by Robert Galbraith
ROME, Feb 9 (APM) - A billion euros fund dedicated to paying for hepatitis C drugs announced by the Italian government will be used to fund other medicines as well, it has emerged, as experts also heard the country's plan to tackle the infectious disease is now seriously under threat.
The Italian provision for the one billion euros be used to pay for new hepatitis C treatments over the next two years (APMHE 40811) was already 500 million euros less than originally planned and now conference delegates in Rome have heard the remaining one billion will also be used to pay for other therapies.
The country's plan to eradicate hepatitis C was referenced during the event at the health ministry late last week, which was devoted to all aspects of policy and to highlight the challenges of providing a uniform service.
There was consensus that new drugs are cost-effective treatments but the upfront spend made it very difficult for the national health service to afford them, many speakers warned.
Francesco Saverio Mennini, professor of health economics at Rome’s Tor Vergata university, said the government has made clear the 1 billion euros will be used to pay for all innovative new treatments, not only hepatitis C drugs.
This was confirmed later in the conference by the health ministry’s pharmaceutical and medical devices chief, Marcella Marletta who said the government will provide 400 million euros in 2015, with a further 100 million euros coming from innovation funding generated by generics savings, and 500 million euros in 2016.
“The funding will be used to pay for other innovative drugs such as those to treat Alzheimer's disease and targeted oncology therapies. However, the vast majority of the finance will be spent on hepatitis C drugs,“ she told the conference.
Several speakers said they hoped the cost of hepatitis C treatments in Italy will fall under a joint procurement fund being set up by some EU member states. (APMHE 41371)
The conference also heard that prices are expected to fall as competition increases with Gilead’s Sovaldi (sofosbuvir), the only new hepatitis C drug available in Italy
Medicines agency AIFA has authorised reimbursement of Janssen Cilag’s Olysio (simeprevir) although pricing still has to be announced (APMHE 40517). The agreement struck with the regulator specifies that the company’s older hepatitis drug Incivo (telaprevir) will now be excluded from reimbursement.
AbbVie has also now started reimbursement negotiations with medicines agency AIFA for ABT-450/ritonvavir+ombitasvir+dasabuvir, an industry source at the conference told APM.
Mennini predicted the arrival of these and even more advanced therapies will have a significant impact on costs. He said: “Over the next three to five years the reimbursement costs will fall to around one third or even a half of what they are today.”
Massimo Colombo, gastroenterology professor at Milan’s Università degli Studi, echoed the hope that prices in Italy will fall. He said the arrival of AbbVie’s therapy in the U.S. had led to the prices of new hepatitis C drugs falling by as much as 50% there.
However Colombo warned it will still be very difficult to eradicate hepatitis C in Italy. He stressed that this would not necessarily be because of the costs but more from the difficulties in preventing HCV infection and identifying new patients quickly enough.
Several speakers highlighted the need to generate savings elsewhere by more appropriate drug prescribing. Pierluigi Russo, head of drug policy and strategy at medicines agency AIFA, gave an example of what might be achieved.
He said 2% more appropriate prescribing of gastro-protector drugs would generate enough resources to treat 7,000 more hepatitis C patients. Russo suggested that this demonstrates there are ways for Italy to make hepatitis C treatments sustainable for the national health service.
Antonio Gasbarrini, head of the gastroenterology department at Rome’s Università Cattolica del Sacro Cuore di Roma, highlighted the lack of national plan as the biggest concern. He said: “There is still no sign of a document on national policy which is very important for a number of reasons, not least defining the costs of treatments and how they will be provided in the different regions.”
He described as imperative the need for an epidemiological analysis to be conducted and incorporated into a national plan. This would help calculate the number of patients in Italy and allow for the urgency of their cases to be assessed. He said at the moment estimates of how many patients should be treated vary between 300,000 and 1.5 million.
Massimiliano Conforti, vice president of the hepatitis C patients’ group, EpaC Onlus, said a national plan is essential if uniform access is to be provided throughout Italy. He warned that four regions still have not identified the specialist centres to prescribe new hepatitis C drugs. Until they do, there is no access to Sovaldi in those regions.
Conforti said: “A national plan is the biggest priority because it will specify the national policy on prevention of hepatitis C infections, the distribution of resources between the regions and how patients are to be diagnosed and selected as the most urgent cases requiring treatment.”
A former Basque country health minister, Rafael Bengoa Renteria, who is now director of the Deusto Business School, warned that a national hepatitis C plan needs to be comprehensive if it is to be effective.
He said Spain is trying to develop one because of problems which have arisen from significant regional differences which make providing uniform access very difficult.
Bengoa Renteria gave Scotland's national plan as an example of one which provides for effective and fair provision of hepatitis C drugs. “Scotland is a good example because its national plan was drawn up after a broad consultative process, it is outcome driven and supported by serious investment,” he told the conference.
He said Scotland’s policy provides for early detection of HCV-infected patients, ensures good training of professionals in the health service and effective clinical management of treatments.
Bengoa Renteria suggested several other countries, such as France and Australia, have also drawn up effective national hepatitis strategies. The countries that have not done so will find it very difficult to make treatments effective, affordable and provide uniform access, he warned.
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