On 1st August 2019, the text of a new Decree from the Italian Ministry of Health and the Ministry of Economy and Finance that concerns the negotiation of price and reimbursement of medicinal products was approved by the Italian State-Regions Conference.
The decree repeals the previous CIPE provision of February 2001 and introduces some important changes.
The dispositions of the decree apply to:
- The negotiation of price and reimbursement of medicinal products authorized through centralized, mutual recognition, decentralized and national procedures;
- The inclusion of medicinal products in the list provided for by law 648/1996;
- Some specific categories of C/Cnn medicinal products purchased by NHS facilities for public health needs.
Concerning the P&R application, the decree states:
- The need to provide a declaration of the company’s manufacturing capability and ability to manage possible unexpected events that could jeopardize manufacturing and supply,
- The need to quantify any public contributions/incentives received for R&D activities, quantify the economic impact for the NHS consequent to the inclusion of the product in early access schemes as per law 648/96 or law 326/2003, quantify the economic impact consequent to the commercialization of the product in Cnn class and provide information on the patent.
The negotiation procedure is initiated by the company, but it can also be initiated by AIFA:
- In case of drugs whose reimbursement leads to a significant impact on the NHS budget;
- In case of drugs that have never been object of previous negotiation;
- In case of drugs whose previous negotiation ended with collocation in C class (not reimbursed).
The Technical-Scientific Committee (CTS) issues an opinion on the clinical value of the product and on the added therapeutic value in relation with the identified comparator(s). The negotiation is negatively concluded if no clinical superiority on the comparator(s) is identified and the company does not provide an updated proposal with a therapy cost equal to or lower than the comparator(s).
If there is no comparator, the company needs to support the price proposal according to the R&D and manufacturing costs.
The decree introduces the obligation for companies to communicate sales data, revenues, marketing costs and patent status every year to AIFA and highlight any changes to what previously defined.
AIFA can start re-negotiation at any time:
- In case of market changes leading to an increased use of the drug or an unfavourable cost/therapy ratio compared to other alternatives;
- In case new efficacy/safety evidence changes the drug’s place in therapy or significantly resizes the drug’s estimated clinical benefits;
- In case of shortage of the product in the Italian market.
The decree will become effective only after the publication in the Italian Official Journal. A new article will be released by Regulatory Pharma Net as soon as any updates become available. Stay tuned!
Regulatory Pharma Net is available to support pharmaceutical companies with strategic analysis and advice, development and submission of the Pricing and Reimbursement application, follow-up of the procedure and attendance to negotiation meetings with the Authority.