foxcreek9
Recycles dryer sheets
- Joined
- Sep 19, 2015
- Messages
- 319
From WSJ
In April the FDA approved Padcev along with Merck’s immunotherapy blockbuster Keytruda as a first-line bladder cancer treatment after a trial showed the combination shrank or eliminated tumors in 68% of patients. New trial results reported last week showed the combination cut mortality by half. The first-line designation will greatly expand the population of patients who benefit from Padcev.
Seagen also planned to study whether Padcev could help patients with an earlier-stage nonmuscle-invasive version of the disease, which makes up 75% of newly diagnosed bladder cancer cases. But Mr. Epstein said at last week’s Prix Galien USA conference that Seagen “killed the program” because the return on investment wouldn’t be worth it.
That’s because Padcev will become eligible for the law’s price controls in 2030, shortly after a new indication might eventually be approved. “Why should we do it?” Mr. Epstein asked. Approval “would come so late in the life cycle that there will be no economic return from doing it.”
The IRA makes medicines eligible for Medicare price controls seven years (for small molecule drugs) and 11 years (for biologics) after approval. This shifts the cost-benefit analysis for studying new potential indications for existing treatments. Why spend hundreds of millions of dollars and several years conducting trials that won’t yield a return on investment?
In April the FDA approved Padcev along with Merck’s immunotherapy blockbuster Keytruda as a first-line bladder cancer treatment after a trial showed the combination shrank or eliminated tumors in 68% of patients. New trial results reported last week showed the combination cut mortality by half. The first-line designation will greatly expand the population of patients who benefit from Padcev.
Seagen also planned to study whether Padcev could help patients with an earlier-stage nonmuscle-invasive version of the disease, which makes up 75% of newly diagnosed bladder cancer cases. But Mr. Epstein said at last week’s Prix Galien USA conference that Seagen “killed the program” because the return on investment wouldn’t be worth it.
That’s because Padcev will become eligible for the law’s price controls in 2030, shortly after a new indication might eventually be approved. “Why should we do it?” Mr. Epstein asked. Approval “would come so late in the life cycle that there will be no economic return from doing it.”
The IRA makes medicines eligible for Medicare price controls seven years (for small molecule drugs) and 11 years (for biologics) after approval. This shifts the cost-benefit analysis for studying new potential indications for existing treatments. Why spend hundreds of millions of dollars and several years conducting trials that won’t yield a return on investment?