Cladribin (1) – Mavenclad®
Highly active relapsing multiple sclerosis (MS)
Characteristics
| Start date | 01.12.2017 – Marketing authorisation: 22.08.2017 |
|---|---|
| Resolution | 17.05.2018 |
| INN | Cladribin |
| Brand name | Mavenclad® |
| Pharm. company | Merck Serono GmbH |
| G-BA Procedure ID | D-327 |
| ATC code | L04AA40 Selective immunosuppressants (L04AA) |
| ICD-10 codes (AIS) | G35.10, G35.11, G35.30, G35.31, G35.9 |
| Alpha-ID codes (AIS) | I98549Multiple sclerosis with predominantly relapsing-remitting course, I98551Multiple sclerosis with secondary-chronic course, I99339Multiple sclerosis |
| DDD | 0.34 mg O |
| Therapeutic area | Nervous system diseases Multiple sclerosis (MS) / Neuromyelitis optica spectrum disorders (NMOSD) |
| Reason for procedure | Initial assessment – New data exclusivity (known INN) |
| Therapeutic indication of the resolution |
|---|
|
MAVENCLAD is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with highly active relapsing-remitting multiple sclerosis, as defined by clinical or imaging findings, who have not previously received disease-modifying therapy | Interferon beta-1a or interferon beta-1b or glatiramer acetate |
| b) | Adult patients with highly active relapsing-remitting multiple sclerosis, as defined by clinical or imaging findings, despite treatment with disease-modifying therapy | Alemtuzumab or fingolimod or natalizumab or interferon beta-1a or interferon beta-1b or glatiramer acetate |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (CLARITY, CLARITY EXTENSION) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + ITC (Bucher) |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
- Clinical trials
- To demonstrate the additional benefit, the pharmaceutical manufacturer has submitted the CLARITY and CLARITY EXTENSION registration trials. Both trials are multicentre, randomised, double-blind, placebo-controlled Phase III trials.
a) for patients who have not yet received any disease-modifying therapy
- For adult patients with highly active relapsing-remitting multiple sclerosis, defined by clinical or imaging findings, who have not yet received disease-modifying therapy, the additional benefit of cladribine is not proven.
- The additional benefit is not proven.
- Side effects
- Overall, there are therefore no usable data available to demonstrate the additional benefit of cladribine compared with the appropriate comparator therapy—interferon beta-1a, interferon beta-1b or glatiramer acetate—taking the marketing authorisation into account.
b) for patients with highly active disease despite treatment with a disease-modifying therapy
- For adult patients with highly active relapsing-remitting multiple sclerosis, defined by clinical or imaging findings, who have highly active disease despite treatment with a disease-modifying therapy, the additional benefit of cladribine is not proven.
- An additional benefit is not proven.
- morbidity
- The pharmaceutical manufacturer presents results for the adjusted indirect comparison of cladribine with fingolimod only for endpoints in the morbidity category (annual relapse rate, disability progression, disability progression and new or newly enlarged T2 lesions).
- Side effects
- In particular, data on side effects are therefore completely lacking for the benefit assessment, making it impossible to weigh up the benefits and harms of the treatment options.
- Due to the lack of data on the endpoint categories of side effects, mortality and health-related quality of life, as well as uncertainties regarding the comparability of the study populations, the results of the indirect comparison are therefore not used for the benefit assessment.
Courtesy translation only, please refer to the German original.
Associated procedures
| Cladribin (1) | Mavenclad® | Merck Serono GmbH | Highly active relapsing multiple sclerosis (MS) | 40,300–41,000 | 100% additional benefit not proven |
<< List of all resolutions