On Monday, the United States Food and Drug Administration approved a new drug for a range of cancers who all share a specific genetic mutation. In fact, the drug is designed to help, specifically, those patients who have this genetic mutation; and does not work by finding the cancer tumor’s location like traditional cancer drugs.
This advanced directive is a step forward in the controversial field of medicine known as “precision medicine.” And this drug is called larotrectinib, under the brand name Vitrakvi.
Developed by a very small—and very unknown—company called Loxo Oncology, this medicine helps patients with a rare genetic mutation. In this case, then, the drug has been tested in patients who have breast, colon, lung, and thyroid cancers. More specifically, the drug is supposed to help patients whose cancer tests show they are positive for a specific type of mutation known as “gene fusion” in a gene called neurotrophic receptor tyrosine kinase (NTRK).
Because of its success leading up to this point, Loxo signed a licensing deal with German drug company Bayer, who would be responsible for figuring out exactly how much to charge for the drug. Bayer decided that a one-month supply of 100 mg oral capsules for adults should carry a price tag of $32,800.
Yes, that is per month—roughly $393,000 per year.
They also offer a liquid oral formulation for children and some adults that they say will cost $11,000 per month for some pediatric patients.
Anticipating the public outcry, Bayer asserts that these are not the prices patients will pay. Indeed, the drug company insists that the monthly out-of-pocket expense for most patients will be no more than $20. In fact, in a statement, the company said, “Bayer will ensure that no eligible patient with TRK fusion cancer will go without this highly effective therapy.”
And in order to keep their word, the company has promised to help patients by providing Vitrakvi for free to some patients with tricky insurance situations or will help those who have extremely high co-pays. In the meantime, though, Bayer also says that they are funding a charity to help provide the drug at no cost to those patients who truly cannot afford it. In addition, Bayer even commits to reimbursing any patients who do not show clinical benefit within the first three months of treatment (or issue refunds to insurers/government programs).