Press review

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Italy close to allowing therapeutically equivalent drugs to compete in same tenders

MILAN, 9 Nov (APM) - The Italian government is considering introducing a measure to allow drugs which are judged to be therapeutically equivalent for specific diseases, including biosimilars, to be put into competition with each other in the same tenders, according to Tuesday’s Il Sole 24 Ore.
The paper said it understands that such a provision would only be for products used in hospitals or sold directly to health bodies by pharma companies. Regions would be able to apply to the scientific board at medicines agency AIFA to have homogenous therapeutic classes approved for the tenders.
The measure would be deliberately framed to exclude pharmacy-distributed drugs so that regions could not put all generics into therapeutically equivalent tenders, the paper said.
In the same article, Il Sole 24 Ore gave details of how the government intends to change reimbursement budgets by settling outstanding payback which is still owed to regions (APMHE 60480). According to the paper, it is preparing for a gradual transition to a system where companies cover overspending according to market share rather than based on sales of individual products.
An extensive revision of AIFA’s pricing formulary may be another provision in the legislation whose passage is linked to the 2019 budget law, Il Sole 24 Ore said.
The idea would be to create a system based on the cost of treatment for different therapeutic categories rather than the prices of individual products. This would allow comparison between treatment with a drug still covered by patent and an off-patent one.
However, the paper stressed that it is still not clear whether this is an alternative to the measure allowing competition in therapeutically equivalent tenders, or something that would be introduced alongside.

Italy will lose pharma investment if R&D tax credit is cut - Chiesi

Chiesi has warned that a decision to cut the R&D tax credit will mean Italy misses out on valuable pharma investment, Il Sole 24 Ore reported on Tuesday.
Alberto Chiesi, the company’s chairman, suggested Italy was already lagging behind other European countries in incentives for pharmaceutical and biotech research. “Italy introduced a tax credit law and now they want to halve the amount. It was already at the lowest levels in Europe but this will mean it has no effect,” he told the paper.
Chiesi also criticised the approach to Italy’s patent box, which has failed to have a single approval for a pharma company. He described it as “discrimination" against the industry. “If this attitude goes on, there is no doubt that investment in research will be diverted to other European countries and not come to Italy,” he warned.
The company’s CEO, Ugo Di Francesco, stressed the need to keep pace with other countries. “The trials are now all international, with competitive recruitment going on between the various countries,” he told the paper.
On the other hand, Di Francesco insisted that Italy will remain at the heart of the company’s operations. He said investment in R&D will amount to 20% in coming years and the focal point of its drugs development will continue to be Italy.

293 scientific bodies authorised to issue medical guidelines

The health ministry has published a list of 293 scientific bodies which will be authorised to issue guidelines to be used by doctors and health operators, Il Sole 24 Ore reported on Thursday.
A law passed in March 2017 provided for an official register to be drawn up so that no responsibility can be attributed to staff if guidelines have been followed in a treatment.
The legislation states: “If an adverse event has occurred due to lack of knowledge, the punishment is excluded as long as the recommendations provided for by the guidelines as defined and published in accordance with the law are respected,” the paper reported.

Doctor fined for prescribing non-reimbursable treatment

A doctor has been fined for prescribing a drug for a treatment which is not paid for by the national health service, La Gazzetta del Mezzogiorno reported on Sunday.
Clasteon (clodronate) is only reimbursed in Italy when used to treat Paget’s disease or bone cancer but it is also used off-label for osteoporosis, the paper said.
Guglielmo Facchini, a doctor from Molfetta in southern Italy, prescribed the drug for off-label use using a ‘red’ prescription pad which indicates that it has to be reimbursed. The cost for the national health service was around €56,000.
Facchini, who is known as the “illegal immigrants’ doctor” after announcing that he will treat all migrants regardless of their legal status in Italy, pleaded guilty. The court recognised that he had acted in the interests of the patient rather than to profit himself. It ordered Facchini to pay only half of the reimbursement costs as a fine, around €23,000.
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