Market Access Overview
Step 1 – Companies submit their product dossier to AIFA – Agenzia Italiana del Farmaco (Italian Medicines Agency), specifying whether they wish to be considered an innovative medicine. Non-orphan products cannot submit until they have achieved Marketing Authorisation, however orphan products may submit before this point.
Step 2 – The dossier is reviewed by the CTS – Comitato Scientifico e Tecnico (Scientific Technical Committee) who issue a decision as to whether the product is innovative, and whether it is reimbursable for general use (class A), hospital use (class H) or is not eligible for reimbursement (class C).
Products in class C will not proceed to the pricing negotiation stage and are free to set their own prices subject to reasonability checks by AIFA and the Ministry of Health, a mandatory 50% reduction when selling to hospitals, and Law no. 149 which permits price increases on a 2-yearly basis only.
Step 3 – The dossier for class A and H products will be reviewed by the CPR – Comitato Prezzi e Rimborso (Pricing and Reimbursement Committee) who conduct pricing negotiations to agree a base price for the product. Innovative medicines usually receive speedier decisions and more favourable pricing outcomes, and the CPR is able to offer financial-based or outcome-based agreements in order to achieve pricing decisions for products with high prices or limited data regarding efficacy and safety. By contrast, generic medicines will not be approved unless they are at least 20% cheaper than the originator product. After the base price and associated conditions have been agreed, final approval must be given by the AIFA directorate and a Pricing and Reimbursement Decree will be issued.
It is worth noting that the base price will rarely be the final price achieved by pharmaceutical companies, unless the submission concerns an innovative product. Obligatory discounts will normally be applied at a later stage, and the payback system ensures that certain pharmaceutical or hospital overspends are partly compensated for by pharmaceutical companies.
Step 4 – Approved drugs will not necessarily be added to regional formularies; SSRs – Servizio Sanitario Regionale (Regional Health Services) and ASLs – Azienda Sanitaria Locale (Local Health Authorities) have complete discretion in this matter, aside from with regards to innovative medicines which are automatically included. If the product is added to the regional formulary, SSRs and ASLs will also decide the applicable level of patient co-payments, if any.
MAP provides insights on:
- Pricing – Criteria for pricing negotiations, P&R process timelines, pricing for generics
- Reimbursement – Orphan drugs reimbursement, HTA for orphan drugs, new innovation assessment process, re-assessment of innovations, automatic renewals
- Early Access – Applications through Law 648/96, revision of law 648/96, law 648/96 approved applications, self-certification for the AIFA 5% fund, patient access to orphan and life-saving drugs, overview of the AIFA 5% fund applications