Vice President Jipan Xie Discusses Importance of Evidence Based on Surrogate Outcomes for Drug Reimbursement Approval

December 11, 2018

A recent article in Informa's Scrip examines the growing pressure for faster drug approvals, sparking an ongoing debate over an increasing reliance on surrogate markers. Proponents may press for the inclusion of surrogate endpoints if patients have limited options at the time of the drug's approval submission. However, critics question whether these drugs can eventually meet expectations and are improving quality of life or survival. Vice President Jipan Xie joined the discussion, mentioning the importance of gathering evidence for payers that demonstrates clinical and economic values based on surrogate outcomes.

Payers may hesitate to cover drugs based on surrogate endpoints, as there is more uncertainty about the economic values if only surrogate outcomes are available. Dr. Xie noted the significance of pairing surrogate endpoint evidence with economic evaluations in determining drug reimbursement, especially in certain countries outside the US. Dr. Xie stated, “Unfortunately, there are no clear rules in the US. But payers have to play catch up. Regulators will continue to support early access and approve innovative treatments, especially where there are few or no treatments available.” Dr. Xie continued, “So, they have a risk if the only evidence is a surrogate endpoint. But how do they evaluate a benefit, from both a clinical and economic perspective?" Dr. Xie mentioned that payers ought to consider how they can provide clear guidance to pharmaceutical companies on the types of data they need to submit throughout the reimbursement approval process. Rigorous economic analyses, paired with clinical evidence based on surrogate endpoints, may help accelerate access to innovative treatments.

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