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Dyslipidemia: Blockbuster Therapies Are on the Horizon
Dyslipidemia is recognized as a prominent risk factor for cardiovascular disease (CVD); every 1% decrease in cholesterol levels is linked to a 2% decrease in coronary heart disease risk.1,2 This disease continues to present a large economic burden in the U.S., with approximately 1.33 million patients diagnosed in 2013.1,3 Given that the number of patients is expected to rise in the coming years, the acute coronary syndrome market is projected to expand globally from $12.3 billion to $43.4 billion in sales by 2023.3
Dyslipidemia is defined by elevations in low-density lipoprotein-cholesterol (LDL-C) and triglyceride concentrations, in addition to low levels of high-density lipoprotein-cholesterol (HDL-C).4 Statins are a universally established therapy due to their ability to dramatically reduce LDL-C levels and lower CVD risk. However, there is a gap in clinical practice when it comes to achieving LDL-C goals for many patients, and 5% to 10% of people cannot tolerate statin treatment.1,2 Specifically, patients with familial hypercholesterolemia are more likely to suffer from statin resistance and require additional effective therapies.2
Future therapies include the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, a new class of agents with blockbuster potential that are expected to launch this year and may address the needs unmet by statins. These self-injectable monoclonal antibodies work by increasing the liver’s ability to filter LDL-C from circulation.2 Additional novel cholesterol-lowering therapies with specific effects on LDL-C and/or HDL-C levels are also on the horizon. These agents are expected to revolutionize the dyslipidemia market.
||Phase 3||140 mg once every two weeks via SC injection
||PROFICIO||2015||$10.2 billion by 2023; using the once-every-four-weeks regimen, it is expected that one dose of evolocumab will cost twice as much as one dose of Humira, which is used every two weeks|
||Phase 3||150 mg once every two weeks via SC injection||ODYSSEY||2016||$5.2 billion by 2023; expected to be about 5% lower than current pricing for Humira, which costs $1,921 per 40-mg injection|
||Phase 2/3||One dose once every two weeks via SC injection||SPIRE||2018||$2.2 billion by 2023; expected to be about 10% lower than current pricing for Humira|
||Phase 3||130 mg once daily orally||ACCELERATE||2017||$1.1 billion by 2023; expected to be about 30% higher than current cost of Crestor|
||Phase 3||100 mg once daily orally||DEFINE REVEAL||2018||$538.3 million by 2023; expected to be priced about 25% higher than Crestor’s current cost of about $8.23 per pill|
SC = subcutaneous
Sources: FDA; GlobalData; company websites;
||2009||Hyperlipidemia; mixed dyslipidemia||1 mg to 4 mg daily||$2,606|
||2003||Hyperlipidemia; mixed dyslipidemia; pediatric HeFH; HoFH (adjunct therapy)||5 mg to 40 mg daily||$3,004|
||2002||Primary prevention of CAD; CAD; hyperlipidemia||20 mg to 60 mg daily||$6,764|
||1997||Prevention of CV disease; hyperlipidemia||10 mg to 80 mg daily||$2,652–$3,783 (generic, $134–$702)|
||1993||Hypercholesterolemia; mixed dyslipidemia; secondary prevention of CV disease||20 mg to 80 mg daily||$2,230–$4,460 (generic, $1,377–$2,759)|
||1992||Hyperlipidemia; HeFH; reductions in risk of CHD mortality and CV events||5 mg to 40 mg daily||$1,235–$2,888 (generic, $1,028–$1,814)|
||1991||Prevention of CV disease; hyperlipidemia||40 mg daily||$2,478 (generic, $1,206)|
||2002||Hyperlipidemia; HoFH; homozygous sitosterolemia||10 mg daily||$3,142|
||1997||Primary hyperlipidemia; mixed hyperlipidemia||500 mg||$1,981 (generic, $1,546)|
|Fibricor (fenofibric acid)
||2009||Hyperlipidemia; mixed dyslipidemia; severe hypertriglyceridemia||105 mg daily||$1,503 (generic, $1,096)|
|Trilipix (fenofibric acid)
||2008||Mixed dyslipidemia; severe hypertriglyceridemia; hypercholesterolemia||135 mg daily||$3,084 (generic, $1,947)|
||2005||Hypercholesterolemia; mixed dyslipid- emia; severe hypertriglyceridemia||160 mg daily||$2,916 (generic, $867)|
||2004||Hypercholesterolemia; mixed dyslipidemia; severe hypertriglyceridemia||145 mg daily||$3,235 (generic, $2,091)|
||1981||Hyperlipidemia; reduction in risk of developing CHD||1,200 mg daily||$3,473 (generic, $798)|
||2013||Hyperlipidemia; HoFH||10/10 mg to 10/80 mg daily||$2,409|
|Simcor (niacin ER/simvastatin)
||2008||Hypercholesterolemia||500/20 mg daily||$1,981|
||2004||Hypertension; CAD; prevention of CV disease; hyperlipidemia||5/10 mg to 10/80 mg daily||$3,602–$4,927|
||2004||Primary hyperlipidemia; HoFH (adjunct therapy)||10/10 mg to 10/40 mg daily||$3,113|
|Advicor (niacin ER/lovastatin)
||2001||Hypercholesterolemia||500/20 mg daily||$2,831|
aThis list is not all-inclusive; additional therapies may be available for this disease state.
bAbbreviated indication provided; for full indication, please refer to prescribing information.
cRegimens based on the recommended dosage and maintenance phases from prescribing information; typical doses and titration schedules may vary based on patient-specific requirements.
dCosts calculated using average wholesale price and regimen provided and rounded to the nearest dollar.
Sources: Red Book; Drugs@FDA; and prescribing information for all medications
CAD = coronary artery disease; CHD = coronary heart disease; CV = cardiovascular; ER = extended release; HeFH = heterozygous familial hypercholesterolemia; HoFH = homozygous familial hypercholesterolemia
- Schultz AB, Chen CY, Burton WN, et al. The burden and management of dyslipidemia: practical issues. Popul Health Manag 2012;302–308.
- GlobalData. PharmaPoint Acute Coronary Syndrome: US Drug Forecast and Market Analysis to 2023 July 2014;
- GlobalData. EpiCast Report: Dyslipidemia Epidemiology Forecast to 2023 October 2014;
- Musunuru K. Atherogenic dyslipidemia: cardiovascular risk and dietary intervention. Lipids 2010;45;(10):907–914.