Press review


Confidentiality in reimbursement contracts essential if Italy wants sustainable drug prices - Gilead’s country manager

MILAN, 22 June (APM) - Confidentiality in reimbursement contracts is essential if Italy wants sustainable drug prices, Gilead’s country manager, Valentino Confalone, told Il Sole 24 Ore in an interview published on Tuesday.
He stressed that secrecy is the only way for lower prices to be agreed in different countries. “These are confidential mechanisms that actually make it possible to price the drug in a sustainable way for the national health service,” he told the paper.
“Prices that are not confidential cannot be offered to the authorities in individual countries. Through these mechanisms we have returned several hundred million euros in this country,” he added.
In the same interview, he said his company is working with medicines agency AIFA to find ways to include the long-term benefits and avoided costs in assessment of drugs for reimbursement (APMHE 58599).
The paper asked the Gilead CEO if he thinks that managed entry agreements, which have been the mainstay of Italy’s cost-effectiveness system, will be superseded by partnerships with regulators for different drugs.
He stressed that, for the moment, that is not possible although agreeing that it is definitely the direction to go in the future. “Payment by results is fantastic on paper but the day-to-day management is very complicated especially for the management of all the registries which have accumulated over time. There needs to be a way to have a simpler management otherwise it all become so complex that the benefit is lost from sight,” he said.

Health minister sees price/volume reimbursement deals as useful

The new health minister has highlighted price/volume reimbursement contracts as a useful way to keep spending under control, Il Sole 24 Ore reported on Wednesday.
“There are many tools which should be used as much as possible and ‘price/volume’ is one of them. It is a very important structural regulation that can help us to manage hospital pharmaceutical spending for those drugs that have obtained new therapeutic indications and risk exponentially increasing state spending,” she said after a meeting with regional health officials.
Regional governments are pressing for action on payback, the paper said. They claim that €1.4 billion was owed by pharma companies to cover overspending in previous years but €900 million still has not been paid. They also want to follow the example of Piedmont which is looking to have generics and biosimilars used wherever possible.
Piedmont’s health assessor, Antonio Saitta, said that competitive procurement tenders have generated price reductions of up to 90%. "Manufacturers must find a way to accept the rules of competition which exist in all sectors,” he explained.

Italy on target to reduce HCV-related deaths by 65% within four years

Italy is on target to reduce deaths related to hepatitis C infection by 65% within four years, Quotidiano Sanità reported on Wednesday.
However, to achieve this objective, it will need to improve screening so that hidden populations of patients can be found and treated, the online publication said.
The WHO’s HCV eradication programme foresees a 65% reduction in deaths by 2030. The president of AIFA, Stefano Vella, who was part of a study into HCV infection published in the journal Liver International, has stressed the need to keep numbers of people being treated high, the online publication said. To do that intensive screening has to be done in parts of the population at the highest risk.

Dompé completes €30 million expansion of production site in L’Aquila

Dompé has completed a €30 million expansion of its production site in L’Aquila, news agency Adnkronos reported on Thursday.
The investment was part of an incentives programme with Invitalia, Italy’s national agency for inward investment and economic development, which contributed an additional €9.4 million.
The biotechnology site’s production includes nerve growth factor (NGF), Sergio Dompé, the group’s chairman, told the news agency. The site also includes an R&D centre which is developing drugs for unmet meeds in ophthalmology, oncology, diabetes and organ transplantation.

Regulators must identify real innovation in costly drugs - AIFA chief

Regulators need to identify real innovation before agreeing to reimburse very costly drugs, the head of the medicines agency AIFA said in a comment piece published by Tuesday’s Quotidiano Sanità.
Mario Melazzini highlighted the need to be able to provide accelerated access to products with added therapeutic value to patients.
“However, companies that are successful in the authorisation process of an innovative molecule tend to demand prices that are sometimes unsustainable for health budgets, justifying them with the need to amortise investments in research and development of innovative products which have a high risk of failures,” he said.
That is why regulators need to establish what is really innovative so they allocate the necessary resources to products which provide significant added therapeutic value, he said.



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