If your doctor has been on your back about your cholesterol readings lately, don’t be surprised if he tries to convince you to roll up your sleeve for a shot of the PCSK9 med known as Praluent.
Just two shots a month… and voilà… no more cholesterol worries!
But as an eAlert reader, you know that we’ve been sounding the alarm about Praluent and Repatha (another risky PCSK9 drug) ever since they were approved three years ago.
And as I’ve commented, the very best thing you could say about them is that their sky-high price tag – around $14K a year – has resulted in their selling like week-old pizza.
But all that is about to change.
Sales of one of these “pharmaceutical flops,” Praluent, may now be about to accelerate due to a whole lot of wheeling and dealing on the part of drugmakers Sanofi and Regeneron, as well as Express Scripts, the country’s largest pharmacy benefit manager, or PBM.
But while those giant corporations may well end up ahead of the game, the same can’t be said for patients.
So, before your doctor gives you that cholesterol talk again, here’s what you need to be aware of, because the fewer prescriptions written for Praluent and Repatha, the safer we’ll all be.
How low can they go?
When it comes to who should be taking these high-powered cholesterol drugs, that “story” changes faster than the weather.
First, the FDA said that only those with an inherited disease called HeFH that results in super-high cholesterol numbers should get them.
Then, those who just can’t seem to budge their LDL numbers despite already taking a high-dose statin drug also became candidates for them.
Now, it looks like just about everyone has been given the green light to start up on them!
The danger here is that when cholesterol readings fall to the levels these drugs deliver — down to the 20s and 30s or even lower — the side effects can be horrific where your brain is concerned.
And the FDA was well aware of that even before these drugs were approved, warning the drugmakers about the danger of “neurocognitive adverse events” like dementia.
But that was then. Now, the fix is in, so millions can be sent home with some Praulent.
A just-announced “deal” between Sanofi, Regeneron, and Express Scripts will cut the Praluent price tag in half and make the drug available to any patient whose doctor signs off that the Rx is “appropriate” for them.
Oh, and like buying a printer at Staples, rebates will be offered to patients as well!
Previously, docs had to jump through numerous hoops — like sending in detailed patient histories and lab reports — to prove to insurers that this drug was absolutely, positively needed. But somehow, all of those precautionary requirements got tossed overboard amid the excitement created by the prospect of selling more Praluent.
As I said, a big part of this deal involves Express Scripts, which may be one of the largest companies you’ve never heard of. And even if you have, you probably don’t know that it represents tens of millions of patients… is bigger than Microsoft and Comcast… and carries a lot of clout.
This PBM also makes money on every aspect of drug sales.
It makes money selling drugs and even packing and shipping them. And often, the company becomes the exclusive distributor for certain brands.
So, when the price of Praluent is dropped from an astronomical $14K down to a merely ridiculous $8K, it doesn’t mean that Big Pharma and Express Scripts are providing some kind of charitable public service.
Everyone — and I mean everyone — involved in the production and distribution of this drug will be bringing in lots and lots of money. The only losers here will be the patients.
Remember, your cholesterol number isn’t a golf score. You won’t be awarded a prize if yours is the lowest on the block.
What you might get, however, is a laundry list of side effects ranging from depression and anxiety to cancer and hemorrhagic stroke – all things that are linked to the kind of extremely low cholesterol numbers that Praluent and Repatha are designed to produce.
As I told you just last month, even if your insurance company is more than willing to cover the cost of one of these meds — whichever one it ends up being — you always have every right to say “no thanks.”
“Plan announced to simplify PCSK9 access” Crystal Phend, May 1, 2018, Medpage Today, medpagetoday.com