Legislative updates in France and Italy

Legislative updates in France and Italy


Price negotiations for early access programmes

During a recent EUCOPE members meeting in Brussels, the following findings were reported:

French Social Security Financing Law (PLFSS) 2020

The PLFSS 2020 was promulgated in December 2019, with changes impacting Recommendations for Temporary Use (RTUs), Temporary Authorisations for Use (ATUs) and biosimilars. Conditions will be relaxed for RTUs, which can now be used even if another drug is licensed for the indication if the RTU is deemed to ‘meet the patient’s needs’. However, nominative ATUs can only be used when not prescribing the drug would have serious patient consequences, and a drug’s efficacy and safety must be strongly presumed. In addition:

  • The Government can now issue a maximum number of nominative ATUs.
  • The drug subject to the nominative ATU cannot have been granted marketing authorisation for another indication or have been granted a cohort ATU.
  • The Government will now also determine the price (compensation) for the nominative ATU. No further details are available on how price will be decided.

As for biosimilars, among other changes, automatic substitution by pharmacists is no longer permitted. Previously substitution was permitted by law since December 2013 but had not been implemented in the absence of a decree.

Italian price and reimbursement decree

Publication of a new decree in 2020 is anticipated to result in the following changes:

  • Early access drugs (‘648’) will be subject to price negotiation with AIFA, which was not previously the case. The same applies to C/C(nn) (non-reimbursed) drugs. It is unclear how this price negotiation will be conducted.
  • AIFA will publish the reasoning for any negative P&R decisions.
  • There will be a new template for the AIFA dossier, with several new sections.

However, given recent leadership changes within AIFA, the decree publication and release of practical guidance are likely to be delayed. In addition, the final details of the decree may differ from those detailed above, making the precise nature of the changes difficult to predict.

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