- Date2024-09-09
Publication of Review Result of the Third Serious Illness (Cancer) Review Committee of 2023
□ The Health Insurance Review and Assessment Service (President Kang Jung-Gu) releases the results of the deliberations of the 3rd Cancer Review Committee in 2023 on ‘Reimbursement criteria for drugs used for cancer patients’ as follows.
|
Category |
product |
Pharmaceutical company |
Efficacy and effectiveness |
Deliberation results |
|
Application for Healthcare Benefit Reimbursement |
Piqray Tab (Alpelisib) |
Novartis Korea Ltd |
In combination with fulvestrant in postmenopausal women and men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative and PIK3CA mutation-positive advanced or metastatic breast cancer whose disease has progressed following endocrine therapy |
Reimbursement criteria not to be established |
|
Enhertu Inj (Trastuzumab deruxtecan) |
Daiichi Sankyo Korea Co., Ltd. |
Treatment of patients with unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2-based therapy |
Reimbursement criteria to be established | |
|
Treatment of patients with locally advanced or metastatic HER-2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior therapies, including anti-HER2 therapy |
Reimbursement criteria to be established | |||
|
Megval Inj, Melpspal Inj (Melphalan Hydrochloride) |
Ace Pharma Co., Ltd. H.O. Pharm Co., Ltd. |
Multiple myeloma |
Reimbursement criteria to be established (Includes pretreatment for hematopoietic stem cell transplant, and rhabdomyosarcoma) | |
|
Application for Healthcare Benefit Reimbursement |
Yondelis Inj (Trabectedin) |
Meditip Co., Ltd. |
Advanced soft tissue sarcomas that have failed anthracycline and ifosfamide therapy or are ineligible for these agents. |
Reimbursement criteria to be established (liposarcoma, leiomyosarcoma) |
|
Expand reimbursement scope |
Verzenio Tab (Abemaciclib) |
Eli Lilly and Company Korea |
Adjuvant therapy in combination with endocrine therapy for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, lymph node-positive, early-stage breast cancer at high risk of recurrence |
Reimbursement criteria not to be established |
|
Darzalex Inj (Daratumumab) |
Janssen Korea, Inc |
Combination therapy with bortezomib, thalidomide, and dexamethasone for newly diagnosed multiple myeloma |
Reimbursement criteria to be established (Induction Therapy) | |
|
Xospata Tab (Gilteritinib fumarate) |
Astellas Pharma Korea, Inc |
Treatment of adult patients with relapsed or refractory acute myeloid leukemia who are FLT3 mutation-positive |
Reimbursement criteria to be established | |
|
Tecentriq Inj (Atezolizumab) |
Roche Korea, Inc |
Adjuvant therapy after resection and platinum-based chemotherapy for patients at stage Ⅱ-Ⅲ A non-small cell lung cancer with early-stage PD-L1 expression greater than or equal to 50% of tumor cells (TCs) |
Reimbursement criteria not to be established |
* Pursuant to Article 5 and Article 5.2 of the Rules on the Criteria for National Health Insurance Reimbursement, the President of the Health Insurance Review and Assessment Service may notify the details of the reimbursement criteria and methods for drugs prescribed and administered to seriously ill patients that are designated and notified by the Minister of Health and Welfare after deliberation by the Serious Illness Review Committee. The reimbursement criteria for such drugs may be set differently according to clinical literature, domestic and foreign guidelines, and expert opinions within the scope of efficacy and effectiveness of the Ministry of Food and Drug Safety approval, and the reimbursement decision and criteria may change in the course of subsequent process.
