Ibrutinib Medicine 12 June 2018 Extended indication Extension of indication to the existing chronic lymphocytic leukaemia (CLL) indication to include combination use with obinutuzumab for the treatment of adult patients with previously untreated CLL. Therapeutic value Possible equal value Total cost € 10,350,000.00 Registration phase Registered and reimbursed Product Active substance Ibrutinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication CLL Extended indication Extension of indication to the existing chronic lymphocytic leukaemia (CLL) indication to include combination use with obinutuzumab for the treatment of adult patients with previously untreated CLL. Current proprietary name Already available biosimilars / generics Proprietary name Imbruvica Manufacturer Janssen Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Proteïnekinaseremmer. Remt irreversibel Bruton’s tyrosinekinase. Is al geregistreerd voor deze indicatie zonder obinutuzumab. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2018 Expected Registration August 2019 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Voor 1e lijns Chronische lymfatische leukemie (CLL) zit ibrutinib in de sluis. Positieve CHMP-opinie in juni 2019. Therapeutic value Current treatment options BR or Chloorambucil + Rituximab Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation De expert ziet mogelijk gelijke waarde voor CLL patiënten met ongemuteerde immuunglobuline genherschikking status van ibrutinib t.o.v chemo-immunotherapie. Dit betreft ongeveer 50% van de CLL patienten Duration of treatment Average 14 month / months Frequency of administration 1 times a day Dosage per administration 420 mg References NCT02264574; EPAR; Moreno et al. Lancet Oncol. 2019 Jan;20(1):43-56. Additional remarks Obinutuzumab 1000 mg IV gedurende 6 cycli: Days 1+2 (100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of Cycle 1 followed by Day 1 only on Cycles 2-6. De expert ziet voorlopig geen meerwaarde in combinatiebehandeling ibrutinib-obinutuzumab voor deze indicatie. Expected patient volume per year Patient volume 100 - 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Aangezien voor CLL patiënten met ongemuteerde immuunglobuline genherschikking status er mogelijk gelijke waarde is van chemo-immunotherapie en ibrutinib, zal uiteindelijk ongeveer 25% van de patiënten hiervoor in aanmerking komen Expected cost per patient per year Cost € 69,000.00 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 Fabrikant Additional remarks Huidige lijstprijs x maximaal gebruik per jaar: €69.043,00. Dit betreft alleen ibrutunib. Voor de indicatie 1e lijns Chronische lymfatische leukemie (CLL) wordt voor een subdeel onderhandeld over een financieel arrangement en zit het geneesmiddel gedeeltelijk in de sluis. Potential total cost per year Total cost € 10,350,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Woyach 2018, Moreno 2019, Shanafelt 2019 Additional remarks Other information Additional remarks