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.
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. |
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|
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. |
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|
Nuove IndicazioniNew Indications |
||
Crizotinib | For treatment of children from 1 year
of age with ALK‑positive ALCL or
unresectable IMT. |
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|
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
|
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|
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. |
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|
Faricimab |
Faricimab is indicated for the treatment of
adults with visual impairment due to macular
edema secondary to branch RVO or central RVO.
|
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|
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. |
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|
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.
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.