(I sent the following to the residents in my program)
Extinction perhaps?
Read below and then consider:
FDA approves drug to counter effect of blood thinner Pradaxa
The U.S. Food and Drug Administration Friday approved the first medication designed to reverse the effects of the blood-thinning drug Pradaxa to lower the risk of excessive bleeding during surgery.Boehringer Ingelheim Pharmaceuticals’ drug Praxbind received accelerated approval.
“The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug’s effects is medically necessary,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research in a released statement. “Today’s approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can’t be controlled.”
Pradaxa belongs to a class of anticoagulants called direct thrombin inhibitors, which inhibit the protein thrombin and thin the blood for those at risk for stroke. Many viewed Pradaxa’s approval in 2010 as a marked improvement over Warfarin, which has been the standard anticoagulant drug for the past five decades.
Patients taking the drug do not require as much monitoring or need to go on dietary restrictions compared to those using Warfarin. But unlike Warfarin, there was not a way to quickly reverse the effects of direct thrombin inhibitors, making it difficult to stop bleeding during surgeries or medical emergencies.
Approval was based on the results of three clinical trial involving more than 280 healthy subjects who took Pradaxa, according to the FDA. Those studies found an immediate reversal of the effects of Pradaxa in those who took Praxbind for a period of at least 24 hours.
Another trial involving 123 patients taking Pradaxa who took Praxbind for uncontrolled bleeding found it was able to reverse Pradaxa’s effects in 89% of patients within four hours of taking the drug.
“We are very pleased to offer Praxbind, the first specific reversal agent for a novel oral anticoagulant,” said Dr. Sabine Luik, senior vice president of Medicine & Regulatory Affairs with Boehringer Ingelheim. “While we anticipate that Praxbind will be rarely used in clinical practice, the availability of a specific reversal agent has the potential to give physicians and patients added assurance in choosing Pradaxa.”
Boehringer Ingelheim did not disclose the price of the drug. But President and CEO Paul Fonteyne said it had been set to “ensure the likelihood that it can be available at institutions where Pradaxa patients seek emergency care.”
If you have an impression, it might be the NOAC antidote holy grail has arrived. Anticoagulation nirvana is upon us, and we all can move on. In with the new and out with the old, right?
However, let me give you something to think about. Let’s assume there are 5 million folks with Afib in the U.S. (we will leave out VTEs for now). Let’s also assume, and maybe it’s a generous guess, 20% will be on Dabigatran, now or in the near term. That’s 1 million people.
If we suppose a major hemorrhage rate of 1.5%, we have 15,000 folks. The drug manufacturer will want to make a profit — we have a free market after all — and they do have product exclusivity and an attractive niche to sell in.
But what kind of revenue might the pharma company expect? Have a look at a list of top sellers
here and you will see (answer: hundreds of millions to the billions).
If you work backwards and surmise an expected gain of 150 million for Boehringer — it’s a drug with narrow indication with a not quite broad appeal…unlike Abilify [insert smiley face]–you can calculate a cost of $10,000/dose. My guess is it will be a little higher, but okay. It does end with “-mab” after all, and anything that ends with “-mab” costs bucks.
Now think not about the patient with a massive hematoma in need of the operating room or a patient with ongoing ICH, but a patient with melanotic stool, a little bit of dizziness, and a hemoglobin of 10. Or a patient with epistaxis that kinda maybe will stop, but we are not sure.
Do you give the antidote? Its $10-15K. Or do you spend it on DM education videos? Or a P/T nurse educator? Or a new ER bay with better technology? It’s all about limited resources.
The
2015 NEJM study has the characteristics of the patients examined, but you would be hard-pressed to glean who should and should not get this drug in real world circumstances. That’s the hard part. Who says yes and who says no. When do you use the reversal agent? It’s on the shelf asking you to dose, but it’s not quite as simple as vitamin K, is it?
Regardless, this is high-value thinking. And when others ask if you hear about high-value care in your program, you can say yes–cause this is it, front and center.
Remember, it’s not about always going down path A to B and seeing the answer. The solution does not always shine like a beacon on the hill. It’s the reasoned course you travel to get there. It’s how you think things through and arrive at a decision under uncertain circumstances.
Drugs are not cheap, and as you progress through your training, the process will not be as easy as checking an order box. You will have to think probabilistically, measure trade-offs, and sometimes take risks.
Hi Brad,
Thank you for a thought provoking blog. While we know that the NOACS are here to stay, the ‘good old’ warfarin is not likely to go away any time soon. The approval of idarucizumab as an antidote for dabigatran is a welcome step in its use, as you rightly mention the cost of the antidote might limit it to a very specific niche of patients..
Rupesh.
[…] Flansbaum of The Hospital Leader writes a letter to his residents warning them that they should “high-value thinking” when considering administering innovative medical treatments such the new NOAC antidote […]
[…] Flansbaum at The Hospital Leader warns his residents that they should “high-value thinking” when considering administering innovative medical […]