Press review

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Italy has reimbursement deal for Novartis' Kymriah but cannot authorise it because AIFA board is incomplete

MILAN, 19 July (APM) - Italy has agreed a reimbursement contract for Novartis' Kymriah (tisagenlecleucel) but cannot give formal approval to the deal because the board of medicines agency AIFA has too few members to do so legally, according to Wednesday's La Stampa.
The paper said the price of the CAR-T therapies thought to have been agreed at between €150,000-€200,000. The deal is said to be for payment by instalments which will only be made if patients treated survive for at least 18 months.
There has been no agreement for Gilead's Yescarta (axicabtagene ciloleucel), the other CAR-T therapy being discussed at AIFA, the paper said.
Health minister Giulia Grillo suggested recently that there has been divergence in the regulatory pathways for the two drugs. "In one case they tell me that the discussion was very fruitful; in the other, no,'' she told the annual meeting of the industry association Farmindustria (APMHE 63578).
Because of the problems at AIFA, patients will have to wait to be treated until new appointments are made to board, La Stampa explained. AIFA's president, Stefano Vella, resigned last year over the government's migrant policy (APMHE 59445). The regions choice to replace him, Antonio Saitta, was rejected by health minister Grillo.
This prompted another member of the AIFA board, Sergio Venturi, to resign in May (APMHE 63011) leaving the agency in regulatory limbo. According to La Stampa, a new board is due to be reappointed by the end of July. However, it is uncertain whether the it will be in place before the summer break which would mean it will be unable to assess the CAR-T dossier until September or later, the paper said.
This will mean further delays for patients. Before treatment can start, AIFA has to publish the criteria for accrediting centres to administer the CAR-T therapies.
For now, patients can only have access to the new CAR-T therapies by being recruited for a trial or having compassionate access. Around 30 patients have been treated in this way and 50% of them are in remission, La Stampa said.

Health minister highlights pharma policies as one of achievements

The health minister has highlighted pharma policies among the achievements in her first year in office, Il Sole 24 Ore reported on Wednesday.
Giulia Grillo made the comments during a parliamentary hearing to review health policies over the last 12 months. A settlement which has allowed €2.4 billion of outstanding payback to be paid to regions was mentioned as one of the most important.
Grillo identified reform of the way that drugs are assessed for reimbursement as another. A measure introducing changes to the way drug prices are determined is ready and will shortly be sent to the regions for approval. A revision of the national medicines formulary is also underway, she told the hearing.

Italy's public, private drugs spending was €29 billion in 2018

Italy's public and private drugs spending was €29 billion in 2018, in line with the previous year, Il Sole 24 Ore reports on Friday.
The figure came from the OSMED Use of Medicines report which was published by medicines agency AIFA on Thursday, the paper said. About 77% of the €29 billion spending was reimbursed by the national health service and pro-capita expenditure was around €482.
The very young and the elderly were identified as accounting for disproportionate amounts of expenditure.
Almost half of children had at least one drug prescription in 2018 while 77% of infants under the age of 12 months also had at least one, AIFA chief Luca Li Bassi told a meeting to present the report. The elderly on average take 6.7 different drugs over the course of a year and account for 70% of daily doses and 60% of spending, he said.

Italy's non-prescription drugs spending rises despite falling volumes

Spending in Italy's non prescription drugs market is continuing to hold up despite lower volumes being dispensed, Quotidiano Sanità reported on Tuesday.
A report from the industry association Assosalute showed volumes of drugs not requiring a prescription falling 2.2% between June 2018 and May 2019. But the value of sales rose 1%, which is an improvement over previous years, the online publication said.
However, Assosalute, said that competition in the sector continues to be fierce, especially where it is with non-drug products sold by pharmacies.

Merck KGaA regains commercialisation rights to Congescor in Italy

Merck KGaA has regained the commercialisation rights to the beta-blocker Congescor (bisoprolol) in Italy, Il Sole 24 Ore reported on Wednesday.
No details were given about the deal. Merck sold the rights in Italy to Congescor to Daiichi Sankyo in 2009 (APMHE 14507).
The drug is used to treat high blood pressure and heart failure, which is the second most common reason for a person being admitted to hospital after childbirth in Italy, the paper said.
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