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 2022


Report June 2022

Principio AttivoActive Ingredient IndicazioniIndications

Nuove Entità ChimicheNew Chemical Entities
Faricimab

Faricimab is indicated for the treatment of adult patients with Diabetic macular edema

ScaricaDownload
Faricimab

Faricimab is indicated for the treatment of adult patients with wet neovascular agerelated macular degeneration.
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Relatlimab/Nivolumab

Relatlimab/Nivolumab is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell programmed cell death protein 1 expression < 1%.
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Teclistamab

Teclistamab is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
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Tezepelumab

Tezspire is indicated as an addon maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
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Tirzepatide

Tirzepatide is indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise: 
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;
- in addition to other medicinal products for the treatment of diabetes


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Voclosporin

Voclosporin is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) Lupus Nephritis.
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Vutrisiran

Treatment of hereditary transthyretinmediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy

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Nuove IndicazioniNew Indications
Fosdenopterin

Fosdenopterin is indicated for the treatment of patients with molybdenum cofactor deficiency Type A

ScaricaDownload
Ibrutinib

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

Brexucabtagene autoleucel is indicated for the treatment of adult pts 26 years of age and above with relapsed or refractory BCP-ALL.
ScaricaDownload
Ravulizumab

Ravulizumab is indicated as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis who are Acetylcholine Receptor Ab+
ScaricaDownload
Setmelanotide

Setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome.
ScaricaDownload
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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