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 Gennaio 2025


Report January 2025

Principio AttivoActive Ingredient IndicazioniIndications

Nuove Entità ChimicheNew Chemical Entities
Datopotamab deruxtecan

Datopotamab deruxtecan as monotherapy is indicated for the treatment of adults with unresectable or metastatic HR+, HER2- breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.
ScaricaDownload
Tedizolid phosphate

Tedizolid powder for concentrate for solution for infusion is indicated for the treatment of ABSSSI from birth.
Tedizolid phosphate tablets are indicated for the treatment of ABSSSI in adults and adolescents and children weighing ≥35 kg.
ScaricaDownload
Tisotumab vedotin

Tisotumab vedotin as monotherapy is indicated for the treatment of adults with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
ScaricaDownload

Nuove IndicazioniNew Indications
Durvalumab

Durvalumab as monotherapy is indicated for the treatment of adults with LS-SCLC, whose disease has not progressed following platinum-based chemoradiation therapy.
ScaricaDownload
Ipilimumab

Ipilimumab in combination with nivolumab is indicated for the first‑line treatment of adults with unresectable or advanced HCC.
ScaricaDownload
Lisocabtagene maraleucel

Lisocabtagene maraleucel is indicated for the treatment of adults with relapsed or refractory FL after two or more lines of systemic therapy.
ScaricaDownload
Nivolumab

Nivolumab in combination with ipilimumab is indicated for the first‑line treatment of adult patients with unresectable or advanced HCC.
ScaricaDownload
Ultime novità dal CHMP

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

Reports will be available next month on this page.

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