committee when evaluating a biosimilar is that the data generated by the manufacturer are not strictly an independent evaluation of its safety and efficacy . Biologics and biosimilars are produced from a living cell line , and the FDA approval process requires submission of a combination of analytical data , which evaluate the physicochemical and biological properties of the biosimilar , and preclinical studies , to compare the in vivo pharmacokinetic and pharmacodynamic properties . As mentioned previously , the FDA considers what has been coined the ‘ totality of the evidence ’ and is thus aimed at demonstrating the similarity with the reference product rather than a thorough clinical evaluation of the biosimilar . 3 , 4
Therapeutic interchange An important consideration for a P & T is whether the biosimilar has received an interchangeable designation by the FDA , as this will allow for substitution of the reference product . Most US
Adding a biosimilar to a hospital formulary is a complex process that requires consideration of several different and , in some cases , opposing factors states have passed laws that allow pharmacists to substitute a biosimilar for a reference product if it has been given an interchangeable status but to date , no biosimilars have been given this status . One possible solution to this problem for the P & T is to utilize the therapeutic interchange process . 5 A therapeutic interchange is the authorized exchange or substitution of therapeutic alternatives in accordance with previously established and approved written guidelines or protocols , within a formulary system . When deciding to use the therapeutic exchange system , the substituted product has to be considered therapeutically equivalent in terms of both safety and efficacy , although the protocol will normally include an option to avoid substitution if the prescriber feels this is clinically required .
The P & T must therefore be completely satisfied that although the biosimilar is not recognized as interchangeable , the safety and efficacy data are sufficiently compelling to permit the substitution . When considering enacting the therapeutic interchange process , the P & T committee is to understand that unless studies have been conducted among patients with the other clinical conditions for which the reference product is licensed , there remains a question over whether extrapolation can be assumed . This is clearly relevant where the P & T wishes to replace the reference product with the biosimilar for all of the licensed indications . While committees may therefore have some reservations over complete exchange of a reference product with a biosimilar , the FDA allows for extrapolated uses based on the totality of the evidence and provided that there is scientific justification to do so without further clinical studies . 6 For example , in 2016 , the FDA approved Inflectra ( infliximab-dyyb ) for the same multiple indications given to infliximab . 7
Cost and reimbursement When the first biosimilar enters the market , it is inevitably priced below the reference product , although the anticipated and substantial savings that can be achieved from using biosimilars will not be fully realized . These savings are only realized when several biosimilars enter the market and compete on price in order to gain market share . In practice , however , providers will need to conduct a financial analysis prior to adoption of a biosimilar because the ‘ actual ’ cost of a biosimilar is far more complex than a straightforward comparison of the acquisition costs of each biosimilar . Providers need to be mindful of the fact that health insurers are also effectively ‘ buyers ’ and can directly negotiate a rebate with the manufacturer . This has important implications for a hospital ’ s preferred agent as further discussed below .
Payer considerations The current 340B drug discount program treats a biosimilar in the same way as the reference product . Medicaid services have set biosimilar reimbursement for hospital outpatient clinics as the average sales price ( ASP ) plus 6 % ( of the reference product ASP ) which gives providers an incentive to use a biosimilar . One way in which providers can achieve a satisfactory discounted price is through committing to a multi-year contract with a biosimilar manufacturer with an attractive volumebased incentive scheme . Nevertheless , the projected savings from a multi-year contract can be offset by the insurers . For example , if after securing a
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