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Most of the patients this could be prescribed to are on Medicare. At $56k per patient and 5.5 million patients that's $308Billion. Oh and the drug causes edema
by vajrabum 5y ago
Most of the patients this could be prescribed to are on Medicare. At $56k per patient and 5.5 million patients that's $308Billion. Oh and the drug causes edema in the brain in 40% of patients who are APOE e4 carriers which will be overrepresented in the patient population. That edema lead to confusion and patient falls. The scientific advisory board voted 10:0 with one abstention against approval. I'd just as soon not pay for something that doesn't work and in some cases causes harm.
- shkkmo 5y agoI don't understand how a drug gets approved if the science board votes unanimously against it... who chose to override that decision?
- nceqs3 5y agoThe FDA.
- nceqs3 5y agoMEDICARE DOESN'T PAY LIST PRICES!
- NoImmatureAdHom 5y agoTHIS PERSON IS CORRECT https://www.rjhealth.com/2019/07/31/drug-pricing-101-reimbursement-rj-health-methodologies-drug-claims-code-level-unit-level-hcpcs-ndc/ https://www.rjhealth.com/2019/07/31/drug-pricing-101-reimbur...
- NoImmatureAdHom 5y agoI appreciate you doing the math! I'd appreciate it even more with sources for 5.5m :-)
- derbOac 5y agoSo then isn't the issue medicare reimbursement, not FDA approval? To be honest, this, along with several other things over the last year, has reinforced my perception that drug regulation in general is a failure and that the FDA needs to move away from an approval role (that is, approving the availability of the drug) to a truth-in-labeling role (that is, is this drug what the seller says it is).
- aliasEli 5y agoHow do you handle any medical claims by the manufacturer? Few consumers will be able to determine independently whether or not such claims are justified. How should consumers judge the quality of the research into this drug? How should they judge potential side-effects?