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

Next steps for the revision of the Orphan Drug Regulation

22 March 2023

The European Commission's official proposal is due to be published on 29 March 2023, but during the World Evidence, Pricing and ...

Valeria Viola at OSSFOR report presentation

Scenario analysis

Proposed regulatory reform of 648/96 for fast access to orphan drugs

2 February 2023

Rome, 31 January 2023. The following text summarises the speech by Valeria Viola, owner of Pharma Value, during the presentation of the VI ...

Drug Policy

Towards the reform of governance of the Italian Medicines Agency and the Single Committee

11 January 2023

This is our English version of the analysis 'Towards the reform of governance of the Italian Medicines Agency and the Single Committee' ...

Team Pharma Value

Pharma Value Agenda 2023

9 January 2023

Il tema dell’agenda Pharma Value 2023 è “soldi e valore”. L’agenda di quest’anno è il frutto di un lavoro collettivo di tutto ...

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 – ...