TLV beslutar om subvention för EVENITY®

EVENITY® (romosozumab), ett nytt läkemedel för behandling av osteoporos, ingår i högkostnadsskyddet med viss begränsning utifrån godkänd indikation meddelar TLV i sitt beslut.¹

Sverige 7 juli 2020 – Tandvårds- och läkemedelsförmånsverket (TLV) har beslutat att EVENITY® (romosozumab) ska ingå i högkostnadsskyddet från och med den 3 juli 2020. Sedan tidigare har EVENITY® blivit godkänt av europeiska läkemedelsmyndigheten, EMA, för behandling av svår osteoporos hos postmenopausala kvinnor med hög risk för fraktur. EVENITY® är ett nytt benbyggande läkemedel som både ökar benbildning och minskar benresorption (benförlust).

TLV:s beslut om subvention, med viss begränsning utifrån godkänd indikation, innebär att EVENITY® endast subventioneras vid behandling av osteoporos hos postmenopausala kvinnor som haft en klinisk kotfraktur eller en höftfraktur de senaste tolv månaderna.¹

Subventionsbeslutet baseras på data från ARCH-studien (Active-contRolled FraCture Study in Postmenopausal Women With Osteoporosis at High Risk of Fracture) som visade att en sekventiell behandling med EVENITY® följt av alendronat signifikant minskade frakturer än behandling enbart med alendronat.² TLV konstaterar att det är kostnadseffektivt att behandla kvinnor som haft en klinisk kotfraktur eller höftfraktur de senaste 12 månaderna med EVENITY® först istället för att starta med standard of care. Kostnaden för behandling med EVENITY® för den utvärderade patientpopulationen, postmenopausala kvinnor med osteoporos som haft en klinisk kotfraktur eller en höftfraktur de senaste tolv månaderna, bedöms som rimlig i förhållande till den nytta läkemedlet ger.¹

Osteoporos är en kostsam folksjukdom som ökar risken för frakturer. En halv miljon svenskar är drabbade och varje år sker det ca 80 000 - 90 000 osteoporosrelaterade frakturer. Cirka 50 procent av alla kvinnor beräknas få benskörhetsfrakturer under sin livstid. ³ Eftersom befolkningen lever allt längre kommer antalet troligtvis att öka. Trots detta får endast 17 procent av kvinnorna över 50 år i Sverige med osteoporos behandling.⁴

Presskontakt:
Estelle Bajtner, medicinsk chef osteoporos UCB Norra Europa 
estelle.bajtner@ucb.com
0730-73 59 43

Patric Berling, VD UCB Sverige 
patric.berling@ucb.com
070-552 90 98

Referenser

1. TLVs beslut om EVENITY®, Läs beslutet i sin helhet på www.tlv.se.

2. Saag KG, et al. N Engl J Med 2017;377:1417-1427.

3. Socialstyrelsen (2020) Nationella riktlinjer för rörelseorganens sjukdomar

4. IOF, Brutna ben, trasiga liv. En åtgärdsplan får att låsa krisen med trasiga liv 2019; http://share.iofbonehealth.org/EU-6-Material/Repor...

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Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on the development of romosozumab for the treatment of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB are joining forces to translate a genetic discovery into a new medicine, turning conceptual science into a reality.

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SE-N-RM-OP-2000019 07.06.2020