> Other epinephrine injectors have been approved before, but they struggled to gain market share against a brand that used lobbying and marketing to establish a virtual monopoly on the market.
This got me thinking that consumers are at fault as well. But then I read the following from the linked article.
> “Their most brilliant maneuver, clearly, was giving them [EpiPens] away to schools and making it the thing that they could say, ‘Well, the nurse knows how to use it,’ ” said R. Adams Dudley, a pulmonologist at the University of California at San Francisco. “What are the parents afraid of? Their child will be away from them, and they won’t be there to use it. If they can say the school nurse knows how to use an EpiPen; she’s never seen an Adrenaclick ... It’s just a fear thing.”
With such (understandable) absolute risk averseness what is the way out?..
It's also partially the doctors. If a doctor writes a prescription as "EpiPen," then the pharmacist has to provide a drug with the brand EpiPen. The doctor has to specify "EpiPen or generic equivalent" on the prescription in order for the pharmacist to be able to fill it with a generic. If doctors don't realize that EpiPen is a name brand -- and "EpiPen" is so ubiquitous as to be nearly genericized at the point -- then doctors may not realize the issue.
AJM Confirming that all states have Generic Substitution laws to lower drug costs: https://www.amjmed.com/article/S0002-9343(10)01087-9/abstrac...
Source : son with severe peanut allergy and insurance that doesn't cover epipens. Made several trips to Canada (for other reasons); bought Epipens there for us and various friends.
Because, unlike the generic version described in the original article, none of those were generic versions of the EpiPen. They were alternate delivery systems.
AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements
Andrenaclick is "BX rated".
BX Drug products for which the data are insufficient to determine therapeutic equivalence
The new generic version from Teva is "AB rated".
In fact, in the hospital setting, a portion of a Physician's reimbursement is tied to the ratio of generics to brand name drugs that their patients were given.
I'm not sure if this is the case for outpatient stuff, but internists are absolutely incentivized to prescribe generics.
Consider the scenarios here. How would someone get a prescription for a non "EpiPen" epinephrine injector? They would have to be very savvy with access to a doctor as well as incredibly price conscious. They would have to convince their doctor to write a prescription for a specific other device. All of which is a very unlikely chain of events.
Doctors have to specify when writing a prescription if an generic is acceptable or not. It is always a deliberate choice with each and every prescription. There is no "Just forgetting." Paper prescriptions, for example, have two different places for signatures. Most doctors know that insurances often require generics.
There are good reasons not to substitute for some medications: Lithium (common for bipolar disorder), for example, sometimes absorbs differently between brands. Even with drugs that have no generics, most doctors will write a prescription saying that a generic is acceptable in case one has been approved without their knowledge. Doctors really only need to know when there are differences with generics vs brand names.
Not only that, but if the doctor requests the brand name, most pharmacies will call the doctor to see if they can switch to a lower-cost generic if the patient requests it. This is done a lot, sometimes simply because the patient doesn't realize the medicacation costs when they are at the doctor's office - they often don't realize the costs until the pharmacy runs the prescription through their insurance.
The same is true if the doctor prescribes something not covered by a patient's drug formulary: some insurances require folks start off with x or y drug and only give special acceptance to drug z if they've tried the other drug.
> The same is true if the doctor prescribes something not covered by a patient's drug formulary: some insurances require folks start off with x or y drug and only give special acceptance to drug z if they've tried the other drug.
The U.S. private health insurance system is so weird.
And to make it weirder: The formularies are generally based on agreements the insurer has made with the drug companies and/or pure cost of medicine if there was no deal to be made. I'd not mind some generally accepted standards in treatment based on patient outcome, so long as the patient doesn't have factors that change the standard treatment, but long-term outcome and cost over time doesn't seem to be the focus. This is likely due to many folks not keeping the same insurance long-term.
Whenever you go to get your script filled, the pharmacist will ask "would you like a generic?"
If you look at the above form box #10 - there is a box a doctor will tick if there is a specific reason not to substitute. In that case the pharmacist will not be able to give you a generic version. But that generally is an exception and not the norm.
If I send my child to school with an "off-brand" epipen with a doctor's note and direct the school to use this instead, they have to observe it -- a nurse is in no way capable of making a drug administration decision without the consult of a licensed medical doctor.
Nurse isn't a protected title, so it's possible a school nurse has minimal qualification and no professional registration.
I dunno if it's similar in the US.
It honestly is a completely irrational fear.
People forget there is also a human factors element:
If the pen is not easy to use, it could lead to an inability to deliver the medication simply because the person can't read the directions while their airway is closing up.
For instance: 1 pen on the market now has a speaker built into the pen which gives voice directions for anyone to be able to administer a dosage to someone who needs it .
If the pen mechanism itself is not robust, and delivers inadequate or overdosages - then this is also bad, and is also where other competitors have failed .
The EpiPen itself is actually a bit of a work of art because it gets most of these things right on - this is why they've dominated.
0 - https://www.auvi-q.com/
1 - http://www.twinject.com/
Mylan continues to try to restore their exclusive rights.
The fact that Auvi-Q, TwinJect and many other Epi-autoinjectors are allowed on the market as New Drug Applications (Non-generic) shows us that the FDA has allowed healthy competition from other Autoinjector designs -- they simply have not been as effective, safe or simple to use, leaving EpiPen as the standard.
It's not an economic monopoly, but (at least in the case of the EpiPen) it's bad regulation with similar impact.
When is this ever the case? Especially when the decision results in a comparative loss?
I think the risk of reusing injection equipment is chance of infection. Also a more reasonable solution to the wastage is to do a long term study to extend the expiry date. The drug manufacturer don't do a long study because of the lost time plus potential extra sales.
The simpler thing is do enough testing to extend the life of the current solution to 3-5 years. The manufacturer will have no incentive to do that unless there is some competition.
A good idea, but also possibly a point of failure (by the end user) in an emergency. Epipens come in pairs for these rare, but possible, occurrences.
Spot-on. I remember when I was doing my anesthesiology residency and I asked the guy who ordered drugs for our department what a 1cc vial or ampoule of epinephrine (an auto-injector delivers precisely that amount) costs; he replied (this was the late 1970s, mind you), "About 10 cents." Even allowing for inflation, I can't imagine it's more than $1/dose today.
If you're worried about backcountry safety, taking a first aid class is probably more useful than carrying an epipen.
Sure, those 6-year-olds know how to use them because they've been trained on how to use them. So have their caregivers. Usually this is because they might need to use one on themselves, a sibling, or a parent - who has a known condition.
The random person that doesn't come in contact with such a relative or housemate, however, might not even properly recognise the reaction. Even when they do, they still need the training on how to use the pen so they know how to respond. The prudent thing to do in these cases is to give a first aid and CPR course to those that wish to have one.
Epinephrine costs maybe $5 for a dosage. It's been sold for over 100 years. It's a WHO essential medicine for anaphylaxis, and is life saving for humans and pets. It's the same thing with other critical hormones like insulin.
The market for this stuff (even with generics) doesn't work. We know how much these drugs cost to manufacture and it's very little. Essential medicines with overwhelming human impact need to have strict pricing regulation that makes them available worldwide at close to the manufacturing cost.
My physicians are writing the prescription properly. One year out of frustration I made my doctor actually write "Adrenaclick" and "may substitute with generic" and they still filled it with an Epi and the tech tried to argue with me that "Adrenaclick" was another word for "Name brand Epi-pen"
Last 2 years my allergist let me know Auvi-Q will give you them for free as long as you have any commercial insurance. They submitted the paperwork, I answered one call confirming my address and I got four Auvi-Q injectors in the mail the next day. Glad I didn't have to pay $100+ and argue at the pharmacy.
I live in Canada, and there are already drug shortages. You cannot buy any EpiPens in Canada. Period. For whatever reason, we are all out. I had an allergic reaction this week, and took a gamble to go the emergency room before the anaphylaxis really kicked in, because I only have one (expired) EpiPen left and want to save it until I'm really desperate. Each EpiPen costs $35 to manufacture,and I have no idea how a multi-billion dollar company like Mylan can have a manufacturing shortage of a life-saving drug, especially given their 17x (!) profit margin. I'm usually not a religious person, but I can only hope there's a hell so those corporate executives can rot in it.
Edit: We talked about them when we were using the EpiPen trainers in the first aid class I took.
It Costs $30 to Make a DIY EpiPen, and Here's the Proof - MIT Technology Review
MIT Technology Review
The trick is getting people who need epipens to ask the pharmacist if they have the generic version available.