Lasmiditan (1) – Rayvow®
Migraine acute therapy
Characteristics
| Start date | 15.04.2023 – Marketing authorisation: 17.08.2022 |
|---|---|
| Resolution | 05.10.2023 |
| INN | Lasmiditan |
| Brand name | Rayvow® |
| Pharm. company |
Dossier: Lilly Deutschland GmbH
New distributor: Organon Healthcare GmbH |
| G-BA Procedure ID | D-932 |
| ATC code | N02CC08 5HT1 agonists (N02CC) |
| ICD-10 codes (AIS) | G43.0Migraine without aura, G43.1Migraine with aura, G43.2, G43.3, G43.9Migraine, unspecified |
| Alpha-ID codes (AIS) | I3593Migraine without aura, I3596Migraine with aura, I3602Complicated migraine, I75550Migraine headaches, I77056Migraine status |
| Therapeutic area | Nervous system diseases Migraine (MÄ) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
RAYVOW is indicated for the acute treatment of the headache phase of migraine attacks with or without aura in adults. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with migraine with or without aura who require acute treatment. | A patient-specific therapy taking into account the previous treatment, the severity of the attack as well as existing concomitant diseases under selection of selective serotonin 5HT1 receptor agonists (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan) and non-steroidal anti-inflammatory drugs (acetylsalicylic acid, diclofenac, ibuprofen). |
Studies and Results
|
No. of studies
(best subpopulation) |
3 (LAHJ (SAMURAI), LAHK (SPARTAN), LAIJ (CENTURION)) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- The studies presented in the dossier – LAHJ (SAMURAI), LAHK (SPARTAN) and LAIJ (CENTURION) studies presented in the dossier are randomised controlled trials comparing lasmiditan with placebo in the acute treatment of the headache phase of migraine attacks with or without aura.
Adults with migraine with or without aura who require acute treatment
- For adults with migraine with or without aura who require acute treatment, the additional benefit of lasmiditan is not proven.
- The pharmaceutical manufacturer has not provided any data for the assessment of the additional benefit of lasmiditan compared with the appropriate comparator therapy for adults with migraine, with or without aura, who require acute treatment.
- In accordance with the pharmaceutical manufacturer’s approach set out in the dossier, these studies are not taken into account for the present benefit assessment due to the lack of comparison with the appropriate comparator therapy.
- Overall assessment
- An additional benefit of lasmiditan compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Lasmiditan (1) | Rayvow® | Lilly Deutschland GmbH | Migraine acute therapy | 2,750,000 | 100% additional benefit not proven |
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