Medicines for Ireland Calls for Policy Overhauls to Encourage Biosimilars

While the European experience with biosimilars is often hailed as a model that the United States could benefit from following, some EU member states continue to grapple with policy barriers that limit biosimilar uptake. Medicines for Ireland, an industry group representing generic and biosimilar manufacturers, has issued a new report that claims that Ireland’s policies are keeping the nation from benefitting from €25 million (approximately $29 million) in annual savings to its national health system.

The report claims that as of January 2018, biosimilars had an approximate 2% market share for biologic therapies in Ireland, despite the fact that, as of the report’s date, 38 biosimilar products are approved for use in the European Union. Among the products with the lowest market share are biosimilar etanercept, with 1% of the market, and biosimilar insulin glargine, with just 0.2% of the market.

According to Medicines for Ireland, the Irish government must enact key policy measures if the uptake of biosimilars is to improve. In addition to such familiar suggestions as undertaking an awareness campaign to educate patients and providers about biosimilar therapies, the report calls for financial incentives to encourage biosimilar prescribing, particularly at the hospital level: gainsharing would allow hospitals to undertake switches to biosimilar drugs and retain a portion of the savings achieved, and quotas, which would set targets for biosimilar prescribing, would be beneficial in “creating a culture of cost consideration.”

Additionally, Medicines for Ireland suggests doing away with Ireland’s current mandatory price reductions for branded products when competitors enter the marketplace; currently, under a national agreement with the Irish Pharmaceutical Healthcare Association, when a generic or biosimilar drug is launched, the innovator product’s price must be discounted by 30%. Eliminating this mandated price drop could spur greater competition among new market entrants, the report states.

Finally, the report took aim at the national government, which has not yet delivered its promised National Biosimilar Policy. In August 2017, the nation’s Minister for Health published a consultation paper, with an open comment period, on the development of a new approach to biosimilars.

The paper put forth a variety of policy options, including prescribing biosimilars to new patients, switching stable patients to biosimilars, undertaking educational programs, implementing tendering programs, setting reference pricing guidelines, and limiting drug companies’ interactions with educational institutions or physicians. Medicines for Ireland’s report calls on the government to enact the new national policy in a timely way to allow for a more coherent approach to these therapies.

“With affordability now a key concern in respect of ensuring Irish patients have access to the medicines they need when they need them most,” said Owen McKeon, chairperson of Medicines for Ireland in an accompanying statement, “the Department of Health, Government, and wider medical community cannot afford to continue to ignore opportunities for further savings.”