You have a lifesaving drug, it cures chronic myeloid leukemia (CML), but you are charging more than double the average household annual income for it, so you know FOR SURE that most people cannot afford it and, unless they are covered by insurance, they will die. What do you do?

The answer is you keep on hiking the price, year after year, up and up and UP.

Let me back up a but, before I explode…

Just for once, Big Pharma has a worthwhile product, it works, and it brings the life expectancy of a relentlessly fatal disease almost back to normal. It’s not often that drugs can completely transform the trajectory of a killer disease – but for chronic myeloid leukemia, that is what tyrosine kinase inhibitors (TKIs) have done.

(CLL is characterized by overwhelming quantities of white cells (leukocytes, stained purple) in the blood; hence leukemia)

Before these drugs came along, there were about 20,000 patients with CML in the United States. Now there are about 112,000 such patients, and that projected to rise to 180,000 in 2050.

However, the catch is that patients need to stay on the drug indefinitely. And this is an issue, because these drugs are very expensive indeed. The high prices [if TKIs] has been described by caring doctors (not so many of those) as a scandal – they cost an exorbitant amount and put an enormous financial burden on patients and their families and the healthcare system.

So everyone was hoping that when the first of this class of drugs – Imatinib – Came off patent, generic versions would reduce cost of treatment.

Ludicrous Pricing

When Imatinib entered the marketplace in 2001, it was priced at about $30,000 a year. That remained flat for a while and then rose steeply. By 2012 it was priced at $92,000, and then jumped to $132,000 in 2014, and then to $146,000 in 2016 when the generic version became available. This is in a country where the median household income is around $63,000, according to official 2018 figures.

Surely, the generic version would be much cheaper than that? But it was not to be. See, Novartis cut what’s called a pay-for-delay deal. What’s that, you ask? The patent holder – in this case Novartis – agrees to pay a potential competitor a large sum of money to keep their product out of the market for a time. Tey calculate the cost of the deal is less than the extra profit they stand to make.

With cars it could (maybe) be considered a clever strategy. But with a life-saving pharmaceutical product IT IS NOTHING SHORT OF OBSCENE.

Thousands more died, while Novartis went on harvesting its greedy profits, stamping out any hope of an affordable cure.

One always has to consider that mass protests are sometimes staged. But I think it’s pretty clear that the Indian people are telling Novartis where to shove its patent!

Eventually a generic entered the US market in early 2016. Because of tricky laws, the generic company (a subsidiary of Sun Pharmaceuticals Industries) was tentitled to 6 months of marketing exclusivity. That mean that no other generic versions of Imatinib could be launched in the US until at least August 2016.

The generic was priced just a few thousand dollars less than the branded Imatinib. In 2016, branded Imatinib cost $146,000 pr year, while the generic version was priced at $140,000.

It makes me so angry.

Ski-High Cancer Drug Prices

The US has the dubious distinction of having the highest expenditures in healthcare, but ranks far from the top in terms improvement in life expectancy. Part of this is driven by the cancer drug experience, and healthcare costs have risen faster then gross domestic product!

Cost escalation began in the early 2000s, and eventually exceeded the median household income of a typical family. The price tag of any new cancer drugs now exceeds $10,000 per month ($120,000 annually).

This has been described as ‘financial toxicity’ which comes on top of the usual toxicity of cancer treatment, and cam limit treatment decisions, access to care, and affect outcomes.

But it’s not just a burden on patients. It’s a burden to society as a whole. These monstrous corporations have wormed themselves into a position where they are, in effect, a horrendous additional tax on us all, sick or not.

I’ve railed for decades that the UK has supposedly socialized medical system. But they didn’t “nationalize” (take ownership) of the drug companies. Therefore British citizens pay a heavy common “tax” that goes straight pay a heavy common “tax” that goes straight to the private coffers of Big Pharma. Not the utopian ideal that the socialists like the boast about, is it?

But here’s the bit that made me rage and rush to my keyboard: in the USA the generic Imatanib was almost as expensive as the branded product. It’s held artificially high everyone can get a slice of the lucrative cake, while patients die in large numbers because they are not in on the game.

Contrast that price-fixing with other countries as follows: in Canada, the patended product cost $38,000, whereas the generic was priced between $5000 to $8000; the generic in India… are you ready for this?

… runs at about $400.

$146,000 (current) vs. $400. The price in India is not a charity figure; they make a profit! Go figure.

We have a clear disconnect between pricing in the US and what’s available in the rest of the world.

Things are Improving (slightly)

At the beginning of 2018 the average price for Imatinib was about $2000 for a 30-day supple, whereas through September 2017, the price was about four times higher (roughly $8000).

Approached for comment, Stacie B. Dusetzina, PhD, associate professor of health policy and associate professor of cancer research at Vanderbilt University School of Medicine in Nashville, Tennessee, was cautiously optimistic, noting that prices of generic products have very recently fallen.

With more competition now, the price should drop even lower. Coupons offered through places like GoodRx will allow patients to purchase a month’s supple of the drug for a few hundred dollars. The lowest price was at Costco, where a 30-day supply of 400 mg tablets sold for $245.74 which is 97% off the average retail price of $11,475.

Despite that, in 2017, generic Imatinib represented still only 28% of prescriptions for newly diagnosed patients. Of course there is the usual vicious disinformation by Big Pharma, that generics are “dangerous”, or they don’t work as well. All of it bullshit… there, see? They are making me cuss.

Maybe patients who can afford it should fly to India, have a nice holiday in the land of the Maharajahs, and fly home with a year’s supple of the generic, all for less than cost of a month’s Big Pharma prescription.

I’m on the scientific advisory board to an Indian company and I have no problem with their standards.

Neither, it seems, do Novartis and others: they have all their branded products made in India, the same place as the generics. Do I smell hypocrisy? Or is it the stench of B*S? (ooops, there, I nearly said it again).

Prof. Keith Scott-Mumby

The Official Alternative Doctor

SOURCE:

American Society of Hematology (ASH) 2019. Presented December 7, 2019.