A policy designed to help the HSE save millions of euro on its drug bill has yet to be published almost 18 months after a consultation process closed.
The Government has had a strategy in place since 2017 to target 50 per cent of prescriptions in hospitals of biosimilars – "copycat"drugs with no clinically meaningful differences from high-tech patented biologic medicines.
However, there has been no announcement of plans for a similar regime elsewhere in the medicines budget.
The failure to deliver a money-saving policy two years after the plan was first announced comes against a backdrop of ongoing budgetary pressures in the health service.
A massive overrun on the cost of building the new children’s hospital is likely to exacerbate this.
Though a capital project, the scale of the additional money required to build the hospital means the entire health budget is likely to come under even closer scrutiny.
The Government spends more than €280 million a year on high-tech biologic medicines – new, innovative and generally more expensive therapies, sometimes targeting conditions for which no other therapy is available – according to Medicines for Ireland, which represents producers of generic and biosimilar drugs.
Biosimilars are available for some of the most widely used drugs in the Irish health system.
These include the inflammatory drug Humira, which represented the single biggest cost in the HSE drug budget before its patent expired last year, and arthritis medicine Enbrel, also among the big items on the medicines bill.
But, according to Medicines for Ireland, biosimilars account for just €17 million of HSE spending, giving them market share of just six per cent.
The lobby group argues the failure to introduce a policy on biosimilars and improve access for competing drugs has deterred many of the pharma companies specialising in these therapies from bringing their cheaper drugs into the Irish market ina move that could lower drug costs for the HSE.
There are 53 biosimilar drugs approved by European regulators. Just 11 are on sale in the Republic.
In the UK, the NHS issued guidance that 90 per cent of new patients should be treated with the best-value medication within three months of a biosimilar coming to market.
If the price made it competitive, that could still be the originally patented medication.
For patients already in therapy, at least 80 per cent should move to the best value product, the NHS advised.
Other countries, particularly in Scandinavia, have adopted a similar active targeted approach.
While biosimilars for Enbrel have just 1.3 per cent of the market in the State, they account for 58 per cent of the UK market and 82 per cent in Norway.
Biosimilar competition for another inflammatory disease drug, Remicade, accounts for 90 per cent or more of the market in Britain, Denmark and Norway but just 28 per cent in Ireland.
Medicines for Ireland chairman Owen McKeon, who is country manager for generics drug producer Mylan, urged the Minister for Health Simon Harris and the industry to recognise the value of biosimilars to the Irish health service and the economy.
“Increased use of biosimilars are part of a critical, long-term approach needed to medicines in Ireland to ensure sustained and enhanced patient access to quality medicines.”
In an answer to Kerry Fianna Fáil TD John Brassil last month, Mr Harris said his department and the HSE were "engaging in a number of initiatives which will endeavour to lead to better access to medicines for patients, value for the taxpayer and the cost-effective provision of medicines in Ireland".
But he had no word on the publication timeline for a biosimilars policy, beyond saying that responses to the consultation were still being considered and he expected the department “will make progress in this regard in 2019”.
