Lessons Learned From Denmark's Biosimilars Success
Lessons Learned From Denmark's Biosimilars SuccessAmong 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.
Kelly DavioOctober 24, 2018 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, th e 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, âwe were surprisedâ¦actually, we werenât prepared, at all. In 2009, it wasnât a success, but we learned a lot.â One of the key lessons from the rocky start with filgrastim, she said, was that Danish prescribers had low confidence in the European Medicines Agencyâs ability to regulate medicines, little faith in the quality of biosimilars, and a disbelief in the extrapolation of indications.
âSince 2009, we have worked a lot with the doctorsâ¦because we actually found out that [education] was a big problem. They didnât believe in the data, they didnâ t believe in biosimilarsâ introduction to the market. In the setting that we have in Denmark, we are very good at making tenders, but if the doctors donât believe, we do have a problem.â
Coordinated educational efforts and the preparation of guidelines including biosimilar infliximab before CT-P13âs launch in 2015 meant the nation was able to achieve nearly 100% uptake of biosimilar infliximab within 3 months of it becoming available. âWe made this [a] success by preparing implementation in the hospitals. Everybody who could be involved, we talked with,â and âthe new guidelines were just in time for the product come to the market.â
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 productâs 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 Denmarkâs needs if it wins the tender. âWe are aware that we are small country, but we are very forceful that we need the product day 1,â she said, adding that, in some circumstances, she said, more than one 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. âWe need to make all of this very practical,â 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. âNow we have adalimumabâ¦we are totally prepared. Hopefully we can roll it out from the middle of November,â she said. In rolling out biosimilar adalimumab, âTo make a small effort with a lot of people...we can gain this very huge amount of money.â
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