Now that 30 days have passed, I can, within my contract, post Charley Hooper’s and my whole op/ed in the Wall Street Journal. Here it is.
Expensive Prescription Drugs Are a Bargain
The Inflation Reduction Act gives the government the ability to ‘negotiate’ prices. People will die.
By Charles L. Hooper and David R. Henderson
Sept. 13, 2022 12:37 pm ET
The Inflation Reduction Act has eight provisions intended to reduce future drug prices. Some observers were surely pleased that Congress gave the Centers for Medicare and Medicaid Services new powers to negotiate with pharmaceutical companies. They shouldn’t have been. The Inflation Reduction Act won’t noticeably reduce inflation and it will do little or nothing to lower the cost of healthcare. Forcing drug companies to charge lower prices will likely lead to fewer new drugs.
Virtually no products are more valuable than the modern medicines produced by the biopharmaceutical industry. They cure diseases and extend lives. We’ve all heard that Americans pay higher drug prices than people in other countries. That’s true, but only when comparing retail prices of brand-name drugs. Very few Americans pay retail prices; most pay a fraction—a copay dictated by their insurance plan. Most country-to-country comparisons also leave out generics. Nine of 10 prescriptions in the U.S. are filled with generic drugs priced lower than in most other countries.
In many countries, the government is the sole purchaser of pharmaceuticals. For a new drug to be used, the government must buy and distribute it. If the government declines, the drug won’t be available. These governments negotiate with a take-it-or-leave-it attitude. Drug companies often take it, because once research and development costs are covered, some money is better than no money.
Except in rare cases, pharmaceutical companies develop drugs for the U.S. market. For drugs that make it in America, potential sales in Europe, Japan, Canada, China and elsewhere are gravy. Drugs that can’t make it in the U.S. are scuttled. Probable success in America is a necessary and sufficient condition for the development of new drugs. There are four main reasons for this:
First, the U.S. is a relatively large country. Second, the U.S. is a wealthy country; Americans are 46% richer than the British, 59% richer than the French, and 36% richer than the Germans as measured by per capita gross domestic product. Third, negotiating prices with government bureaucrats takes time, resulting in one to two years of lost sales. Fourth, prices in the U.S. are somewhat more influenced by market forces and, until the Inflation Reduction Act, weren’t determined by negotiations with the government.
Where CMS is concerned, “negotiations” is a “Godfather”-esque euphemism. If a drug company doesn’t accept the CMS price, it will be taxed up to 95% on its Medicare sales revenue for that drug. This penalty is so severe, Eli Lilly CEO David Ricks reports that his company treats the prospect of negotiations as a potential loss of patent protection for some products.
Drug research and development involves enormous fixed costs. As of 2013, the cost per new drug approved by the Food and Drug Administration was $2.9 billion. Historically, these fixed costs have doubled in real terms every nine years. So in 2022, the inflation-adjusted fixed cost per approved drug is close to $7 billion.
That huge cost must be spread out over a small fraction of the world’s population during a limited period of marketing exclusivity. Without wealthy American consumers and insurers who pay retail or close to it for brand-name drugs, some drugs won’t be developed at all. While it’s true that foreign governments mostly free-ride on the enormous investments in R&D made by the U.S., it’s also true that somebody has to pay. If nobody pays, many treatments that would improve and extend people’s lives won’t exist.
Research by Columbia University economist Frank Lichtenberg suggests that 73% of the increase in life expectancy that high-income countries experienced between 2006 and 2016 was due solely to the adoption of modern drugs. He also found that the pharmaceutical expenditure per life-year saved was $13,904 across 26 high-income countries and $35,817 in the U.S. Most Americans would pay $36,000 to live an extra year.
Even though the U.S. shoulders the lion’s share of global pharmaceutical R&D costs, Americans get a great deal. New drugs are a fantastic investment for humanity, and Americans benefit as much as everyone else. Whether to accept that deal and get a good outcome or reject the deal and get a worse outcome should be an easy decision. Before Congress attacks drug prices again, it should account for the tremendous value of the products that originate from this amazing yet maligned industry and consider the possibility that the U.S. will be shooting itself in the foot if it tries to imitate more-restrictive governments.
Mr. Hooper is president of Objective Insights, a life-science consultancy, and author of “Should the FDA Reject Itself?” Mr. Henderson is a research fellow with Stanford University’s Hoover Institution and was senior health economist with President Reagan’s Council of Economic Advisers.
READER COMMENTS
Mark Brady
Oct 16 2022 at 5:59pm
“Second, the U.S. is a wealthy country; Americans are 46% richer than the British, 59% richer than the French, and 36% richer than the Germans as measured by per capita gross domestic product.”
Is that comparison based on market exchange rates between the dollar, the pound, and the euro? Or is it based on purchasing power parities?
And would a better measure be median household income rather than GDP per capita?
Charley Hooper
Oct 17 2022 at 3:36pm
Here’s the link: https://data.worldbank.org/indicator/NY.GDP.PCAP.CD
Mark Brady
Oct 16 2022 at 6:50pm
Here are some questions that economists should ask.
We live in a world of scarce resources. How does the number of new drugs that the present system of exclusive patent rights for pharmaceuticals (twenty years from the date of FDA approval) produces compare with the number of new drugs that alternative patent systems would produce?
Would fewer drugs distributed at lower prices lead to greater welfare overall (as measured by willingness to pay)?
Should the exclusivity of a patent be curtailed so that independent inventors can reap their rewards without having to wait until the term of the patent has expired?
What are the alternatives to the present system? Changing the scope and term of patents? Philanthropy? Tax-financed research? Or some combination of one or more?
A good starting point is Arnold Plant’s seminal article “The Economic Theory Concerning Patents for Inventions,” Economica 1 (February 1934): 30-51, an essay that David Henderson cites in his entry on patents in The Fortune Encyclopedia of Economics (1993). Another article to consult is Stan Liebowitz’s entry on intellectual property here: https://www.econlib.org/library/Enc/IntellectualProperty.html
Brandon Berg
Oct 16 2022 at 9:58pm
Patents last 20 years from date of patent filing, not from date of FDA approval. As a result, the effective life of patents on drugs is generally short of 20 years. There’s a renewal program provided to counter this problem, but it only allows extension to a maximum of 14 years from date of FDA approval.
Mark Brady
Oct 17 2022 at 6:21pm
I had read that patents for pharmaceutical drugs expire 20 years after FDA approval. Hence my statement. But thank you for your comment that got me to research the topic further.
I recommend that anyone interested visit the FDA’s answers to “Frequently Asked Questions on Patents and Exclusivity” here: https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity. This makes clear the difference in U.S. law between patents and exclusivity. Both can operate to the advantage of the inventor/manufacturer.
“Patents and exclusivity apply to drugs in different ways. Patents can be issued or expire at any time regardless of the drug’s approval status. Exclusivity attaches upon approval of a drug product if the statutory requirements are met. Some drugs have both patent and exclusivity protection while others have just one or neither. Patents and exclusivity may or may not run concurrently and may or may not cover the same aspects of the drug product.”
That said, there certainly is scope for pharmaceutical patents to be extended, although it is not as straightforward as I had assumed. Go here: https://www.upcounsel.com/how-long-does-a-drug-patent-last and scroll down.
“Due to the rigorous amount of testing that goes into a drug patent, many larger pharmaceutical companies file several patents on the same drug, aiming to extend the 20-year period and block generic competitors from producing the same drug.”
Brandon Berg
Oct 16 2022 at 9:48pm
We still pay full price for the drugs via insurance premiums, and if our employers pay the premiums, we pay via reduced wages. The only people who don’t pay one way or another are people on tax-funded insurance.
Still worth it, though. On average, anyway. I have my doubts about specific drugs.
Charley Hooper
Oct 17 2022 at 3:57pm
Three responses:
1: Almost all drugs are discounted from full retail prices when sold to the government (Medicaid and Medicare Part D) and payers (insurance companies, PBM’s, hospitals). The discounts range from 10% to 50% or even more.
2: Even most cash-paying customers—and there aren’t very many of them—don’t pay the full retail price. Many of them get free or discounted drugs from drug companies. Yes, of course, there is someone somewhere that paid the full retail price for his or her drug.
3: The insurance premium you pay is for heath insurance, which includes branded drugs, generic drugs, doctors’ fees, hospital charges, medical devices, diagnostics, imaging, etc. Total spending on drugs is 13.7% of all health care costs. Some spending on drugs reduces the spending on other health care. Some spending on drugs reduces the morbidity and mortality of covered individuals. Some spending on drugs increases our quality of life.
Let’s say a drug has a full retail price of $1,000. Your insurance company might only pay $600. That drug might reduce the expected cost of surgery by $700.
The cost of the drug to you as the insurance customer is hard to determine because it depends on the characteristics of the drug and the way that your insurance company covers it and the way that you and your doctor put it to use.
But, yes, in the short-term, if the price of a drug goes up by x% and the discount and other factors don’t change, your insurance would go up by a very small percentage.
Mactoul
Oct 17 2022 at 6:25am
Cholesterol lowering statins don’t lead to overall lower mortality. They are also one of the most prescribed drugs and one of the most profitable.
You cite that 73 percent of increase in longevity from 2006 to 2016 can be ascribed to drugs but isn’t it so that longevity is actually declining in US.
Jon Murphy
Oct 17 2022 at 11:29am
It’s only fallen the past two years and that is likely due to a pandemic of a novel virus, coupled with the denial of medical care due to lockdowns.
Charley Hooper
Oct 17 2022 at 4:02pm
Regarding statins, I don’t see how you can be right.
A paper published in the New England Journal of Medicine in 2016 examined the results of 12,705 people from 21 countries with “intermediate risk” for cardiovascular disease. After 5.5 years, the statins in the study reduced the risk of heart attack and stroke by 24 percent.
According to the UC Berkeley Wellness Letter, 1,500 heart attacks and strokes are prevented within each group of 100,000 statin users per year.
Mactoul
Oct 17 2022 at 7:48pm
But no effect on overall mortality. At best, heart attacks are exchanged for cancer.
Jon Murphy
Oct 18 2022 at 8:41am
I’m missing something. If we take your comment literally, then given we all face that Rider on a Pale Horse eventually, nothing changes “overall mortality.” Antibiotics that prevent me from dying from an infected blister just mean I’ll die from something else.
I don’t think you mean such a silly conclusion, so I’m missing your point
Mactoul
Oct 19 2022 at 12:21am
Mortality as calculated within a specific period, say 5 years.
It was already known in 2006 by J-LIT trial that was held in Japan.
Jon Murphy
Oct 19 2022 at 11:31am
Sure. So? It doesn’t logically follow that “cholesterol lowering statins don’t lead to overall lower mortality.”
Let’s say I have two health problems:
1: Cholesterol which will kill me in 2 years
2: Cancer which will kill me in 3 years
For the sake of simplicity, assume that these outcomes are known with 100% certainty.
Now consider two possible outcomes:
1: The statins they prescribe work 100% perfect and remove my deadly cholesterol but the cancer is uncurable. My life expectancy has increased by 1 year.
2: The statins they prescribe do not work at all. The cholesterol kills me. My life expectancy is 2 years, rather than 3.
If mortality is calculated in a 5 year time frame, then you are right. There appears to be no change in my mortality. But the fact I am trading cholesterol for cancer is proof positive that the drug works!
If mortality is calculated in, say, a 6-month timeframe, then you are wrong. There is a change in my mortality even though I am still trading cholesterol for cancer!
So, what you are observing is really a measurement issue, not a drug issue. You are picking up a problem rife throughout science: how we measure outcomes depends both on the technology avalible to us and arbitrary decisions by the analyst of how to measure. The issue is not with the drug (and, as I note above, there is a tacit admission that the drug works given the trade-off you mention). The issue is with measurement.
Charley Hooper
Oct 18 2022 at 7:22pm
Are you saying that eventually cancer replaces heart attacks or that in the near-term that happens?
In other words, do we all die of something eventually, as Jon asked, or do statins increase the rate of cancer enough to offset the reduction they provide in heart attacks?
Mactoul
Oct 19 2022 at 12:38am
In JUPITER trial (2008)
Heart attack deaths on statin: 9
Heart attack deaths on placebo: 6
There were 3 stroke deaths in statin group and 6 in placebo.
Exactly enough to cancel the heart attack effect.
Charley Hooper
Oct 19 2022 at 11:05am
I think you are misinterpreting the results of that trial. The trial was stopped early because the statins worked so well.
From the study itself:
Johnson85
Oct 17 2022 at 2:39pm
Two comments:
“Very few Americans pay retail prices; most pay a fraction—a copay dictated by their insurance plan.” This statement seems extremely out of character coming from an econlog contributor. I’m guessing you would criticize anybody who claimed healthcare in Canada or Britain is free? I know you had a co-author but I’m pretty sure most econlog contributors would (rightfully) lambaste an author for making such a statement.
I would prefer the status quo rather than just allowing Medicare and Medicaid to use their virtual monopsony power to set drug prices, but I think maybe a good alternative would be to provide that Medicare and Medicaid won’t pay more than “X percent” more than the average OECD country price? And put in stiff penalties for trying to manipulate pricing with rebates or other systems for countries to claw back the price. Or maybe it should just be more than X% more than the average of the 8 next richest countries? That would cut down on some of the free riding by making pharmaceutical companies weigh the revenue they’d make from other countries against the revenue they’d lose from the US.
Charley Hooper
Oct 17 2022 at 4:05pm
That statement is literally true.
A drug might cost $500 at retail but I get it for a $30 copay. That’s how health insurance plans work.
Johnson85
Oct 18 2022 at 4:41pm
“A drug might cost $500 at retail but I get it for a $30 copay. That’s how health insurance plans work.”
If that statement is true, then it’s also true that most country clubs let people swim for free because they don’t charge anything to swim, you know other than the pretty hefty membership fee.
Going back to the original statement:
“Very few Americans pay retail prices; most pay a fraction—a copay dictated by their insurance plan.”
Now certainly the first half of the statement (up to the em dash), taken by itself, is true. Most people don’t pay full retail and you are right to point out that people should keep that in mind when they here sticker prices that sound eye popping. But when you follow that em dash by “a copay dictated by their insurance plan,” I think it’s fair to call that inaccurate. Insureds pay some portion of their premium for prescriptions and then the copay. There may be some drugs where you literally pay nothing but the copay b/c the insurance company thinks it saves enough money to be worth it (maybe birth control?). But that’s going to be the exception, not the rule.
And I guess along with my original two comments (whose formatting was lost when I posted it), I should have also pointed out that it was a good article; it’s persuasive and I think the overall point is correct and well supported, although again, I’d be willing to at least consider some “gamesmanship” to reduce the amount of subsidy flowing to other relatively rich countries. And the one statement I’m zeroing in on does not change the balance of the article. But even after reading your responses, I still think my criticism is fair.
David Henderson
Oct 18 2022 at 5:21pm
I agree with you that it sounds as if we’re claiming a free lunch for the patient just because the insurer pays for it. In retrospect, I would have written that section differently. But doing so would have involved making the points Charley makes in response to Brandon Berg, and with the WSJ’s word limit, we didn’t have space for that.
Charley Hooper
Oct 18 2022 at 7:37pm
There are two things going on here.
First, my decision whether to pay for a drug is based on my copay and my anticipated value of the drug. If the expected value is greater than the cost, I’ll buy it (if I’m rational).
Second, am I paying for the whole price of the drug anyway, even though my initial outlay is limited to the copay? I would say not necessarily. If my actions caused my insurance company to incur an extra cost of $1,000, there are two reasons I won’t pay that $1,000. One, I’m one of many insured individuals. That cost will be spread among all of us. Two, the linkage between that cost and my premiums is tenuous. My insurance company may decide to raise premiums in aggregate by $1,000 or it may decide to skip some senior management bonuses, close some office space, negotiate harder on imaging costs and doctors’ fees, cut back on landscaping, or skip an employee lunch.
There’s no rule that premiums must rise by $1,000.
David Henderson
Oct 17 2022 at 5:02pm
You write:
I think you’re right that they would lambaste an author for such a statement IF they were unaware of key institutional details about insurance companies and bargaining on prices. Charley, my co-author, lays it out nicely in his response to Brandon Berg above, especially his point #1.
Rob Rawlings
Oct 17 2022 at 8:02pm
I was also a little surprised at the claim that the copay was the relevant price point. The explanation given seems to be backing away from the “copay” claim and saying instead that insurance companies negotiate lower prices. Negotiating lower prices would have no effect on copays – meaning the explanation is irrelevant to the original claim. Am I reading this correctly ?
David Henderson
Oct 17 2022 at 10:53pm
No, it’s not backing away from the original claim. I’m responding to the point that we should take into account the overall cost to the insurance company because we pay that in premiums. The lower the amount the insurance company pays for drugs, the lower are the premiums.
Rob Rawlings
Oct 17 2022 at 8:06pm
Correction: I guess the negotiated may have some effect on copay if copay is a % of total cost. But I suspect that many insurance companies base the discount on the retail price not the price they actually pay.
Mactoul
Oct 17 2022 at 9:05pm
Actual record of pharmaceutical drugs is far too unclear. Diabetes drugs don’t cure diabetes– and are far inferior to non-drug approaches. Statins are useless. Alzheimer’s has no cure yet.
Depression and mental health drugs haven’t led to an era of mental health, to say the least of it.
Cancer treatment has barely advanced in half a century despite a plethora of new expensive drugs.
It is arguable that all the focus on drugs is misplaced — each drug requires many other drugs to manage its side-effects.
For instance,metabolic disorder may be helped with low-carb diet rather than drugs based upon incorrect paradigm that the drug industry is based upon.
Charley Hooper
Oct 18 2022 at 7:39pm
I completely disagree with you and there is ample evidence to back up my side of the argument.
But, it’s a free country. If you don’t think drugs help, don’t take them.
Jon Murphy
Oct 19 2022 at 11:44am
It appears to me that you are using “cure” as the only standard by which drugs should be measured. If I am wrong, then please correct me and ignore what follows.
Curing is not the only desirable outcome. Management goes a long way, especially pain management.
Again, just take me for example. I have a very unique liver condition. Indeed, my doctors have never noticed something like this before. Either this is an extraordinarily rare condition or I am about to get something named after me.* The doctors, obviously, do not have a cure.
But they do have ways of mitigating the worse of it. At its peak, the symptoms made me so nauseous I couldn’t leave my apartment for fear of getting sick. But, with some medicines, they relieved that pain and let me live a normal life. That relief allowed me to take on lifestyle changes that have reduced the symptoms to almost 0 (although the condition persists).
It is true that the medicine did not cure me. But it did make me better. Do not underestimate the miracles of modern medicine in simply relief. God willing, there will be a cure eventually. But that will be another advancement on top of the small one we already have.
*I hope to have my name associated with my economic contributions, but hey, if I advance human understanding in this manner, I guess I’ll take it.
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