New PSP for Lorlatinib in 2nd line ALK translocated - Amivantamab + Lazertinib in first line mEGFR - Amivantamab + CT in second line EGFR post Osimertinib -

Update 5 October 2025

Erdafitinib

Bladder / Metastatic

Québec / Canada

7 yrs

positive 10 May 2025

Clinical Trials

7 yrs

positive 20 January 2018

Health Canada

positive 5 February 2025

INESSS (QC)

positive 28 January 2025

pCODR (CA)

in-progress

pCPA

in-progress

RAMQ / LM

Comparison with other countries

Canada

Canada

14 mos.

positive 20 January 2018

Health Canada

United States

United States

5 yrs

positive 12 April 2019

FDA approval

Europe

Europe

positive 27 June 2024

EMA approval

Reimbursement is post at least one treatment that included an IO.

If IO was given in neoadjuvant or adjuvant, disease progression had to occur within 12 months.

There has been no application for approval for IO naive pretreated patients as per the Cohort 2 of THOR trial. With availability of EV+Pembro in first line, this approval is not relevant to practice.

Testing is encouraged for all patients and not wait until progression to avoid missing rapid progressors.

The use of Erdafitinib post IO showed that it is safe and we would not have to go through a washout period, yet surveillance of toxicities for Erdafitinib is warranted especially occular toxicity.

Sequencing of Erdafitinib and EV has not been fully explored in randomized trials, however we have some retrospective data from the UNITE database showing good efficacy and the use of both agents is associated with longer survival when feasible than using EV alone in FGFR2/3 alt aUC.

Private Insurance

For patients with a personal health insurance, search for the drug (using sometimes its commercial name) download and fill out the appropriate prior authorization form. If you are unable to find the drug, you should fill out the General Form available on the same page (contact me if you have trouble locating it).
Manulife and Sunlife have a more complicated way, links will download a detailed pdf, please open it and follow the instructions :

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