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Table 1 Assessment of conventional value metrics in evaluating I-O therapies

From: The promise of Immuno-oncology: implications for defining the value of cancer treatment

Conventional value metric (examples)

Why insufficent

For I-O

Areas where new I-O value measures are needed

(beyond QALY)

Clinical Efficacy Assessment

OS, PFS, ORR

I-O therapies offer potential for durable response and due to delayed kinetics may not demonstrate early ORR or improvements in PFS

Milestone Survival;

Treatment Free Survival

Safety Assessment

Late-stage cancer patients may be more willing to accept high risk of toxicity for possible benefit (durable response); long-term impact of adverse events not fully known

More nuanced evaluation of patient preferences based on their risk tolerance and profile; longer follow up studies post treatment

Patient Reported Outcome

Current measures fall short in measuring the value to patients of Treatment-free Survival; (extended time off treatment)

Treatment Free Survival impact on patient’s QoL; Hope for durable response

Economic Measures, e.g.

Cost of ongoing treatment; Cost of treatment for side effects; cost of lost productivity

Typically focuses on patient-related expenses or drug cost during active treatment

Return to productivity; Economic benefit of Treatment-Free Survival, including reduced expenditures on ongoing treatment, scans and other follow up; Amortize costs over the longer horizon of benefit in a “cure-rate” model; consider other stakeholder fiscal impact