Minister for Health to publish consultation paper on biosimilar drugs

Minister for Health Simon Harris will publish a consultation paper on the use of biosimilar drugs in the next few weeks as the Government looks for ways to save money in the health budget.

Mr Harris said he believed the increased use of biosimilar medicines offered one option to free up resources.

Biosimilars are cheaper versions of off-patent biologic medicines that have no clinically meaningful differences from the originals in terms of safety, quality and effectiveness.

The Minister said the bill for high-tech medicines had jumped from €170 million in 2005 to €590 million last year, and was up almost 10 per cent last year alone.

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“It is no good for [the pharma] industry having these products that can improve outcomes for patients if we cannot afford it,” Mr Harris told a conference hosted by the Health Enterprise Alliance (HEA), a lobby group for the generic drug and biosimilar sector, on Wednesday.

He added that the European Union needed to look at levers, including joint procurement, to try to rein in spending on medicines.

He also acknowledged that it has been a challenge for biosimilars to gain acceptance from medical professionals in Ireland.

Poor biosimilar use

The conference heard that Ireland has the second poorest figure for biosimilar use within the EU. The only biosimilar drug introduced to the Irish market since the signing of the Framework Agreement on Supply and Pricing of Medicines last August, the rheumatoid arthritis drug Benepali, sold just three packets by the end of 2016.

The agreement, which is targeting savings of €785 million over four years, mandates a 30 per cent cut in the price of off-patent biologics once a competing biosimilar enters the Irish market.

However, Benepali’s off-patent branded competitor, Enbrel, still sold close to 10,000 packets in the same period, despite being 10 per cent more expensive.

Sandra Gannon, president of the HEA, said the 30 per cent discount on the price of a branded drug in the framework agreement was the "general price entry point for a biosimilar".

“If the originator is the same price as the biosimilar, where is the incentive? There is no incentive for prescribers, most of whom are unaware of the price implications,” she said. “The State has garnered savings [from the drug pricing agreement], but biosimilars have suffered. So, for the next savings to come [from a biosimilar entering the market in competition with a branded drug], why would the biosimilar enter the market?”

National policy

Mr Harris said the Department of Health would publish the first national policy on biosimilars later this year, following the consultation paper. He said policy would be guided by the regulatory agencies and clinicians, but warned that the current situation "cannot go on forever".

“We are looking to encourage more cost-effective prescribing,” the Minister said, adding that securing savings was critical to pay for new drugs and for the health budget.

“There cannot be a disconnect between the role of the prescriber and policy,” he added. “Every euro we save goes back into new drugs and access to new medicines.”

Mr Harris conceded that it had been a “difficult number of days for the health service”, especially on waiting lists.

Responding to criticism of his comment that, as Minister for Health, he felt ashamed at some recent revelations about patients on waiting lists, Mr Harris said: “If people want a Minister to be an HSE spokesman, I’m not it.”

He urged the pharmaceutical industry to back his efforts to tempt the European Medicines Agency, which regulates all drugs in the EU, to relocate to Dublin from London post-Brexit. He said such a move would provide 900 jobs and up to 30,000 professional visitors a year. Moving to Dublin would benefit industry by ensuring there was no slowdown in the work of the agency, he said.