A Government Guide to Keeping Insulin Unaffordable
fee.org
fee.org
One thing that is not mentioned is that the dynamics of prescription-writing in the first place is anti-competitive in terms of price. Fiasp and Humalog are equivalent fast acting insulins from Novo-Nordisk and Lilly - competition will only happen when patients can decide which one to take instead of their doctors, who are not sensitive to small price differences (and in most cases are not themselves taking the drug).
How many people would be dying if there wasn’t the same level of incentives to research these drugs in the first place?
Diabetes is a common health problem around the world. Nothing stopped say a non-profit or government from beating Lilly and Novo Nordisk to the punch developing these drugs. But profit seeking corporations are simply better at innovation than governments and non-profits.
I don't think a profit seeking corporation would've done that.
It is somewhere between $75-$125 USD for a person with T1D per year.
Remember, T1D is an autoimmune and insulin-dependent form of diabetes. Within 5 years post-diagnosis (if not much sooner) your body basically effectively no longer produces any insulin whatsoever.
Last time I checked (in March 2019), you could buy 13.5 [10 mL] vials of Novorapid/Novolog in Canada for 1 [10 mL] vial of Novorapid/Novolog in the United States. I am actually going to buy insulin in Canada on a trip in a couple of weeks due to formulary restrictions imposed by my insurance company (cannot obtain this type of insulin via insurance--not due to cost...).
It makes me absolutely sick to my stomach that people with T1D ration insulin. You cannot safely or effectively ration insulin with T1D, ever.
Anyways, I am one of the most stubborn people you will ever meet, but honestly, I do not see a future in this country (the United States). I expect the Affordable Care Act to be either partially or completely overturned next year (June-July 2020), based on the rare cases where the Solicitor General did not defend a case at the Supreme Court. Based on those cases, the likelihood of a partial or complete overturn of the ACA is staggeringly high.
I am trying to warn you that things may get really bad, and to be prepared. Consider other countries, with universal healthcare, in fact, even actually any country in the European Union. They will accept you regardless of the cost of your medical care, as long as you can get a visa. Same goes for citizenship, in the long run. No medical inadmissability restrictions whatsoever.
The Anglo-Saxon countries (US, UK, Canada, Australia) are largely closed to immigration, and the latter 2 have medical inadmissability criteria. Remember that.
I'm confused - wouldn't the new patent only cover the improved method, and the patent on the original, un-improved version would still expire?
Plus developing a product from the old patent still requires extensive FDA approval. Very expensive stuff.
I've even seen it done when the previous version and the new version were still both once daily (tamsulosin, I'm looking at you!)
Yes, some insurers will hesitate to cover the new formulation when it comes out, but not all.
Sometimes the insurer will make a deal with the manufacturer so that the manufacturer is only getting paid the generic-equivalent price. But who knows what happens behind closed doors.
Who's the customer here, the prescriber or the patient? Is a prescription for the weekly formulation valid for the daily one too?
2. While they still had the patent on the regular tamsulosin formulation, they stopped making it. Effectively forcing everyone onto the XR formulation unless they wanted to change molecules entirely.
The data showed little difference as I recall in terms of effectiveness because the half life was long enough to take once daily, regardless of formulation.
The article says some people need up to 6 of those vials per month. So, it can still end up being $1,800 per year.
Other non-US countries are able to provide a yearly supply of the newer biosimilar insulin for just $72-133 per year: https://gh.bmj.com/content/3/5/e000850
However, if a brand manufacturer has an old product delisted, then physicians can no longer prescribe generic equivalents. That's become more and more common.
However, there is a workaround: compounding pharmacies. To my knowledge, accredited compounding pharmacies can make, on a customer-by-customer basis, any product that the FDA has ever approved. And many of them are mail-order pharmacies. In my experience, prices are comparable to mass-market generics, or lower.
>However, if a brand manufacturer has an old product delisted, then physicians can no longer prescribe generic equivalents. That's become more and more common.
Why is the ability to prescribe a drug tied to whether the branded version in still "listed"?
Also: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
And: https://www.drugs.com/history/
Physicians can only prescribe FDA-approved drugs. Only brand drugs are approved on their own. Generic drugs are approved, with much less documentation required. There's no need to demonstrate effectiveness, safety, etc. Applicants must only demonstrate that products are therapeutically equivalent to approved brand drugs. That's mainly about chemical identity, purity, and rate and degree of absorption.
At Drugs@FDA, search for a brand name. If there are generics, you'll see "Therapeutic Equivalents for NDA ...". Clicking that will display links to them.
If there's no listed brand drug, there's nothing for a generic to be equivalent to.
But the real reason is almost always that they have a new version, which costs much more, and they don't want competition from inexpensive generics to their old product.
There have been some antitrust suits over that. I don't know how they turned out.
The real issue is that nobody has an incentive to prescribe the older, less good but still acceptable drug. (In the case of insulin, note, it’s not only the delivery mechanisms that have improved, but the insulin itself.) the insurance company, in particular, under the ACA, have no incentive to cut costs to improve profits.
Evergreening is absolutely a thing, and absolutely planned and executed by the companies that profit from it.
https://www.fda.gov/drugs/questions-answers/transition-cfc-p...
The issue is that doctors keep proscribing the newer, slightly improved methods.
Trying to evergreen on purpose is also dangerous since your competitor can patent an improvement on your invention. I somewhat doubt it is a purposeful strategy. But rather it just reflects the iterative nature of invention.
I recommend the following book: Against Intellectual Property by Stephan Kinsella.
One of the things I always wanted was to create a black market for electronics in my home country (Brazil) because taxation here is really high.
You should also know that the government with its patents system is the root cause of this price spike.
I wish black market organizations doing legit and good stuff (like selling medicine that is pricey due to state granted monopolies) was the norm and I hope someday it will be. However, we are not there yet.
Here is a great podcast on the matter. If you want to know about drug patents and how they are gamed, this is your bible.
http://www.econtalk.org/robin-feldman-on-drugs-money-and-sec...
https://slatestarcodex.com/2019/04/30/buspirone-shortage-in-...
We need to work on bringing these costs down, so more companies can actually compete. Government regulation schemes will only reduce the amount of companies willing to go through the process and give us less choice in the end.
There is a definite problem in the US with drug pricing, and middlemen gauging the market, but it’s a straw man to claim new insulin products don’t bring any change. If you ask the patients there’s a world of difference between the cheap genetics and the main brand products, which is why they want the newer products and not the generics. But of cause patients also want the newer products at the same price as the generics which will never happen, even if the government fixes the drug pricing market.
The expensive, newer, patent-covered formulations like Lantus are what are prescribed over here in the UK - lucky that the NHS shields us from the ridiculous prices!
I purchased a car from a manufacturer, the base price was 20,000. Now the same model car has the base price 25,000. Sure, they added side impact airbags, backup cameras and lane assist but why can't I buy it for 20,000?
If you and others who think like you dislike the current system and want to improve everyone's quality of life, you are quite welcome to invest the time and capital to start a drug research lab, invent new and novel medicine, patent it, get it FDA approved then license it to anyone who wants to make and sell it.
Volvo was committed to the idea of safety that when they developed a seatbelt system they did just that.
The idea of taking someone's work with out paying them fair compensation is akin to slavery. The only difference it that slavery is forcing someone to do something and this is promising someone compensation then withholding it.
Now, if we believe that this new formulation is so revolutionary and would be such a great benefit then why not just buy the patent from the maker? Put together a company, raise the funds. Anything can be bought and sold. The only question is price. Trying to force the government to use a version of eminent domain by lying about the situation to the public to spark outrage is scummy.
The main problem is the $25 insulin is R and not fast-acting. It's not the difference between generic and name-brand, it's about using an insulin that takes over twice as long to be absorbed by your body.
You can’t have it both ways. Cheap alternatives are available. But yes newer main brand products are better in tons of ways, which is not surprising as they are culmination of decades of research. You can’t both claim there are no differences and than want those differences in the cheaper generics.
It is this additional regulation that should be subject to scrutiny, since the price of humalog has continued to rise, even after its patent expired. A vial of humalog costs~$5-10 to manufacture, while its list price is nearly $300 and rising quickly. I’m guessing because pharmas want to milk their golden cow while these regulations are still in place. We could drop the price of Humalog 90% within a matter of days by simply cutting regulation against import, as it is already being manufactured safely abroad.
By the way, when Humalog was under patent, on day one, the list price was something like $30 per vial.
Using cheaper alternatives is also strongly correlated with worse outcomes, including amputations and death.
In a word, yes, it literally is exactly as unconscionable and greedy as it looks on the tin.
It’s a wired definition of milking a product to lower your take home year after year. The PBMs have rebates close to 70% they are literally making more on the drugs than both the companies producing them and the companies providing them through insurance. List prices are high because the people who own the consumer side of the market don’t care how high the prices go as long as they can set up rebates that increase their own profits.