REVLIMID (lénalidomide)
Reason for request
Key points
Favourable opinion for reimbursement as monotherapy in the maintenance treatment of adult patients with previously untreated multiple myeloma who have undergone autologous stem cell transplantation.
What therapeutic improvement?
No clinical added value compared to no therapy.
Role in the care pathway?
In symptomatic patients with previously untreated multiple myeloma, the first-line treatment depends on eligibility for intensive chemotherapy combined with autologous stem cell transplantation.
In eligible patients, having received intensive chemotherapy combined with autologous stem cell transplantation, post-transplant consolidation treatment may be considered with the aim of improving the quality and extent of the response. Post-transplant maintenance therapy aimed at delaying the first relapse is one of the treatment options that may be proposed in the first-line treatment strategy for multiple myeloma.
Role of the REVLIMID (lenalidomide) in the care pathway?
REVLIMID (lenalidomide) is a maintenance treatment following autologous stem cell transplantation.
As a precaution, the Committee recommends that REVLIMID (lenalidomide) be administered for a maximum period of two years and not until disease progression, in the absence of data supporting the optimal duration of this treatment.
Clinical Benefit
Low |
The clinical benefit of REVLIMID (lenalidomide) is low in the indication “as monotherapy in the maintenance treatment of adult patients with previously untreated multiple myeloma who have undergone autologous stem cell transplantation. |
Clinical Added Value
no clinical added value |
Considering:
the Committee considers that REVLIMID (lenalidomide), as a maintenance treatment following autologous transplantation, provides no clinical added value (CAV V) compared to no therapy, in adult patients with previously untreated multiple myeloma who have undergone autologous stem cell transplantation.
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