Dr. Ikpeme Neto draws attention to the non-inclusion of African subjects in locally relevant drug trials
I happened upon a pharmacy benefit manager in an African country that was helping Novartis to push their new heart failure drug Entresto. In the article I saw, the theme was of Entresto being superior to Enalapril and that patients should have better access to it. Samples of the drug were seemingly being given to cardiologists who replaced Enalapril with Entresto in their patients.
The cardiologists would then go on to inquire how their patient could afford the drug once the samples had finished. A credit agreement would then be offered to allow patients pay in installments for the drug. Amazing! Finally Africans now have access to blockbusting new drugs you may want to think. There is however one missing but vital question. Is Entresto instead of Enalapril actually cost effective and is it really the appropriate clinical thing to do?
Here’s a quick back-of-the napkin math and extra simplified analysis that suggests perhaps not.
Entresto costs about $30 for a month’s supply while Enalapril costs about $2 for the same duration. That’s a massive difference of $336 annually! Enalapril, the drug Entresto is looking to replace, reduces the risk of death and hospitalizations in patients with heart failure.
To prevent the aforementioned events, people would have to take the drug over 3–4 years. Entresto on the other hand has a superior value as shown in the trial published in the prestigious New England Journal of Medicine. The demonstration of this superior efficacy won it top recommendation by several professional bodies and prime position in newly issued guidelines.
Digging deeper, however, it may seem that the numbers aren’t as representative of Africans as they are of Causcasians, the primary study population. In the Enalapril study, around 15% of the participants were black, not a great number. Entresto was even worse, only 5% were black. Read black as African American, a group that are not as genetically diverse as Native Africans.
So based on this alone, Enalapril’s efficacy is essentially more applicable to blacks than Entresto. Even more interesting is the forest plot for Entresto. When broken down by race, their own numbers show that this drug is simply not efficacious for blacks.
Entresto crosses the hazard ratio line and can’t be said to be better than Enalapril in blacks.
So imagine being saddled with $336 of debt for a treatment that’s not efficacious for you. This is what we are allowing people to promote to African patients. With Enalapril, the data is more representative and the treatment is cheap.
It is well documented that Africans are overlooked in much of medical research. Newsweek recently covered this in a feature with a Nigerian born American medical researcher. His work has brought to light the value of looking at African DNA for new clues in the fight against cancer.
We need regulators and professional bodies making calls that promote local drug testing and scientific research. Drug companies must be made to demonstrate specific benefit to Africans or do local trials that show benefit before they are allowed a license for drugs.
That a drug works for Caucasians does not mean it will work for Africans.
You and I need to trust that when a drug is recommended to us for an extra $336, that there isn’t a better alternative that costs just $2.