Novartis's $475,000 Price on Cancer Therapy Meets Resistance

[Sgent]

Source: Bloomberg

The $475,000 price tag on Novartis AG’s latest breakthrough cancer therapy came under fire from one of the biggest managers of drug costs in the U.S., underscoring the challenges the Swiss drugmaker will face in promoting the potential blockbuster.

The cost of the leukemia treatment, called Kymriah, is “dramatically higher” than other such complex treatments, and the health-care system isn’t ready to pay for it, Steve Miller, chief medical officer at Express Scripts Holding Co., said Thursday in a blog post on his company’s website. Gene therapies like Novartis’s are targeted at a small number of patients and typically used just once, meaning that drug companies have limited chances to recoup their investment.

“Therein lies the challenge,” Miller wrote. “We need a new payment model.”

Kymriah is the first drug approved from a new class of treatments called CAR-Ts that have been heralded as a promising approach to treating and potentially curing cancers as well as genetic conditions such as blindness. Paying for CAR-Ts and similar therapies, some of which cost as much as $1.4 million, will require new collaborative approaches among payers, drugmakers and policymakers, the executive wrote.



Read more: https://www.bloomberg.com/news/articles/2017-09-22/novartis-s-475-000-price-tag-on-cancer-drug-meets-resistance

[bucolic_frolic]

1. Until lawmakers delve into costs rather than pricing

these problems will continue. The cost of producing a drug has many components. Research, lab space and time, doctor and research labor, overhead, capital borrowing costs, production, marketing, profits to shareholders, etc, etc.

I have no idea how transparent pharmaceutical companies are, and I suspect as long as the campaign cash keeps flowing into incumbents' war chests that legislative bodies won't look too deeply. There is also the issue of free market capitalism, as opposed to government regulation.

And time was research was government paid or sponsored, researchers were motivated for the good of humanity. Now there must be a payday. A fat one.

[GeorgeGist]

3. Meanwhile, the CAR-T discussion has become dominated by cost concerns.

Critics argue that tisagenlecleucel’s $475,000 price tag is unaffordable and unjustifiable given the taxpayer-supported basic research underpinning its development, while manufacturers point to the tremendous investment required to produce the drug and fund trials. With many patients unable to afford their medications and ongoing instances of unconscionable drug-company profiteering, these discussions are both essential and complex. Regardless of the finances, we all hope that these remissions are prolonged or, even better, turn out to be cures. There is no way to know whether they will without prolonged observation, but while we carefully observe each patient, it is important to remember that therapeutic advances are motivated by more than money — that it’s the hope, vision, and perseverance of both patients and investigators that have made this critical conversation possible.

http://www.nejm.org/doi/full/10.1056/NEJMp1711886#t=article

[airplaneman]

2. So when they really find a cure for cancer what will it cost.

It will cost so much only a had full of the richest people in the USA will be able to afford it.
For you and me it will be a million times more than we can afford.
So why bother even trying.
-Airplane

[DK504]

4. Therein lies the challenge, Miller wrote. We need a new payment model.

There's a no-shit Shirley comment. $500K for a maybe treatment. FU and your BS attempts to fleece people.

[Cicada]

11. Money back if it doesn't work, plus this approach may cure most cancers

They take your cells, genetically engineer them to trigger your immune reaction to your cancer, grow a hundred million of them, put them into you. Apparently these engineered cells cures you permanently in most cases. Like 83% have zero cancer cells after one treatment. They refund the money if it doesn't work. Is your life worth the money?

And there seems a reasonable chance that this same approach will cure most cancers. This thing may actually be a cure for cancer, basically, as it is refined. Is that worth a ton?


The primary genius behind this particular drug is apparently Carl June who rides his bike to the University of Pennsylvania. If I were the CEO of Novartis I would hire armored cars to drive ahead of him, behind him and on both sides of him along his drive.

The patent runs 20 years. If these companies suck out billions and billions for twenty years but then we can stop most worries about cancer, I can live with that.

Other drugs? I'm with you. But this drug looks special.

[BigmanPigman]

5. I believe these corrupt business people are much more sick

than any of the people who need the treatment. Their level of greed is truly SICK! I wish there was a cure for greed.

[elmac]

6. I used to work for them years ago

but like all capitalistic economic models profit and share holders are are their only major concern.

[TexasBushwhacker]

7. Switzerland regulates the cost of drugs

as do most other countries, besides the US. So it's not going to cost that in Switzerland, or the UK or France or Canada, etc. That's the problem with our lack of regulation. The drug companies have to jack up prices in the US because we're the only country where they can make an obscene profit. If we regulated drug costs, it's likely prices would go up in other countrues because drug companies would no longer bleed us dry.

[BumRushDaShow]

10. THIS

in a heartbeat.

[Bengus81]

8. No problem for the Kochs,they'll take a 100 count bottle. The rest of us can just die....n/t

[jmowreader]

9. I looked into this stuff. And I was surprised.

At first, I thought what you did: This is why doctors wear masks.

Then I found out what it really is.

The treatment is called tisagenlecleucel. It is $450,000, but the company has a special deal: if it doesn't work and you're on Medicaid, they refund the cost of the treatment to the government. They're working on insurance programs and patient access programs. So, in essence, no one is really going to pay half a million dollars for this.

It is a one-time therapy for one very narrowly-defined disease: B-cell acute lymphoblastic leukemia that doesn't respond to the standard treatments for it, in patients up to 25 years old. In the US, only 2500 cases of B-cell ALL present each year, and only 600 of those cases don't respond to chemotherapy. (According to https://en.wikipedia.org/wiki/Acute_lymphoblastic_leukemia, this is one of the first cancers they found effective chemotherapy for.)

They also have bone marrow transplants and stem cell transplants, which are more expensive than this treatment - multiply by 150 percent and you're in the neighborhood. Doctors are calling this product a bargain.

What it does: You have six different kinds of white blood cells, but here we are worried about Lymphocytes. There are three kinds - B cells, T cells and Natural Killer Cells. Many leukemias (blood cancers) are the result of B cells gone wrong - they lose their ability to fight infection (the reason you have them) and they take over your body's ability to produce any other kinds of blood cells (so your blood can't carry oxygen and nutrients, and it can't clot if you get cut). Kymriah reprograms your T-cells to kill off all your B-cells and the parts of your bone marrow that make the cancerous ones.

How it is made: There are fewer than thirty hospitals in the entire country that do this. You get referred to one. On your first visit, they start two vein punctures and route your blood through a machine that extracts all the T-cells in a 3- to 6-hour procedure. They need a certain amount of T-cells, so if you're running low they might need to do this more than once. The T-cells are then sent to Novartis AG. They are purified and infected with a lentivirus that trains the T-cells to destroy B-cells. This takes three weeks. When it's done, a bag is labeled with your name and other identifying data (I've seen pictures of the bag; it doesn't have your SSN on it), freeze it in liquid nitrogen, and ship it back to the hospital. It is then infused back into your arm.

Why it won't become super popular: Several reasons, actually.
1) In most cases it's not necessary. Most B-cell ALL resolves with much cheaper therapies.
2) It can kill you. The first disease on the list is Cytokine Release Syndrome (CRS), which is where your immune system decides you're pissing it off and retaliates. Line up five Kymriah recipients at random; four of them will get CRS. The treatment for this is an immunosuppressive drug called tocilizumab, which the package insert clearly states, "ensure this is available on site before infusing Kymriah." CRS can appear any time up to 22 days after you receive Kymriah, so you have to live within two hours of the hospital you were treated at for a month after you receive it. It also causes neurological toxicities like headaches, tremors, voting for Donald Trump (the package insert says "delirium" which is pretty much the same thing, and 21 percent of everyone who got this stuff came down with it), mutism, aphasia...it also causes hypersensitivity, serious (including life-threatening) infections, other cancers, inability to drive for two months after you get it...and then we get to "adverse reactions."

Oh yeah...the lentivirus they make this with and HIV look enough alike that you can throw a false positive on an AIDS test after you get this.

All tolled, $450,000 looks almost reasonable.

https://www.consumerreports.org/drug-prices/kymriah-first-gene-therapy-costs-475000-dollars-childhood-cancer/
https://en.wikipedia.org/wiki/Acute_lymphoblastic_leukemia
https://en.wikipedia.org/wiki/Tisagenlecleucel
https://en.wikipedia.org/wiki/White_blood_cell
https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM573941.pdf
https://en.wikipedia.org/wiki/Cytokine_release_syndrome