MILAN, Jan 28 (APM) - Italy’s regionalised health system is obstructing access to Gilead’s Sovaldi (sofosbuvir) in hepatitis C and only five regions have started providing the drug with just 30 patients treated, according to the health minister Beatrice Lorenzin who has again raised the prospect of coordinated European action to make innovative therapies affordable.

In a joint Tuesday statement, the minister and the head of medicines agency AIFA, Luca Pani, commented on the use of medicines report, published by AIFA on Monday (APMMA 41240), which gave a detailed breakdown of pharma spending in the first nine months of 2014.

Lorenzin cited divergences in regional provision of healthcare as one of the main concerns to emerge from the report. She said: “Territorial fragmentation is a feature of our country which creates difficulty in providing uniform access to drugs throughout the land. The AIFA data also show there are too many differences among the regions in appropriateness of prescriptions.”

Lorenzin noted Italy has created a special one billion euros fund to pay for new treatments, especially hepatitis C drugs. She said that, for the first time, the funding will be managed by the health ministry rather than the finance ministry. It is aimed at eradicating hepatitis C from Italy, the minister added.

However, regional fragmentation of policy is undermining the national plan and access has been limited since the drug became available in early December. “Despite the efforts of the government, so far only 30 patients in five regions have been treated which confirms the difficulty of transferring centrallly-planned action to the local level.”

In his comment, AIFA’s director general, Luca Pani, highlighted the importance of increasing the hospital drugs budget. He said the current ceiling of 3.5% of total national health spending is too low.

Pani suggested it will not be enough to pay for “very expensive new drugs which will come onto the market in 2015 and in the following years which, in the majority of cases will be dispensed by public health structures”.

The most recent projections are for a 1.2 billion euros overspend on hospital drugs in 2014 (APMMA 40792). A former head of the medicines agency, Nello Martini, who is now in charge of R&D at the national medicines academy, recently predicted there will be 3.8 billion euros of overspending on drugs used in hospitals between 2014-2016. (APMMA 41163)

In her comment, health minister Lorenzin repeated her call for coordinated international action on funding for innovative drugs. She stressed the need to prepare for the arrival of new, costly therapies to treat diseases such as Alzheimer’s and Parkinson’s.

In September, during Italy’s EU presidency, Lorenzin proposed joint European action on hepatitis C drug prices and even suggested an EU fund could be created to pay for innovative drugs (APMMA 39801).

In December she admitted, despite movement towards a common approach, that little progress had been made. (APMMA 40642)

However, it has emerged that officials from EU member-state health departments have been meeting for months with a view to forming buying consortia for drugs - apparently driven by the cost of new hepatitis antivirals. (APMMA 41209)

While it is not known if Italy was involved in these talks the Italian health minister showed she remains committed to the idea in her statement. “Managing highly innovative medicines is not just an Italian or a European problem but a global one and western countries need to have common purpose especially when it concerns treatments with very high costs which are to be used for very large patient populations such as in hepatitis C,” she said.

She suggested negotiation of prices at a European level will become “unavoidable” in the future. “It will become a question of reconciling the rights of patients to treatment and maintaining the sustainability of the system. We must be ready to tackle this at a national and international level,” she argued.

Elsewhere, the European parliament on Tuesday heard calls for the European Medicines Agency to be involved in pricing decisions from an adviser to AIFA, Francesco Perrone. (APMMA 41249)

rg/ns