Nolasiban Medicine 13 December 2018 Extended indication Improving pregnancy rate following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) procedures. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Nolasiban Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Other metabolism and Endocrinology Extended indication Improving pregnancy rate following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) procedures. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer ObsEva Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Oxytocine receptor antagonist Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fase III IMPLANT2 studie, eerste resultaten bekendgemaakt in februari 2018. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Primary endpoint gehaald. Absolute toename aantal zwangerschappen na 10 weken met 7,1% met nolasiban vs. placebo. De verwachting is dat de impact niet groot is. Duration of treatment Frequency of administration Dosage per administration 900 mg References ObsEva persbericht 26-02-2018; NCT03081208 Additional remarks Eenmalige dosis nolasiban op 10 weken na embryo transfer. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Freya.nl Additional remarks In 2016 werden er 14.584 IVF/ICSI-behandelingen uitgevoerd. Nolasiban zou bij een deel hiervan kunnen worden ingezet. Aangezien geen grote impact verwacht wordt, zal het mogelijk een klein aantal patiënten betreffen. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks