lymphoma before transplantation.
4. Revlimid: Active ingredient lenalidomide. In addition to previous indications, reimbursement was extended to mantle cell lymphoma.