Version 3

Inavolisib

Medicine

Extended indication Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA‑mutated, oestrogen receptor (ER
Therapeutic value No estimate possible yet
Total cost € 8,596,480.00
Registration phase Positive CHMP opinion

Product

Active substance Inavolisib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Breast cancer
Extended indication Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA‑mutated, oestrogen receptor (ER)‑positive, HER2‑negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment (see section 5.1). Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence. In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone‑releasing hormone (LHRH) agonist.
Proprietary name Itovebi
Manufacturer Roche
Portfolio holder Roche
Mechanism of action Unknown
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Werkingsmechanisme: PI3K remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date May 2024
Expected Registration July 2025
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie in mei 2025.

Therapeutic value

Current treatment options Palbociclib, ribociclib of abemaciclib in combinatie met fulvestrant, of alpelisib in tweede lijn.
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation Na 21,3 maanden mediane follow-up was de mediane progressie vrije overleving 15 maanden in de inavolisib arm en 7,3 maanden in de placebo arm (HR 0,43; p<0,0001). In het geval van positieve studieresultaten, zal het mogelijk een vervanging worden van de huidige behandelopties.
Duration of treatment Median 9 month / months
Frequency of administration 1 times a day
References NCT04191499 (INAVO120) https://clinicaltrials.gov/study/NCT04191499 Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer Authors: Nicholas C. Turner, M.D., Ph.D., Seock-Ah Im, M.D., Ph.D., Cristina Saura, M.D., Ph.D., Dejan Juric, M.D., Sibylle Loibl, M.D., Ph.D., Kevin Kalinsky, M.D., Peter Schmid, M.D., Ph.D, +14 , and Komal L. Jhaveri, M.D.Author Info & Affiliations Published October 30, 2024 N Engl J Med 2024;391:1584-1596 DOI: 10.1056/NEJMoa2404625 VOL. 391 NO. 17

Expected patient volume per year

Patient volume < 146

Market share is generally not included unless otherwise stated.
References Fabrikant; CBS; Meer et al 2021; IKNL NKR 2023; Maaren et al 2018; Pan et al 2017; André et al 2019; horizonscan alpelisib; Vrinzen et al 2023
Additional remarks Ongeveer 11.000 patiënten met diagnose borstkanker (CBS), waarvan 10.600 stadium I-III (IKNL). 76% is HR+/HER2- (IKNL) en 65% ontvangt hiervoor een behandeling (Maaren et al, 5244 patiënten), daarvan ontwikkelt 9% binnen 6 jaar gemetastaseerd recidief (Pan et al) en heeft 30% een PIK3CA-mutatie (André et al, 146 patiënten). De vraag is wel of alle patiënten getest gaan worden voor deze mutatie en of ze in dat geval niet met een CDK4/6 remmer behandeld zullen worden. Indien alle patiënten hier wel op getest zullen worden zal het maximale patiëntvolume 146 patiënten bedragen.

Expected cost per patient per year

Cost € < 58,880.00

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 (1); NCT04191499 (INAVO120) (2).
Additional remarks Voor inavolisib is nog geen prijs bekend. De behandelduur is 9,2 maanden. De fabrikant geeft aan dat het minder dan €58.880 per patiënt per jaar gaat kosten (9,2*€6.400) (1,2).

Potential total cost per year

Total cost € 8,596,480.00

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information