AIFA Updates the Guidelines for Pricing and Reimbursement Dossiers: Toward a Fully HTA-Based Framework

AIFA has published the new Guidelines for compiling the Dossier to Support the Health Technology Assessment (HTA) of a medicinal product for reimbursement and pricing purposes, replacing the 2020 version. The new framework will apply from 1 April 2026, with a transitional period for companies.

This update marks a shift in how pricing and reimbursement submissions are positioned within the Italian system.

From Negotiation Tool to HTA Instrument

The dossier is no longer conceived primarily as a negotiation tool, but as an HTA document supporting a multidimensional assessment of value. Clinical, economic, organizational, and — where relevant — social dimensions are now expected to be presented in a coherent and methodologically robust way.

This reinforces the need for a structured value narrative rather than a collection of independent sections.

Alignment with the European HTA Regulation

The new Guidelines reflect the integration of the EU HTA Regulation and the Joint Clinical Assessment (JCA). Where a JCA is available, duplication of clinical sections can be avoided, while national contextualization — including comparator choice and relevance to Italian clinical practice — remains essential.

Stronger methodology of the Economic Evaluation

The economic section is now more structured, with:

clearer separation between Budget Impact Analysis and Cost-Effectiveness Analysis,
defined thresholds triggering mandatory submissions,
standardized templates,
and editable models required.

This increases transparency and predictability, while raising methodological expectations.

Innovativeness as a cross-cutting driver

Innovativeness is no longer treated as a standalone step but is increasingly integrated across the dossier. Clinical benefit, quality of evidence, and economic considerations are more closely connected, requiring earlier strategic alignment during development.

What this means for companies

The new framework calls for earlier collaboration between Regulatory, Market Access, and HEOR functions. Greater evidentiary rigor is required, but clearer rules and standardized processes may improve regulatory predictability.

The transition toward an HTA-based approach is now explicit. For companies, the dossier becomes a strategic tool that must reflect how a product generates value within the healthcare system.