Most Heartrending Consumer Medication Guide Ever
I saw an ad for Sabril (vigabatrin) in the current issue of Neurology Now, unlike any ad I've seen for a prescription drug in a consumer-oriented magazine. The ad was nothing more than a headline reading "Help for hard-to-treat seizures," the Sabril logo
and 2.75 pages of patient /consumer information. That's it. No smiling people, no images implying one's life getting back together, no toddler with the helmet on the ground instead of on her head. Just easy-to-read text on epilepsy-awareness purple. If you fill out and send in the postage-paid card attached by the ad, Lundbeck will mail you a package of education materials that may have warm & fuzzy pictures.
Like most ads for medications these days the bulk of the ad buy is comprised of some or all of the medication guide / patient information leaflet. Sabril's medication guide is also unlike any I've ever seen due to two words used repeatedly throughout the document: your baby.
Whenever the phrase "your baby" is used in consumer information it's always in the context of warning you that a drug could harm your baby if you take it while pregnant and/or breastfeeding. Infants and 0-year-old children get all sorts of medications and have their own doctors, but in the world of consumer medication information babies rarely do. Babies get vaccinations, caffeine citrate oral solution is given to premature babies, but little else.
In the second paragraph it states that Sabril is used to treat babies and you and your doctor or your baby's doctor have to decide if the infantile spasms (West Syndrome) is so bad you'll risk vision loss (which is not total blindness, but blurry tunnel vision).
And the which sucks less for your baby equation is repeated over and over.
There are treatment options that probably suck less. There's prednisone, prescription-strength & pharmaceutical-grade vitamin B-6, ACTH (at the low, low price of $23,000, yes, 23 THOUSAND DOLLARS a vial), Topamax (topiramate), Lamictal (lamotrigine), Zonegran (zonisamide), Depakote (divalproex sodium), Keppra (levetiracetam) and Klonopin (clonazepam). If the kid's been weaned the ketogenic diet is also an option.
If you look at these treatment guidelines and the American Academy of Neurology's official ones, the only treatments that "probably" work are ACTH (dropped by most insurance companies due to cost), Sabril, and the ketogenic diet, which can take anywhere from two to five months to start working. Everything else is classified as "maybe it will work." B-6 is probably listed as first-line treatments due to a lower side effect profile. I don't know why prednisone is, as it has a possible side effect of death.
Left untreated or poorly treated, infantile spasms can result in death. Which sucks less?
Sabril was approved for use in the US in August 2009, but available to desperate parents since 1988 after the FDA updated its personal use guidelines. Lundbeck doesn't make it any easier to obtain Sabril now that it is approved in the US. Lundbeck's SHARE program that doctors, pharmacies and patients must pass in order to prove they are qualified to respectively prescribe, dispense, and take (or give to their babies) is just as, if not more complicated than the Clozaril registry upon which it was probably based. At least there is just one Sabril registry. Every company that manufactures generic clozapine has its own registry.
and 2.75 pages of patient /consumer information. That's it. No smiling people, no images implying one's life getting back together, no toddler with the helmet on the ground instead of on her head. Just easy-to-read text on epilepsy-awareness purple. If you fill out and send in the postage-paid card attached by the ad, Lundbeck will mail you a package of education materials that may have warm & fuzzy pictures.Like most ads for medications these days the bulk of the ad buy is comprised of some or all of the medication guide / patient information leaflet. Sabril's medication guide is also unlike any I've ever seen due to two words used repeatedly throughout the document: your baby.
Whenever the phrase "your baby" is used in consumer information it's always in the context of warning you that a drug could harm your baby if you take it while pregnant and/or breastfeeding. Infants and 0-year-old children get all sorts of medications and have their own doctors, but in the world of consumer medication information babies rarely do. Babies get vaccinations, caffeine citrate oral solution is given to premature babies, but little else.
In the second paragraph it states that Sabril is used to treat babies and you and your doctor or your baby's doctor have to decide if the infantile spasms (West Syndrome) is so bad you'll risk vision loss (which is not total blindness, but blurry tunnel vision).
And the which sucks less for your baby equation is repeated over and over.
There are treatment options that probably suck less. There's prednisone, prescription-strength & pharmaceutical-grade vitamin B-6, ACTH (at the low, low price of $23,000, yes, 23 THOUSAND DOLLARS a vial), Topamax (topiramate), Lamictal (lamotrigine), Zonegran (zonisamide), Depakote (divalproex sodium), Keppra (levetiracetam) and Klonopin (clonazepam). If the kid's been weaned the ketogenic diet is also an option.
If you look at these treatment guidelines and the American Academy of Neurology's official ones, the only treatments that "probably" work are ACTH (dropped by most insurance companies due to cost), Sabril, and the ketogenic diet, which can take anywhere from two to five months to start working. Everything else is classified as "maybe it will work." B-6 is probably listed as first-line treatments due to a lower side effect profile. I don't know why prednisone is, as it has a possible side effect of death.
Left untreated or poorly treated, infantile spasms can result in death. Which sucks less?
Sabril was approved for use in the US in August 2009, but available to desperate parents since 1988 after the FDA updated its personal use guidelines. Lundbeck doesn't make it any easier to obtain Sabril now that it is approved in the US. Lundbeck's SHARE program that doctors, pharmacies and patients must pass in order to prove they are qualified to respectively prescribe, dispense, and take (or give to their babies) is just as, if not more complicated than the Clozaril registry upon which it was probably based. At least there is just one Sabril registry. Every company that manufactures generic clozapine has its own registry.
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2 comments:
Interesting post about Sabril. I have been following the situation with this drug and its competitors and the only thing I'll add is that the Achtar gel (ACTH) is actually reimbursed by just about every insurance company. Very expensive of course but insurance does seem to be paying for it routinely now.
Good to learn that Acthar is still covered. Companies were probably not reimbursing the costs on a case-by-case basis, considering dropping it their formularies, etc.
However, the wording I see in Cigna's policy, and on epilepsy sites all over the place is the same, which doesn't mean that is a permanent status.
To date, no drug is approved in the U.S. for the treatment of infantile spasms.
Sabril has the FDA's stamp of approval.
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