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Monday, June 7, 2021

The FDA Approved Aducanumab for Alzheimer's, Despite Debate


... I haven't had time to read the details yet, just the breaking news blurb that it was approved. 

I may add any additional thoughts here, once I've had time to read and review the latest.

Until then, read my post at the bottom of this page or HERE.

In the meantime, let me just say this ... 

Regardless of the debate, the FDA approved it - so PCPs and Neurology practices?

I do hope you're ready for the deluge of phone calls you're about to get, I feel sorry for you! lol

More importantly, for those willing prescribe it, I hope that you either have an in-office infusion center already at your practice (or at least within your outpatient healthcare system), are planning on getting one, or that you have contracts with infusion clinics and centers, because insurance companies are trying to move away from hospital-based infusion centers as too expensive for infusion care and they are beginning to deny payment to patients sent to hospital-based infusion centers.

I'm not sure this will happen with aducanumab, but some insurance companies (and even some manufacturers) are mandating  "white-bagging" - meaning sending a product only through their specialty pharmacy, directly to the provider or clinic, rather than going through a PBM, GPO, or a local pharmacy.  

It does save middle-man costs for them, and insurance can begin negotiating rebates directly with manufacturers rather than through a pharmacy - but there are also a host of other concerns that need to be addressed.

Like ... the infusion products might go on the patient's medical benefit, rather than pharmacy benefit, and it's specialty - meaning these often six-figure drugs would result in higher out-of-pocket cost to the patient, due to high deductibles or higher-tiered specialty products.

Secondly, if you're a 340B, you're good, because you get a lump-sum bundled payment - but that typically requires affiliation with a hospital, which as we've just said, insurance companies are moving away from hospital infusion centers due to facility fees, so most of these infusion centers are not covered under 340B.

And though there's an administration fee paid to the physician by the insurance company, if they administer the drug themselves,  most prescribing physicians don't administer these drug themselves - and there's no compensation to them just to to store the infusion products, which often require refrigeration, and that costs money and staff time, so I hope insurance companies have worked out either how to compensate the prescribing doc for storage or how to send it to the infusion clinic  for storage, without the prescribing physician there?

And let's not even talk about the accountability, product-integrity, product-safety, and shipping concerns.

Those are just the tip of the iceberg of things that need to be sorted first, but nevertheless, even if aducanumab won't be "white-bagged, ""white-bagging" is rapidly becoming the new trend with insurance companies and even some manufacturers, and some are already doing it.

Now, to be fair to insurance companies complaining, they have a point when they say the PBMs have really gotten out of control with their greediness - specifically with getting those extra rebates through discounts that benefit them greatly, but do not "trickle down" and result in much savings for the actual insurance company, or more importantly, the members (and sometimes the preferred drugs by PBMs aren't the best in efficacy, which frustrates physicians to no end.)

However, why then not use a GPO, at least, as a better option for both insurance companies and members?  

That way, the physicians and/or clinic administrators themselves can choose their specialty pharmacy. You won't save as much money, no - but you still will, because they'll still get large-volume discounts, sometimes portfolio-of-products discounts, plus the GPO assumes the cost for both storage and product-integrity accountability, rather than arguments that will ensue about who is responsible for what and the charges for that, if there's a problem with white-bagging?

Just a thought, but I know even less about GPOs than I do PBMs, so maybe there's a reason for that I'm just not aware of?

Also, infusion centers?  

I hope you have enough chairs, or are ready to extend your hours to handle the influx.

But then again, many physicians are vowing they will never prescribe this drug, so who knows?  

Maybe none of that will be required, we shall see. 

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