MILAN, Dec 10 (APM) - The Italian government is planning to introduce an amendment to a law undergoing parliamentary scrutiny to provide 1.5 billion euros of special funding to pay for new hepatitis C drugs over the next two years.
The rush to settle funding plans has been prompted by the publication of the official prices agreed with Gilead for Sovaldi (sofosbuvir) in the statutes record, Gazzetta Ufficiale, on Friday (APMMA 40714).
The drug has been priced at 45,000 euros for the 84 tablets required for a twelve-week course of treatment. But medicines agency AIFA specified that Sovaldi will be sold at an undisclosed obligatory discount to public health bodies and hospitals.
Only treatment for the most urgent cases will be reimbursed. Patients who decide not to wait, or do not qualify, for national health service treatment will be able to have the 12-week therapy at the end-user price of just over 74,000 euros.
The actual reimbursement costs of the drug are therefore still not known and may vary according to the terms of agreement between AIFA and Gilead. The decision to keep this information reserved may be so other countries do know what price was agreed in Italy which had unsuccessfully called for joint EU action.
In September, ahead of an EU health ministers’ summit, Italy’s health minister, Beatrice Lorenzin, suggested there should not only be joint action on pricing but also perhaps pooled funding for innovative medicines. (APMMA 39801)
However, during question time in parliament in early November, the Italian health minister admitted a coordinated European strategy might not be possible and announced her intention to set up an “ad hoc fund” for hepatitis C treatments in Italy.
In Brussels, in early December, an EU council meeting ended without proposals for the coordinated action sought by Italy and France after other member states, including Germany and UK, opposed such a move. (APMMA 40642)
On Wednesday, La Stampa was one of several newspapers to say an amendment will shortly be introduced in a package of budgetary measures known as the Stability Law to provide funding for new hepatitis C treatments.
According to the paper, Lorenzin has already agreed with the finance minister the total of 1.5 billion euros and has only to draft the relevant legislation to make it possible. The Stability Law is in the final stages of the parliamentary approval process and is subject to confidence votes to make sure it goes through.
The government believes that a part of the resources provided for hepatitis C treatments can be recouped through savings on patients who are cured of the disease.
A compassionate use programme started by Gilead in the summer, after it called for a pause in Sovaldi pricing negotiations, is to be closed, AIFA announced in a statement earlier this month.
The regulator said the company has agreed to continue providing Sovaldi free of charge to patients who have already completed the application process by December 15, the date when the programme officially ends.
By the end of November, that last time official figures were available, 894 patients had been accepted for the compassionate use scheme, around 62% of the people who had applied to join it.
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