Lenvatinib Medicine 08 June 2021 Extended indication Extension of indication to include lenvatinib in combination with pembrolizumab for the treatment of adult patients with advanced endometrial carcinoma (EC) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation; as a consequence. Therapeutic value No estimate possible yet Total cost € 1,233,000.00 Registration phase Registration application pending Product Active substance Lenvatinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Extension of indication to include lenvatinib in combination with pembrolizumab for the treatment of adult patients with advanced endometrial carcinoma (EC) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation; as a consequence. Current proprietary name Already available biosimilars / generics Proprietary name Lenvima Manufacturer Eisai Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Receptortyrosinekinase inhibitor van VEGFR1, 2 en 3, FGFR1, 2, 3 en 4 en PDGFRα, KIT en RET Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2021 Expected Registration November 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in november 2021. Therapeutic value Current treatment options Chemotherapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het komt naar waarschijnlijkheid overeen met dostarlimab. Meerdere geneesmiddelen voor eenzelfde kleine indicatie. Mogelijk verdringt het en/of substitutie van dostarlimab. Duration of treatment Median 231 day / days Frequency of administration 1 times a day Dosage per administration 20mg References "Makker V et al., SGO Virtual Annual Meeting On Women's Cancer 2021, abstract id 11512. https://157slyoyo4y17zpa538hczs1-wpengine.netdna-ssl.com/wp-content/uploads/2021/01/FRIDAY_2021-Virtual-Annual-Meeting-on-Womens-Cancer.pdf Studie: E7080-G000-309 / KEYNOTE-775 (NCT03517449)" Additional remarks 20mg (= maximum startdosering. Dosis reductie stappen 14mg, 10mg, 8mg) Expected patient volume per year Patient volume 40 - 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Follow-up after primary therapy for endometrial cancer: a systematic review. Fung-Kee-Fung. Gynecol Oncol. 2006 Jun;101(3):520-9. Epub 2006 Mar 23.; Sorbe B, Juresta C, Ahlin C. Natural history of recurrences in endometrial carcinoma. Oncol Lett. 2014;8(4):1800–1806. doi:10.3892/ol.2014.2362. Additional remarks Er waren in 2018 in totaal 1.903. De recurrence rate voor endometrium carcinoom bedraagt ongeveer 10%-20%. Er wordt verwacht dat er 40 tot 50 patiënten in aanmerking zullen komen voor deze behandeling. Expected cost per patient per year Cost € 27,400.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References G-standaard Additional remarks AIP per april 2021: €1.780,12 verpakking á 30 capsules (4mg of 10mg). Uitgaande van een behandeling van maximaal 20mg/dag (= max. 2 capsules) voor 231 dagen zou dat gaan om maximaal €27.400 per patiënt per jaar Potential total cost per year Total cost € 1,233,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Weergegeven in de Horizonscan Geneesmiddelen. References Fabrikant Additional remarks Other information Additional remarks