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

New AIFA Special Update: CSE and REORGANISATION

12 February 2024

Update 1 March 2024 Below is the updated document with appointments and update timeline to 1 March 2024. Original text Pharma Value has ...

Scenario analysis

The Orphan Drug Comparator: a survey to identify challenges in price negotiations with AIFA

6 February 2024

In collaboration with Rarelab, we launched a survey with the aim of assessing the actual impact of the use of comparators in the negotiation of orphan drugs, ...

Scenario analysis

Interministerial Decree for new AIFA regulation published

16 January 2024

Yesterday, 15 January 2024, the Ministerial Decree for the reform of AIFA was published in the OJ. It will enter into force on 30 January 2024. ...

Notes

FDA vs EMA - Comparison of marketing authorisations issued in 2023

15 January 2024

Pharma Value has developed a paper comparing marketing authorisations issued by the FDA and EMA in 2023. The objective of the analysis is to ...

Team Pharma Value

Pharma Value Agenda 2024

12 January 2024

Each year the introduction of the Pharma Value Agenda tells how the inspiration for the theme came about and the methodology behind the construction of the content. The Agenda has become a ...

Scenario analysis

VII Ossfor Annual Report

14 December 2023

On Tuesday 12 December 2023, the 7th Ossfor Annual Report was presented in the Zuccari Room of Palazzo Giustiniani in the Senate.

Notes

Regional Access Timelines in Italy: Factors Affecting Speed and Equity

27 November 2023

The analysis addresses differences in regional access times for drug reimbursement in Italy. Following the official publication for drug reimbursement in the ...