sizeable rebate from a multi-year contract , a major insurer negotiates a larger rebate with the higherpriced reference product , the insurer may decide to only reimburse the reference product . Similarly , this problem will be compounded if the other payers negotiate separate deals with different biosimilar manufacturers and also decline to reimburse the hospital ’ s preferred option . In fact , payers are already starting to reach agreement with biosimilar manufacturers . For example , Express Scripts has restricted use of Herceptin , and three biosimilars ( Herceptin Hylecta , Herzuma and Ogivri ) and will only reimburse Trazimera and Kanjinti . 8 Ultimately , when both providers and insurers have different preferred biosimilar options , it is likely that the pharmacy will have to stock a wider range of biosimilars to ensure proper reimbursement which increases , rather than decreases the stockholding costs .
Supply chain While the primary goal of cost-effective procurement is designed to ensure high quality products at the lowest possible price , a further and critical factor is the capacity of the manufacturer to maintain a consistent supply chain for their product . As biosimilar manufacturers seek to gain a higher market share , they will enter tendering negotiations in several different markets . However , if manufacturers that are unsuccessful in securing a contract leave the market , the increased demand for the biosimilar from the main supplier can lead to supply issues . 9 This has important implications for patients . The lack of sufficient stock can either interrupt or delay a patient ’ s course of therapy and possibly increase health care costs where physicians are forced to prescribe a more expensive alternative biosimilar . From a clinical perspective , there is also the potential risk of adverse events such as immunogenicity if patients are switched to an alternative agent . 10
Infrastructure A further and less tangible cost to determine is the associated infrastructure costs that accompany the addition of a biosimilar ; for example , adding the new biosimilar to the electronic health record , assessing and updating any impacted order sets . The pharmacy will need to take account of the extra workload from either producing a new order set or creating a new , product specific order set . Changes to the automated dispensing cabinets and barcode medication administration systems will also be required , to ensure that these systems use and document the correct product . Similarly , robust pharmacovigilance systems are required for biosimilars due to their complexity and sensitivity to any manufacturing changes . A pharmacovigilance system should therefore seek to track and monitor patients ’ responses to treatment and any adverse events and to record any adverse events for the new agent . 4
Providers should also explore if there are any relevant workload issues arises from adopting the new biosimilar . If the P & T wants to switch all existing patients from the reference product to the biosimilar , this may lead to additional workload for health care staff having to explain the change to patients and convincing physicians to switch their patients . Alternatively , if the preferred biosimilar is only to be used with new patients , this might slow the adoption process due to the delay caused by existing patients needing to complete their treatment courses and thus cost savings will take
References 1 News . Biosimilars approved in Europe . GaBI-Generics Biosimilars Initiat [ Internet ]. 2020 ;
www . gabionline . net / Biosimilars / General / Biosimilars-approved-in- Europe ( accessed August 2020 ). 2 FDA . Biosimilars Action Plan : Balancing Innovation and Competition . 2018 ;( July ): 1 – 12 .
www . fda . gov / downloads / Drugs / DevelopmentApprovalProcess / HowDrugsareDevelopedand Approved / ApprovalApplications / TherapeuticBiologicApplications / Biosimilars / UCM613761 . pdf ( accessed August 2020 ). 3 Markus R et al . Developing the totality of evidence for biosimilars : Regulatory considerations and building confidence for the healthcare community . BioDrugs 2017 ; 31 ( 3 ): 175 – 87 . 4 Cuellar S , McBride A , Medina P . Pharmacist perspectives and considerations for implementation of therapeutic oncology biosimilars in practice . Am J Health Syst Pharm 2019 ; 76 ( 21 ): 1725 – 38 . 5 Lucio SD . Biosimilars : Primer for the health-system pharmacist . Am J Health Syst Pharm 2013 ; 70 ( 22 ): 2004 – 17 . 6 US FDA . Scientific considerations in demonstrating biosimilarity to a reference product . Guidance for Industry 2015 ;( February ). 7 FDA . FDA approves Inflectra , a biosimilar to remicade . FDA news release 2016 . 8 Express _ Scripts . 2020 National preferred formulary exclusions . 2020 . 9 Dranitsaris G et al . Drug tendering : Drug supply and shortage implications for the uptake of biosimilars . Clinicoecon Outcomes Res 2017 ; 9:573 – 84 . 10 Griffith N et al . Formulary selection criteria for biosimilars : Considerations for US healthsystem pharmacists . Hosp Pharm 2014 ; 49 ( 9 ): 813 – 25 . 11 Leonard E et al . Factors affecting health care provider knowledge and acceptance of biosimilar medicines : A systematic review . J Manag Care Spec Pharm 2019 ; 25 ( 1 ): 102 – 12 . 12 Dolan C . Opportunities and challenges in biosimilar uptake in oncology . Am J Manag Care 2018 ; 24 ( 11 ): S237 – 43 . 13 US FDA . Health care provider materials 2019 .
www . fda . gov / drugs / biosimilars / health-careprovider-materials ( accessed August 2020 ). 14 Sarnola K et al . Physicians ’ perceptions of the uptake of biosimilars : A systematic review . BMJ Open 2020 ; 10 ( 5 ). 15 Teeple A et al . Patient attitudes about non-medical switching to biosimilars : results from an online patient survey in the United States . Curr Med Res Opin 2019 ; 35 ( 4 ): 603 – 9 . 16 Chau J et al . Patient perspectives on switching from infliximab to infliximab-dyyb in patients with rheumatologic diseases in the United States . ACR Open Rheumatol 2019 ; 1 ( 1 ): 52 – 7 . 17 FDA . Patient materials 2020 .
www . fda . gov / drugs / biosimilars / patient-materials ( accessed August 2020 ). 18 Colloca L , Panaccione R , Murphy TK . The clinical implications of nocebo effects for biosimilar therapy . Front Pharmacol 2019 ; 10 ( November ): 1 – 11 . longer to accrue . Finally , if the hospital decides to have more than one preferred biosimilar as a result of payer preferences , this will also create additional work as pharmacy staff need to have system safeguards , such as flags in the electronic health records , to assure that the correct product is selected for patients .
Physician / patient factors One influential stakeholder group for biosimilar acceptance and uptake is healthcare professionals . However , in a recent survey it was revealed how healthcare professionals still approach biosimilars with caution due to insufficient knowledge , low prescribing comfort and safety concerns 11 although US oncologists tend to be more comfortable trying new therapies such as biosimilars . 12 In an effort to raise awareness of biosimilars , the FDA has produced a number of resources to help support and educate physicians . 13 Despite these efforts , it seems that a continued educational effort is required to convince physicians to make greater use of biosimilars . In a recent review of studies on physicians ’ perceptions of the uptake of biosimilars , it was found that knowledge varied considerably and that biosimilars tended to be used for biologic naïve patients . Moreover , while cost savings were seen as the main advantage to biosimilars , there still appeared to be concerns related to safety , efficacy and immunogenicity . 14
Patient acceptance of biosimilars is equally important to the success of uptake . This is particularly true where the provider intends to implement a program of non-medical switching , that is , changing a treatment for non-clinical reasons . Objections against non-medical switching were highlighted in a study of 1696 patients with an autoimmune disease . The study showed that 85 % of patients were concerned that the biosimilar would not treat their condition as effectively as the reference product and a similar proportion did not want to switch products where their current biologic was helping their disease . 15 In contrast , a recent US study among 100 patients switched from infliximab to infliximab-dyyb , found that with respect to disease control , 80 % were satisfied to very satisfied with the switch . 16 As for physicians , the FDA has taken steps to produce patient-focused materials on biosimilars . 17 This is a much-needed step given that a recognized problem with biosimilar acceptance among patients is the nocebo effect , which is largely due to patient ’ s negative expectations of a biosimilar rather than any systemic effect from treatment . 18
Conclusions With an increasing number of biosimilars approved by the FDA and entering the US market , there is huge opportunity for healthcare providers to lower treatment costs and to utilize the fiscal room created from these savings , to further increase access to treatment for patients . However , while a consideration of the safety and efficacy of a biosimilar is paramount , the challenge for health care providers is to juggle the demands of achieving organizational cost savings with ensuring that the major health insurers reimburse the preferred biosimilar and greater acceptance of biosimilars among both physicians and patients . Once each of these challenges are aligned , formulary adoption of biosimilars will enable the provision of high-quality care at an affordable price .
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