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Value

To be able to find the right path for the introduction of a medicine in Italy, it is necessary to explore and translate the map of the regulatory environment, identifying and analysing the expectations and reports of decision-makers.

We assist those who turn to us in understanding and obtaining a fair price and reimbursement for a medicine. Finding a common ground, by appropriately mediating between Company profit, patient needs and the limited resources of the National Health Service, is a victory for all interest groups involved.
Through the years, we have learnt that the reality of things is more complex than whatever had been planned.
Even when everything is well-prepared and strategies corresponding to the value of the medicine, in accordance with the regulatory objectives of the agencies, and accommodating to drug governance guidelines, are proposed, the pathway to the authorisation of a medicine may well progress differently than expected. Not to mention any external variables that could slow down, if not hinder, the access of a medicine to the market.
Integrated skills are needed to help with navigation
Though quite detailed, the map we have provided cannot define the complexity of the terrain. Our experience comes to the aid when it is not clear.
About us
  • All
  • Scenario analysis
  • Notes
  • Drug Policy
  • Rare Diseases
  • Mapping
  • Team Pharma Value
All
  • All
  • Scenario analysis
  • Notes
  • Drug Policy
  • Rare Diseases
  • Mapping
  • Team Pharma Value
COVID19 Technical Scientific Committee Mapping

Redefinition of the Scientific Technical Committee (STC) COVID-19

24 February 2021
Con ordinanza del Capo Dipartimento della Protezione civile n. 663 del 18 aprile 2020 e delle successive ordinanze: n. 673 del 15 ...
Notes

New Criteria and Procedures for the negotiation of prices of medicines reimbursed by the Italian Health Service

19 February 2021
On 30 December 2020 AIFA approved the document containing the provisions required by art. 2 of Ministerial Decree of 2 August 2019, ...
Notes

AIFA National Report 2019 'The use of antibiotics in Italy'

22 January 2021
Il 29 Dicembre è stato presentato il Rapporto Nazionale 2019 “L’uso degli antibiotici in Italia” il quale fornisce dati e analisi sull’andamento ...
Notes

Highlights on the AIFA Pricing Guidelines

21 January 2021
Sono state finalmente pubblicate le Linee Guida AIFA per la compilazione del dossier a supporto della domanda di rimborsabilità e prezzo di ...
Scenario analysis

ICMRA, an international coalition of health regulators from every region of the world

18 January 2021
Oggi si è riunita l’ICMRA, la coalizione internazionale di regolatori sulla salute di ogni regione del mondo. Al suo interno ci sono ...
Notes

2021 Stability Law and reshaping of pharmaceutical expenditure ceilings

12 January 2021
È stata pubblicata in GU la Legge 30 dicembre 2020, n.178 “Bilancio di previsione dello Stato per l’anno finanziario 2021 e bilancio ...
Team Pharma Value

CHRISTMAS 2020, our best wishes

23 December 2020
Il Team di PharmaValue ti propone di cimentarti in questo gioco. Lo potrai risolvere solo ampliando la tua visione. L’augurio che ti ...
notebook cover 2021 Team Pharma Value

Why this notebook

21 December 2020
A partire da marzo ho avuto difficoltà a programmare e ad immaginare il futuro. Ho fatto di tutto per mantenere il controllo ...
Mapping

Covid Vaccines Scientific Committee

19 December 2020
L’AIFA ha costituito un Comitato Scientifico per la Sorveglianza dei Vaccini contro il COVID-19 che rimarrà in carica 2 anni. Nella scheda ...
Notes

Vaccine report 2019

18 December 2020
Nel nostro Paese la vaccinovigilanza si avvale di un solido network che prevede la collaborazione di diverse istituzioni nazionali e regionali (come ...
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