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[ cost-effectiveness analysis ]”. Typically , a BIA will assess the short-term financial consequences of introducing a new technology into a specific setting from a specific payer perspective .
The National Pharmaceutical Council ( NPC ), a US-based biopharmaceutical industry member organisation focusing on health policy research , based on evidence , value of medicines for patients , and innovation , has published recommendations on the use of BIAs . 7 They say that a BIA should :
• Include all costs to and offsets in the healthcare system , not just medication costs
• Utilise timeframes long enough to incorporate all costs and cost offsets associated with the disease and patient management ( e . g ., some costs , such as avoided hospitalizations , may only become apparent in the longer term ), including lower costs of medications when generics become available ; examples could include 3 years to capture the costs of avoided hospitalizations or 10 years in keeping with the US Congressional Budget Office budget projections
• Include realistic estimates for all necessary inputs , incorporating information from stakeholders with expertise
• Conduct sensitivity analyses or report ranges around estimated results .
It is important to recognise that a BIA is only a measure of resource use , or ‘ affordability ’ and not a measure of value . It can inform users about how much they are paying , but not about its value . Simoens and colleagues note that wellconducted BIAs , in line with published guidance , form an important part of affordability evaluation but that other complementary assessments are required to demonstrate the value of biosimilars . They conclude that “ BIAs on their own are inadequate to fully evaluate the economic impact of changes in treatment patterns , pricing , and market dynamics ”. 8
The NPC argues that “ By not incorporating the full value and benefits of medical innovation , and incorporating the patient ’ s input , frameworks will fall
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