Serplulimab Medicine 06 June 2023 Extended indication Hetronifly in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma Therapeutic value Possible equal value Total cost € 27,000,000.00 Registration phase Positive CHMP opinion Product Active substance Serplulimab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Hetronifly in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma Current proprietary name Already available biosimilars / generics Proprietary name Hetronifly Manufacturer Shanghai Henlius Biotech Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date August 2025 Expected Registration July 2026 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Broadly excluded Additional remarks Positieve CHMP-opinie in mei 2026. Therapeutic value Current treatment options Pembrolizumab in combinatie met carboplatine en (nab-)paclitaxel. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Uit de fase 3 studie blijkt dat serplulimab de algehele overleving verlengt ten opzichte van enkel chemotherapie. Serplulimab is de eerste PD(L)-1 remmer die voor deze indicatie op de markt zal komen. De verwachting is dat de PASKWIL-criteria gehaald zullen worden. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 300mg References NCT04033354 (HLX10-004-NSCLC303) Additional remarks Expected patient volume per year Patient volume 500 - 700 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL (1); Perez-Moreno et al. Clin Cancer Res. 2012 (2); Declaratiedata (3); Expertopinie (4) Additional remarks In 2023 werden er 4.891 diagnoses stadium 4 NSCLC geregistreerd (1). Plaveiselcelcarcinoom komt voor bij 30% van de NSCLC-tumoren (2). In 2024 waren er 1.043 gebruikers van pembrolizumab voor dezelfde indicatie (3). De inschatting is dat er uiteindelijk 500 tot 700 patiënten in aanmerking kunnen komen voor deze behandeling (4). Expected cost per patient per year Cost € 30,000.00 - 60,000.00 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 GIP-databank, Horizonscan Additional remarks Gegeven de andere PD1 remmers binnen dit indicatiegebied is de verwachting dat de kosten €30.000 tot €60.000 per patiënt per jaar zullen bedragen. Potential total cost per year Total cost € 27,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Fase 3: Oesophageal cancer Gastric cancer Colorectal cancer Cervical cancer References Adis Insight, Clinicaltrials.gov Additional remarks Other information Additional remarks