Factors determining inclusion of biosimilars onto formularies
This article provides an overview of the most important factors that a committee needs to address when considering adding a new biosimilar to their formulary
Ali McBride PharmD MS BCOP FASHP FAzPA The University of Arizona Cancer Center and The University of Arizona College of Pharmacy , AZ , USA
Biologic drugs have revolutionized the care of millions of patients in a number of therapeutic areas . Nevertheless , due to the complexity involved in the manufacture of biologics , these drugs are extremely expensive , creating enormous cost pressures on health care systems across the globe . The introduction of biosimilars into the European market in 2006 provided health care providers with an opportunity to achieve huge savings on drug costs and treat a larger number of patients . Alhough not identical to biologics , biosimilars are considered to be clinically equivalent to the original or reference biologic . A total of 58 biosimilars have been approved by the European Medicines Agency 1 and clinicians have gained considerable experience of using these drugs .
In contrast , uptake and adoption of biosimilars by the US has lagged behind Europe , with the Food and Drug Administration ( FDA ) approving its first biosimilar in 2015 . Nevertheless , in recent years , the pace of FDA approvals has increased and once a biosimilar enters the market , the drug can be added onto a hospital formulary . Because biosimilars are not strictly identical to the reference product , formulary committees require a more careful evaluation of efficacy and safety prior to adoption of the drug . However , adding a biosimilar to a hospital formulary is a complex process that requires consideration of several different and , in some cases , opposing factors .
Adoption of a biosimilar onto the formulary The responsibility for adding new drugs to a hospital formulary resides with the Pharmacy and Therapeutics committee ( P & T ). This committee frames policy and makes recommendations to the hospital medical and administration staff on all matters relating to the therapeutic use of drugs and is composed of pharmacists , physicians and other healthcare professionals . In short , the P & T serves to ensure that medication use is safe and effective , economically feasible and that it does not have a negative impact on either workflow or patient throughput . Prior to biosimilar adoption , the P & T requires a comprehensive system to evaluate the drug and needs to address the following overarching questions :
• Will there be any restrictions placed upon use of the biosimilar ?
• Will the biosimilar only be used for approved indications or extrapolated to all reference product indications ?
• Is the intention that the biosimilar will replace the reference product ?
In trying to answer these questions , the P & T has to consider a range of different factors that are highlighted in Figure 1 .
Efficacy and safety A P & T committee will assess both the safety and efficacy of a drug prior to inclusion in a formulary . A biosimilar is approved by the FDA following the 351 ( k ) regulatory pathway and is required to have “ no clinically meaningful differences in terms of safety or potency from an existing FDA approved reference product ”. 2 However , a difficulty for a P & T
FIGURE 1
Factors influencing inclusion of a biosimilar in a formulary
EFFICACY AND SAFETY
BIOSIMILAR FORMULARY ADOPTION
THERAPEUTIC INTERCHANGE
PAYOR APPROVAL FOR BIOSIMILAR OR REFERENCE DRUG
COST AND REIMBURSEMENT
PHYSICIAN / PATIENT EDUCATION
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