Fingolimod (1) – Gilenya®
Rapidly progressing relapsing-remitting multiple sclerosis (MS)
Characteristics
| Start date | 15.04.2011 – Marketing authorisation: 17.03.2011 |
|---|---|
| Resolution | 29.03.2012 |
| Limitation date | 29.03.2015 |
| INN | Fingolimod |
| Brand name | Gilenya® |
| Pharm. company | Novartis Pharma GmbH |
| G-BA Procedure ID | D-004 |
| ATC code | L04AA27 Selective immunosuppressants (L04AA) |
| DDD | 0.5 mg O |
| Therapeutic area | Nervous system diseases |
| Reason for procedure |
Initial assessment
Reassessed in: Fingolimod (3) (01.10.2015) |
Associated procedures
| Fingolimod (5) | Gilenya® | Novartis Pharma GmbH | Multiple sclerosis (MS), ≥ 10 to < 18 years | 190–840 | 57% Hint for non-quantifiable additional benefit | |
| Fingolimod (4) | Gilenya® | Novartis Pharma GmbH | Highly active relapsing-remitting multiple sclerosis (MS), after inadequate pre-treatment | 14,000–16,000 | 100% additional benefit not proven | |
| Fingolimod (3) | Gilenya® | Novartis Pharma GmbH | Rapidly progressing relapsing-remitting multiple sclerosis (MS) |
4,600–12,300
17,100–24,800 |
21% Indication of considerable additional benefit repealed subpopulations | |
| Fingolimod (2) | Gilenya® | Novartis Pharma GmbH | Multiple sclerosis (MS), pre-treated |
0
8,240–8,390 |
100% additional benefit not proven repealed | |
| Fingolimod (1) | Gilenya® | Novartis Pharma GmbH | Rapidly progressing relapsing-remitting multiple sclerosis (MS) |
0
9,500–7,500 |
18% Hint for minor additional benefit repealed |
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