Claudia Garimberti -

In Italy, law 648/96 allows NHS funding for the use of unauthorized medicinal products or for off-label indications of authorized products included in a dedicated list (the so-called “648 list”) created and regularly updated by the Italian Medicines Agency AIFA.

The medicinal products which can be included into the 648 list are the following:

When there is no valid, licensed therapeutic alternative for the concerned serious disease:

  • innovative medicinal products not authorized in Italy but registered in other countries;
  • medicinal products under clinical investigation for which the results of phase II trials are available;
  • medicinal products for a therapeutic indication other than the one approved and for which the results of phase II trials are available.

When there is a valid, licensed therapeutic alternative for the concerned serious disease

  • medicinal products to be used for a therapeutic indication other than the one approved, provided that the concerned therapeutic indication is known and compliant with researches performed by the national and international medical-scientific community, on the basis of criteria of inexpensiveness and appropriateness.

The request for inclusion into the 648/96 list can be submitted by physicians, Scientific Societies, Universities, hospitals, patients’ associations, Technical-Scientific Commission of AIFA, but not by pharmaceutical companies.

AIFA has recently provided a new template to be used for the applications by physicians, Scientific Societies, Universities, hospitals, patients’ associations. 

Moreover, further to the publication of 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”) and of AIFA Resolution no. 1372/2020 (adopting the “Guidelines for the preparation of the dossier supporting the Pricing and Reimbursement application of medicinal products”), it has been established that, in order to be included in the 648 list, medicinal products now need to be subject to a price negotiation with AIFA.

Pharmaceutical companies will therefore be informed by AIFA of any request of inclusion of their products in the 648 list submitted by physicians, Scientific Societies, Universities, hospitals, patients’ associations and will be asked to provide a dedicated dossier and to actively participate in the price negotiation.

 

At Regulatory Pharma Net we are ready to support pharmaceutical Companies with strategic analysis and advice, development of dossiers supporting the inclusion in the 648 list in accordance with the new guidelines, submission and follow-up of the procedure, including attendance to negotiation meetings with the Authority.

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