The introduction of a biosimilar drug into the Irish market will save the Health Service Executive (HSE) millions of euro this year alone.
In September Biogen’s Benepali became the first biosimilar approved for the Irish market since the signing of a new drug pricing agreement in July.
Industry sources said earlier this week that the price cut meant the two drugs would now cost the same, raising fears that Enbrel, already established in the market, would smother the rival Biogen treatment’s chances of competing.
However, the HSE said it was receiving an additional rebate from Biogen for using its Benepali drug, a factor that makes it “more advantageous from a cost-saving perspective”.
“Benepali now offers a very significant opportunity for Irish healthcare professionals to assist the HSE in delivering millions of euro of savings which can be used to support service provision,” a HSE spokesman said.
Scale of rebates
The HSE does not disclose the precise scale of rebates it receives from drug companies. However, industry sources had said the State had lost between €4 million and €5 million by the delay in reducing Enbrel’s price. That indicates that the HSE could expect to make savings of up to €5 million on just this one drug between now and the end of the year.
The HSE spokesman took issue with concern expressed by the Healthcare Enterprise Alliance – which represents manufacturers of generics – that the terms of the new pricing agreement effectively amounted to “biosimilar blocking” as the 30 per cent price cut imposed on high-profile branded drugs facing new generic competition would make it economically non-viable for a new biosimilar to enter the market.
“These statements in the view of the HSE are not consistent with the empirical evidence of biosimilar entry to Etanercept [the active drug in both Enbrel and Benepali] and the resultant net pricing terms that are more cost-advantageous to the State,” the HSE said.
Where a generic medicine is a cheaper identical “copy” of a branded traditional small-molecule drug, biosimilars are “me-too” versions of modern, large-molecule complex biologic medicines.
The nature of biologics means biosimilars cannot be identical to them, but to be licensed they must show no meaningful difference in safety, purity or potency from the original drug.