Press review

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About 600 patients eligible annually in Italy for Gilead's CAR-T therapy Yescarta after reimbursement green light

MILAN, 15 Nov (APM) - Around 600 patients a year will be eligible to be treated with Gilead Sciences' Yescarta (axicabtagene ciloleucel), according to Tuesday's Il Sole 24 Ore.
The decision of medicines agency AIFA to approve reimbursement of the CAR-T therapy in a 'payment at result' contract was published on Monday (APMHE 65077).
The paper said that Gilead’s country manager Valentino Confalone had predicted in January it would take until the autumn for a reimbursement deal to be worked out in Italy. It comes after more than year of negotiations with AIFA and several months after Novartis' Kymriah (tisagenlecleucel) was approved, it added.
Paolo Corradini, president of the Italian Society of Haematology, described CAR-T therapies as revolutionary because, unlike many new drugs, they are therapies that are intended to cure. He noted that some patients who had been left without therapeutic options are in complete remission five years after being treated.
"We are excited and proud that axicabtagene ciloleucel is to be reimbursed in our country as well: this valuable innovation will bring hope to patients and caregivers who are fighting (the disease)," he said.
He added: "It is the beginning of a revolutionary pathway for oncology because we believe that cell therapy will become an important treatment option for other types of cancer, including solid ones."

Health minister rules out regions taking responsibility for pharma regulation

Health minister Robert Speranza has ruled out regions being allowed to take control of some pharma regulation, Quotidiano Sanità reported on Thursday.
In February, a plan for greater devolution was presented. It included a proposal that some regions be allowed to decide autonomously whether different drugs are therapeutically equivalent (APMHE 61782).
"I believe autonomy is an opportunity but at the same time a risk. The aim of politicians is to find the right balance because rivalry between autonomists and neo-centralists does not serve the country well," Speranza told the hearing.
He made clear pharma is one area which he does not believe can be devolved. "I am inclined to consider any further requests to expand the sphere of regional autonomy, for example, in the pharmaceutical sector, to be very problematic," he said.
He suggested giving regions responsibility for areas currently managed by medicines agency AIFA, such as therapeutic equivalence and payback, would be against the constitution.

Chiesi buys rights to iron chelator deferiprone from Apotex

Chiesi has acquired the worldwide rights for the iron chelator deferiprone, which is indicated for patients with thalassemia, from Canada's Apotex and its U.S. subsidiary ApoPharma, About Pharma reported on Thursday.
The Parma-based group has already been marketing the drug for Apotex. The terms of the deal will see 60 ApoPharma employees joining Chiesi and allow it to open offices in Toronto.
Michael Spino, ApoPharma's president, said the companies have worked together for over 20 years in a partnership for deferiprone. "I look forward to starting this new adventure with Chiesi and exploring how our current ApoPharma team can strengthen Chiesi's plan to develop new drugs in the area of rare diseases," he said.
Ugo Di Francesco, Chiesi's CEO, said: "Deferiprone strengthens our overall range for patients suffering from rare diseases and further consolidates our presence in this difficult area with an innovative and high quality solution."

Zambon opens new life sciences headquarters near Milan

Zambon has opened a new life sciences headquarters at Bresso on the outskirts of Milan, according to Thursday's Corriere della Sera.
The building is an open campus which already houses 25 pharmaceutical and biotech organisations, the paper said. Z-Life, as it has been named, took 426 days to build and was designed by two internationally renowned architects, Michele De Lucci and Carlo Ratti.
Elena Zambon, the company's president, said Z-Life is aimed at bringing new energy to the company's inventiveness. CEO Roberto Tascione added: "Zambon is a company that has a strong propensity for innovation. Z-Life is the concrete expression of our identity: a company able to tackle important global challenges but also one which can preserve the family warmth and human touch in caring for people."

Global initiative to monitor evidence-based heathcare launched

A global initiative to monitor evidence-based healthcare (EBHC) has been launched by an Italian think tank, Il Sole 24 Ore reported on Monday.
Gimbe held a conference in Sicily last week which was attended by more than 200 experts from 33 countries. The meeting identified a number of issues that need to be resolved, the lack of enough good quality evidence, too much ineffectual analysis and difficulties in transferring evidence into clinical practice.
Gimbe hopes Globee (GLobal OBservatory on Ecosystem of Evidence) will help address these difficulties.
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