Novartis' compassionate use requests worldwide: Just 0.5% came from lower-middle- and low-income countries
From 2018 through 2020, Novartis received almost 32,000 requests from 110 countries to use one of the company’s experimental drugs (known as “compassionate use” requests, or in the US, “expanded access“) for patients with serious or life-threatening medical conditions.
But when the requests were divided by each participating country’s GDP, the Novartis researchers found that just 0.5% of the requests came from lower-middle- and lower-income countries. When stratified by gross national income, only 3% of the requests came from lower-middle- and lower-income countries.
So what’s holding these countries back? Often times they might not have regulations in place to facilitate such emergency use outside of an approval.
“As long as a country has CU regulations in place, and our CU criteria (as available on our website) is fulfilled, we will be able to provide the product,” Paul Aliu, head of Novartis’ global governance office told Endpoints News.
Aliu and colleagues recently published the results of their analysis of these nearly 32,000 requests, finding that 73% came from only 10 high-income countries, all with more than 1,000 requests each (in order: US, Belgium, Australia, Italy, France, Canada, Spain, Poland, Netherlands, and the UK).
Among the countries from which Novartis did not receive any compassionate requests during the study period, only 6 (7%) had compassionate use regulations in place — Algeria, Bulgaria, Congo, Cuba, Guinea, and Latvia.
But as far as collecting information on racial or ethnic disparities, Aliu said Novartis does not currently collect race/ethnicity data from its compassionate use programs, adding:
However, this is under consideration especially in light of recent FDA guidance. Having said that, some of our CU programs, for example in Sickle Cell Disease, is largely addressing minority populations e.g. African Americans, and patients of Middle Eastern and Mediterranean origin.
As far as next steps, Aliu said the Novartis team will be further evaluating the country-level compassionate use regulations, and based on its experience will be proposing a framework to help countries either looking to put in place new compassionate use regulations or to update existing regulations.