The entry of up to 50 innovative and expensive new drugs into Italy’s hospital sector in the coming year could lead to the national authorities refusing to reimburse EU-approved drugs, an expert has warned.
The arrival of the 50 or so innovative new products, many of which will be cancer treatments, could increase spending in the hospital sector by as much as 1 billion euros, Andrea Messori, vice president of the Italian Society of Hospital Pharmacists (SIFO), told the national congress of the Italian Association of Medical Oncologists (AIOM), held in Rome on November 6-8.
This extra expenditure will only worsen the sector’s pharmaceutical spending deficit, which currently stands at 2 billion euros and totalled 4 billion euros last year, he said, and warned that the new wave of extra costs will increase the likelihood that in 2011-12 the government will refuse to reimburse innovative new drugs approved by the European Medicines Agency (EMA), on the grounds of insufficient funds.
A number of new biosimilar products for use in the treatment of life-threatening conditions are also set to come to market in Italy, but these products are expected to produce only modest savings for the hospital system, given that the take-up of already-available biosimilars has been limited and that doctors will be even more cautious about prescribing the new products to treat serious conditions, Mr Messori forecast.
However, he did suggest that extra funding for innovative new hospital drugs could be freed up if spending regulations for medical devices used in hospitals were to be tightened; these restrictions are currently far looser than those for medicines, and spending on hospital-use devices is rising much more quickly than is the case for drugs.
Commenting on Mr Messori’s remarks, analysts at IHS Global Insight point that while EMA-approved drugs currently receive reimbursement in Italy, having been first approved by the national drugs agency AIFA, many Italian regions have their own hospital formularies and may choose, for economic reasons, not to reimburse new products approved by AIFA for some time.
However, they add: “it would be a different matter if AIFA itself were to start blocking reimbursement for new innovative medicines approved for marketing in the EU, although the current economic situation in Italy and the considerable debts in the hospital sector may suggest that this would be a prudent step.”
Business Monitor International (BMI) recently described Italy as “the least attractive” European pharmaceutical market out of 10 surveyed. Its low levels of growth are largely a result of widespread price cuts and shaky levels of economic growth, which translate into insufficient funds for pharmaceutical expenditure, especially for innovative products, it says.
Included in the austerity package unveiled by Prime Minister Silvio Berlusconi in the summer is a planned review of pharmaceutical expenditures in Italy’s regions by AIFA, which will monitor in particular their spending on innovative and expensive new treatments and develop tools to boost prescribing in the regions of cheaper generics, with the aim of making savings of at least 600 million euros a year.
The legislation also introduced a 12.5% overall reduction in the retail prices of generics, to run for six months to December 2010, while from next year the maximum reimbursement paid for generics by the Italian health service will be based on the drugs’ prices across Europe, a development which the government says should save a further 600 million euros annually.