basic knowledge , safety and efficacy , and the FDA regulatory process . 4 Within the US , survey evaluations included responses from dermatologists , physician specialists and rheumatologists . A total of 97 dermatologists were surveyed to assess their knowledge and awareness of biosimilars . Sixty-two percent of the surveyed dermatologists reported a basic understanding of biosimilars and 84 % reported previously prescribing biosimilars in their practice . 5 Of the 1201 physician specialists surveyed , 55.2 % were unsure / concerned about biosimilar safety . 6 Of the 131 rheumatologists surveyed , 74 % were extremely / moderately familiar with the FDA definition of biosimilars and 66 % were extremely likely / likely to prescribe a biosimilar in biologic treatment-naïve patients with rheumatoid arthritis . 7 In the rheumatologists ’ survey , 60 % of providers were unlikely to switch from the originator product to the biosimilar product if the patient was doing well . Providers need more education regarding the biosimilar approval process and assurance regarding the biosimilar manufacturing procedures to help overcome their hesitation to prescribe these products .
Trotta et al evaluated 7082 therapeutic plans containing a granulocyte colony-stimulating factor ( G-CSF ) over a one-year period . 8 Midway during the evaluated year , the providers received additional education on evidence-based guidelines and recommended cost-effective prescribing approaches for G-CSF biosimilar alternatives . Biosimilar prescribing significantly increased after the educational initiatives ( 34.4 % versus 49.8 %; p < 0.0001 ). In a survey of 510 community oncologists , 77 % replied being receptive to receiving additional biosimilar educational opportunities . 9 The need for more provider education on biosimilars is evident and it will be important to address this barrier to improve prescribing practices .
Patient acceptance Patients might have inadequate knowledge regarding biosimilars , fear of not being administered the originator product , or concerns related to patent litigation and perceptions from the media . A study evaluated 121 adult patients with inflammatory bowel disease regarding their perception of the utilization of biosimilars . 10 Results revealed that awareness of biosimilars was low , and only 27 % of the participants reported previously hearing of biosimilar medications . Approximately threequarters of the patients were uncomfortable using a biosimilar and 57 % were uncomfortable switching to a biosimilar from the originator product . Another study evaluated 75 oncology patients regarding their perception of biosimilars and cost associated with treatment . 11
Approximately 60 % of the patients correctly reported that a more expensive medication ( reference ) and less expensive medication ( biosimilar ) have the same effect ; however , of these patients only 40 % stated they would feel comfortable receiving the less expensive medication for their anti-cancer treatment . The reasons given for not wanting to receive the biosimilar included a desire for the most expensive medication their insurance will cover , and wanting the best possible medication . Providing education to patients may assist with acceptance of the use of biosimilar medications in their care .
Limited availability The manufacturing of a biologic requires many steps that are difficult to replicate . Developers seeking FDA approval of a biologic product submit manufacturing information to the FDA as part of the biologics licensing application . 12 Despite the FDA having the biologic manufacturing information , they are prohibited from sharing this information with the biosimilar manufacturer . With the biosimilar manufacturer having to recreate the process as closely as possible to the reference product without details of the manufacturing process , delays are inevitable . It takes on average 8 – 10 years and $ 100 – 250 million to create a biosimilar product , and even more if that product is a monoclonal antibody . These challenges in manufacturing result in limited availability of products on the market to stimulate price competition . Even after FDA approval for a biosimilar , the product is not immediately commercially available . Manufacturers of the originator product often use patent infringement litigation to delay the marketing of the biosimilar . Under the Biologics Price Competition and Innovation Act , the originator biologic product has 12 years of market exclusivity when no biosimilar approval application is permitted to be approved in the US . 13
Extrapolation In a survey of 1201 physician specialists , 12 % responded they were comfortable with biosimilar extrapolation . 6 In addition , in a survey evaluating 131 rheumatologists , 34 % of respondents were extremely likely to prescribe a biosimilar for an extrapolated indication . 7 Ultimately , it is the prescriber ’ s confidence in the extrapolated indication that determines uptake of biosimilars .
Barriers to uptake Economic issues The majority of biologic products are administered in an outpatient setting and paid for by the patient ’ s medical insurance rather than pharmacy benefit , which influences the product ’ s reimbursement . 14 For example , medications administered in a physician office or infusion clinic are usually reimbursed by Medicare at the average sales price ( ASP ) plus a 6 % administrative fee . To help incentivize the prescribing of biosimilars , the Centers for Medicare and Medicaid Services set the biosimilar reimbursement to be based on the ASP of the originator product plus 6 % of the originator product ’ s ASP . It is important to note that 340b hospital-based ambulatory clinics do not have the same incentives . The hospital outpatient prospective payment system adjusted biosimilar reimbursement to be ASP minus 22.5 % for these centers , resulting in potentially less profit .
Hospital formulary considerations In the acute care arena , institutional Pharmacy and Therapeutics ( P & T ) committees review agents for formulary addition . 14 These committees consider clinical effectiveness , operational objectives , and cost and product supply chain . For biosimilars and biologics , it is important to consider the approved uses for each product and lack of interchangeability . From an operational perspective , it is important to evaluate pharmacy drug storage space , if the hospital plans to have multiple biologics on formulary which can increase the risk for administering the incorrect product due to similarity in name and require IT support to incorporate the product into the electronic ordering system . Moreover , there is a risk for errors in prescribing if more than one product is available .
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