Pharma Value

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.

Scenario analysis

Nomos Pharma Value SPECIAL No. 2: AIFA reform - scenario and next steps

13 December 2022

Nomos e Pharma Value hanno sviluppato un documento di approfondimento per analizzare la riforma di AIFA definita nelle scorse settimane al Senato ...

Rare Diseases

Timing of access to drugs and advanced therapies (ATMP) for ultra-rare diseases

1 December 2022

Martedì 29 novembre 2022 Ginevra Mastroianni, Institutional and Regulatory Affairs Specialist di Pharma Value, ha presentato all’8° Congresso Nazionale dell’ISPOR Italy – ...

Team Pharma Value

15 years of the DRMKA Master, a TEDx on regulatory and market access activities

20 October 2022

Venerdì 14 ottobre 2022 Valeria Viola ha partecipato con un TEDx all’evento organizzato dal professor Armando Genazzani per i 15 anni del ...

Scenario analysis

AIFA Business Plan 2022

6 October 2022

ll 28 settembre 2022 la Conferenza Stato Regioni ha rinviato il parere (punto 7) per il Piano attività di AIFA 2022. Il piano individua 3 mission ...

Team Pharma Value

Unconventional team building

4 October 2022

Dal 20 al 22 settembre 2022 i team di Pharma Value e di MA Provider SUMA (Start up Market Access) si sono ...

Notes

New simplified P&R negotiation procedures

21 July 2022

Nel 2020 AIFA ha introdotte le nuove procedure semplificate in materia di negoziazione P&R: procedura semplificata di prezzo e rimborso per la ...

Team Pharma Value

10 years of Pharma Value

30 June 2022

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

31 May 2022

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.

22 May 2022

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