From Ali Sadeghi-Khomami PhD, Precision BioLogic scientist. Access to national and global testing databases is needed to answer the NBA test order volumes question. I am unsure if such a database exists, but relevant data could also be retrieved from insurance companies to estimate the annual rate of NBA inhibitor assays. Yearly marketing report documents from companies specializing in market analysis are another approach, but I found them expensive and questionable when the source of information is not fully disclosed. For these reasons, reports published by non-profit organizations such as WFH, NBDF, and NMOs are a good source of information. For instance, the attached graphs only represent data from the Annual Global Survey (WFH). Again, the reality estimate depends on how accurately countries filled out their survey.
Although emerging non-factor replacement therapies and by-passing agents for HA are expected to reduce the risk of FVIII inhibitor development, the improved treatment protocols/standards and higher education/awareness of inhibitor testing could influence the overall outcome. So, the answer to NBA inhibitor volume depends on the geographical location. For example, the accessibility of Hemlibra (2017 FDA approved) varies between countries due to regulation, cost, and health insurance coverage (affordability). According to the WFH global report-2022, the highest amount of Hemlibra was purchased in the USA (25 kg per year), followed by Japan (6.5 kg), the UK (4.5 kg), France (4 kg), Canada (3 kg), Australia (2.5 kg), Germany (1.5 kg), and Netherland (1.5 kg/year) (click for chart). Therefore, we expect to see less NBA inhibitor testing in the USA as more novel by-passing and rebalancing agents will be approved by the FDA. However, there are still circumstances such as surgery and invasive procedures in which clotting factor concentrate (CFC) should be used, and if the protocols are followed the NBA inhibitor testing should be ordered. Interestingly, as novel therapies are adopted more in countries with high GNI (Gross National Income), there would be an affordable FVIII supply for prophylaxis in other countries, and globally more NBA inhibitor testing will be ordered. AGS-2023 is due in October, so it is better to wait and see what picture could be deduced from the recent report.
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