by Belen Diego
MADRID, Feb 13 (APM) - The Spanish region of Catalonia will propose ‘rethinking’ of the country’s healthcare budget in upcoming meeting with the ministry to avoid shortage of funds for innovative therapies such as Gilead’s Sovaldi (sofosbuvir), APM has learnt.
In a telephone interview on Thursday, Antoni Gilabert, head of Catalonia’s pharmaceutical services, said the region’s suggestion will be heard in the upcoming meeting of the council of regions, which gathers regional health chiefs with the Spanish minister to co-ordinate health policies. The council meets approximately every six weeks and the most recent meeting took place on January 15.
Gilabert said special funds such as those used in the past to pay off regions’ debt with pharma (APMMA 35846) are useful, but only temporary patches in sight of what is coming. “Unless the government plans ahead and assigns healthcare budgets accordingly, we will see shortage of funds every time innovative therapies come to the market”, he said.
In January, the ministry said real-world hepatitis data will be collected before targeting spend on specific drugs. (APMMA 41112)
José Ignacio Nieto, health chief of La Rioja region, told APM on Thursday special funds have their drawbacks. “If a special fund to pay for new hepatitis C drugs had been assigned beforehand, it would have most likely been already spent by now”, he said.
Catalonia has been the first Spanish region to implement risk-sharing schemes for new drugs. Gilabert said there are 14 of these deals enforced in the region so far.
Based on experience, he said a pay-per-performance scheme could be right for sofosbuvir. “Even with the drug’s efficacy results, which are extremely high, this kind of deal can be considered because they could vary in patients different from those included in clinical trials”, he said.
In 2014, Catalonia announced a pay-per-performance deal for Merck KGaA Erbitux (cetuximab) in colorectal cancer. Under the terms of the agreement, the company has to refund the cost of the therapy if patients do not meet certain treatment goals (tumour shrinkage) (APMMA 37278).
The idea would be to reach a similar agreement for Sovaldi, or other new hepatitis C drugs, based on viral load, Gilabert said.
Pending a definite report by a panel including representatives of patients associations, specialists and health authorities, so far the ministry of health has published a guidance on the use of sofosbuvir which compels regions to use the drugs in severe disease only.
However, one of the authors of the guidance told APM in November it would be ultimately each region’s decision whether to allow wider use or not (APMMA 40497).
Last week, Catalonia sent its own guidance to hospitals in the region leaving up to specialist to prescribe the drug when considered convenient and guaranteed reimbursement in all cases under physicians’ judgment. The announcement was made by Gilabert.
Gilabert told APM: “It is not a matter of running ahead of the ministry, our specialists needed guidance and we offered it following recommendations of scientific societies”.
Health authorities from other Spanish regions, like Castilla y León and Andalusia, have said clinical criteria will prevail when deciding how to use new hepatitis C treatments and financial concerns will be addressed afterwards.
Late last week, health minister Alfonso Alonso said there were over 4,500 hepatitis C patients treated with new drugs across the country at the end of January.
Spanish regions, which are the ones who buy drugs in the country, may contribute to make the figure higher.
Speaking at the Bio CEO & Investor conference in New York on Tuesday, Gilead's chief operating officer John Milligan, said the firm expects the number of patients receiving Sovaldi to increase dramatically this year (APMMA 41422).
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