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Genmab — December 2016

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • E Offline
    E Offline
    E_L
    wrote on sidst redigeret af
    #1601

    Final Recommendation/Notification to implement
    Issued for Daratumumab 16 Dec

    1 Reply Last reply
    0
    • G Offline
      G Offline
      gentogen
      wrote on sidst redigeret af
      #1602

      Det er jo helt oforståeligt

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      0
      • G Offline
        G Offline
        gentogen
        wrote on sidst redigeret af
        #1603

        Myeloma Canada submits that pERC failed to fully comprehend the gravity of this stage of disease in
        patients. At this stage, patients have run out of options for treatment and are close to death. In
        particular, the statement “there is a low probability that daratumumab would be cost-effective in this
        population compared to other treatments” is at best conjectural and at worst insensitive.

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        • G Offline
          G Offline
          gentogen
          wrote on sidst redigeret af
          #1604

          What other
          “cost-effective” treatments is pERC recommending for this patient population? At the very least, a
          recommendation should have been made for a sub-section of the indicated population.

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          0
          • G Offline
            G Offline
            gentogen
            wrote on sidst redigeret af
            #1605

            Myeloma Canada is of the opinion the pERC recommendations and comments are not supported by clinical
            practices and are in fact contradictory to the evidence presented in the Clinical Guidance report.

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            • G Offline
              G Offline
              gentogen
              wrote on sidst redigeret af
              #1606

              pERC also made some
              assumptions that are not supported by either our patient survey or by the clinician survey, with respect to
              the administration of daratumumab.

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              0
              • G Offline
                G Offline
                gentogen
                wrote on sidst redigeret af
                #1607

                Jeg kan desværre ikke kopiere fra selveafgørelsen men følg selv linket fra E L

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                0
                • digafarmD Offline
                  digafarmD Offline
                  digafarm
                  wrote on sidst redigeret af
                  #1608

                  https://www.cadth.ca/sites/default/files/pcodr/pcodr_daratumumab_darzalex_mm_fn_rec.pdf

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                  • digafarmD Offline
                    digafarmD Offline
                    digafarm
                    wrote on sidst redigeret af
                    #1609

                    En beslutning truffet 1/12 så vidt jeg kan se?

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                    • J Offline
                      J Offline
                      Jedi
                      wrote on sidst redigeret af
                      #1610

                      Undskyld, men jeg kan kun finde Final Recommendation fra 1/12, men hvor ser I afgørelsen? (Som skulle være faldet 16/12)

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                      0
                      • J Offline
                        J Offline
                        Jedi
                        wrote on sidst redigeret af
                        #1611

                        Eller der kommer måske bare ikke nogen notification ved negativ recommendation?

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                        0
                        • J Offline
                          J Offline
                          Jedi
                          wrote on sidst redigeret af
                          #1612

                          En skandale for patienterne

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                          0
                          • digafarmD Offline
                            digafarmD Offline
                            digafarm
                            wrote on sidst redigeret af
                            #1613

                            Tror d. 16. er implementeringsdatoen p.b.a. deres recommendation fra d. 1.

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                            • digafarmD Offline
                              digafarmD Offline
                              digafarm
                              wrote on sidst redigeret af
                              #1614

                              Hvordan kan de komme frem til konklusionen om at darzalex ikke er kosteffektivt nok ift. andre behandlinger i min. 3. linje når det ikke har været et tema for FDA eller EM
                              A?

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                              0
                              • BulderB Offline
                                BulderB Offline
                                Bulder
                                wrote on sidst redigeret af
                                #1615

                                Ja, det kan undre at de kan se så forskelligt på sagerne. Det hele er galt: for dyrt, for lidt effektivitet, for lang infusionstid, ingen bedre livskvalitet. Hvorfor har vi mon ikke hørt noget fra Janssen/Genmab? Kan de stadig være i dialog med de canadiske myndigheder?

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                                0
                                • G Offline
                                  G Offline
                                  GeorgeBest
                                  wrote on sidst redigeret af
                                  #1616

                                  Genmab meddeler, at der er indsendt registreringsansøgning for daratumumab til behandling af recidiverende/refraktær myelomatose i Japan og opdaterer sine resultatforventninger

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                                  0
                                  • G Offline
                                    G Offline
                                    GeorgeBest
                                    wrote on sidst redigeret af
                                    #1617

                                    Der er indsendt registreringsansøgning i Japan for daratumumab til behandling af recidiverende eller refraktær myelomatose
                                    Ansøgningen er baseret på data fra studierne SIRIUS, CASTOR og POLLUX
                                    Genmab modtager milestonebetaling fra Janssen på USD 10 mio. — resultatforventningerne opdateres

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                                    0
                                    • J Offline
                                      J Offline
                                      JKY_VH
                                      wrote on sidst redigeret af
                                      #1618

                                      tak for den GB og god morgen

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                                      0
                                      • J Offline
                                        J Offline
                                        JKY_VH
                                        wrote on sidst redigeret af
                                        #1619

                                        godt for japanerne, synd for canadierne.

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                                        • SolsenS Offline
                                          SolsenS Offline
                                          Solsen
                                          wrote on sidst redigeret af
                                          #1620

                                          Opjustering med 70 mio dkk

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