From 2018 to 2020, Novartis received nearly 32,000 requests from 77 countries to use one of the company’s investigational drugs (known as “compassionate use” requests, or in the United States, “extended access“) for patients with serious or life-threatening illnesses.
But when claims were divided by the GDP of each participating country, Novartis researchers found that only 0.5% of claims came from lower-middle-income and lower-middle-income countries. When stratified by gross national income, only 3% of applications came from lower- and lower-middle-income countries.
So what is holding these countries back? Often they don’t 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) are met, we will be able to supply the product,” said Paul Aliu, Head of Novartis Global Governance Office. Terminal news.
Aliu and his colleagues recently published the results from their analysis of these nearly 32,000 requests, finding that 73% came from just 10 high-income countries, all with more than 1,000 requests each (in order: United States, Belgium, Australia, Italy, France, Canada, Spain, Poland, the Netherlands, and the United Kingdom).
Of the countries from which Novartis received no compassionate requests during the study period, only 6 (7%) had compassionate use regulations in place – Algeria, Bulgaria, Congo, Cuba, Guinea and Latvia.
But regarding the collection of 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 review, especially in light of recent FDA guidelines. That said, some of our UC programs, for example in sickle cell disease, largely cater to minority populations, for example African Americans and patients of Middle Eastern and Mediterranean descent.
Regarding next steps, Aliu said the Novartis team will further assess compassionate use regulations at the national level and, based on its experience, come up with a framework to help countries looking to implement introduce new compassionate use regulations or update existing regulations. regulations.