Sponsored – Biosimilars: Production to patient | Page 33

Administration of biosimilars Most biologics and biosimilars are normally safe to be administered 8 via intravenous ( IV ) infusion or subcutaneous ( SC ) injection at the outpatient department of hospitals or infusion clinics , which negotiate with biosimilar manufacturers to obtain a suitable discount that , for example , will be volumebased or contract-based . However , a complicating factor is that health insurers may also seek to obtain discounts from a manufacturer via pharmacy benefit managers , and often this may be different to the hospital ’ s preferred biosimilar . In addition , the insurer can sometimes arrange for the drug to be delivered directly to the hospital which can potentially undermine any agreement negotiated between the hospital and a manufacturer subsequently affecting the reimbursement for the hospital . These competing negotiations can be problematic for the patient , particularly where their insurer will not pay for the hospital ’ s preferred biosimilar .
In recent years , a further and perhaps more pressing problem that directly impacts on the hospital reimbursement is the drive from insurers towards greater use of SC biosimilars that can be self-administered at home . In part , this development has been driven by the additional time and expenses incurred by providing biosimilars in an outpatient setting . As an example , IV trastuzumab is initially administered as a loading dose over a period of 90 minutes and recommended practice is that the patient is observed , under the supervision of a healthcare provider ( in case an anaphylactic reaction occurs ), over the next 6 hours after the start of the infusion . Subsequent infusion doses are given over 30 minutes yet it is still a requirement to observe the patient for 2 hours . 9 An additional factor is the time ( and ultimately cost ) required for the preparation of infusion bags . Either a nurse or a pharmacist has to add a vial of the biosimilar to the infusion bag and , given the potential risks due to preparation errors , this is a carefully monitored process . Finally , IV transfusion doses are based on patient weight and given that the vials contain a specific amount of drug , there is inevitably a drug wastage cost that can soon accumulate . For example , if based on a patient ’ s weight , a dose of 510mg is required ; this is prepared from 4 x 150mg trastuzumab vials , leading to wastage of 90mg .
However , an increasingly attractive alternative to IV infusions is the use of SC formulations which might be self-administered at home . A SC formulation of trastuzumab has been available in Europe for several years and , in 2019 , the FDA approved the SC Herceptin Hylecta . 10 Using an SC formulation does not affect the pharmacokinetics of trastuzumab and efficacy is comparable 11 and more recently , it has been demonstrated that the Herceptin Hylecta SC product provides similar survival rates to the intravenous formulation . 12 An important advantage of SC formulations is that the patient receives a fixed dosage ( that is , not based on weight ) administered over a 2 – 5 minute period , which is considerably shorter than the time required for IV administration , and this benefit appears to be welcomed by patients . An example of a successful clinical trial using the SC formulation is the BELIS study which examined the safety and tolerability of SC trastuzumab in patients with HER2-positive early breast cancer . 13 This open-label study enrolled 102 patients from various European sites and while two treatment cycles were provided via infusion at the hospital , the third and final doses were provided at home with a healthcare professional administering the dose . The home treatment session was completed
Increasing use of SC formulations has potentially a huge impact on use of hospital health care resources and treatment costs , which are important considerations for payers
in two hours with 96 % of patients indicating that their at-home treatment was acceptable . Similarly , other studies have also indicated that patients favor SC formulations . For example , in the study by Pivot el al , 14 85.9 % ( n = 92 ) of patients expressed a preference for the SC trastuzumab . Based on the evidence of lower costs of SC biosimilar treatments , hospitals are developing strategies to transition IV biologic / biosimilar treatments to SC administrations . In order to overcome the challenge of small volume SC administration manufacturers use recombinant human hyaluronidase ( rHuPH20 ) to degrade hyaluronic acid in the dermal extracellular matrix so it is relatively safe and pain-free to give large fluid volumes in SC administration . For example , Herceptin Hylecta co-formulates trastuzumab with rHuPH20 for SC administration , with modification of pH value and drug stabilizer . 15
These shifts in practice for more SC administered products are not surprising given that there is a considerable reduction in drug preparation time and a patient ’ s ‘ chair time ’ from SC administration , less emotional stress , and pain associated with the injection . Increasing use of SC formulations has potentially a huge impact on use of hospital healthcare resources and treatment costs , which are important considerations for payers . The reduction in chair time eases the burden on hospital outpatient settings , enhancing patient capacity . Whereas this is more convenient for patients , the hospital or outpatient clinic is no longer able to bill payers for the drugs leading to loss of revenue . In addition to trastuzumab , other biologics ( abatacept , alemtuzumab , rituximab , tocilizumab ) were initially approved for IV infusion treatments , and now have become available for SC administration . Some groups have suggested that reformulated SC biologics should be considered as a biosimilar of the reference IV biologic drug , but this has not gained traction nor consensus among the scientific community . As more biosimilars are developed in the SC form for self-administration , this potentially increases availability and accessibility of oncology biosimilars to patients although , on the flip side , can create billing challenges for oncology centers .
Oncology treatment using home-care biosimilars Several anticancer biosimilars have been approved in Europe and the US , driven by the anticipated expiration of many patented drugs . The biosimilar for the anticancer drug rituximab became the first biosimilar approved in Europe . 16 Since then , a number of oncology care biosimilars have been approved . 16 For example , as of 2020 , six biosimilars of the reference biologic anticancer drug rituximab , which is used in the treatment of non-Hodgkin ' s lymphoma , were approved in Europe , 16 while two , Truxima ( 2018 ) and
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Ruxience ( 2019 ) are FDA approved .
SC formulations of anticancer biosimilars could enable cancer patients to administer the treatment themselves at home . While self-administration is generally perceived as quick and acceptable to patients , healthcare professionals would need to ensure that risk management strategies are devised to help identify and support those individuals for whom treatment with SC biosimilars is appropriate .
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