Lessons Learned From Denmark's Biosimilars Success

Among European nations, Denmark has had some of the greatest success with leveraging biosimilars to reduce cost burdens on its healthcare system, and during the fifth DIA Biosimilars Conference, held October 22 to 23, 2018, in London, United Kingdom, stakeholders heard directly from Dorthe Bartels, MSc, on how Denmark has achieved its strong biosimilar uptake.

Bartles has served as the strategic advisor for pharmaceuticals at Amgros, the national procurement organization for Denmark, for 10 years, and she is responsible for the national biosimilar task force. Bartles explained that Denmark is unique among European nations in that it works with a national tender system to buy all biologic products for hospitals and, also, establishes national guidelines for all biologic use.

When biosimilar filgrastim came to the market in 2009, she explained, “we were surprised…actually, we weren’t prepared, at all. In 2009, it wasn’t a success, but we learned a lot.” One of the key lessons from the rocky start with filgrastim, she said, was that Danish prescribers had low confidence in the European Medicines Agency’s ability to regulate medicines, little faith in the quality of biosimilars, and a disbelief in the extrapolation of indications.

“Since 2009, we have worked a lot with the doctors…because we actually found out that [education] was a big problem. They didn’t believe in the data, they didn’t believe in biosimilars’ introduction to the market. In the setting that we have in Denmark, we are very good at making tenders, but if the doctors don’t believe, we do have a problem.”

Coordinated educational efforts and the preparation of guidelines including biosimilar infliximab before CT-P13’s launch in 2015 meant the nation was able to achieve nearly 100% uptake of biosimilar infliximab within 3 months of it becoming available. “We made this [a] success by preparing implementation in the hospitals. Everybody who could be involved, we talked with,” and “the new guidelines were just in time for the product come to the market.”

Given the strong education provided on CT-P13, she said, gastroenterologists and rheumatologists actually recommended switching to the biosimilar infliximab because of their confidence in the product’s data and their understanding of the potential benefits to the healthcare system.

Both of these product launches, Bartles said, taught her task force important lessons. Crucially, guidelines should be in place 1 to 2 years before biosimilar come to the market to allow for education and acceptance. It is also key to make sure that a biosimilar developer can provide enough supply to meet Denmark’s needs if it wins the tender. “We are aware that we are small country, but we are very forceful that we need the product day 1,” she said, adding that, in some circumstances, more than 1 supplier of a therapy may be necessary to mitigate possible supply issues.

Practical concerns should also be addressed early: in some cases, Danish information technology systems may not be able to handle more than one option for a given product, so systems may need updates. “We need to make all of this very practical,” said Bartels, so that everyone can prepare in advance in order to have a launch-day introduction.

This year, Bartels said, Denmark is looking forward to the implementation of biosimilar adalimumab and the cost savings that it could bring. “Now we have adalimumab…we are totally prepared. Hopefully we can roll it out from the middle of November,” she said. In rolling out biosimilar adalimumab, “To make a small effort with a lot of people...we can gain this very huge amount of money.”