Users of monitored Drug Registries are advised that, as of , the procedures for implementing risk-sharing agreements, i.e. Managed Entry Agreements (MEAs), are no longer active for registries for the following therapeutic indications:
is indicated in adult patients with:
- acute lymphoblastic leukemia with Philadelphia chromosome positive (Ph ALL) resistant to dasatinib; intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or in which the T315I mutation has been identified.
With regard to the risk sharing agreements (MEA) applied to the registries in question, it is specified that these procedures will remain active for treatments with a date of first drug dispensing prior to .Therefore, packs dispensed after the date will be refundable only if they refer to a treatment whose first dispensing is prior to that date.
The complete circular in PDF format is available at:
https://www.aifa.gov.it/documents/20142/_Iclusig.pdf
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Source — https://www.univadis.it/viewarticle/chiusura-managed-entry-agreements-mea-registri-iclusig