Medical EthicsUncategorized

Acthar – 97,000% Drug Price Increase, Is It Ethical?

“The tale of how a 65-year-old brand medication, Acthar, could rise in price from $40 per vial in 2001 to over $35,000 per vial by 2015 is a story of, perhaps, the most egregious monopolistic conduct and unfair trade practice in US history.” – City of Rockford, HR Department

There are many back-stories to this conversation of ActharNo, I did not add the extra zeroes. As for the back-stories, they are guaranteed to break your heart. They are stories of ordinary Americans who dearly love their children and who struggle with trying to figure out how to keep their children alive. As we go through the story, please keep in mind that behind the numbers are real-life tragedies.

About Acthar

Infantile spasms is a form of epilepsy that occurs, as its name implies, at a young age. One seizure after another, the disease is in all ways devastating. The good news is that there is a drug that greatly reduces or even stops the seizures. Is it a “miracle drug?” It could certainly be viewed as such. I might add that the seizures can go away with treatment but they can – and do – return requiring the drug to be administered again.

However, the price of a single vial keeps rising at an astronomical pace. In less than 20 years, and depending on the insurance carrier, the drug has risen from a reasonable price to anywhere between $23,000 and $35,000 per vial. It may cost insurers as much as $125,000 to get the disease in check. Again, there is no guarantee that the drug won’t be needed again just a few weeks later. In fact, the cost of the drug to those families not fully covered may equal the costs of their homes.

The medical community has repeatedly expressed outrage at the high price of Acthar, especially as it is hardly a new, breakthrough medication. It was invented more than 80 years ago. The outrage of the medical community boiled over to government hearings. The hearings exposed a strange mix of contradictions.

For example, the two drug makers who make Acthar, Questcor and Mallinckrodt, also market the drug to the elderly who experience seizures. Medicare has spent close to $2 billion on covering the drug and it was also revealed that millions of dollars in “bonuses and gifts” were paid out to physicians who wrote prescriptions. Not surprisingly, the sales of Questcor and Mallinckrodt have skyrocketed.

The government successfully sued the drug makers for their exorbitant pricing and while Mallinckrodt (who owns Questcor) settled without any admission of wrongdoing to the tune of $100 million, they have not slowed down in their marketing outreach to physicians.

Where lousy ethics really kick-in

Questcor, owned by Mallinckrodt, purchased the rights to a drug called Synacthen, a synthetic version of Acthar. Questcor Pharmaceuticals paid only $100,000 in 2001 for the U.S. rights. Then the price of Acthar slowly started to creep up. In August 2007, without warning, the price of Acthar shot up from $1,600 to $23,000 a vial.

Mallinckrodt has made the claim it will cover the cost of Acthar if insurance can’t, we know that line of reasoning is fictitious. Across the board healthcare costs continue to rise due to higher premiums for everyone. So, if Mallinckrodt covers the costs in a few cases, the costs will get carried over to all insurers.

Despite claims that price increases were in the single-digits, the true percentage since Mallinckrodt purchased Questcor is about 97,000%

In 2015, Acthar net sales were about $1 billion. Meanwhile families are pulling money out of their homes to avoid bankruptcy.

The ugly truth

Though Acthar’s high price might make us believe it is a bioengineered miracle, it is actually extracted from the pituitary glands of slaughterhouse pigs. The drug was initially thought to treat other diseases, and it got “bounced around” from one pharma house to the other. It was found to be (according to the drug company) far superior to other treatments such as prednisone, though some doctors debate those findings. Strangely, the drug has never actually been approved by the FDA. Acthar is used “off-label.”

Though Mallinckrodt was fined $100 million for its exorbitant pricing, it amounts to a slap on the wrist. Unless we address drug costs in this country under an ethical guise, we will all continue to suffer.

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