Italy’s regions have agreed to make innovative drugs which have been approved for reimbursement available to all patients who need them as soon as the reimbursement decision takes effect.
It is hope that the deal, agreed between the central government and Italy’s regions and autonomous provinces, will bring to an end the country’s “post-code lottery,” under which cash-strapped regions have often delayed for some time the addition of new drugs approved by the national drugs agency (AIFA) to their hospital formularies, for economic reasons.
The decision, which was agreed by the Permanent Conference for Relations between the State, Regions and Autonomous Provinces in Italy, takes effect immediately. It will not apply to all new drugs approved for reimbursement, only those which AIFA’s scientific and technical committee has judged to be important innovations or to have innovative therapeutic potential - particularly those which are shown to satisfy currently-unmet clinical needs - and these will now have to be made available by the state and regional provinces as soon as the assessment is announced.
Procedures for the drugs’ inclusion on hospital formularies should commence within 30 days of AIFA beginning its examination of an application for reimbursement, the agreement also states. However, the regions and provinces will be able to challenge a reimbursement decision by AIFA if they do not agree that the product meets the criteria for reimbursement, and the matter will then be taken up by the agency’s science and technical panel.
Hospital formularies will be monitored by a permanent board whose members will include representatives of the regions and autonomous provinces, AIFA and the Ministry of Health, and any changes to hospital formularies must be notified to AIFA within 15 days.
Analysts at IHS Global Insight say the decision represents “a major breakthrough” for patients, as the regions and provinces have varied considerably in their uptake of AIFA-approved drugs; they generally add them to their formularies eventually but the process can take as long as 250 days, they note.
It is also potentially very good news for the pharmaceutical industry but, the analysts caution, many hospitals in Italy have enormous debts, much of which relates to drug expenditures. The sector’s drug spending deficit currently stands at 2 billion euros and reached 4 billion euros in 2009, and the requirement that hospitals must now make the most innovative new products available will like push these debts up still further.
However, IHS Global Insight also points out that AIFA has said it plans to apply closer monitoring to spending by the regions and provinces on expensive new drug treatments, with the aim of saving at least 600 million euros a year, and also that the prices of many cancer drugs are likely to be cut in 2011.