Within the last few months, the significant changes proposed to the Italian pricing and reimbursement (P&R) system have begun to materialise. These reforms seem to be driven by a desire to limit drug expenditure, and when combined with a national drive to increase transparency within the P&R process, may result in the most significant changes to occur in the last twenty years.
What has changed
The major change to the P&R process is that the Italian Medicines Agency (AIFA) will now consider the additional clinical benefit (similar to the P&R processes in France and Germany) against the standard of care. This is a separate assessment to the innovation rating system. As part of the submission, the manufacturer must indicate the expected level of additional therapeutic value relative to currently available treatments.
The five benefit rating categories, which are determined by the Technical Scientific Committee (CTS), are:
- Maximum: Greater efficacy demonstrated on clinically-relevant outcomes than therapeutic alternatives; curative or significantly modifies disease progression
- Important: Greater efficacy demonstrated in clinically-relevant outcomes; reduces risk of complications; better risk vs. benefit ratio; modifies disease progression in patient subpopulation; provides quality of life benefit
- Moderate: Greater efficacy in some subpopulations of patients or on surrogate outcomes; limited impact on quality of life
- Poor: Greater efficacy demonstrated on non-clinically relevant outcomes; minor product advantage (e.g. route of administration)
- Absent: no additional benefit demonstrated
In the case where a drug is assessed not to provide additional therapeutic value over the comparator(s) selected by the CTS, the manufacturer must offer a price equal to or lower that of the comparator(s) to avoid non-reimbursement. If a comparator is not available, then reimbursement can be approved if the proposed price is appropriate based on the clinical and economic evidence provided.
Currently, it is not fully clear how the additional benefit rating determined by the CTS will be used by the Pricing & Reimbursement Committee (CPR) to negotiate price premiums.
What else has changed?
A number of other changes that may impact the market access process in Italy have also been announced. Previously, the P&R process was initiated by manufacturers. Now, AIFA can begin negotiations independently. There are three scenarios in which AIFA may initiate negotiations:
- When the reimbursement of the new product is expected to have significant impact on healthcare expenditure (not yet defined)
- Where the drug is yet to go through the negotiation process
- C-class drugs where the manufacturer previously failed to reach an agreement on price
The submission process will now take twice the duration (180 days), and a stop-clock (which can be requested by manufacturers) has been introduced. Additionally, manufacturers can now request a scoping meeting with AIFA, which is anticipated to be similar to the National Institute for Health and Care Excellence (NICE) scoping meeting process and will be an opportunity to engage in preliminary discussions with AIFA.
Dossier requirements have also been updated, to cover five distinct categories:
- T1: New chemical entities
- T2: New fixed-dose combinations or formulations
- T3: Generics or biosimilars
- T4: Revision of reimbursement conditions (e.g. patient population)
- T5: Special procedures (e.g. Class C drugs)
All dossiers must include the expiry date of the patent on the active ingredient, three years of sales forecasts and marketing costs (not two years) and self-certifications attesting production capacity and the ability to continue supply following unexpected events.
Additionally, AIFA will now require pharmaco-economic analyses (e.g. cost-effectiveness, cost-utility), modelling both the direct and indirect costs, as part of T1 dossiers: failure to provide such an analysis will have to be justified.
Finally, there is also a new simplified version of the P&R process for generics and biosimilars, with several steps being removed to streamline the process.
While the HTA process in Italy is now better defined, it may make the process more challenging as the incremental therapeutic value and economic value (in terms of cost-per-QALY) must now be demonstrated to secure a reimbursed price. Additionally, a number of questions regarding the new process remain e.g. the relationship between additional benefit rating and the opportunity for price premiums. Any company considering an Italian reimbursement submission should monitor the evolving situation carefully.
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