Table 4.
Comparison of ACT used by manufacturer in the EBA dossiers, ACT defined by G-BA, and comparators used in phase III trials
| Phase III comparator [5] | ACT in manufacturers’ dossiera,b | ACT defined by G-BAa,b | |
|---|---|---|---|
| ACT recommendation by G-BA different from Phase III comparator but accepted by manufacturer | |||
| Fampridine | Placebo (add-on immunomodulatory therapy) | Physiotherapy | Physiotherapy according to German remedies regulations; OST for multiple sclerosis |
| Abiraterone acetatec | Placebo (add-on to prednisone or prednisolone) | II: Docetaxel | II: Docetaxel (add-on to prednisone, prednisolone) |
| Fingolimodd |
a) Placebo b) β-Interferon |
I: Glatiramer acetate | I: Glatiramer acetate |
| Vandetanib | Placebo | BSC | BSC |
| ACT recommendation by G-BA not accepted by manufacturer | |||
| Microbial collagenasee | Placebo | Partial fasciectomy (PF) |
I: No therapy II: Percutaneous needle fasciotomy (PNF) III: PF IV: PNF |
| Ticagrelorf | Clopidogrel + ASA | Clopidogrel + ASA |
III: Prasugrel + ASA IV: Monotherapy with ASA |
| Cabazitaxel | Mitoxantrone (add-on to prednisone and prednisolone) | Mitoxantrone (add-on to prednisone and prednisolone) | I (BSC): Dexamethasone, prednisone, prednisolone or methylprednisolone + BSC |
| Pirfenidone | Placebo | Not determined | BSC |
| Aliskiren/amlodipine | Aliskiren and amlodipine alone | Aliskiren and amlodipine alone | Combination of ACE-inhibitor (lisinoprile or ramiprile or enalaprile) and calcium-antagonist (amlodipine or nitrendipine) |
| Linaglipting | Placebo alone or add on to metformin, a combination of metformin plus sulphonylurea or pioglitazone | Sitagliptin |
I: Sulphonylurea (glibenclamide, glimepiride) II: Sulphonylurea (glibenclamide, glimepiride) + metformin III: Metformin + human insuline |
| Retigabine | Placebo | Lacosamide | Lamotrigine or topiramate |
ASA acetylsalicylic acid, BSC best supportive care, OST optimised standard treatment
aInformation on http://www.g-ba.de/informationen/nutzenbewertung/ in manufacturer’s dossier and G-BA decision
bACT can differ among subgroups. Subgroups are marked with Roman numerals
cPatients, where re-exposure with Docetaxel is possible
dRelapsing-remitting multiple sclerosis (RRMS), non-responder to completed β-interferon therapy
eSubgroup classification according to disease severity (Tubiana stage)
fSubgroup classification according to indication (III: ST-elevation myocardial infarction (STEMI) managed with percutaneous coronary intervention (PCI); IV: STEMI managed with coronary artery bypass grafting (CABG)
gSubgroup classification according to use of mono- (I), dual (II) or triple (III) therapy with linagliptin