CFRV del Veneto

Progetto Horizon

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 Settembre 2022


Report September 2022

Principio AttivoActive Ingredient IndicazioniIndications

Nuove Entità ChimicheNew Chemical Entities

Loncastuximab tesirine

Loncastuximab tesirine as monotherapy is indicated for the treatment of adult patients with relapsed or refractory DLBCL and HGBL, after two or more lines of systemic therapy.

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Mitapivat

Mitapivat is indicated for the treatment of PK deficiency in adult patients.

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Octreotide

Octreotide is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

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Sutimlimab

Sutimlimab is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease.

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Nuove IndicazioniNew Indications

Axicabtagene ciloleucel

Axicabtagene ciloleucel is indicated for the treatment of adult patients with DLBCL and HGBL that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy, and who have received at least two previous systemic therapies.

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Ibrutinib

Ibrutinib in combination with venetoclax is indicated for the treatment of adult patients with previously untreated Chronic Lymphocytic Leukaemia.

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Tralokinumab

Tralokinumab is indicated for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent pts 12 years and older who are candidates for systemic therapy.


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zanubrutinib

Zanubrutinib as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma  who have received at least one prior anti-CD20-based therapy.

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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-18-...) 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-18-...) you can consult the latest news from the CHMP.

Reports will be available next month on this page.

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