IHS Global Insight Perspective | |
Significance | Italy's regions and autonomous provinces have reached a breakthrough agreement, which stipulates that innovative drugs approved by AIFA for reimbursement will be made available at hospitals across Italy as soon as the reimbursement decision comes into force. |
Implications | This agreement stands to bring an end to the "postcode lottery" for patients in Italy, many of whom have been denied access to treatments for some considerable time because their region has chosen not to add them to their therapeutic hospital formulary. |
Outlook | This agreement will bring considerable improvements for patients, and for pharmaceutical companies producing highly innovative drugs meeting unmet clinical needs, it will mean faster time to reimbursement in Italy's regions. However, a note of caution should be struck concerning the high levels of debts in Italy's hospitals, much of which relates to drug expenditure; the agreement is likely to result in higher expenditure on hospital medicines, as the formularies have been used by hospitals as a means of curbing expenditure. |
An agreement has been made by the Permanent Conference for Relations between the State, Regions and Autonomous Provinces in Italy that is intended to bring about significant improvements in access to innovative drugs approved at the national level by the Italian Medicines Agency, AIFA, in Italy's regions and autonomous provinces. As a result of the agreement, medicines judged by the Scientific and Technical Committee (CTS) of AIFA to represent an "important" therapeutic innovation, or to have innovative therapeutic potential on the basis of the criteria followed by the CTS, are due to be made available at hospitals in all Italian regions and autonomous provinces immediately after reimbursement decisions come into force. The agreement emphasises that when the medicine concerned is the only practical alternative to meet the needs of patients, then there should be no delay in the ability of patients to have access to these medicines.
New Innovative Drugs Must Be Added to Formularies Within One Month
The agreement requires medicines that fall into the categories described to be made available in hospitals across the regions immediately. Furthermore, it calls for the administrative procedures relating to their inclusion in the regional hospital therapeutic formularies to take place within 30 days of the start of the application of a reimbursement decision by AIFA.
Regions Free to Dispute Reimbursement Decisions
Under the terms of the agreement, individual regions and autonomous provinces will be free to dispute the reimbursement decisions made by AIFA, if they should judge that a drug does not meet the criteria to be eligible for coverage under the national health service. In such cases, the regions will be required to inform AIFA, and the matter will be dealt with at the following meeting of the CTS. Representatives from the region that has disputed the reimbursement, as well as representatives of other regions, and ministers will be present at these meetings. Any potential changes to reimbursement decisions adopted by AIFA following these meetings will subsequently be applied to all regions.
Regions Must Inform AIFA of Discrepancies; Regional Formularies to Be Monitored
Regions and autonomous provinces will be required to inform AIFA within 15 days of any updates to their therapeutic hospital formularies, or any decisions that restrict or exclude access to medicines approved for reimbursement by AIFA. Such changes to formularies made by regions will be the subject of meetings under a permanent regional hospital therapeutic formulary monitoring board, which will consist of representatives of AIFA, all the regions, and the appropriate officials from the Ministry of Health. Any decisions taken by AIFA at these meetings will be applicable across all the regions and autonomous provinces.
Outlook and Implications
This agreement is a major breakthrough for Italian patients, who have for years been subjected to a kind of "postcode lottery" in terms of whether or not certain drugs are included on the therapeutic hospital formulary of their region (see Italy: 19 November 2010: Results of Federfarma Study Bring to Light Regional Differences in Access to Medicines in Italy). Although innovative drugs are usually added to these formularies in the end, it can take up to around 250 days before this happens. It should be noted that there are limitations on the scope of the agreement's application; the drugs to which it refers are limited to those assessed by the CTS as representing an important innovation, or having innovative therapeutic potential, and therefore it will not be applied in the case of all drugs approved by AIFA for reimbursement. Particularly, the drugs to which the agreement applies will most often be those that are shown to meet unmet clinical needs; in other words, drugs for which there are no existing alternatives.
This is excellent news for patients, and will also potentially increase sales for pharmaceutical companies, with faster time to reimbursement in the Italian regions likely to result from the agreement. However, it should be recalled that many of Italy's regions have huge hospital debts, a significant proportion of which relate to expenditure on pharmaceuticals. The therapeutic hospital formularies are used by regions as a means of saving money on drug reimbursement; if it is made mandatory to add expensive innovative drugs to the formularies and reimburse these drugs, then these debts are likely to rise even more. However, potential increases in expenditure could be tempered by closer monitoring of regional expenditure on innovative drugs, which AIFA plans to introduce, as well as the possibility of price cuts to many cancer drugs, announced by the director of the agency earlier this year (see Italy: 24 September 2010: AIFA's Drug Policy Co-Ordinator Plans New Regional Monitoring Scheme for Expensive Innovative Drugs in Italy and Italy: 8 July 2010: Cancer Drug Price Cuts Likely in Italy from 2011 As Studies Call Effectiveness Into Question).