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 Febbraio 2024


Report February 2024

Principio AttivoActive Ingredient IndicazioniIndications

Nuove Entità ChimicheNew Chemical Entities
Danicopan

Danicopan is indicated as an add-on to RAV or ECU for the treatment of adults with PNH who have residual haemolytic anaemia.
ScaricaDownload
Retifanlimab

Retifanlimab is indicated as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel Cell Carcinoma not amenable to curative surgery or radiation therapy.
ScaricaDownload
Tofersen

Tofersen is indicated for the treatment of adults with ALS associated with a mutation in the SOD1 gene.
ScaricaDownload

Nuove IndicazioniNew Indications
Ciltacabtagene Autoleucel

Ciltacabtagene Autoleucel is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an IMiD and a PI, have demonstrated disease progression on the last therapy and are refractory to lenalidomide.
ScaricaDownload
Hydroxycarbamide

Hydroxycarbamide is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients aged >9 months.
ScaricaDownload
Luspatercept

Luspatercept is indicated for the treatment of patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).
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Pembrolizumab

Pembrolizumab, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non‑small cell lung carcinoma at high risk of recurrence 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-18-21-march-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-18-21-march-2024) you can consult the latest news from the CHMP.

Reports will be available next month on this page.

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