As multiple patents on statins and other low-density lipoprotein (LDL)-lowering drugs expired between 2010 and 2018, investigators found that switching patients to generic cholesterol drugs saved Medicare billions of dollars.1

According to investigators, 95 million adults in the United States have a total cholesterol level that is higher than 200 mg/dL, and most are told to lower their LDL cholesterol through a combination of lifestyle changes and medication.1 Statins are the most popular option, with more than 35 million people being prescribed the medications.1

The results of multiple studies have shown that converting patients from brand-name to generic cholesterol-lowering medications is largely effective and safe. An earlier study investigating the switch to lovastatin from simvastatin examined 33,318 patients who converted between April 2002 and March 2003.2 The conversion was based on an equipotent dose ratio of 1 mg simvastatin to 2 mg lovastatin. The primary effectiveness end point was a comparison of the postconversion and preconversion LDL levels, and safety end points included an analysis of alanine aminotransferase (ALT) tests and creatine kinase values.2

The mean LDL level was lowered to 108.4 mg/dL from 110.9mg/dL following the conversion to generic lovastatin, according to the study authors.

The percentage of patients with serum ALT levels greater than 3 times the upper limit of normal (ULN) was similar before and after the conversion, as was the percentage of patients with creatine kinase elevations greater than 10 times the ULN.2

Based on these findings, the study authors concluded that patients had a notable improvement in their lipid profiles without evidence of hepatic or muscle enzyme elevations, demonstrating that patients can be effectively and safely converted to generic cholesterol-lowering medications.2

Once generic options are available, transitioning patients quickly can not only save the health care system millions of dollars but also improve affordability for patients.

“It’s amazing to see these drug advances in medicine,” first author Andrew Sumarsono, MD, said in a statement. “But we also want to make sure that everyone who needs these drugs can afford them.”1

In a new study, investigators used the Medicare Part D prescription drug event database to analyze data between January 2014 and December 2018. During this period, they found that the number of Medicare Part D enrollees grew to 44.2 million from 37.7 million, and the total number of prescriptions for LDL-lowering drugs increased by 23%.1

Despite this increase, the authors found that the number of prescriptions for generic drugs rose by 35%, and the overall spending on statins declined by 52%, to $2.3 billion in 2018, from $4.8 billion in 2014.1

“One of the most important contributors to our health care costs is expenditure on prescription drugs,” Ambarish Pandey, MD, said in a statement. “The switch to generics is an effective strategy to cut the costs incurred by health systems.”1

Notably, during the study period, Medicare still spent $9.6 billion on brand-name LDL-lowering medications and could have saved an additional $2.5 billion of that by switching to generics more quickly.1 For example, PDSK9 inhibitors were made available in 2015, and the investigators found that prescriptions for these drugs were low, though they increased by 144% between 2016 and 2018.1

“Statins are one of the most important drugs to study in this context because they’re just so widely prescribed,” Pandey said. “But there are also other drugs that certainly have substantial costs to the health care system and need to be studied in this respect as well.”1

REFERENCES
  1. Generic cholesterol drugs save Medicare billions of dollars, study finds. University of Texas Southwestern Medical Center. September 9, 2020. Accessed October 20, 2020. https://www.utsouthwestern.edu/newsroom/articles/year-2020/generic-cholesterol-drugs.html
  2. Cheetham TC, Chan J, Benson V, Richmond C, Levin E, Campen D. Successful conversion of patients with hypercholesterolemia from a brand name to a generic cholesterol-lowering drug. Am J Manag Care. 2005;11(9):546-552.