By Alex Kacik | September
11, 2017
Cleveland Clinic is one of the most prolific users of the heart
drugs nitroprusside and isoproterenol, so when their respective prices surged
30-fold and 70-fold over a three-year span, it caught the provider's attention.
Doctors have long relied on the widely used drugs during life-threatening situations. They use nitroprusside to lower blood pressure and treat critical hypertension and congestive heart failure, as well as to keep blood pressure low during surgery. Isoproterenol is used primarily for treating low heart rate and heart block and is used to increase a patient's heart rate while doctors operate.
Valeant Pharmaceuticals acquired the rights to the off-patent drugs in 2015 and drastically increased the prices. The company's executives told Congress that they did not expect that fewer patients would have access to the drug, but new data shows that wasn't the case.
When nitroprusside wholesale acquisition costs increased from $28 to $881 for 50 milligrams from 2012 to 2015, utilization across 47 hospitals studied decreased 53%, Cleveland Clinic researchers found in a study published in the New England Journal of Medicine. As isoproterenol wholesale costs jumped to $1,790 from $26 per milligram, usage fell 35%.
Cleveland Clinic's bottom line inevitably took a hit as there weren't viable substitutes for either drug. They were able to come up with a plan that saved the organization more than $8.6 million over two years by reducing waste and finding alternatives for specific indications.
Hospitals are not going to escape the financial consequences of such a dramatic jump in price, said Dr. Umesh Khot, vice chairman of cardiovascular medicine at Cleveland Clinic and lead author of the study.
"But now we have the information to show that these price increases impacted patient care," he said.
While the drugs were likely undervalued initially, there needs to be a balance between raising prices to cover costs and remain sustainable while ensuring affordability, experts said. The heart drug price hikes had a ripple effect across the whole supply chain and inevitably dented hospital margins, said Michael Militello, a Cleveland Clinic pharmacist who co-authored the study. There seemed to be no reason for such substantial price increases other than inflating profits, he said.
"The cost of everything goes up," Militello said. "The real challenge for me as a pharmacist is keeping that cost issue as the last thing I think about when making decisions. I don't want it to bias my decisions, but I think about it every day."
The clinic looked for proactive solutions to reduce that thought process while care is being delivered, Khot said.
There were no therapeutic alternatives to nitroprusside for acute heart failure and none to isoproterenol for electrophysiology testing, thus those critical uses were retained.
But the clinic did find areas where the drugs were overused. The organization ended the routine ordering of nitroprusside for the treatment of hypertension following cardiac surgery, removed the high-concentration option for nitroprusside in the electronic medication order, and reduced the typical dispensing quantity of isoproterenol.
Cleveland Clinic found three therapeutic alternatives for specific indications including IV nitroglycerin taking the place of nitroprusside for hypertension following cardiac surgery, adding clevidipine as an alternative to nitroprusside for aortic dissection, and using dobutamine instead of isoproterenol for the intraoperative testing of myectomy patients.
These tactics saved the organization nearly $8.1 million over two years on nitroprusside costs as well as about $582,000 on isoproterenol.
"It is important that each hospital has an open discussion between all stakeholders to come up with how we as an organization are responding to this in a way that protects patients and balances the financial issues," Khot said.
Many providers are re-evaluating their "just in case" supplies of drugs. The University of Utah removed isoproterenol and blood pressure drug vasopressin from its crash carts after they became prohibitively expensive, said Erin Fox, who directs the Drug Information Center at the University of Utah. Medical professionals can still get a dose to patients just as quickly, the organization just stocks less, she said.
"Pharmacists are going to triage their efforts to make sure everyone is safe and to make sure the highest-cost drugs are being used appropriately," Fox said.
The FDA and lawmakers are implementing strategies they hope will lower drug prices. An introduction of generic competitors has since decreased the price of nitroprusside. The FDA's efforts to accelerate the agency's review of generics and remove artificial impediments as well as pending legislation like the CREATES Act will continue to curb drug prices, said Scott Knoer, chief pharmacy officer of Cleveland Clinic.
"The bottom line is that the value equation for cost-effective therapy constantly changes," he said. "Pharmacists across the country are continuously reassessing the market. Ensuring that we provide cost-effective treatment for our patients is a core component of our jobs."
The FDA aims to bolster generic drug development and better control drug prices by posting a list branded drugs that are not protected by a patent and are not facing looming generic drug competition. The agency will also fast-track its review of generic-drug applications that have less than three competitors.
The CREATES Act and FAST Generics Act look to close regulatory loopholes and potentially save up to $5.4 billion a year in reduced drug costs. Lawmakers aim to amend the FDA's Risk Evaluation and Mitigation Strategies program that some branded-drug makers use to invoke REMS patents to create closed distribution networks that prevent generic competitors from coming to market.
"If you improve or increase the ability to get generic competitors out there, it should drive down the cost of other drugs, unless there is collusion," Militello said.
Doctors have long relied on the widely used drugs during life-threatening situations. They use nitroprusside to lower blood pressure and treat critical hypertension and congestive heart failure, as well as to keep blood pressure low during surgery. Isoproterenol is used primarily for treating low heart rate and heart block and is used to increase a patient's heart rate while doctors operate.
Valeant Pharmaceuticals acquired the rights to the off-patent drugs in 2015 and drastically increased the prices. The company's executives told Congress that they did not expect that fewer patients would have access to the drug, but new data shows that wasn't the case.
When nitroprusside wholesale acquisition costs increased from $28 to $881 for 50 milligrams from 2012 to 2015, utilization across 47 hospitals studied decreased 53%, Cleveland Clinic researchers found in a study published in the New England Journal of Medicine. As isoproterenol wholesale costs jumped to $1,790 from $26 per milligram, usage fell 35%.
Cleveland Clinic's bottom line inevitably took a hit as there weren't viable substitutes for either drug. They were able to come up with a plan that saved the organization more than $8.6 million over two years by reducing waste and finding alternatives for specific indications.
Hospitals are not going to escape the financial consequences of such a dramatic jump in price, said Dr. Umesh Khot, vice chairman of cardiovascular medicine at Cleveland Clinic and lead author of the study.
"But now we have the information to show that these price increases impacted patient care," he said.
While the drugs were likely undervalued initially, there needs to be a balance between raising prices to cover costs and remain sustainable while ensuring affordability, experts said. The heart drug price hikes had a ripple effect across the whole supply chain and inevitably dented hospital margins, said Michael Militello, a Cleveland Clinic pharmacist who co-authored the study. There seemed to be no reason for such substantial price increases other than inflating profits, he said.
"The cost of everything goes up," Militello said. "The real challenge for me as a pharmacist is keeping that cost issue as the last thing I think about when making decisions. I don't want it to bias my decisions, but I think about it every day."
The clinic looked for proactive solutions to reduce that thought process while care is being delivered, Khot said.
There were no therapeutic alternatives to nitroprusside for acute heart failure and none to isoproterenol for electrophysiology testing, thus those critical uses were retained.
But the clinic did find areas where the drugs were overused. The organization ended the routine ordering of nitroprusside for the treatment of hypertension following cardiac surgery, removed the high-concentration option for nitroprusside in the electronic medication order, and reduced the typical dispensing quantity of isoproterenol.
Cleveland Clinic found three therapeutic alternatives for specific indications including IV nitroglycerin taking the place of nitroprusside for hypertension following cardiac surgery, adding clevidipine as an alternative to nitroprusside for aortic dissection, and using dobutamine instead of isoproterenol for the intraoperative testing of myectomy patients.
These tactics saved the organization nearly $8.1 million over two years on nitroprusside costs as well as about $582,000 on isoproterenol.
"It is important that each hospital has an open discussion between all stakeholders to come up with how we as an organization are responding to this in a way that protects patients and balances the financial issues," Khot said.
Many providers are re-evaluating their "just in case" supplies of drugs. The University of Utah removed isoproterenol and blood pressure drug vasopressin from its crash carts after they became prohibitively expensive, said Erin Fox, who directs the Drug Information Center at the University of Utah. Medical professionals can still get a dose to patients just as quickly, the organization just stocks less, she said.
"Pharmacists are going to triage their efforts to make sure everyone is safe and to make sure the highest-cost drugs are being used appropriately," Fox said.
The FDA and lawmakers are implementing strategies they hope will lower drug prices. An introduction of generic competitors has since decreased the price of nitroprusside. The FDA's efforts to accelerate the agency's review of generics and remove artificial impediments as well as pending legislation like the CREATES Act will continue to curb drug prices, said Scott Knoer, chief pharmacy officer of Cleveland Clinic.
"The bottom line is that the value equation for cost-effective therapy constantly changes," he said. "Pharmacists across the country are continuously reassessing the market. Ensuring that we provide cost-effective treatment for our patients is a core component of our jobs."
The FDA aims to bolster generic drug development and better control drug prices by posting a list branded drugs that are not protected by a patent and are not facing looming generic drug competition. The agency will also fast-track its review of generic-drug applications that have less than three competitors.
The CREATES Act and FAST Generics Act look to close regulatory loopholes and potentially save up to $5.4 billion a year in reduced drug costs. Lawmakers aim to amend the FDA's Risk Evaluation and Mitigation Strategies program that some branded-drug makers use to invoke REMS patents to create closed distribution networks that prevent generic competitors from coming to market.
"If you improve or increase the ability to get generic competitors out there, it should drive down the cost of other drugs, unless there is collusion," Militello said.
Alex Kacik is the hospital operations reporter
for Modern Healthcare in Chicago. Aside from hospital operations, he covers
supply chain, legal and finance. Before joining Modern Healthcare in 2017,
Kacik covered various business beats for seven years in the Santa Barbara,
California region. He received a bachelor's degree in journalism from Cal Poly
San Luis Obispo in Central California.
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