An independent researcher said the results should spark a re-evaluation of some medicines, but do not necessarily mean patients are being harmed.
Italy spent more than €1 billion in 2022 on dozens of medicines that may do patients more harm than good, a new analysis found.
Prescrire International, a French nonprofit, appraises drugs that have been authorised in France or the European Union since 2010. Every year, the group determines whether the risks or side effects of these medicines outweigh the clinical benefits, and in 2023 identified 115 such “drugs to avoid”.
The year before, 56 of these drugs were being reimbursed by the Italian health authority, with a €1.15 billion price tag, according to researchers from the Italian Medicines Agency (AIFA).
“It is a quite high number,” Fabrizio Gianfrate, a professor of health economics at the University of Ferrara who was not involved with the study, told Euronews Health.
Prescrire’s team, which is made up mostly of doctors and pharmacists, analyses research on medications and patient outcome data, compares the drugs with standard treatment options, and assesses their known and suspected negative effects.
They also monitor which other medicines are available that have a better “harm-benefit balance” for patients.
Even so, inclusion on Prescrire’s list doesn’t necessarily mean the drugs are hurting patients, given new medicines face extensive scrutiny from the European Union’s medicines regulator before they’re authorised.
However, sometimes problems come up down the line, and the drugs are reassessed.
“I take the information to say, ‘Oh, my God, what’s happening?’ Let me check,” Gianfrate said.
“It is a way for stimulating a re-evaluation, because some [of Prescrire’s] evidence may be wrong, some may be right, but we have to check”.
The AIFA did not respond to a Euronews request about whether it would take action in response to the findings.
What kinds of medicines were prescribed?
The analysis, published in the journal JAMA Network Open, shows that 15 medicines comprised 75 per cent of Italy’s spending on drugs to avoid, and 80 per cent of their consumption by patients.
They included five cardiovascular agents, three type 2 diabetes medicines, four antidepressants, two cancer and immunosuppressive drugs, and a monoclonal antibody to treat osteoporosis.
Overall, Italians took the 56 drugs to avoid at a rate of 86.2 doses per 1,000 people every day, making up 6.9 per cent of all reimbursed drug consumption.
Gianfrate noted that cutting out the identified drugs wouldn’t necessarily save Italy the €1.15 billion it spent on them in 2022.
Many people taking those medicines would likely be moved to other drugs, which could be even more expensive.
“That patient will be a cost-generator anyway,” he said.
While the report focused on Italy, patients across the EU have access to at least some of these medicines, given pharmaceutical companies can either ask a national regulator or the European Medicines Agency (EMA) to greenlight their drug.
Once that happens, national and regional authorities decide on pricing and reimbursement for the drug, medical groups make recommendations about how it should be used, individual doctors write prescriptions, and patients ultimately decide whether to take them.
That means there are a lot of checks in place in case the drug doesn’t work as it should, Gianfrate said.
“After all the steps and the filters … there is the single prescriber,” he said. “If a product doesn’t work, it is not prescribed”.
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