Gabriele Maria Pistillo -

The Italian HTA Agency (AIFA) has published the first guideline in order to harmonize the structure and the requirements for a correct development of the Pharmacoeconomic Chapter of the Pricing & Reimbursement (P&R) Dossier.

The Companies may present the following types of analysis:

  • Cost Effectiveness Analysis (CEA) and/or Cost Utility (CUA) of the medicinal product concerned, in comparison with the standard of care (SoC) identified in the Italian NHS context (time horizon of 5 years, 10 years and lifetime);
  • Budget Impact Analysis (BIA) from the NHS perspective, providing a forecast of expenditure and cost saving effects of the drug reimbursement (time horizon of at least 2 years).

The submission of these analyses is recommended for the following types of P&R applications:

  1. Orphan drugs, including any extensions of the therapeutic indications;
  2. New active substances, including reclassifications of active substances not reimbursed and associations that contain at least one new active substance;
  3. Extension of the therapeutic indications of drugs subject to patent coverage, except in case of a population extension for the indication already authorized and reimbursed.

During the Pharmacoeconomic Chapter development, the Companies are recommended to follow and respect the new guideline in order to mitigate possible questions or objections during the Pricing & Reimbursement Committee (CPR) assessment.

In addition to the AIFA Guideline, in order to verify the completeness of the information contained in the dossier regarding the pharmacoeconomic assessments, it is recommended to refer to the CHEERS Checklist (prepared by a Task Force of the ISPOR) and to the principles of good practice relating to the development of budget impact analyses, published by ISPOR (Sullivan et al 2014).

Regulatory Pharma Net can support Pharmaceutical Companies during the whole P&R process, from the development of the dossier, including the Pharmacoeconomic Chapter, to the negotiation phase with the HTA Agency.

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