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 Luglio 2024


Report July 2024

Principio AttivoActive Ingredient IndicazioniIndications

Nuove Entità ChimicheNew Chemical Entities
Elafibranor

Elafibranor is indicated for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

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Odevixibat

Odevixibat is indicated for the treatment of cholestatic pruritus in patients with ALGS, aged >6 months.
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Toripalimab

Toripalimab, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adults with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC.

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Zolbetuximab

Zobetuximab, in combination with fluoropyrimidine- and platinumcontaining chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2‑negative gastric or GEJ adenocarcinoma whose tumors are CLDN 18.2 positive

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Nuove IndicazioniNew Indications
Amivantamab

Amivantanab in combination with carboplatin and pemetrexed, is indicated for the treatment of adults with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR TKI

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Atezolizumab

Atezolizumab as monotherapy is indicated for the first-line treatment of adult pts with advanced NSCLC who are ineligible for platinum-based therapy

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Encorafenib + Binimetinib

Encorafenib and binimetinib in combination are indicated for the treatment of adults with advanced NSCLC with a BRAFV600E mutation.

ScaricaDownload
Enfortumab vedotin

Enfortumab vedotin, in combination with pembrolizumab, is indicated for the first-line treatment of adults with unresectable or metastatic UC, who are eligible for platinumcontaining chemotherapy
ScaricaDownload
Pembrolizumab

Pembrolizumab, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.
ScaricaDownload
Ultime novità dal CHMP

Al seguente link (https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-july-2024) 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-22-25-july-2024) you can consult the latest news from the CHMP.

Reports will be available next month on this page.

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