Log in or register to see all Alerts
New HTA Decisions in Germany
June 2020
Drug name
AJOVY® (fremanezumab)
Company
Teva
Decision date
07/11/2019
Therapeutic area
Neurological conditions
Therapeutic sub area
Headaches
G-BA decision date
07/11/2019
Orphan Drug?
No
Decision
No change from previous decision
Indication
Adult patients with at least 4 migraine days per month - untreated patients as well as patients for whom at least one prophylatic treatment is not tolerated or suitable Main comparator therapy: - Metoprolol - Propranolol - Flunarizine -Topiramate -Amitriptyline
Decision
No change from previous decision
Indication
Adult patients with at least 4 migraine days per month - patients who do not respond to or are intolerant to metoprolol, propranolol, flunarizine, topiramate or amitriptyline Main comparator therapy: - Valproic acid - Clostridium botulinum Toxin type A
Decision
Additional benefit not quantifiable
Indication
Adult patients with at least 4 migraine days per month - patients who do not respond to or are intolerant to metoprolol, propranolol, flunarizine, topiramate, amitriptyline, valproic acid or clostridium botulinum toxin type A Main comparator therapy: Best supportive care
Decision Detail
Main study: FOCUS Main driver of decision: The company redefined the sub-group populations in the pivotal study and re-did the data analysis.
Summary
In this addendum to commission, the additional data submitted by the company changed the benefit statement for the third indication to an unquantifiable benefit. For the other indications there was no change from the inital submission.