@somarco
Question for you: How are those select outpatient drugs under Part B, administered in a docs office or sometimes in an outpatient hospital facility, covered with a Medigap (supplemental) plan Does the Medigap Insurance company pick up part of the cost of the drug ????
Medicare.gov - Medicare Part B (Outpatient) Coverage of Certain Drugs Administered by a Physician
Seems this drug would be about the same - doesn't it fit this type of scenario (from the link -
- Injectable and infused drugs: Medicare covers most of these when given by a licensed medical provider because they aren't usually self administered.
Medicare.gov says Medicare Part A AND Medicare Part B help pay for an injectable drug for osteoporosis . . . .
Further Medicare.gov say
https://www.medicare.gov/coverage/prescription-drugs-outpatient
Your Costs in Original Medicare
In most cases, you pay 20% of the Medicare-approved amount for covered Part B prescription drugs that you get in a doctor’s office or pharmacy, and the Part B deductible applies. Flu, pneumococcal, and Hepatitis B shots have no cost sharing, and the deductible doesn’t apply. In a hospital outpatient setting, you pay a copayment of 20%. If your hospital is participating in a certain outpatient drug discount program (called “340B”), your copayment will be 20% of the lower price, with some exceptions. Doctors and pharmacies must accept assignment for Part B-covered drugs, so you should never be asked to pay more than the coinsurance or copayment for the Part B drug itself.
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As far as how the FDA approved it - under the "Accelerated Approval" process - clinical trial & various supportive testing will continue until final conclusion is reached. That's why I said, it looks like just a clinical trial method to get more people into the trial & pharma co gets some monetary benefit.
From the link: FDA.gov 06/07/2020 - FDA Grants Accelerated Approval for Alzheimer’s Drug
News Release from the FDA - It describes the Accelerated Approval Pathway - another manner of approval by the FDA like the EUA. Yes, very similar, as the process used in Orphan Drug approval -
from the above FDA link above:
. . . . Under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.
Aduhelm was granted Fast Track designation, which seeks to expedite the development and review of drugs that are intended to treat serious conditions where initial evidence showed the potential to address an unmet medical need.
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Maybe no person is gonna pay - and the government is just gonna pick up the cost all the way around 😮 since at this point, it is still just a glorified clinical trial with perhaps more test subjects -
It's Always Something . . . . Roseanna Roseannadanna