Vimseltinib Medicine 03 December 2024 Extended indication Romvimza is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. Therapeutic value No estimate possible yet Total cost € 119,624,500.00 Registration phase Registered Product Active substance Vimseltinib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Romvimza is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. Current proprietary name Already available biosimilars / generics Proprietary name Romvimza Manufacturer Deciphera Pharmaceuticals Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2024 Expected Registration September 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Included in the sluice Additional remarks In september 2025 is vimseltinib in de sluis geplaatst voor zover verstrekt in het kader van geneeskundige behandelingen. Therapeutic value Current treatment options Synovectomie (verwijdering van het synoviale weefsel rond een gewricht). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Geen farmacotherapeutische opties naast synovectomie. Uit de motion studie bleek een significante respons van vimseltinib ten opzichte van placebo. Er zijn geen vergelijkende studies gedaan met andere opties zoals imatinib, nilotinib. Duration of treatment Frequency of administration 2 times a week Dosage per administration 30mg References NCT05059262 (MOTION) Additional remarks Expected patient volume per year Patient volume < 419 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Mastboom et al. Acta Orthop. 2017 (1); CBS (2); Dharmani et al. Future Oncol. 2024 (3); Sluisadvies vimseltinib Additional remarks De Nederlandse incidentie van de diffuse vorm van TGCT (DTGCT) is 5 per miljoen per jaar. Dit zijn 90 Nederlanders per jaar (1,2). Ongeveer 16% van de D-TGCT patiënten worden niet chirurgisch behandeld (n=14) (3). De Nederlandse incidentie van de lokale vorm van TGCT (L-TGCT) is 45 per miljoen per jaar. Dit zijn 810 Nederlanders per jaar (1,2). Ongeveer 50% van de LTGCT patiënten wordt niet chirurgisch behandeld (n=405) (3). Het aantal patiënten komt uit op 14 + 405 = 419. Expected cost per patient per year Cost € 285,000.00 - 286,000.00 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 Drugs.com; Sluisadvies vimseltinib Additional remarks In de Verenigde Staten is een verpakking van 8 tabletten van 30mg $25.529,73 (ongeveer €21.955,57). Bij een dosering van tweemaal per week kost een behandeling dan €285.422 per patiënt per jaar. Potential total cost per year Total cost € 119,624,500.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks