Nivolumab (25) – Opdivo®
Melanoma, adjuvant therapy, adolescents ≥ 12 to 18 years, monotherapy
Characteristics
| Start date | 01.07.2023 – Marketing authorisation: 31.05.2023 |
|---|---|
| Resolution | 21.12.2023 |
| INN | Nivolumab |
| Brand name | Opdivo® |
| Pharm. company | Bristol-Myers Squibb GmbH & Co. KGaA |
| G-BA Procedure ID | D-957 |
| ATC code | L01FF01 PD-1/PDL-1 inhibitors (L01FF) |
| ICD-10 codes (AIS) | C43.0Malignant melanoma of lip, C43.1Malignant melanoma of eyelid, including canthus, C43.2Malignant melanoma of ear and external auricular canal, C43.3Malignant melanoma of other and unspecified parts of face, C43.4Malignant melanoma of scalp and neck, C43.5Malignant melanoma of trunk, C43.6Malignant melanoma of upper limb, including shoulder, C43.7Malignant melanoma of lower limb, including hip, C43.8Malignant melanoma of overlapping sites of skin, C43.9Malignant melanoma of unspecified site of skin |
| Alpha-ID codes (AIS) | I111156Malignant melanoma of the hairy scalp, I111633Malignant melanoma of the ear and external auditory canal, I133333Familial melanoma of the skin, overlapping several areas, I18282Malignant melanoma, I18791Malignant melanoma of the eyelid, I3412Malignant melanoma of the lip, I3416Malignant melanoma of the face, I96395Malignant melanoma of the trunk n.c, I96441Malignant melanoma of the upper extremity n.c, I96442Malignant melanoma of the lower extremity n.c |
| Therapeutic area | Oncological diseases Melanoma (MA) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling ACT change |
| Therapeutic indication of the resolution |
|---|
|
Nivolumab is indicated as monotherapy in adults and adolescents aged 12 years and older for the adjuvant treatment of melanoma with lymph node involvement or metastasis after complete resection. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adolescents aged 12 and over with melanoma with lymph node involvement or with metastasis after complete resection, adjuvant treatment | Pembrolizumab |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (CA209-915) |
|---|---|
|
Study design
(best subpopulation) |
Case reports |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 06.06.2023 – BSG-Urteil |
Young people aged 12 years and over with melanoma involving lymph nodes or with metastases following complete resection; adjuvant treatment
- The additional benefit is not proven.
- For the assessment of the additional benefit of nivolumab for the adjuvant treatment of adolescents aged 12 to 17 years with melanoma involving lymph nodes or with metastases following complete resection, the pharmaceutical manufacturer has not provided any data directly comparing the treatment with the appropriate comparator therapy.
- Furthermore, no clinical trial relevant to the present therapeutic indication could be identified, and therefore no indirect comparison with the appropriate comparator therapy could be carried out.
- Consequently, no data were submitted for the assessment of the additional benefit of nivolumab compared with the appropriate comparator therapy for the adjuvant treatment of melanoma with lymph node involvement or metastasis following complete resection in adolescents aged 12 years and over.
- Overall, no additional benefit compared with the appropriate comparator therapy can be inferred for adolescents aged 12 years and over.
- Summary of the assessment
- No data were submitted by the pharmaceutical manufacturer that would enable an assessment of the additional benefit.
- The pharmaceutical manufacturer also deemed it unfeasible to conduct an evidence transfer from the adult population to adolescents aged 12 and over.
- An additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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