Favorable opinion is given for indicating the drug in newly diagnosed multiple myeloma patients and who are eligible for an autograft of stem cells. The drug is approved in combination with bortezomib, thalidomide, and dexamethasone
Favorable opinion is given for reimbursing in combination with bortezomib, melphalan and prednisone in treatment naïve patients who are not eligible for an autograft of stem cells
Favorable opinion is given for reimbursing in combination with lenalidomide and dexamethasone in treatment naïve patients who are not eligible for an autograft of stem cells
All the indications received SMR Important, 65% of the cost of drug therapy will be now reimbursed in France
HAS published three opinion documents suggesting the reimbursement of Darzalex for multiple myeloma in treatment naïve patients
Treatment naïve patients who are eligible for an autograft of stem cells The currently recommended drugs are - the VTd protocol (bortezomib + thalidomide + dexamethasone) - the VRd protocol (bortezomib + lenalidomide + dexamethasone) Darzalex (daratumumab) with bortezomib, thalidomide, and dexamethasone showed superiority compared to VTd protocol in terms of progression-free survival. The drug has also demonstrated significant improvement in the minimum undetectable residual disease compared to VTd protocol (64% versus 44%). Overall, the product has achieved ASMR IV compared to VTd protocol.
Treatment naïve patients who are not eligible for an autograft of stem cells The currently approved drugs for this indication are -Velcade, melphalan, and prednisone (VMP protocol) for a fixed duration of treatment -Revlimid in combination with low doses of dexamethasone Darzalex in the combination of VMP Darzalex given in combination of VMP (D-VMP) shown superiority compared to VMP protocol in terms of overall survival. HAS recommended the use of D-VMP combination instead of VMP as first line treatment for patients suffering from multiple myeloma. In terms of progression-free survival, the median gain of 17 months was reported. Darzlex, in combination with VMP, has achieved ASMR III compared to VMP alone.
Darzalex in the combination of Rd Darzalex in the combination with Revlimid and dexamethasone, has shown significant improvement in terms of progression-free survival, however, low benefit was shown in terms of overall survival. The product has achieved ASMR IV when compared to the combination of Revlimid and dexamethasone.