The 4-5 December 2024, Pharma Value participated in the 10th National Congress ISPOR Italy - Rome Chapter with two scientific contributionsof which one selected for a oral presentation.
This is an important recognition that enhances our commitment to investigating issues of great relevance to the regulatory and market access sector.

Back in November, Pharma Value participated in ISPOR EUROPE 2024always with the same intent.

During the ISPOR congress in December, a number of topics were addressed that contributed to rich comparisons and meaningful insights.

• Insight into strategies for costing adverse events in oncology and oncohaematology, with a focus on research methods and the contribution of clinical experts
• Indirect comparisonsmethodology and their fundamental role in view of the new HTA Regulation.
• The role of Managed Entry Agreements (MEAs)explored both from an Italian and international perspective, with a look at the experiences of Spain and the UK.
• The role of economic evaluations in price setting and reimbursement
• The role of Horizon Scanning from different points of view, including that of AIFA.
• The importance of the use of Real World Data and their applicability in the Italian context

Poster 1

HTA Regulation: procedure and impact on regulatory processes in Spain, France, Germany and Italy.
The study analysed the impact of the new HTA Regulation and Joint Clinical Assessment (JCA) on national regulations and pricing and reimbursement processes in the Big4: Spain, France, Germany and Italy.

Critical issues were mainly identified at two stages of the JCA process that directly involve Member States: during the assessment scope phase and during the publication of the JCA report.

The aims of the HTA regulation are ambitious and well structured. Despite some delays in publications and communications, the European HTA coordination group has provided all the necessary tools to carry out an effective JCA. The impacts of the Regulation will be significant and will deeply affect national HTA bodies. However, with the exception of Spain, the other countries have not yet provided details on how the JCA report will be used and what role it will play in their national pricing and reimbursement processes.

Poster 2

Law 648/96: trend analysis of applications in the three-year period 2022-2024, with a focus on CTS/CSE assessments.
The objective of the analysis was to identify any criticalities in the approval process of applications under Law 648/96.

The analysis shows that the timing of the evaluation is not a problem and that there are fewer applications with favourable outcomes than with unfavourable outcomes. In addition, there are very few applications for new active substances not yet reimbursed in Italy, with the majority receiving unfavourable outcomes. Therefore, it is concluded that the problem does not lie in the 648 process, but could be attributed to a limited and not entirely precise allocation of resources. This should be verified in a future analysis.