I received the same letter from my insurance company. It must have gone into effect the beginning of 2012 as I received a 3 month supply of Humalog the end of last year at my usual $80 co-pay. I'm not sure what the increase will be now, but I will try the Novolog. Humalog has been fine for me so I hope I do not see any changes with the switch.
Essentially correct.
Manufacturers of generics aren't actually barred from making insulins . . but rather most likely choose not to because there's no money it for them. Making generics is rather quite easy, as the "name brand" has already done all the research, studies, clinical trials to get the product approved and to market. This is money and time the "generics" don't have to spend. All they have to do is make the product and prove through a small scale study that their product reaches the same therapeutic level as the "name brand". They don't even have to prove it works, that it justs reaches the same level therapeutic level in the human body.
The regulations don't specifically ban any one from making insulin, but rather place the same regulations and processes involved that the big names have to follow to get an insulin to market. The patents on animal and regular insulins died out years ago and no ones making a generic. Certainly there are plenty of people worldwide using R to justify a generic company taking one to market.
Unfortunately the costs of bringing an insulin to market are prohibitive for the generics (and doesn't fit their business model), what with starting up the rDNA department to alter/construct the bacteria to make the insulin, all the clinical trials to prove efficacy and then applying for approval. With a generic having to go through all the steps the original went through to get to market along with the costs associated is just not financially lucrative enough.
It will be interesting to see what will happen when the patents run out on the current "analouges" as there is nothing in the pipeline to replace them. That with added pressure on the FDA to relax it's position on biologics may change the picture. I would think that relaxing the regulations on the manufacturing of insulins would make it cost effective for a generic to come to market, but would we trust it?
If you live near the Canadian border and can go across to get insulin you can get it even cheaper. The standard pharmacy in any big grocery there has great prices. For example, Humulin Regular is $25 a vial.
Hi ThunderOwl. It is my understanding that if your doctor writes to your insurance company that you have a special need, that the insurance company will give you a break. It's worth a try.
Thanks for a great explanation. I too have been forced to pay OTC and was aghast at the cost. One thing it did was motivate me to lower my carb intake to make that vial last as along as possible.
One thing that would impact prices for health care would be if consumers had a personal financial stake in costs. We'd see many fewer "nice to do" tests of dubious value. Demand would drop and so would costs. But with insurance and government paying the freight there is no motivation for consumers to make decisions based on costs. Further, many doctors get compensated on how much medicine they practice, not how well. Unfortunately we are getting farther and farther away form any models that will encourage cost containment and that applies to insulin as well.
Another consideration guiding pricing is that with insulin, nothing else will do. Not purchasing it is not an option and just like other similar goods and services price does not correlate to demand. The only alternative would be cost controls imposed by the government but every time that has been tried it inevitably leads to shortages - a sitiuation that insulin users literally cannot live with.
This information below came from here. I find they generally have solid information about availability of generics.
There are at least two major obstacles preventing generic Humalog from becoming available. First, Humalog is considered a "biologic" medication and is under different rules and laws than most other medications. At this point, generic biologics, including generic Humalog, are not allowed to be manufactured in the United States. Currently, legislation is under way that may change the laws concerning generic biologics (including insulin), but it is not clear when (or even if) this may happen.
Second, Humalog is protected by unexpired patents, the first of which is currently set to expire in May 2013. Even if the laws change and allow generic versions of insulins, generic Humalog would not be expected to become available until 2013 at the earliest.
Actually, I don't know if this legal situation is any longer true. Several insulins (insulins aspart, glargine, and lispro) are coming off patent and the FDA has apparently made clear a position which opens the door for "biosimilar" products. Pfizer has entered into an agreement with an Indian firm which produces a formulation of glargine (Lantus).
"Opens the door" sounds like code for "it will be a long legal battle unless the companies themselves decide to do what is right"
I would be VERY suprised if we even heard wind of "generic" analogs until well after Humalog loses it's legal patent protection. These companies do not have a newer analog coming out. They will fight tooth and nail to keep it non-generic in the States. Our only hope is that the people "working for us" (e.g. congress)do actually sign legislation forcing the companies to do so. Even then I see a whole lot of foot dragging.
Not for nothing, but if analogs become generic I would have a tough time even contemplating switching over, even if it saves me money in fear of losing my control. I am on Synthroid, and when I did a trial of the generic, my levels went crazy.
Insulinopoly--perfect, Danni.
Well, I am just saying that the rules have changed since then (the quote was from 2008), particularly as they relate to biosimilar products. And my point was that Pfizer (which flopped with Exhubera) has made a move to secure a source of biosimilar insulin by investing in Biocon. You are no doubt right that there are still many battles ahead, but Pfizer is no naive small potatoes in the drug game.
While I hear what you're saying, Tom, about consumers having a greater personal financial stake in cost of care, the idea of that happening is terrifying to me because I see a system where only the wealthy can properly care for their health.
I think medical costs place a huge financial burden already on those with chronic illness and not everyone is financially capable of taking on a greater financial stake in the cost of their care. So what I see happening if a system were in place that required greater financial stake by consumers is that more people with chronic illness would not get the care that they so desperately need...this is already happening.
Those in this world who are currently rationing their insulin because they're in the Medicare gap are a good example. If they can't afford insulin, they sure can't afford a greater financial stake in the cost of a heart cath or some other procedure.
Amen.
Yeah I agree. I actually dug for quite a while on the FDA website and although what I found was only a draft it really suprised me. They consider bioequivalence (same as the regular drug) if it's action provile is 80-125% of Area Under the Curve (definition of AUC- The amount of a therapeutic agent that is present in the circulation in a determined time period). Don't know about you but that dosen't sound "equivalent" to me- in fact like you synthroid story, many people have stories of obvious unequivalence. I have no idea if "biologicals" have tighter restrictions or not but it doesn't give me much hope that the FDA has their ducks in a row. Can you imagine the mess it would cause if the generic Humalog you got sometimes had an action profile 80% as effective as usual all the way up to 125% as effective as usual? Talk about adding another "layer" to diabetes.......
I'm going to sound like an old person here (thank God I've lived to be one!) but when I was in college back in the early '70s and ran out of insulin, I could walk up to the drug store and buy a bottle of Lente for under $10 They say health care has improved? I say it's improved the medical industry's pocketbook!