Refusjonsrapport - Statens legemiddelverk

12/14012-6 LØ/LR/HNE 28-05-2013 side5/20INNHOLDSFORTEGNELSEFORORD .......................................................................................................................................................... 2OPPSUMMERING ......................................................................................................................................... 3SØKNADSLOGG ............................................................................................................................................ 61 BAKGRUNN ........................................................................................................................................... 71.1 UNDERLIGGENDE HELSEPROBLEM (EPILEPSI) ................................................................................... 71.2 BEHANDLING .................................................................................................................................... 71.2.1 Behandling med perampanel (Fycompa)..................................................................................... 81.2.2 Behandling med komparator ....................................................................................................... 92 INNSENDT KLINISK DOKUMENTASJON FOR PERAMPANEL (FYCOMPA) ..................... 102.1 OVERSIKT OVER RELEVANTE, INNSENDTE STUDIER ........................................................................ 102.2 INDIREKTE SAMMENLIGNING AV PERAMPANEL (FYCOMPA) OG ANDRE ANTIEPILEPTIKA ................ 112.2.1 Studiedesign og pasientkarakteristika ....................................................................................... 122.2.2 Effekt og bivirkninger ................................................................................................................ 122.2.3 Heterogenitet ............................................................................................................................. 142.3 LEGEMIDDELVERKETS VURDERING AV TILSENDT KLINISK DOKUMENTASJON ................................. 143 INNSENDT ØKONOMISK ANALYSE AV PERAMPANEL (FYCOMPA) ................................. 153.1 MODELL, METODE OG FORUTSETNINGER ........................................................................................ 153.1.1 Analyseperspektiv ...................................................................................................................... 153.1.2 Pasientpopulasjonen .................................................................................................................. 153.1.3 Intervensjon ............................................................................................................................... 153.1.4 Komparator ............................................................................................................................... 153.1.5 Effekt, bivirkninger og helsenytte (input data) .......................................................................... 153.1.6 Kostnader (input data) ............................................................................................................... 163.2 RESULTATER .................................................................................................................................. 163.2.1 Kostnader .................................................................................................................................. 163.2.2 Kostnadseffektivitet .................................................................................................................... 163.3 SENSITIVITETS- OG SCENARIOANALYSER ........................................................................................ 163.4 KRITISK VURDERING AV INNSENDT ØKONOMISK ANALYSE ............................................................. 173.4.1 Relevans av analysen mht søkt PICO ........................................................................................ 173.4.2 Resultater av analysen ............................................................................................................... 173.5 OPPSUMMERING ............................................................................................................................. 184 DISKUSJON ......................................................................................................................................... 184.1 REFUSJONSVERDIGHET I HHT LEGEMIDDELFORSKRIFTEN ............................................................... 184.2 REFUSJONSBERETTIGET BRUK ........................................................................................................ 185 BUDSJETTKONSEKVENSER .......................................................................................................... 196 KONKLUSJON .................................................................................................................................... 19REFERANSER .............................................................................................................................................. 20