Lisdexamfetamindimesilat (Elvanse Adult, 1) – Elvanse Adult®
Attention deficit hyperactivity disorder (ADHD), ≥ 18 years
Characteristics
| Start date | 01.05.2019 – Marketing authorisation: 26.02.2019 |
|---|---|
| Resolution | 17.10.2019 |
| INN | Lisdexamfetamindimesilat |
| Brand name | Elvanse Adult® |
| Pharm. company |
Dossier: Shire Deutschland GmbH, jetzt Teil der Takeda Group
New distributor: TAKEDA GmbH |
| G-BA Procedure ID | D-452 |
| ATC code | N06BA12 Centrally acting sympathomimetics (N06BA) |
| ICD-10 codes (AIS) | F90.0Attention-deficit/hyperactivity disorder, predominantly inattentive presentation, F90.1Attention-deficit/hyperactivity disorder, predominantly hyperactive impulsive presentation, F90.8Attention-deficit hyperactivity disorder, other type, F90.9Attention-deficit hyperactivity disorder of childhood or adolescence NOS |
| Alpha-ID codes (AIS) | I117261ADHD (attention deficit hyperactivity disorder), I3280Hyperkinetic disorder, I3284Hyperkinetic syndrome with social behavior disorder in childhood, I3285Erethism |
| DDD | 30 mg O |
| Therapeutic area | Mental illnesses Attention deficit hyperactivity disorder (ADHD) |
| Reason for procedure | New therapeutic indication |
| Specialty | Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
Elvanse Adult is used as part of an overall therapeutic strategy for the treatment of attention deficit hyperactivity disorder (ADHD) in adults. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with attention deficit hyperactivity disorder (ADHD) since childhood with at least moderate severity (at least moderate impairment of functioning in two or more situations and affecting several aspects of life) who have already received drug therapy. | A patient-specific therapy with a choice of atomoxetine and methylphenidate, in which the possible continuation or resumption with a drug already in use is also to be examined and presented, as part of an overall therapeutic strategy. |
| b) | Adults with attention deficit hyperactivity disorder (ADHD) since childhood with at least moderate severity (at least moderate functional impairment in two or more situations and affecting several aspects of life) who have not yet been treated with medication. | Atomoxetine or methylphenidate, as part of an overall therapeutic strategy. |
Studies and Results
|
No. of studies
(best subpopulation) |
3 (RP104.303, SPD489-316, SPD489-403) |
|---|---|
|
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 of lisdexamfetamine dimesilate compared with the appropriate comparator therapy, the pharmaceutical manufacturer submitted five RCTs.
- Using a placebo as a bridge comparator, lisdexamfetamine was compared with atomoxetine (SPD489-403 and NCT00510276) and with methylphenidate (NRP104303 and NCT01259492) were compared with one another.
- A study with a crossover design (SP489-316) was not used for indirect comparison, as no suitable study with the appropriate comparator therapy was identified.
a) Adults with attention-deficit/hyperactivity disorder (ADHD) present since childhood of at least moderate severity (at least moderate functional impairment in two or more situations, affecting several aspects of life), who have already received drug therapy
- An additional benefit is not proven.
- The studies submitted are not suitable for establishing any additional benefit of lisdexamfetamine dimesilate compared with the appropriate comparator therapy, as there was insufficient documentation to show that the prior treatment formed part of a comprehensive therapeutic plan, nor did the studies ensure this.
- It cannot therefore be assumed that the drug is being used in accordance with the marketing authorisation.
- Furthermore, the study duration was too short to allow for a benefit assessment in the context of a chronic condition.
- Overall, therefore, for patient population a), an additional benefit is not proven.
b) Adults with attention-deficit/hyperactivity disorder (ADHD) present since childhood of at least moderate severity (at least moderate functional impairment in two or more situations and affecting several aspects of life), who have not previously received drug treatment
- The additional benefit is not proven.
- On balance, therefore, an additional benefit is not proven for patient population b).
Courtesy translation only, please refer to the German original.
Associated procedures
<< List of all resolutions