MILAN, Dec 15 (APM) - Italy is changing its payback rules so companies are required to cover a part of overspending on their own innovative drugs, as the government introduced specialist funding primarily for new hepatitis C drugs.
The health minister, Beatrice Lorenzin, announced on Twitter on Saturday the government has included an amendment in a package of budgetary measures to create a 1 billion euro fund to pay for new hepatitis C drugs.
She thanked the finance minister, Pier Carlo Padoan, for his support in introducing the legislation which had been drafted by her department.
The funding settlement has been prompted by the publication of the official prices agreed with Gilead for hepatitis C drug Sovaldi (sofosbuvir) in the statutes record, Gazzetta Ufficiale, earlier this month (APMMA 40714).
The funding will be available for all innovative drugs although it is to be primarily used to pay for new hepatitis C drugs. A total of 1 billion euros will be provided over two years. This is lower than the 1.5 billion euros originally proposed when details of the plan were announced last week (APMMA 40760).
In a Monday interview broadcast by public broadcaster Rai, the health minister said Italy is aiming to eradicate hepatitis C. She described approval of the amendment as a “beautiful day” for the 1.5 million people infected by the virus.
However, Lorenzin warned the 1 billion euros will initially cover treatment of only the most serious cases. Further on, the minister said prices of the new treatments are expected to fall significantly.
In its amendment, which has been seen by APM, the government explained the need for the fund and the payback changes. It said it wants to promote and support the production of innovative medicines as well as mitigate the effects of overspending on very costly new drugs.
Currently any product, defined as innovative, is paid for through a special innovation fund and attributed an annual budget. If this is exceeded, the company itself is not required to cover the overspend, Instead the rest of the market has to cover it through a payback procedure.
This will now change and the owner of highly-priced innovative products will have to contribute too.
The amendment said: “If the sales of an innovative drug are more than 300 million euros then any overspending by the fund will be covered by 20% of the company owning the commercialisation rights to the product while the remaining 80% will be divided between all companies in proportion to their sales of their non-innovative, on-patent medicines.”
The government said the changes to the payback scheme for innovative drugs are designed to ensure that other companies are not excessively penalised by the approval of reimbursement of costly innovative drugs.
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