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 Maggio 2022


Report May 2022

Principio AttivoActive Ingredient IndicazioniIndications

Nuove Entità ChimicheNew Chemical Entities

Eptacog beta

Eptacog beta is indicated in adults and adolescents (>12 years) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in: 

  • pts with congenital haemophilia with high-responding inhibitors to coagulation factors VIII or IX (i.e. ≥5 Bethesda Units (BU)); 
  • pts with congenital haemophilia with low titre inhibitors (BU <5) but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX

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Lonafarnib

Zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of Hutchinson-Gilford progeria syndrome (HGPS) or a processing-deficient progeroid laminopathy associated with either a heterozygous LMNA mutation with progerin-like protein accumulation or a homozygous or compound heterozygous ZMPSTE24 mutation



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Olipudase alfa

Olipudase alfa is indicated as an enzyme replacement therapy for the treatment of  non-Central Nervous System manifestations of Acid Sphingomyelinase Deficiency in paediatric and adult pts with type A/B or type B.

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Nuove IndicazioniNew Indications

Baricitinib

Baricitinib is indicated for the treatment of severe alopecia areata in adult pts

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Pembrolizumab

  • Pembrolizumab as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.

  • Pembrolizumab as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection


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Secukinumab

Secukinumab alone or in combination with methotrexate, is indicated for the treatment of active enthesitis-related arthritis and juvenile idiopathic arthritis in pts 6 years and older, whose disease has responded inadequately to, or who cannot tolerate, conventional therapy

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Selinexor

Selinexor is indicated in combination with bortezomib and dexamethasone for the treatment of adult pts with multiple myeloma who have received at least one prior therapy

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Tofacitinib

Tofacitinib is indicated for the treatment of adult pts with active ankylosing spondylitis who have responded inadequately to conventional therapy

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Upadacitinib

Upadacitinib is indicated for the treatment of adult pts with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent

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Ultime novità dal CHMP

Al seguente link (CHMP Highlights June 2022) 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 (CHMP Highlights May) you can consult the latest news from the CHMP.

Reports will be available next month on this page.

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Telefono: 0458124904