Following the publication of the new Decree relevant to the negotiation of Price and Reimbursement of medicinal products (Decree 2nd August 2019), AIFA has started a public consultation on the new draft practical guidelines on the preparation and requirements for the Pricing and Reimbursement dossiers of medicinal products.
The new proposed draft guidelines provide detailed indications on the information to be included in the dossier.
Main important updates to the P&R dossier contents and template concern:
- Information on the Company’s manufacturing capability and ability to manage possible unexpected events and guarantee an adequate supply
- Description of clinical trials according to a new outline and specific tables
- High focus on comparators/therapeutic alternatives, both in terms of clinical outcomes and in terms of therapy cost
- Information on commercialization, consumption, reimbursement and prices, including negotiation agreements, of the concerned product in other EU Countries
- Impact on the NHS expenditure consequent to the inclusion of the product in early access schemes as per law 648/96 or to the commercialization of the product in Cnn class
- Information on patent
- Details on any public contributions/incentives received for R&D activities
Involved parties are invited to submit comments on the draft guidelines to AIFA within 30 September 2020 and then the final guidelines will be consolidated and adopted within the month of October.
Updates on the final version of the guideline will be provided as soon as available. Stay tuned!
Regulatory Pharma Net is ready to support pharmaceutical companies with strategic analysis and advice, development 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.