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 2024


Report June 2024

Principio AttivoActive Ingredient IndicazioniIndications

Nuove Entità ChimicheNew Chemical Entities
Crovalimab

Crovalimab as monotherapy is indicated for the treatment of adult and paediatric patients >12 years of age with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH): 

• in patients with haemolysis with clinical symptoms indicative of high disease activity;

• in patients who are clinically stable after having been treated with a complement component 5 (C5) inhibitor for at least the past 6 months.
ScaricaDownload
Erdafitinib

Erdafitinib as monotherapy is indicated for the treatment of adults with unresectable or metastatic UC, harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.
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Odronextamab

Ordspono as monotherapy is indicated for the treatment of adults with r/r FL after two or more lines of systemic therapy. Ordspono as monotherapy is indicated for the treatment of adult pts with r/r DLBCL after two or more lines of systemic therapy.
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Sotatercept

Sotatercept, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adults with WHO Functional Class (FC) II to III, to improve exercise capacity.
ScaricaDownload

Nuove IndicazioniNew Indications
Crizotinib

For treatment of children from 1 year of age with ALK‑positive ALCL or unresectable IMT.
ScaricaDownload
Durvalumab

Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with: Durvalumab as monotherapy in endometrial cancer that is dMMR. Durvalumab in combination with olaparib in endometrial cancer that is pMMR

ScaricaDownload
Epcoritamab

Epcoritamab as monotherapy is indicated for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
ScaricaDownload
Faricimab

Faricimab is indicated for the treatment of adults with visual impairment due to macular edema secondary to branch RVO or central RVO.

ScaricaDownload
Olaparib

Olaparib in combination with durvalumab is indicated for the maintenance treatment of adult pts with primary advanced or recurrent endometrial cancer pMMR whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel. 
ScaricaDownload
Ultime novità dal CHMP

Al seguente link (https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-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-24-27-june-2024) you can consult the latest news from the CHMP.

Reports will be available next month on this page.

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