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Dyslipidemia: Blockbuster Therapies Are on the Horizon

Rinki Patel PharmD
Kunj Gohil PharmD, RPh

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.

Tables

Future Therapies

Drug
Manufacturer
Status Regimen Information Pivotal Studies Expected Approval Anticipated Peak Year Sales/Pricing
PCSK9 Inhibitors
Repatha (evolocumab) Amgen Phase 3 140 mg once every two weeks via SC injection or 420 mg once every four 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
Praluent (alirocumab) Sanofi/Regeneron 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
Bococizumab Pfizer 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
Cholesteryl Ester Transfer Protein Inhibitors
Evacetrapib Eli Lilly 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
Anacetrapib Merck 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; ClinicalTrials.gov

Current Therapiesa

Drug
Manufacturer
Approval Date Indicationb Regimen Informationc Cost of Course of Therapy per Yeard
3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase Inhibitors
Livalo (pitavastatin) Kowa Pharmaceuticals 2009 Hyperlipidemia; mixed dyslipidemia 1 mg to 4 mg daily $2,606
Crestor (rosuvastatin) AstraZeneca 2003 Hyperlipidemia; mixed dyslipidemia; pediatric HeFH; HoFH (adjunct therapy) 5 mg to 40 mg daily $3,004
Altoprev (lovastatin) Shionogi 2002 Primary prevention of CAD; CAD; hyperlipidemia 20 mg to 60 mg daily $6,764
Lipitor (atorvastatin) Pfizer 1997 Prevention of CV disease; hyperlipidemia 10 mg to 80 mg daily $2,652–$3,783 (generic, $134–$702)
Lescol (fluvastatin) Novartis 1993 Hypercholesterolemia; mixed dyslipidemia; secondary prevention of CV disease 20 mg to 80 mg daily $2,230–$4,460 (generic, $1,377–$2,759)
Zocor (simvastatin) Merck 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)
Pravachol (pravastatin) Bristol-Myers Squibb 1991 Prevention of CV disease; hyperlipidemia 40 mg daily $2,478 (generic, $1,206)
Selective Cholesterol Absorption Inhibitor
Zetia (ezetimibe) Merck 2002 Hyperlipidemia; HoFH; homozygous sitosterolemia 10 mg daily $3,142
Niacin/Nicotinic Acid
Niaspan (niacin) AbbVie 1997 Primary hyperlipidemia; mixed hyperlipidemia 500 mg $1,981 (generic, $1,546)
Fibrates
Fibricor (fenofibric acid) Mutual Pharmaceutical 2009 Hyperlipidemia; mixed dyslipidemia; severe hypertriglyceridemia 105 mg daily $1,503 (generic, $1,096)
Trilipix (fenofibric acid) AbbVie 2008 Mixed dyslipidemia; severe hypertriglyceridemia; hypercholesterolemia 135 mg daily $3,084 (generic, $1,947)
Triglide (fenofibrate) Shionogi 2005 Hypercholesterolemia; mixed dyslipid- emia; severe hypertriglyceridemia 160 mg daily $2,916 (generic, $867)
Tricor (fenofibrate) AbbVie 2004 Hypercholesterolemia; mixed dyslipidemia; severe hypertriglyceridemia 145 mg daily $3,235 (generic, $2,091)
Lopid (gemfibrozil) Pfizer 1981 Hyperlipidemia; reduction in risk of developing CHD 1,200 mg daily $3,473 (generic, $798)
Combination Therapies
Liptruzet (ezetimibe/atorvastatin) Merck 2013 Hyperlipidemia; HoFH 10/10 mg to 10/80 mg daily $2,409
Simcor (niacin ER/simvastatin) AbbVie 2008 Hypercholesterolemia 500/20 mg daily $1,981
Caduet (amlodipine/atorvastatin) Pfizer 2004 Hypertension; CAD; prevention of CV disease; hyperlipidemia 5/10 mg to 10/80 mg daily $3,602–$4,927
Vytorin (ezetimibe/simvastatin) Merck 2004 Primary hyperlipidemia; HoFH (adjunct therapy) 10/10 mg to 10/40 mg daily $3,113
Advicor (niacin ER/lovastatin) AbbVie 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

Author bio: 
Dr. Patel is a Post-Doctoral Fellow with Medical Services at MediMedia Managed Markets in Yardley, Pennsylvania. Dr. Gohil is Central Services Manager with Medical Services at MediMedia Managed Markets.

References

  1. Schultz AB, Chen CY, Burton WN, et al. The burden and management of dyslipidemia: practical issues. Popul Health Manag 2012;302–308.
  2. GlobalData. PharmaPoint Acute Coronary Syndrome: US Drug Forecast and Market Analysis to 2023 July 2014;
  3. GlobalData. EpiCast Report: Dyslipidemia Epidemiology Forecast to 2023 October 2014;
  4. Musunuru K. Atherogenic dyslipidemia: cardiovascular risk and dietary intervention. Lipids 2010;45;(10):907–914.