Favourable opinion for reimbursement only “as monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received chemotherapy based on platinum salts and a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting”
Unfavourable opinion for reimbursement in the other situations covered by the MA indication.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of BALVERSA 3 mg, 4 mg, 5 mg (erdafitinib) film-coated tablets is substantial only “as monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received chemotherapy based on platinum salts and a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting”.
Insufficient
The Committee deems that the clinical benefit of BALVERSA 3 mg, 4 mg, 5 mg (erdafitinib) film-coated tablets is insufficient to justify public funding in the other MA situations.
Clinical Added Value
minor
Considering:
evidence of the superiority of BALVERSA (erdafitinib) compared to chemotherapy (docetaxel or vinflunine), in a randomised, open-label phase 3 study in terms of overall survival, with an HR = 0.64; CI95% [0.47; 0.88]) and progression-free survival (HR = 0.58; CI95% [0.44; 0.78]);
the medical need partially met by the available alternatives;
and despite:
a toxicity profile marked by the development of central serous retinopathy, skin and mucosal reactions (hand-foot syndrome, stomatitis and onycholysis), serious hyponatraemia and hyperphosphataemia;
a lack of evidence of an improvement in quality of life;
the lack of robust comparative data versus enfortumab vedotin, a medicinal product already available in the treatment of adult patients with locally advanced or metastatic urothelial carcinoma, who have previously received chemotherapy based on platinum salts and an anti-PD-1 drug or an anti-PD-L1 drug. However, the absence of a direct comparison is justified on the date of the present assessment given their concomitant development;
the Committee deems thatBALVERSA 3 mg, 4 mg, 5 mg (erdafitinib) film-coated tablets provides a minor clinical added value (CAV IV) compared to chemotherapy in the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received chemotherapy based onplatinum salts and a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.
In the other situations of the MA: not applicable.
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