Can anyone please explain to me how it works when a new treatment is approved in the USA?
Once a treatment is approved are doctors immediately able to administer it? Do insurance companies balk and refuse to pay? What (if any) hoops does one have to jump through to receive said drug?
~ Stephanie
Typically, once a new drug is approved the pharma company is already prepared to ship out the drug to pharmacies, it may take the insurance companies sometime to add the drug to their formulary. Also my experience is that the Insurance companies will make sure the patient meet the exact indication before they will cover the costs. Always check to see if a Pharma company has a patient support/access program if you are getting a new drug it may cover your co-pay or most of the cost depending on your insurance.
Great answer!
Doctors can legally give a patient anything that is FDA approved, even if it is approved for another purpose (called "off-label"use).
Insurance companies don't have to pay for anything that is FDA approved, although they usually will eventually. If the "treatment" is a drug, the drug plan will decide what it pays for.
So, in a hypothetical where Lu177 is approved for metastatic castrate-resistance, do you believe a doctor (or a facility, etc) could administer this treatment to someone who is castrate-sensitive, i.e. as an “off-label” use?
I guess the other half of that question is whether or not insurance would cover this.
Insurance/Medicare won't cover it. If you are willing to shell out for it, and find a doctor willing to give it, you can probably pay for it. But expect a hefty price tag. Alternatively, you can go to Germany or India and pay less. Or if you haven't been taking ADT for more than 45 days, you can try this clinical trial:
clinicaltrials.gov/ct2/show...
Are you saying even if its FDA approved my commercial insurance wont pay for it?
I am not saying they won't pay for an FDA-approved drug.
TA is saying they won’t pay for off-label use of an FDA-approved drug. My question was based on getting something off-label once it’s FDA approved, since off-label is my only option — I’m not mCRPC (as is required for the now-currently FDA-approved use of Lu177).
It’s my understanding (and my hope) that eventually, Medicare and private insurance will subsidize the cost. Perhaps, at least in the Medicare case, with retroactive reimbursement.
Alternately I have no idea what I’m talking about.
Insurance companies typically drag their feet unless the newly approved drug or treatment option is cheaper than SOC. That rarely happens.
I've been wondering the same thing. We've been hoping for LU177 to be approved soon but also wondering what we're going to go through to be able to get it.
According to my Jeff’s doctor at Mayo, Rochester LU-177 is on the very brink of being approved. This information is what prompted my question. They are bringing Jeff back for a PSMA PET scan to see if he qualifies for LU-177, but also explained when approved it may not be readily available. Jeff is running out of options and hasn’t really responded to any treatments. We are guardedly hopeful that LU-177 is what he needs.
🙏❤️
Let's hope everyone involved with new meds gets off their fat asses and work for once!!!
Good Luck, Good Health and Good Humor.
j-o-h-n Saturday 03/19/2022 3:13 PM DST
Seriously!
Half in jest, whole in earnest.......
Good Luck, Good Health and Good Humor.
j-o-h-n Saturday 03/19/2022 7:17 PM DST
Holy Toledo---Now Olaparib Gets Full FDA Approval
FDA approves darolutamide for non-metastatic castration-resistant prostate cancer
New here newly diagnosed trying to decide treatment
