MILAN, 10 May (APM) - The health minister, Giulia Grillo, has warned pharma to make good its promise to settle all outstanding payback or face action from the government, according to Quotidiano Sanità on Thursday.
Pharma is committed to paying €2.3 billion to regions in outstanding payback which was frozen after companies took legal action questioning the amounts they had to pay. The payback is owed to cover overspending of the hospital drugs budget between 2013-2018. Pharma is required to cover half of any deficit (APMHE 61523
Citing a report on news agency Adnkronos, the online publication said the deadline is fast approaching. “I hope this agreement will be respected: the terms are about to expire and I hope I have not been mistaken about the good faith of our interlocutors. In the coming days, or even hours, we will know for sure,” the health minister was quoted as saying.
Grillo said she is aware the industry associations Farmindustria and AssoGenerici are making efforts to ensure all goes to plan. But she added: “Needless to say, any failure to comply with the rules would result in action by the government to achieve the results we expect anyway.”
In response, Farmindustria’s president, Massimo Scaccabarozzi, confirmed that work is continuing to make sure all outstanding payback is settled. “I believe we are very near to the end, even though we cannot know for sure because it is something that concerns individual companies. But we are very close,” he was reported as saying.
Scaccabarozzi said that discussions are already underway to draft a new system once the outstanding debts have been fully paid. He said it will provide a better balance between different reimbursement budgets.
Italy could eradicate HCV if funding is sustained
Italy could eradicate hepatitis C through its programme to provide universal access to direct-acting antivirals but only if all people infected with the virus can be discovered and treated, Il Messaggero reported on Monday.
The paper said that the drugs have been used to eliminate HCV in more than 96% of patients. Italy has treated more than 180,000 patient so far.
The country has already reached the first objective of the World Health Organisation’s eradication plan - a more than 65% reduction in HCV-related deaths, Stefano Vella, director of global health at the national health institute ISS, was quoted as saying.
He suggested that Italy can continue towards eradication but only if numbers of patients being treated remains high. It is estimated that around 20% of infected people do not know they are carrying the virus.
News agency ANSA highlighted warnings on Tuesday that special funding used to pay for direct-acting antivirals, which have been recognised as innovative, will start to be phased out from the end of this year.
Real world evidence key to biological/biosimilar switches
The importance of real world evidence in decisions about switching patients from biological drugs to biosimilars was highlighted at a recent conference, Il Sole 24 Ore reported on Monday.
The mid-year meeting of the International Society of Pharmacoepidemiology (ISPE) held in Rome in April included a discussion about interchangeability of originators and biosimilars.
It was noted that medicines agency AIFA’s second position paper confirmed that biosimilars can be considered as interchangeable with their reference originators.
This led to a discussion at the conference on the importance of having the right data sources and methodological approaches.
A series of observational studies using data from multiple administrative databases were shown to generate evidence in the real world setting. They were described as being very useful and functional to support regulatory decisions at national and local-regional level on biologicals, including biosimilars.
Falling sick after flu vaccine not grounds for damages claim, court rules
Falling sick after have a flu jab is not grounds for claims unless there is a direct link to the vaccine, Il Sole 24 Ore reported on Thursday.
The Cassazione, Italy’s supreme court, said there must evidence from scientific literature if legal action is to be valid. The case involved a woman who contracted Guillain Barrè syndrome after being vaccinated. She sued the GP who had administered the flu vaccine.
A lower court had rejected the claim saying there was no evidence of a link. The Cassazione upheld this decision.
Are drug shortages caused by industry?
Drug shortages may be caused by industry as they seek to push more costly products, Quotidiano di Sicilia suggested in a comment piece published on Friday.
It cited the example of pizotifen describing it as an effective treatment for migraine which affects around 15% of the global population. It costs around €2.12 a month or €25.44 a year.
However, it has the “misfortune” to be produced by the same company (Novartis) which recently registered a new treatment, Aimovig (erenumab), Quotidiano di Sicilia explained. It costs €5860 a year.
It may be a coincidence, but pizotifen is increasingly difficult to find in parts of Italy, the paper said. So much so that local health bodies have been forced to go to Spain for supplies.