CFRV del Veneto

Progetto Horizon

Attività

I sistemi di Horizon Scanning si inseriscono in un contesto sempre più complesso che richiede alle Regioni di effettuare scelte programmatorie sempre più celeri di fronte ad uno scenario complesso di analisi su benefici e costi di nuovi farmaci sempre più costosi, a fronte di risorse sanitarie limitate.

Il sistema di Horizon Scanning della Regione Veneto ha come obiettivo la valutazione precoce di nuove entità chimiche e nuove indicazioni che hanno ricevuto la Positive Opinion dal Comitato per i Medicinali per Uso Umano (CHMP) dell’European Medicines Agency (EMA), mediante la redazione di report che forniscono un supporto alle commissioni che operano in ambito regionale: Commissione Tecnica Regionale sui Farmaci, Gruppo di Lavoro (GdL) sui Farmaci Onco-ematologici e GdL sui Farmaci Oncologici.

I report prevedono la caratterizzazione e classificazione del farmaco con le principali informazioni regolatorie, una sintesi dei dati di efficacia e sicurezza derivanti dagli studi clinici pivotal e una stima dell’impatto economico e organizzativo del farmaco sul Servizio Sanitario Nazionale.


Nella tabella sottostante sono disponibili i report (in lingua inglese) redatti per i farmaci che hanno ottenuto la Positive Opinion nel mese scorso.


Nell'archivio è possibile trovare i report dei mesi precedenti.

Horizon Scanning systems are part of an increasingly complex setting that requires the Regions to make ever more rapid planning choices to deal with the complex scenario of analysis of benefits and costs of new and increasingly expensive drugs, despite limited health resources.

The Horizon Scanning system of the Veneto Region aims the early evaluation of new chemical entities and new indications that received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP), through the preparation of reports that provide a support to the commissions operating in the regional context: Regional Technical Commission on Drugs, Working Group (WG) on Onco-haematological Drugs and WG on Oncological Drugs.

Reports contain the description and classification of the drug with the main regulatory information, a summary of the efficacy and safety data deriving from the pivotal clinical studies and an estimation of the economic and health impact of the drug on the national health service.

Reports drafted for the drugs that obtained the Positive Opinion in the previous month are available below.

In the archive you can find reports of the previous months.

ArchivioArchive


Report Giugno 2025


Report June 2025

Principio AttivoActive Ingredient IndicazioniIndications

Nuove Entità ChimicheNew Chemical Entities
Dorocubicel / Allogeneic umbilical cord-derived CD34- cells, non-expanded

Dorocubicel and non-expanded CD34- cells is indicated for the treatment of adults with haematological malignancies requiring an allogeneic HSCT following myeloablative conditioning for whom no other type of suitable donor cells is available.
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Nirogacestat

Nirogacestat as monotherapy is indicated for the treatment of adults with progressing Desmoid tumour who require systemic treatment.
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Nuove IndicazioniNew Indications
Cabozantinib

Cabozantinib is indicated for the treatment of adults with unresectable or metastatic, well differentiated extra-pancreatic neuroendocrine tumours and pancreatic neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.
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Daratumumab

Daratumumab as monotherapy is indicated for the treatment of adults with smouldering multiple myeloma at high risk of developing Multiple myeloma.

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Darolutamide

Darolutamide is indicated for the treatment of adult men with Metastatic hormone‑sensitive prostate cancer in combination with androgen deprivation therapy.
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Ibrutinib

Ibrutinib in combination with R-CHOP alternating with R-DHAP (or R-DHAOx) without ibrutinib, followed by ibrutinib monotherapy, is indicated for the treatment of adults with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplantation

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Isatuximab

Isatuximab is indicated in combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

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Ultime novità dal CHMP

Al seguente link (https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-july-2025) sono consultabili le ultime novità del CHMP. 

I report saranno disponibili il mese prossimo su questa pagina.

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Latest CHMP News

At the following link (https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-july-2025) you can consult the latest news from the CHMP.

Reports will be available next month on this page.

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