I had planned to publish the final installation of No More Cliff Diving (part two, part three) last week, but in light of the recent announcement of the FDA’s approval of Esbriet and Ofev I wanted to devote an entry to that. And, I needed a few days to
On October 15, 2014 the FDA announced it was approving the use of Esbriet/ pirfenidone and Ofev/ nintedanib for the treatment of Idiopathic Pulmonary Fibrosis in the United States. Don’t get me wrong, I applaud the FDA for finally approving not one, but two drugs for the treatment of this devastating and terminal illness. However, I can’t help but think about all the patients for whom this news is too little too late. About all the patients that died waiting for something like pirfenidone in the U.S.
According to a press release on Drugs.com, Intermune first submitted a New Drug Application to the FDA on November 4, 2009. I completely understand the need for due diligence, particularly in respect to prescription drugs, but pirfenindone is not a new drug.
It has been in use since 2008 in Japan under the trade name Pirespa, and in India as Pirfenex, since 2010. I could go on.
According to the Coalition for Pulmonary Fibrosis, approximately 40,000 people die from pulmonary fibrosis every year. So… that’s about 160,000 people dead in the four complete years since the initial drug application to the FDA. Sure, I’m biased; I’m emotionally invested. But I doubt the families of those 160,000 people (remember I’m not counting 2009 or 2014 so the estimate is on the low side) think the FDA’s approval was all that prompt either.
An article in the NY Times published the same day as the approval stated Esbriet would cost roughly $94,000 a year.
“Roche said the wholesale price of Esbriet would be about $7,800 a month, or about $94,000 a year — two to three times what the drug sells for in Canada and Europe.”
And that’s down from one account I read (I’ll link to it, if I can find it again) that estimated the cost to be closer to $100,000. Either way the exorbitant cost will likely prevent patients, many of whom have been disabled by this disease, from receiving the drugs that can slow the progression of their disease.
The Pulmonary Fibrosis Foundation has alluded to a possible subsidy in some of their tweets, but I haven’t been able to find any concrete information on it.