Mandatory tablet splitting
I came across my first instance of an insurance company requiring a patient to split tablets about a month ago. One of our regulars has recently switched to a new doctor, and the doctor is adjusting doses on his various therapies. In any case, the doc prescribed citalopram 20mg qd #30, but the insurer (UnitedHealth for the win!) would only pay for citalopram 40 ½ tab qd #15.
What the hell is with that? You're going to make a guy with acid reflux, anxiety, depression, hypertension, hyperlipidemia, BPH, and T2DM split his fricken tablets?? Are you kidding me? This guy can barely remember all the medical conditions he has, nevermind what pills he takes at what time for which condition. (There's about 15 meds in all that he takes on a daily basis.)
I felt awful. I called UnitedHealth to no avail. I tried doing a prior auth — yeah, I do that sometimes when insurance companies let their little algorithms run wild without human supervision — nothing.
So now this guy has to remember to split his tablets as well when he's lucky he can get out of bed and tie his shoes in the morning. What assholes. This guy is NOT going to remember to do this right, and there's nothing I can do about it.
What about the money lost through patient non-compliance? I suppose that's not so easily measured when compared to a guaranteed savings of ~$5 per fill by instituting mandatory tablet splitting, so fuck it. We'll deal with the excessive cost of less-than-optimal therapeutic outcomes later.
(I'm conflicted about the idea behind splitting tablets for people since it destroys the tablet's integrity, and can confuse people when they open a bottle and see a bunch of little half tabs staring back at them. I would have asked anyway, but I was so pissed off at UnitedHealth when I got off the phone that it didn't occur to me.)
[tags]Medicine, pharmacy, HMOs, UnitedHealth, tablet splitting[/tags]
"What's this made out of? Gold?"
How many times have you heard this phrase?
No, my fabulous pharmacy friends, these items are often considerably MORE expensive than gold… we're talking Americium expensive.
For comparison, the price of Ridaura — a gold salt in capsule form — is $295.79 for 60 caps.*
In no particular order:
- Zyvox (linezolid): $1,546.78 for 20 tablets.
- Cocaine HCl 135mg: $1,144.80 for 100 tablets
- 1L of normal saline: $100**
- Casodex (bicalutamide): $519.76 for 30 tablets.
- Enbrel (etanercept): $7,500/ounce.
- Lamisil (terbinafine): $435.84 for 30 tablets.
- OxyContin 80mg: $662.31 for 90 tablets. (Street value is approximately $7,200 for these same 90 tabs).
- Aldara (imiquimod) cream: $268.38 for 12×1 gram packets.
- Vancocin: $651.85 for 20 pulvules
- Iressa (gefitinib): $2,127.35 for 30 tablets
- Gleevec (imatinib): $3,563.26 for 30 tablets.
Got anything to add?
* All prices are AWP.
** Except this one. 
Merck's replacement for Vioxx (Arcoxia) doing well in trials
Arcoxia (etoricoxib), Merck's replacement for Vioxx, is doing well in tests comparing its upper GI side effects against diclofenac. Results suggest that it's better, though how much better is unclear. This is pretty good news since diclofenac is (mostly) more patient-friendly than ibuprofen, and ibuprofen is of course wildly popular for treating inflammation.
The billion dollar question remains how Arcoxia affects the heart. One study suggests that it's more friendly than diclofenac, but a better question would be how it fares against placebo. Though if it's "better" than diclofenac — a drug that's been on the market for years — does that mean it's a shoe-in for FDA approval when the time comes regardless of how it fares against placebo?
[tags]Medicine, pharmacy, COX-2, NSAIDs[/tags]
Will Lovenox eventually have an approved generic?
Sanofi Aventis had its patent overturned in a California court the other day, but the millionbillion dollar question is whether or not a generic can be approved to compete with the brand. That's thanks to the lack of a generic biologic approval pathway. Basically, the law which allows non-biologic generic drugs uses the process laid out in 505(b)(2) or 505(j) of the Food, Drug, and Cosmetic Act.
An equivalent approval route for biologic drugs hasn't been established yet, but now the question is whether or not enoxaparin can be approved under 505(b)(2) or 505(j). The door isn't completely closed through 505(b)(2), but it's not exactly black and white whether a follow-on product is possible, either. So now that the patent's been overturned, does it even matter?
[tags]Medicine, pharmacy, Lovenox, enoxaparin[/tags]
Largest AIDS vaccine trial to start in South Africa
The largest trial of an AIDS vaccine yet has been unveiled, and it will take place in South Africa where HIV infection rates are as high as 1 in 9. The details can be found here, but the main goals are to determine if the vaccine does a few different things:
- Does prevent infection?
- Does it lower the HIV levels in those already infected?
- Does this vaccine work on the C strain of HIV prevalent in South Africa?
- Easier to store (no refrigeration)
- Oral tablet vs injection
- Once a day dosing instead of twice a day poking
- Cheaper
The trial will use 3,000 volunteers of both sexes between the ages of 18 and 35. More inclusion and exclusion details can be found in the clinicaltrials.gov link.
[tags]Medicine, AIDS, HIV, vaccine, AIDS vaccine[/tags]
Januvia is going to eat Byetta's lunch
Januvia hit our shelves this past week, and I marveled at how inexpensive it was for a brand new drug. (~$300, if dim memory serves.) I think Merck's going to have a runaway hit on their hands, and Amylin and Lilly are going to be the ones that lose out. I almost feel like I'm stating the obvious here — heck, maybe I am, I haven't kept with any business news and speculation in several months.
Exenatide (Byetta) is a glucagon-like peptide analog that responds to glucose by stimulating insulin release and inhibiting glucagon release. It also slows gastric emptying, inhibits synthesis of glucagon, and stimulates beta cell neogenesis by preventing beta cell death. It only responds in the presence of glucose, which means there's low risk for hypoglycemia.
Unfortunately, GLP-1 is broken down by DPP-IV, which limits native GLP-1 half-life to about 90 seconds. GLP-1 is also efficiently cleared by the kidneys. The other downside to Byetta is the fact that it's injected.
Sitagliptin (Januvia) prevents the breakdown of the body's own GLP-1 (and other incretin hormones) by inhibiting DPP-IV. As an oral tablet, patient compliance is likely to be higher, or at the very least, it's more convenient than poking oneself.
Despite having entirely different mechanisms of action, the net effect is the same: higher levels of GLP-1 in the body, with low risk of hypoglycemia. Both Byetta and Januvia are likely to help patients lose weight as well. There's been some talk about possibly getting Byetta approved as a weight-loss drug — I don't know how far along this idea is, however.
It's only a matter of time before we start getting insurance rejections for prior authorizations telling us that the doctor needs to try Januvia before they'll approve Byetta. This is good news for those seniors on Medicare Part D plans as well — Januvia can save them a pile of money because it's just so much cheaper than Byetta.
So to recap:
I think all the pieces are in place for Merck is going to eat Eli Lilly and Amylin's lunch here. It seems one investment house is also predicting something similar. (PDF)
Generic clopidogrel: whiplash for the masses
Saturday morning, we received a voicemail sent to all of the branches in our chain about the stopped production of generic clopidogrel. You may recall that Apotex shipped all of the generic it had on hand as soon as their deal with S-A and BMS fell through. Well a judge has just ordered Apotex to stop producing and shipping the generic, so you can see why Apotex was in a hurry to get everything they had out the door, just in case.
Fortunately, there's not going to be a recall, so Judge Stein certainly made the right decision in that case, but I'm waiting to hear what the shakeout ends up being. Will generic clopidogrel remain on the market or will it disappear? The voicemail made it sound like our company's supplies of the generic will hold for as long as it takes to resolve the matter once and for all, but that could just as well have been in response to Apotex assurances that everything would go swimmingly. The possibility that Apotex might lose wasn't even considered, which I found disingenuous. That's in stark contrast to this WaPo article which makes it sound as though Apotex has no chance of winning at all. (Which very well could mean that it was written from a press release from Sanofi-Aventis, given that there's no stock response information for BMS listed, who also has a huge stake in Plavix's fate.)
Frankly, I don't know what to think. I'm not a lawyer, and I'm not familar with the patent dispute in this particular case. The folks at Patent Baristas don't have much more, either. If the generic disappears, it's going to piss a lot of people off, both patients and providers. Myself included. No one likes being jerked around, particularly when it affects their wallet.
[tags]Medicine, pharmacy, plavix, clopidogrel, Apotex[/tags]