by Robert Galbraith
ROME, Feb 6 (APM) - A joint procurement platform for buying new hepatitis C drugs is to be launched by several EU member states after months of talks about how pricing of treatments could be coordinated, according to Italian health ministry officials.
The comments come after APM reported in January that officials from EU states have been involved in discussions about centralised purchasing of new hepatitis C agents since September. (APMMA 41209)
At a conference, ‘HCView, a window on hepatitis C policies”, held at the health ministry in Rome on Thursday, delegates heard that Italy has been driving the process as part of its EU presidency.
In his address, Ranieri Guerra, director general of healthcare prevention at the Italian health ministry said: “Italy joined a joint-procurement platform about a month ago. It is still being set up but, once operational, it will benefit Italy and its provision of hepatitis C drugs.”
Speaking to APM on the sidelines of the conference, Marcella Marletta, the head of pharmaceutical and medical devices at the health ministry, provided more details.
She said the starting point had been a debate instigated by health minister Beatrice Lorenzin at a European health ministers’ meeting held in Milan at the end of September as a part of Italy’s EU presidency. (APMMA 39801)
Marletta said: “The debate continued as officials from different countries told each other about how their health system were coping with the arrival of costly new therapies, especially hepatitis C treatments. Agreement was reached to set up a joint procurement platform in December.”
The only countries confirmed as being part of the project so far are Italy, Spain and Portugal but there are others. “Some member states made clear that hepatitis C drugs pricing is not a priority for them so they do not feel the need to be part of joint-procurement. But for some smaller states this is the only way they will be able to afford to pay for new hepatitis C drugs,” Marletta said.
Some big member states, such as Germany and UK, have resisted the moves towards joint procurement arguing that they are big enough to negotiate their own deals with pharma and expressing concerns about sovereignty (APMMA 40642).
Marletta stressed the work to set up the platform has only just begun and it is too early to say whether the joint procurement platform might be used for centralised purchasing in other therapeutic areas. The health ministry official said: “There is no precedent and so we are having to start pretty much from scratch,” she said.
Italy could provide the model for negotiations in pricing of drugs for the joint-procurement platform, according to an official from medicines agency AIFA.
Pierluigi Russo, head of drug policy and strategy at the regulator, described the joint-procurement platform as “very important step” during his address to the conference. He said. “Joint procurement in Europe could make a significant contribution to having a more sustainable price for the (Italian) national health service.”
Russo pointed to the reimbursement agreement reached with Gilead for its hepatitis C drug, Sovaldi (sofosbuvir), the only one which has been approved for reimbursement in Italy, as being a possible benchmark in Europe.
Neither the terms of the agreement nor the reimbursement cost for the health service have been revealed. All that is known is it is a complex, conditional reimbursement system which involves a sliding scale whereby the price is lower the more patients that are treated.
“When we arrive at joint procurement, people could be grateful to Italy because we probably achieved the best agreement in Europe,” Russo said.
In January, Spain’s health minister told his parliament that centralised purchasing of hepatitis C drugs in Europe is likely to include price per volume, maximum spend thresholds or risk sharing schemes (APMMA 41178). All these are used by AIFA in its reimbursement agreements for innovative drugs.
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