With payers and providers increasingly focused on the cost-effectiveness of healthcare, the demand is growing for more detailed outcomes information. National and European regulatory authorities and corporate institutions such as the National Institute for Health and Clinical Excellence (NICE) in the UK or the Pharmaceutical Benefit Advisory Committee (PBAC) in Australia, increasingly rely on this information to fully understand product value in healthcare and its potential impact in real-world clinical practice.
Achieving a favorable endorsement from healthcare authorities is critical to ensure that new innovations reach the market and patients more quickly and are incorporated into appropriate guidelines of care.
In the past, demonstrating added value on the basis of efficacy and effectiveness was the benchmark. Today with the intensifying focus on cost containment, stakeholders in healthcare need more outcomes information to prove the value of drugs to healthcare authorities and wish to understand the impact of therapies and treatment options.
Demonstrating value
The new questions from decision makers and payers
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What is the economic burden of a disease within the healthcare system?
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Does the new intervention merit public funding?
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What are the economic implications of its use?
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How do the incremental costs compare with the anticipated benefits for specific patient groups?
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Is the target drug used appropriately vs. available alternatives as per its approved label?
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What happens to patients who discontinue treatment with the target drug?