Available cost-effectiveness data for marketed biosimilars Considering the more mature biosimilar market in Europe , switching to the first biosimilar molecule introduced in this region in 2006 – granulocyte colonystimulating factor ( G-CSF ) – has resulted in increased patient access , improved adherence to management recommendations , and reduced costs , with an estimated annual savings of 85 million Euros across 17 EU countries in 2011 alone . 7 In the US , biosimilars have had a slower market penetration . A cost-efficiency analysis comparing four distinct administration scenarios ( considering cost of medication only , patient self-administration , treatment initiation by health care provider followed by self-administration , and full treatment administration by health care provider ) for use of G-CSF in the prophylaxis of febrile neutropenia showed that use of the biosimilar was associated with significant savings compared with the reference products . 8
For the first monoclonal antibody ( mAb ) approved by the EMA for the treatment of rheumatoid arthritis , a biosimilar version of infliximab , budget-impact analyses were conducted for several countries and showed that a switch from the reference product could lead to substantial cost reductions , in the order of hundreds of millions of Euros , and increased market access . 7 Real-world studies in Japan and Norway revealed similar price reductions for the biosimilar , in the range of 67 % to 69 %, compared with the originator . A plethora of evidence , including health economic data , has to be taken into account in the development of guidelines for the treatment of rheumatic diseases , with costs as an important component in the assessment of this evidence . In the UK , the National Institute for Health and Care Excellence explicitly recommends rheumatologists to initiate treatment with the least expensive option . 9
Budget-impact analyses are commonly used by payers to develop reimbursement strategies at the national , regional , and local level . However , there is a scarcity of high-quality data on the affordability of biosimilars , as revealed through a review of published budget impact analyses of biosimilar fusion proteins and mAbs . Some of the limitations identified included a narrow range of cost parameters and sensitivity analyses , absence of adequate validation , and use of assumptions about biosimilar use and prices , instead of evidence . In terms of value , the traditional costeffectiveness and cost-utility analyses incorporating QALY data may not be ideal for biosimilars , as they are supposedly ‘ similar ’ to the originator in efficacy and safety ; other methodologies are then needed to determine value , using parameters that go beyond cost such as efficiency of the supply chain and inventory maintenance , patient support and reimbursement assistance provided by the manufacturer , and broader patients access , and price competition and effects . 10
A recent systematic literature review described the economic impact of switching from a reference product to biosimilar for reasons not related to efficacy or safety showed decreased costs with biosimilars despite the variability between studies due to different designs , patient populations , and price discount rates . However , the estimates were restricted to pricing information and did not include other factors such as rebates , health care resource utilisation , or costs associated with monitoring of side effects . 11
Conclusions In summary , the generation of high-quality and comprehensive outcomes data sets on the effectiveness and safety of biosimilars , as well as impact on budgets and cost savings , should be strongly encouraged . Payers and decision makers need to consider the long-term benefits of these medicines if significant and sustained savings are to be achieved , and physicians should take cost into consideration when defining treatment plans . Ideally , the discounts resulting from a free and competitive market should approach those seen with generics ; however , given the high cost of biologics , the potential for cost saving is already substantial even if this does not occur in the long term . 3
Manufacturers certainly have a role in disseminating the economic and budgetary advantages of biosimilars , because payers do not always provide physicians with the evidence needed to show the benefits to the health systems . However , physicians might mistrust the accuracy of this information , 1 hence the importance of better-designed health economic studies and more robust data .
References 1 IMS Institute for Healthcare Informatics . 2016 . Delivering on the potential of biosimilar medicines . The role of functioning competitive markets . www . medicinesforeurope . com / wp-content / uploads / 2016 / 03 / IMS-Institute-Biosimilar-Report- March-2016-FINAL . pdf ( accessed July 2019 ). 2 Simoens S . Biosimilar medicines and costeffectiveness . Clinicoecon Outcomes Res 2011 ; 3:29 – 36 . 3 Mestre-Ferrandiz J et al . Biosimilars : How can payers get long-term savings ? PharmacoEconomics 2016 ; 34:609 – 16 . 4 Moorkens E et al . Policies for biosimilar uptake in Europe : An overview . PLoS ONE . 2017 ; 12 : e0190147 . 5 Canadian Agency for Drugs and Technologies in Health . 2018 . Health technology assessment , reimbursement trends , and market outlook . https :// cadth . ca / sites / default / files / pdf / ES0317 _ biosimilars . pdf ( accessed July 2019 ). 6 Quintiles IMS . 2017 . The impact of biosimilar competition in Europe . www . medicinesforeurope . com / wp-content / uploads / 2017 / 05 / IMS-Biosimilar-2017 _ V9 . pdf ( accessed July 2019 ). 7 Gulacsi L et al . Biosimilars for the management of rheumatoid arthritis : economic considerations . Expert Rev Clin Immunol 2015 ; 11 : S43 – 52 . 8 McBride A et al . Cost-efficiency analyses for the US of biosimilar filgrastim-sndz , reference filgrastim , pegfilgrastim , and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced ( febrile ) neutropenia . J Med Econ 2017 ; 20:1083 – 93 . 9 Dörner T et al . The changing landscape of biosimilars in rheumatology . Ann Rheum Dis 2016 ; 75:974 – 82 . 10 Simoens S et al . Assessing the value of biosimilars : A review of the role of budget impact analysis . Pharmacoeconomics 2017 ; 35:1047 – 62 . 11 Liu Y et al . Economic impact of non-medical switching from originator biologics to biosimilars : A systematic literature review . Adv Ther 2019 ; doi : 10.1007 / s12325-019-00998-3 ( Epub ahead of print ).
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