Writing in The Hill, Mercatus Senior Research Scholar Robert Graboyes discussed ways to boost the U.S. Food and Drug Administration’s productivity. He and coauthor Jordan Reimschisel discussed seven things the FDA could do to speed approval of drugs and medical devices.
The drug fentanyl — which is up to 50 times stronger than heroin — is available in generic form. It is also a highly addictive street drug, manufactured in back-alley labs and laced in heroin to boost its potency. Fentanyl is used to treat extreme chronic pain that is unresponsive to other opioid pain relievers, such as breakthrough pain cancer patients often suffer. A fentanyl transdermal patch costs from $5 to $12 depending on the dose per hour. A 12 micrograms (mcg) per hour patch retails for about $5 and offers 72 hours of pain relief, whereas the 100 microgram per hour patch is about $12 with GoodRx coupon. Sounds like a bargain; pain-free bliss for $2 to $4 a day. That works out to about $50 to $125 per month.
Last May I wrote about the uproar over Medicare’s proposed changes to how it will pay doctors who inject drugs in their offices. This largely concerns chemotherapy. Currently, physicians buy the drugs and Medicare reimburses them the Average Sales Price (ASP) plus 6 percent. The proposed reform would cut the mark-up to 2.5 percent and add a flat fee of $16.80 per injection.
I did not think the reform would have a positive impact, but I also thought criticism was overblown. Well, Medicare has managed to irritate all the affected interest groups to such a degree that it is likely to toss the proposal and go back to the drawing board.
A few weeks ago, Medicare proposed a pilot program to test a new way to pay doctors who inject drugs. Cancer is the big kahuna, cost-wise, when it comes to injected drugs. Medicare payment policy leads to certain industry practices to profit from the status quo. When the status quo is threatened, the “preservatives” immediately form a defensive coalition to stop the change.
Although I do not endorse this precise reform, the campaign to roll it back has become irresponsible and misleading. Currently, physicians who inject drugs are paid by Medicare a margin of 6 percent on top of a reported price called the Average Sales Price (ASP). The concern is that the oncologists make more margin off an expensive drug than a less-expensive drug.
The Center for Medicare and Medicaid Services (CMS) recently proposed a pilot project to test alternative payment methods for drugs under Medicare Part B. These are the drugs administered in hospital outpatient clinics and physicians’ offices.
A remarkable study published in the BMJ concludes that $1.8 billion of the $18 billion spent on the 20 most expensive cancer drugs in the U.S. is wasted due to cunning marketing by drug-makers. Chemotherapeutic doses are often adjusted by body weight. However, the drugs are shipped in vials containing doses appropriate to bigger people. Once opened, the drug that remains after an oncologist selects the does appropriate for a smaller or average-sized person has to be discarded.
The authors allege the drug-makers do this deliberately, to increase profits. Their proposed solution is that the Food and Drug Administration should regulate the size of vials!
There is a better way.
First, the FDA is not concerned with the cost of medicines. The proposed solution has nothing to do with safety or efficacy, so is not within the FDA’s purview.
The Food and Drug Administration has approved the first biosimilar therapy in the U.S.:
Many newer biotech drugs cost more than $100,000 per year, and together they account for nearly 30 percent of all U.S. drug spending. Five of the top 10 U.S. drugs by revenue are biotech medicines, according to IMS Health. Since their introduction in the 1980s, biotech drugs haven’t faced generic competition because the FDA did not have a system to approve copies.
In 2012, the FDA laid out a regulatory pathway to approve so-called “biosimilars.” That’s the industry term for generic biotech drugs, indicating they’re not exact copies. For years the biotech industry staved off competition by arguing their drugs were too complex to be reproduced by competitors. (Matthew Perrone and Linda A. Johnson, Associated Press via Denver Post)
In this month’s Health Affairs, leading health economists Dana P. Goldman and Tomas Philipson challenge five myths about cancer care. To the right we have an infographic that explains them very clearly.
The most economically interesting one is the fourth. This appears to challenge the notion that we should be skeptical about paying high prices for therapies that might buy only a short time of good life. (In health-economics, we use terms like Quality-Adjusted Life Year [QALY] and Disability-Adjusted Life Expectancy [DALE].)
The classic approach to these calculations was illustrated by Professor Christopher Conover in a recent article:
…[M]ost of the gains were concentrated in the 35-64 age group, which narrows the plausible range of what the average gain in life expectancy might be. Someone who is 60-64 is 7.3 times as likely to die in a given year as someone age 35-39. The reason this matters is that there are reasonably well-accepted rules of thumb about the value of what’s called a quality-adjusted life year (QALY).
One constant refrain heard in national health policy circles is the need for “integrated” or “coordinated” care. To be sure, I have never heard anyone speak favorably of “disintegrated” or “un-coordinated” care. While there are many good-faith practitioners who do want to integrate and coordinate care for patients, these terms are often used to camouflage a more straightforward way to raise prices. Here’s an example from Bloomberg BusinessWeek:
For the past four years, Pennsylvania insurance company Highmark has watched its bills for cancer care skyrocket. The increase wasn’t because of new drugs being prescribed or a spike in diagnoses. Instead, the culprit was a change that had nothing to do with care: Previously independent oncology clinics and private practices have been acquired by big hospital systems that charge higher rates, sometimes three times as much, for chemotherapy drugs. “The site of care and the type of service provided does not change at all,” says Tom Fitzpatrick, Highmark’s vice president of contracting. “The only significant difference that we primarily see is the [patient] gets a wristband placed on them.”
Ezra Klein challenges the notion that patients in the U.S. get better cancer treatment than patients in other developed countries. Klein was writing in response to the Commonwealth Fund’s comparison of health systems in eleven developed countries. As I noted previously, one problem with this survey is that there is no apparent relationship between ranking on the survey and health outcomes. Although the U.S. does poorly in the survey, it does well in health outcomes, especially cancer outcomes.
Or maybe not, according to Klein:
Most of the studies that highlight America’s skill in treating cancer do so by measuring survival rates — that is to say, they measure how many people survive for a certain number of years after the cancer is diagnosed. So if a certain cancer kills 50 percent of people within five years, then the five-year survival rate is 50 percent.
The problem here is simple: survival rates don’t necessarily measure when people die. They also measure when they’re diagnosed — and sometimes, that’s all they measure.
