Download opinion
Add to my selection
Quote this publication Print

LIBTAYO 350 mg (cémiplimab)

Opinions on drugs - Posted on Jan 10 2022

Reason for request

Reevaluation

Key points

Favourable opinion for reimbursement in the subgroup of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation and who are not eligible for chemotherapy (situation of failure or contraindication to chemotherapy).

Unfavourable opinion for reimbursement in the rest of the MA population.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

Role of the medicinal product in the care pathway

Considering the absence of direct comparative data and the absence of an indirect comparison of good methodological quality, the role of LIBTAYO (cemiplimab) in the care pathway cannot be specified compared to the chemotherapy protocols used as first or later-line treatments. Consequently, the Transparency Committee considers that, on the basis of currently available data, LIBTAYO (cemiplimab) is a treatment option only in patients who are not candidates for curative surgery or curative radiation and who are not eligible for chemotherapy (situation of failure or contraindication to chemotherapy).

 


Clinical Benefit
Substantial

The Committee deems that the clinical benefit of LIBTAYO (cemiplimab) is SUBSTANTIAL in the subgroup of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation and who are not eligible for chemotherapy (situation of failure or contraindication to chemotherapy).
Insufficient

The Committee deems that the clinical benefit of LIBTAYO (cemiplimab) is INSUFFICIENT to justify public funding cover in view of the available alternatives in the rest of the MA population.

 

Clinical Added Value
no clinical added value

Considering:

  • the available data based on three cohorts from a phase 2 non-comparative study and on compassionate use programme (ATU) data having suggested an efficacy of cemiplimab in terms of objective response rate in a heterogeneous population with locally advanced or metastatic cutaneous carcinoma,
  • the substantial medical need for patients in whom all the other treatment options have been exhausted (patients who are not candidates for curative surgery or curative radiation and who are not eligible for chemotherapy),

 But taking into account:

  • uncertainties with respect to the specific effect size of this medicinal product, considering the absence of robust comparative data,

The Transparency Committee considers that, as the dossier currently stands, LIBTAYO (cemiplimab) provides no clinical added value (CAV V) in the subgroup of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation and who are not eligible for chemotherapy (situation of failure or contraindication to chemotherapy).

 

 

Documents

English version

Contact Us

Évaluation des médicaments
All our publications