MILAN, Jan 12 (APM) - The Italian government has been urged to end access delays to Gilead’s hepatitis C drug Sovaldi (sofosbuvir) after reports that it is only available in two regions more than a month after reimbursement was authorised.
In a Sunday statement, a politician from prime minister Matteo Renzi’s Partito Democratico party, Riccardo Gelli, called on the government to clarify what steps regional administrations have taken to provide the drug to the most seriously affected patients. He said that he intends to file written question in parliament for the health minister, Beatrice Lorenzin, on the matter.
He described the arrival of the drug in Italy as a “very important opportunity”. But he also warned there are still many regions which have not even identified the specialist centres which will be authorised to administer the drug and treat patients.
According to Gelli, it is only being administered in two regions, Lazio and Lombardy, and the delays risk creating tensions among patients and their families as they fight to have access. “That is why I have asked the government to take action quickly so all regions start providing the drug to the patients who most need it,” the politician said.
He added that there are up to 500,000 HCV-infected people in Italy, of which around 80,000 are deemed to be serious cases. Medicines agency AIFA authorised reimbursement of Sovaldi in September (APMMA 39920) but formal approval was only granted at the beginning of December (APMMA 40714).
The official reimbursement price was put at 45,000 euros for a treatment course of 84 tablets but AIFA specified that Gilead has agreed to provide the drug at a discount. The real reimbursement cost has therefore not been revealed. Patients deciding to go privately will have to pay 70,000 euros for a treatment course.
According to Gelli the reimbursement agreement foresees 50,000 of the most serious patients being treated. He described the price as “very favourable”, specifying that it will fall the more patients that are treated.
He said Sovaldi is “a revolutionary medicine” which can cure people of the disease and will save money over the long term by reducing the number of liver transplants and many of the ancillary costs which result from the disease. That is why he wants the government to act quickly to provide quick access.
An HCV patients’ group, EpaC, has also urged the authorities to press regional administrations to improve access to the new drug. In a Friday statement, the organisation warned that there will be an angry reaction if all regions have not made arrangement for the Sovaldi to be made available to the most serious cases by the end of January.
EpaC said the agreement with Gilead means that the average reimbursement cost per patient is likely to be between 20,000-30,000 euros for a treatment course. In December, parliament approved provisions for a special innovation fund of 1 billion euros to be set up to pay for new hepatitis C treatments. This was 500 million euros less than originally planned.
EpaC said AIFA has already identified which patients are to be treated and that it has been inundated with calls from people wanting to know if they qualify. Others have telephoned to have advice on whether they can take legal action to make the government provide access.
The hepatitis C group expressed hopes that the arrival of other new hepatitis C drugs, which are expected to be approved later this year, will mean that everyone who needs them will have access. The government has also stated that it expects the prices of new hepatitis C treatments to fall as more of them arrive on the market.
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