在不限制创新的情况下降低药品成本

Research Highlights | April 2021 © NORC 2021 www.norc.orgbrand biologics’ ASP.6As a comparison, the FDAestimates that nonbiologic generics are sold at a price of80-85 percent below brand-name medication.7While thebiosimilars’ ASP is typically lower thanbrand biologics,brand manufacturers can compete by increasing theirrebates to encourage payers to maintain preference for thebrand biologic on their formulary.8A study in 2019 foundthat U.S. health plans covered biosimilars as preferred inonly 14 percent of coverage decisions.9Table 1.Biosimilars Launched in the United StatesLaunched Biosimilars (Winter 2020)Reference BiologicMvasi (bevacizumab-awwb)AvastinZirabev (bevacizumab-bvzr)AvastinRetacrit (epoetin alfa-epbx)Epogen/ProcritOgivri (trastuzumab-dkst)HerceptinHerzuma (trastuzumab-pkrb)HerceptinTrazimera (trastuzumab-qyyp)HerceptinKanjinti (trastuzumab-anns)HerceptinOntruzant (trastuzumab-dttb)HerceptinUdenyca (pegfilgrastim-cbqv)NeulastaZiextenzo (pegfilgrastim-bmez)NeulastaFulphila (pegfilgrastim-jmdb)NeulastaZarxio(Filgrastim-sndz)NeupogenNivestym (filgrastim-aafi)NeupogenInflectra (Infliximab-dyyb)RemicadeRenflexis (infliximab-abda)RemicadeTruxima (rituximab-abbs)RituxanRuxience (rituximab-pvvr)Rituxan6Amgen Biosimilars. (2020, September).2020 BIOSIMILAR TRENDS REPORT(Rep.).7U.S. Food and Drug Administration. (2018, June 1). Generic drugs: Questions & Answers. Retrieved March 10, 2021, from https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers#28Carioto, J., & Mirchandani, H. (2018). Barriers and potential paths for biosimilars in the United States.9Chambers, J. D., Lai, R. C., Margaretos, N. M., Panzer, A. D., Cohen, J. T., & Neumann, P. J. (2020). Coverage for biosimilars vs.reference products among UScommercial health plans.JAMA,323(19), 1972-1973.10Carioto, J., & Mirchandani, H. (2018). Barriers and potential paths for biosimilars in the United States.11Niyogi, S., Adolph, N., Pashchinskiy, A. (2021). Biosimilars in the U.S.: Reimbursement and Impacts to Uptake. IQVIA. https://www.iqvia.com/-/media/iqvia/pdfs/us/white-paper/biosimilars-in-the-us-reimbursement-and-impacts-to-uptake.pdf?&_=1617122442873.12U.S. Food and Drug Administration. (2020, December 17).Biosimilar product information. U.S. Food and Drug Administration.https://www.fda.gov/drugs/biosimilars/biosimilar-product-information.13Dean, E. B., Johnson, P., & Bond, A. M. (2021). Physician, practice, and patient characteristics associated with biosimilar use in Medicare recipients.JAMANetwork Open,4(1), e2034776-e2034776.14Niyogi, S., Adolph, N., Pashchinskiy, A. (2021). Biosimilars in the U.S.: Reimbursement and Impacts to Uptake. IQVIA. https://www.iqvia.com/-/media/iqvia/pdfs/us/white-paper/biosimilars-in-the-us-reimbursement-and-impacts-to-uptake.pdf?&_=1617122442873.15Leonard, E., Wascovich, M., Oskouei, S., Gurz, P., & Carpenter, D. (2019). Factors affecting health care provider knowledge and acceptance of biosimilarmedicines: a systematic review. Journal of managed care & specialty pharmacy, 25(1), 102-112. Research Highlights | April 2021Most biologic and biosimilar drugs are currently coveredunder the medical benefit and reimbursed via the “buy-and-bill” method, in which providers purchase thephysician-administered drug and are reimbursed at apercent-of-charge or ASP plus a markup.10Some healthplans have begun to shift distribution for these products tospecialty pharmacies and thus have begun to cover themthrough the pharmacy benefit.11This reduces providerpayment incentives to use one product over another andincreases plans’ ability to control product selection via theirformulary. Future biosimilars are expected to increasinglybe self-administered and covered via the pharmacybenefit.12Beyond these structural limitations, some stakeholderscontinue to question physicians’ willingness to usebiosimilars andpatients’ willingness to take these products.Researchers have tried to examine the patient, physician,and practice characteristics associated with biosimilar use.One study found that the practice setting and hospitalownership status had the largest association with biosimilarusage, with patient characteristics weakly associated withbiosimilar uptake.13Another study finds that biosimilar use ismost likely to grow when its relative reimbursement ratio ishigher than the brand biologic across settings of care.14Numerous surveys of providers were conducted prior to2018, before many biosimilars had launched in the UnitedStates. Many of these surveys were based in Europe andhad very small sample sizes. A systematic review offactors that affect health care provider knowledge andacceptance of biosimilar medicines found that “an overalllack of biosimilar familiarity in U.S. and European healthcare settings accompanies concerns about biosimilarsafety, efficacy, extrapolation and interchangeability.”15In this rapidly shifting market, new and morecomprehensive survey data and qualitative research canyield insights about