{"id":19454,"date":"2026-02-02T19:04:37","date_gmt":"2026-02-02T18:04:37","guid":{"rendered":"https:\/\/pharmavalue.it\/?p=19454"},"modified":"2026-02-02T19:04:37","modified_gmt":"2026-02-02T18:04:37","slug":"aifa-updates-the-guidelines-for-pricing-and-reimbursement-dossiers-toward-a-fully-hta-based-framework","status":"publish","type":"post","link":"https:\/\/pharmavalue.it\/en\/aifa-updates-the-guidelines-for-pricing-and-reimbursement-dossiers-toward-a-fully-hta-based-framework\/","title":{"rendered":"AIFA Updates the Guidelines for Pricing and Reimbursement Dossiers: Toward a Fully HTA-Based Framework"},"content":{"rendered":"

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<\/strong>, replacing the 2020 version. The new framework will apply from 1 April 2026, with a transitional period for companies.<\/p>\n

This update marks a shift in how pricing and reimbursement submissions are positioned within the Italian system.<\/p>\n

From Negotiation Tool to HTA Instrument<\/strong><\/h3>\n

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 \u2014 where relevant \u2014 social dimensions are now expected to be presented in a coherent and methodologically robust way.<\/p>\n

This reinforces the need for a structured value narrative rather than a collection of independent sections.<\/p>\n

Alignment with the European HTA Regulation<\/strong><\/h3>\n

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 \u2014 including comparator choice and relevance to Italian clinical practice \u2014 remains essential.<\/p>\n

Stronger methodology of the Economic Evaluation<\/strong><\/h3>\n

The economic section is now more structured, with:<\/p>\n

    \n
  • clearer separation between Budget Impact Analysis and Cost-Effectiveness Analysis,<\/li>\n
  • defined thresholds triggering mandatory submissions,<\/li>\n
  • standardized templates,<\/li>\n
  • and editable models required.<\/li>\n<\/ul>\n

    This increases transparency and predictability, while raising methodological expectations.<\/p>\n

    Innovativeness as a cross-cutting driver<\/strong><\/h3>\n

    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.<\/p>\n

    What this means for companies<\/strong><\/h3>\n

    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.<\/p>\n

    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.<\/p>\n

     <\/p>\n

    <\/div>