Nivolumab (24) – Opdivo®
Melanoma, adolescents ≥ 12 to 18 years, monotherapy or combination with ipilimumab).
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-956 |
| 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, 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 |
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Opdivo is indicated as monotherapy or in combination with ipilimumab in adults and adolescents aged 12 years and older for the treatment of advanced (unresectable or metastatic) melanoma. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Nivolumab is indicated as monotherapy in adolescents aged 12 years and older for the treatment of advanced (unresectable or metastasised) melanoma. | Pembrolizumab (monotherapy) |
| b) | Nivolumab in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastasised) melanoma in adolescents aged 12 years and older. | Pembrolizumab (monotherapy) or nivolumab (monotherapy) |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: Case reports) |
| Reason for dividing into subpopulations (G-BA) | Number of medications |
| ACT change | 06.06.2023 – BSG-Urteil |
a) Adolescents aged 12 years and over with advanced (unresectable or metastatic) melanoma
- Extent and probability of the additional benefit of nivolumab (monotherapy) compared with the appropriate comparator therapy: The additional benefit is not proven.
- For adolescents aged 12 years and over with advanced (unresectable or metastatic) melanoma, the pharmaceutical manufacturer was unable to identify any randomised controlled trial directly comparing nivolumab 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.
- Overall, no additional benefit compared with the appropriate comparator therapy can be inferred for adolescents aged 12 years and over.
b) Adolescents aged 12 years and over with advanced (unresectable or metastatic) melanoma
- Extent and probability of the additional benefit of nivolumab in combination with ipilimumab compared with the appropriate comparator therapy: The additional benefit is not proven.
- 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.
- Overall, no additional benefit compared with the appropriate comparator therapy can be inferred for adolescents aged 12 years and over.
Courtesy translation only, please refer to the German original.
Associated procedures
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