Module 6

03/10/2024

Who Is Assessing Value?

‘Value’ is assessed continually throughout the drug approval and treatment selection processes – just applying different perspectives • Regulators assess value in terms of possible benefit vs harm • National HTA assess value in terms of investment in healthcare: public health impact; added medical value; effectiveness and cost effectiveness; affordability versus national priorities • Local formularies assess value in terms of affordability versus local priorities; impact on operational targets • Doctors assess value in terms of expected outcomes for an individual – in a context of increasing financial responsibility • Patients assess value in terms of experienced outcomes and willingness to pay (if not fully reimbursed)

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First Value Assessments

Regulatory and Reimbursement /HTA agencies are addressing different questions

Should this medicine be approved? Vs. Should this medicine be purchased?

• The decision to invest in a new medicine is made considering future value in the context of the healthcare system, their unique priorities and their affordability constraints.

Regulatory risk benefit assessment is less dependent on context.

• Investment decisions balance risk, reward and uncertainty.

• Future value cannot be measured pre-launch; but estimates of future value have to be made using pre-launch data.

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