HPE Biosimilars: Where are we and what is next? - Page 19


Cost-effectiveness analysis of biosimilars

Cost-effectiveness is not merely dependent on price , but also on relative effectiveness ; that is , on potential differences in effectiveness that might exist between the biosimilar molecule and its reference product
Olga Delgado Sanchez PharmD Head of Pharmacy Department , Coordinator of Pharmacy , Health Products and Medicines Policy , University Hospital Son Espases , Palma de Mallorca , Spain
Biosimilar medicines have been available in the European Union ( EU ) for more than a decade , and currently play an increasingly important role across a broad range of therapeutic areas , from cancer to diabetes and inflammatory diseases . The main driver for a growing biosimilars market is the promise of substantial cost savings and , consequently , an expanded access of patients to biological products and a reduced burden for health care systems . 1 But do these medicines really bring value , compared with their originators , in the real world , and how is their value assessed ?
The need for cost analyses for biologics and biosimilars Cost-effectiveness analyses are crucial to compare the costs and clinical outcomes of biosimilars versus those of the relevant comparators . Such studies can provide important data for pharmaceutical companies , to inform research and development strategies , as well as for policy makers , to guide decisions about incentives and reimbursement . Some regulatory agencies responsible for the review of market authorisation applications require some level of evidence from economic evaluations . 2
These assessments range from a costminimisation analysis , which calculates costs to project the least costly treatment while taking into consideration the cost of preparing and administering the medicine , to a cost-utility analysis that compares the incremental cost of the medicine expressed as quality-adjusted life years ( QALYs ), or cost-effectiveness analysis . In addition , sensitivity analyses may be carried out to evaluate the effect of uncertainty on cost-effectiveness . Cost-effectiveness analyses are thus needed to understand any differences in perceived value when a product is considered from the point of view of the payer vs . the patient or the caregiver . 2
Cost-effectiveness constitutes a relevant factor in the regulatory approval process , but it should also be determined following the implementation of the biosimilar and the respective reimbursement process because long-term safety and efficacy , which are often not tested or are extrapolated from data derived for the originator , and risk of immunogenicity and unexpected adverse events might affect the original assessment . This postlaunch cost-effectiveness analysis could be based on data from observational studies or Phase IV trials . 2
Cost-effectiveness is not merely dependent on price , but also on relative effectiveness , that is , on potential differences in effectiveness that might exist between the biosimilar molecule and its reference product . A cost-minimisation analysis is sufficient when the equivalence studies conducted for purposes of regulatory approval are properly designed and have an adequate statistical power to demonstrate similar effectiveness between the biosimilar and the already appraised reference product that constitutes the standard of care . However , if there are differences in effectiveness between the two molecules , or if the reference product was not previously appraised , or was appraised but it is not the standard of care due to regulatory / reimbursement rejection or restrictions ( for example , use in second-line therapy only ), a cost-effectiveness or cost-utility analysis , using as comparator the standard of care and not the originator , should be employed . 2 , 3
Cost-effectiveness studies in the biosimilar regulatory pathway The regulatory pathway for biosimilars in the EU was first issued by the European Medicines Agency ( EMA ) in 2005 , and several class-specific guidelines have since been made available . These guidelines require a thorough comparability evaluation as evidence of similar quality , safety , and efficacy between biosimilar and reference product . However , recommendations for substitutions by pharmacists and incentives to promote the use of biosimilars vary from country to country and primarily focus on health care institutions and physicians . As a result , there is heterogeneity in biosimilar uptake across the continent , with health technology assessments conducted by the individual member states as needed . 3 , 4
By contrast , in the US , an abbreviated approval process was only defined in 2010 , and there is currently a regulatory route for biosimilars that includes proof of interchangeability , that is , the possibility of replacing a biologic product with its biosimilar at the pharmacy level , through additional clinical studies that evaluate switching from the reference product to its biosimilar counterpart . 3
In some countries , health technology assessments and cost-effectiveness analyses may be mandatory . For example , sponsors in Canada may have to submit a cost-minimisation model to demonstrate the level of savings that could potentially be obtained with the introduction of the biosimilar in the market . However , if the reference medicine is not reimbursed , a full dossier needs to be submitted and may involve a cost-effectiveness analysis . In Australia , major submissions ( that is , filing for a new drug or new indication for a currently available drug ) require economic models to support a claim of cost-benefit in contrast to minor submissions ( for example , a new strength for an approved drug
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