by Belen Diego
MADRID, Jan 23 (APM) - Top Spanish ministry officials have been discussing centralised purchase of new hepatitis C agents with their equivalents in other EU members at least since September, APM has learned.
Sources close to the ministry who asked not to be identified told APM on Friday a series of low-profile but high-level EU meetings on the matter have been taking place for months, as countries pave the way for potentially ground breaking multi-state centralised purchasing.
While there is still no guarantee this will go ahead, Spanish health minister, Alfonso Alonso went public on Spain’s part in the move earlier this week, although he would not disclose details. (APMMA 41178)
Alonso’s comment that EU states are to work together on centralised purchasing of direct acting antivirals in hepatitis C are not the first, after AIFA head Luca Pani said key regulators were to work together to reduce the price of Sovaldi.
While not a single big-five regulator would publically support this - and some do not have any legislative interest in pricing - (APMMA 39261) this time the idea appears to have traction. There was no indication regulators were involved in the scheme Alonso alluded to.
Gilead Spain would not comment on Alonso's observations and it is not known if companies have been approached by any EU buying consortia.
Asked about which countries have joined the negotiations during a meeting with Spanish entrepreneurs in Madrid on Thursday, Alonso refused to specify. APM understands officials from at least one or two of the biggest EU members have attended talks.
Alonso cautioned centralised purchases are complex and a lot of effort has to be put into this. He noted domestic centralised purchase schemes in Spain have been difficult to implement, but added that it has been done before and will help in finding a balance between innovation and sustainability.
A number of centralised purchases of drugs have been suspended in Spain in the past, then partially reactivated (APMMA 36990).
Contradicting Spanish medical association OMC, which called prices “abusive” (APMMA 41149), Alonso said research is expensive and innovation has to be paid for.
However, he said there are a number of schemes, such as risk-sharing formulae and centralised purchase of drugs, which can make these treatments affordable.
He also said in order to negotiate better more information about the actual number of infected patients and specialists’ recommendations are key, and that is the reason why he decided to appoint a panel to provide the ministry with this information.
Gathering real-life data on hepatitis C drugs before taking any decision on pricing will be core to the ministry’s strategy, as La Rioja health chief told APM late last week. (APMMA 41112)
Alonso’s plan goes beyond hepatitis C drugs. He is looking for the move to apply to other innovative drugs in the future. He said the issue of how to pay for new hepatitis C drugs should not be seen as a problem but as an opportunity to find new ways to allow innovation into the Spanish market.
Alonso’s support for multi-member-state drug purchase comes despite the country’s seeming success in swiftly getting direct acting antivirals on the market using discounts and other devices to buffer the costs.
Spain has approved for reimbursement Janssen's Olysio (simeprevir), Merck & Co's Victrelis (boceprevir), Gilead's Sovaldi (sofosbuvir), Bristol-Myers Squibb's Daklinza (daclatasvir), Gilead's Harvoni (sofosbuvir+ledipasvir) and AbbVie's Exviera (dasabuvir) and Viekirax (ombitasvir+paritaprevir+ritonavir) under risk-sharing schemes over the past six months (APMMA 40951).
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