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Pharma

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.
  • 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
Team Pharma Value

10 years of Pharma Value

23 giugno 2022, Lian Club, il barcone sul Tevere, nel cuore di Roma, la città dove avviene quasi tutto ciò che riguarda ...
Scenario analysis

New authorisations in EU 2019-21. An analysis from AIFA's horizon scanning

L’attività di horizon scanning per AIFA è strategica in quanto permette di identificare le tecnologie sanitarie nuove, emergenti per confrontarle con quelle ...
Scenario analysis

Analysis of applications for inclusion of drugs on the 648/96 list. Focus on CTS evaluations.

Ginevra Mastroianni, Sara De Franceschi, Valeria Viola (Pharma Value) La Legge 648/1996 consente di erogare un farmaco non ancora autorizzato o non ...
Team Pharma Value

Pharma Value's experience at the 1st GIRF Congress - ISPOR Group Rome for Future

On 19 and 20 May, the 1st GIRF Congress - ISPOR Rome for Future Group - was held in Naples, recognising the importance ...
Drug Policy

Recovery of unused resources from the AIFA National Fund 5%

The Fund 5% for rare diseases, which allows access to medicines which do not have a MA in Italy, and which represent ...
Notes

Recovery of unused resources of the AIFA National Fund 5%

The 5% Fund for rare diseases, which allows access to medicines that are not yet marketed in Italy and which represent a hope ...
Notes

The use of antibiotics in Italy: National Report - Year 2020

On 10 March 2022, the 'National Report on the Use of Antibiotics in Italy -2020' was presented on AIFA's YouTube channel ...
Notes

Appeal by Bayer VS Ministry of Health, MEF and AIFA on the new P&R criteria - Council of State ruling

On 7 January 2022, the Council of State issued its judgment (15 March 2021, no. 3095) on the appeal filed by ...
Team Pharma Value

Why this agenda

The year 2021 was the year of starting again, of picking everything up where we left off, while finding that someone or something ...
Notes

New criteria for access to the 5% fund of Law 326/2003

On 30 November 2021, AIFA defined the new access criteria for Law 326/2003. This law was supplemented by Law ...
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