Claudia Garimberti -

With Resolution no. 1372/2020, published on its institutional website on 30/12/2020, AIFA has adopted the consolidated version of the new “Guidelines for the preparation of the dossier supporting the Pricing and Reimbursement application of medicinal products” pursuant to the Ministerial Decree 2 August 2019, Criteria and procedures according to which the Italian Medicines Agency negotiates prices of medicines reimbursed by the National Health Service (Italian OJ no. 185 of 24 July 2020).

In addition to the new general layout of the dossier, the main changes compared to the previous P&R dossier template (as per CIPE Resolution 01.02.2001) include the following:

  • New negotiation types, with specific requirements, introduced in particular for:
    • Medicines and/or therapeutic indications to be included in the List pursuant to Law 648/96;
    • Class C or Cnn medicines acquired by the NHS for specific public health needs;
    • Renegotiations initiated by AIFA for a medicine:
      • With significant impact in terms of NHS expenditure or prescription inappropriateness;
      • That has never been subject of previous negotiation;
      • Not reimbursed (class C) due to failure to reach an agreement at the end of a previous negotiation.
  • Additional details and evidence requested:
    • Self-certified information on production capacity, management of unexpected manufacturing events and guarantee of adequate supply to the NHS.
    • If appropriate, information on the tools (including diagnostic tests) used to identify patients eligible for treatment and/or the infrastructure/setting and/or the level of care envisaged for administration of the Product.
    • Clear identification of the comparator(s), starting with the recommended Standard of Care (SoC), indicating the comparator(s) available in the Italian healthcare system, also including treatments with broader therapeutic indication, identifying the sub-population in common. In the absence of pharmacological therapeutic alternatives and in all pertinent cases, Best Supportive Care (BSC) should be specified and, where relevant, any non-pharmacological therapeutic strategies (e.g. surgery, etc.).
    • Demonstration of the added value of the product over comparators/therapeutic alternatives in terms of clinical outcomes and cost of therapy.
    • Description/discussion of clinical studies according to very specific scheme and tables.
    • Information on prices of the Product in other EU countries and the UK specifying the existence of any negotiated discounts and/or MEA and the existence of confidentiality agreements.
    • Budget Impact Analyses and pharmaco-economic analyses (e.g. cost-effectiveness, cost-utility and/or cost-minimization) now mandatory for: new drugs, orphan drugs, extensions of indications (for originator medicinal products, i.e. not generics), reclassifications of drugs/packs previously not reimbursed (C class).
    • Information on any public contributions/incentives received for R&D activities.
    • Details on the status of the patent on the Product.


The new guidelines will apply starting from 1 March 2021.

A new electronic interface is being developed by AIFA to allow the preparation and online filing of the Dossier.

At Regulatory Pharma Net we are ready to support pharmaceutical Companies with strategic analysis and advice, development of economic models, preparation of the Pricing and Reimbursement application, in accordance with the new requirements, submission and follow-up of the procedure, including attendance to negotiation meetings with the Authority.

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