Prevalencia off‑label používania onkologických liekov a výdavkov na nich s platnou ochranou patentom v populačnej kohorte .....

Prevalencia off‑label používania onkologických liekov a výdavkov na nich s platnou ochranou patentom v populačnej kohorte onkológov v r. 2010

SÚHRN

Cieľ

Prevalencia off‑label použitia protinádorových liekov nie je dostatočne preskúmaná. Rozsah off‑label použitia je znepokojujúci, pretože liečebný prínos nemusí prevážiť náklady spojené s nežiadúcimi zdravotnými účinkami.

Metódy

Analyzované boli údaje zo systému IntrinsiQ Intellidose, poskytovateľa farmaceutického softvéru zabezpečujúceho populačnú kohortnú databázu klinických onkológov. Zisťované bolo používanie najbežnejšie predpisovaných protinádorových liekov v r. 2010, ktoré mali platnú ochranu patentom a boli podávané intravenózne. Použitie liekov bolo klasifikované ako on‑label, ak použitie lieku bolo v súlade s americkým Úradom pre kontrolu potravín a liečiv (Food and Drug Administration, FDA) schválenou indikáciou pre dané nádorové ochorenie, štádium ochorenia a liečebnú líniu. Všetky ostatné použitia lieku boli označené ako off‑label. Použitie off‑label bolo rozdelené podľa toho, či bolo v súlade s liekovým zoznamom NCCN (National Comprehensive Care Network), ktorý tvorí základ pre tvorbu poistných zmlúv týkajúcich sa úhrady liekov. Pomocou IMS Health Sales Perspectives boli zisťované celonárodné výdavky na lieky.

Výsledky

Desať liekov splnilo inklúzne kritériá. Použitie v súlade so schválením FDA (on‑label) bolo vyčíslené na 70 % prípadov a off‑label použitie na 30 % prípadov. Štrnásť percent z off‑label prípadov bolo v súlade s liekovým zoznamom NCCN a 10 % z off‑label prípadov bolo v súlade s FDA schválením pre nádorové ochorenie, avšak nebolo v súlade s NCCN klinickým štádiom ochorenia a/alebo liečebnou líniou. Celkové výdavky na liečbu týmito liekmi tvorili takmer 12 miliard (mld.) dolárov (USD) (7,3 mld. USD on‑label, 2 mld. USD off‑label v súlade s NCCN; 2,5 mld. USD off‑label v nesúlade s NCCN).

Záver

Bežne používané nové onkologické lieky sú používané častejšie v súlade s preskripčnými indikáciami (on‑label) ako off‑label. Off‑label použité protinádorové lieky tvoria približne v rovnakom zastúpení tie, ktoré sú, a tie, ktoré nie sú podávané v súlade s NCCN.

J Clin Oncol 31:1134‑1139. © 2013 by American Society of Clinical Oncology

Celý článek naleznete v časopise Journal of Clinical Oncology číslo 2/2013 na straně 87-92

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Zdroj: Journal od Clinical Oncology