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.

Single National Ethics Committee of the Lazzaro Spallanzan National Institute for Infectious Diseases

Mapping

Single National Ethics Committee of the Lazzaro Spallanzani National Institute for Infectious Diseases

7 April 2020

Article 17 of the Cura Italia decree-law states that the national opinion on protocols for the testing of medicines for the epidemiological emergency by COVID ...

Notes

List 648/96 - AIFA How to apply for inclusion of a drug/therapeutic indication not yet authorised by the SSN

3 April 2020

In these times of the COVID-19 emergency we often hear about the '648/96' list and reimbursed drugs for off-label use... but ...

Notes

Drugs in clinical trials: compassionate use activation procedure

24 March 2020

In this time of COVID-19 emergency we often hear about 'Compassionate Use' The DM 7/9/2017 regulates the free supply by ...

Notes

The course of a drug pricing and reimbursement procedure in Italy

17 March 2020

In these quarantine days, Pharma Value wants to share with you some useful content for those working in the regulatory and market ...

Notes

The Words in the New Decree on Negotiating Criteria

5 February 2020

Many in the industry have analysed the interministerial decree on the new negotiation criteria published in the Official Journal on 24 July 2020, making ...