Monday, May 28, 2018

Drugs

I've mentioned the cost of drugs before. The new drugs getting FDA approval for MM are all very expensive, including two of the drugs I take every month, Revlimid and Ninlaro. A quick review: Revlimid (lenalidomide) is a close relative of thalidomide, a drug famous for causing horrific birth defects in the 1950s, but which really started a revolution in cancer treatment, even though no one really has a clear idea of how it works. It's called an "immune modulator" (IMiD), indicating that it does something to the immune system (up? down? any particular cell type?). One company, Celgene, rescued thalidomide from the ash heap of pharma history and has developed its successors, Revlimid and Pomalyst (pomalidomide). The last two are still under patent, and more about that later.

The other class of drug that has revolutionized MM treatment (to date--more are on the way) is what's called a proteasome inhibitor. The first of these was Velcade (bortezomib), patented by Takeda Pharmaceuticals. Proteasome inhibitors are at least a little better understood from a theoretical perspective, and have a (relatively) good track record in treating patients like me whose tumors have dispensed with the short arm of chromosome 17, home to the TP53 gene, which makes the critical tumor suppressor protein called p53. Takeda has two newer proteasome inhibitors on the market now: Kyprolis (carfilzomib), and Ninlaro (ixazomib). I have been taking Ninlaro for about a year and a half; it's great advantage over the competition is that it's a capsule to be swallowed rather than something to be injected (Velcade) or infused (Kyprolis).

I know that you are all alert readers, and you have undoubtedly detected a pattern here. One company (Celgene) makes three different versions of one class of drug, and another company (Takeda) makes three different versions of another class of drug. All six drugs are still under patent.

Celgene, in particular, has gone to great lengths to protect its monopoly on Revlimid, which has become an essential drug for the vast majority of MM patients. Patent protection will end soon, so in principle generic versions may become available. But in order for a generic drug manufacturer to get its version approved, the prospective drug maker has to show equivalence between its drug and the real thing. Celgene has found a way to take advantage of the fear that thalidomide's history has engendered in (at least) two sneaky ways.

Each month's supply comes with special warnings that women of childbearing age must not handle Revlimid and that men who have sex with women of childbearing age must wear condoms. These instructions are written on the packaging, of course, along with the novel-length "patient information" packet that comes with a new prescription. But they are also delivered, every month, by a nurse either in person or over the phone. It's the same script every month, so after 20 months or so of the same speech it's not clear what the point is (from the patient's perspective). I'd been wondering if this scheme had been cooked up by the FDA, by Celgene, or if it represented some compromise between the company and the regulators. I still don't know, but what is clear from the NPR piece cited above is that this arrangement is working very well for Celgene--because they patented it! Not the drug or the formulation of the capsules (of course they have patented these as well), but the speech, the script, the warnings and the rest. So even if some other drug maker produces a generic Revlimid, the current rules will require them to license the "patient education" materials from Celgene. What's more, they seem to be using these safety concerns to prevent rivals from obtaining enough of the drug to show that a generic version is equally safe and effective. Amazing!

The Ninlaro story isn't quite as nefarious (at least not yet). From my perspective, the main difficulty is that Ninlaro is officially regarded as a kind of "me too" medication rather than a clear first choice for some particular kind of patient. So it is no longer on the formulary (the list of drugs fully covered by my insurer [Express Scripts]). A monthly dose of Ninlaro consists of 3 capsules, each with 4mg of drug. Each capsule carries a list price of approximately $4000. Off formulary, my copay would be about $2000 each month. At the beginning of the year I got a letter on University of Louisville letterhead informing me of this change, but giving me the opportunity to enroll in a program called "SaveonSP" that would reduce my copay to $0. Sounded like a good deal, so I enrolled right away. I expected some letter confirming my enrollment, and after a few weeks I called back to verify my enrollment, since I'd heard nothing. Sure enough, they told me, I was enrolled--there was nothing more I had to do. So imagine my surprise when I was told this month that I had a $2000 copay because I was no longer covered by the manufacturer's copay assistance plan.

After some long and only moderately contentious conversation with a customer service rep, it was finally (I hope) established that I was covered under the SaveonSP program, and hence did not actually owe anybody $2000, at least not until my coverage changes again. It wasn't that hard for me to get things straightened out, as a careful reader and obsessive keeper of documentation, but I can only imagine how difficult it would be for a patient with more advanced disease, less education, maybe some dementia, and fewer resources of all kinds to deal with this level of complexity.

Who pays for my drugs? Well, it depends. If they're injectable, it's my health insurance, if I can swallow them, it's my prescription drug coverage, if I need help paying a high deductible, I might qualify for copay assistance from the manufacturer (each having its own rules about how much they will pay and to whom), or maybe SaveonSP. Who is SaveonSP? Funny you should ask.


Apparently they're part of Express Scripts. I guess it's three different pieces: Accredo (also part of Express Scripts), the specialty pharmacy that actually fills the prescription, Express Scripts, the pharmacy benefit manager that pays the manufacturer for the drug, and SaveonSP that does whatever it is that they do. Do they always rely on patients to let the one hand know what the other hand is doing? It's a way to cut costs, I guess, since we are definitely not getting paid.

1 comment:

  1. Sorry for being anonymous, but, hey, we don't live in a necessarily civilized country for healthcare.

    My university employer did this SaveOnSP thing this year as well, and I figured out why just today. I was googling around and saw your mention of it, so I thought I'd share the following:

    The manufacturer co-pay assistance that Accredo/ExpressScripts bills to, when it's applied to your balance, does not apply towards your yearly maximum out-of-pocket.

    That's important, because the co-pay assistance maximums per year are usually more than that - so, Accredo/ExpressScripts is basically pulling the maximum amount of money from the manufacturer that they can.

    If Accredo/ExpressScripts billed me directly, I'd hit my own $5k yearly maximum in 4 months, and then I wouldn't be billed after that. If my drug manufacturer than reimbursed me on the back-end, they'd be out only $5K, as opposed to the full $12k costs of a non-limited yearly prescription cost.

    How'd I find this out? They called me directly asking if I thought I could cover the per-fill cost of my meds for a couple days until they EFT'd me a refund, so that I'd hit my yearly maximum and they'd pay less.

    Middlemen....

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