Pharmaco-economic advantages of biosimilars
Pharmaco-economic evaluation of biosimilars needs to take into account more than simple acquisition costs ; both budget impact and value need to be assessed and the pharmacist ’ s knowledge and expertise is important for the realisation of benefits
Joao Goncalves PharmD PhD Faculdade de Farmácia Universidade Lisboa , Portugal
There are no clinically meaningful differences between the biosimilar product and the reference product ( RP ) in terms of safety , purity and potency . However , biosimilars are typically 10 %– 40 % cheaper than the RPs and this has provided the opportunity for health services to make savings and / or increase access to treatments . 1
Although biosimilars have been available in Europe since 2006 , uptake of these products was not always swift . Part of the reason for this was misunderstandings about the concept of biosimilarity leading to hesitancy or reluctance to prescribe the newer agents . One important step in increasing the acceptance and use of biosimilars is to build a clear understanding of the pharmaco-economic impact of their use .
Costs and value A price comparison in EU countries showed that rituximab biosimilars were 39 % less expensive than reference rituximab at the manufacturer level and 86 % cheaper at the retail level . 2 Given the significant difference in prices , the use of biosimilars should result in savings of money , the opportunity to treat more patients with the same condition and the opportunity to expand access to include a wider range of patients and diseases . In Europe , where biosimilars have been available for more than 10 years , major savings have been achieved . For example , in the UK , France , and Germany , switching patients from infliximab to the biosimilar CT-P13 for rheumatoid arthritis was estimated to provide savings between 233 and 433 million Euros over a 5-year period ( representing discounts of 20 % and 30 %, respectively ). The savings from the 30 % discount were enough to support biosimilar treatment for more than 7500 additional rheumatoid arthritis patients . 3
Another example shows how savings can be re-allocated to treat patients suffering from other diseases . A UK study explored whether more health gain could be achieved by using biosimilar adalimumab savings to treat additional patients suffering from rheumatoid arthritis or to treat patients with other conditions including melanoma , hepatitis C , multiple sclerosis , Duchenne ’ s disease , or non-small cell lung cancer . 4 The results showed that a greater number of quality-adjusted life years were gained when biosimilar adalimumab savings were spent on treating patients with hepatitis C rather than on treating more rheumatoid arthritis patients .
Where people pay for their treatment , patients could directly benefit from the price competition and cost savings of biosimilars through lower insurance premiums and lower out-of-pocket costs , which enable more patients to choose to take the medication . 1
However , simple cost reduction is not always straightforward . Speaking at an EAHP ( satellite ) symposium in 2018 , Hanne Rolighed-Christensen ( Head of Department of Clinical Pharmacology , Bispebjerg and Frederiksberg Hospital Denmark ) explained that two biosimilar trastuzumab products had received marketing authorisations – Ontruzant ® and Herzuma ® . Although the biosimilars had lower acquisition costs than the reference product , the situation was more complex than it first appeared . More than 80 % of trastuzumab used in Denmark at that time was the subcutaneous presentation , which can be administered in minutes , whereas the biosimilar products were all intravenous presentations that took longer to administer and required more ‘ chair time ’ in the hospital . This underlines the importance of understanding how a product is used , administered and the associated costs and the value that it offers to the payers . 5
One important step in increasing the acceptance of biosimilars is to build a clear understanding of the pharmacoeconomic impact of their use
Clearly it is not enough simply to show that a biosimilar is cheaper to purchase than the reference roduct . In order for health organisations to make rational purchasing decisions , they need more detailed analyses of drug utility coupled with an in-depth understanding of the ways that the drugs are used .
In practice , this has led to the development of the budget impact assessment ( BIA ) as the preferred way to assess the economic impact of biosimilars for many health organisations . Moreover , it should be noted that reimbursement authorities are increasingly asking for BIAs as part of a formulary listing requests or reimbursement submissions .
A BIA considers the wider issue of affordability and complements other forms of economic evaluation , such as cost effectiveness analysis or cost minimisation analysis , rather than replacing them . Good practice guidance has been developed by the International Society for Pharmacoeconomics and Outcomes Research ( ISPOR ) to provide a framework for decision-makers . 6 The guidance describes the benefits and uses of BIA thus : “ BIA addresses the expected changes in the expenditure of a health care system after the adoption of a new intervention . A BIA can also be used for budget or resource planning . A BIA can be freestanding or part of a comprehensive economic assessment along with a CEA
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