Pharmacy Policy System: NotificationsList https://spmedpolicy-ba.ibx.com/ibc/pps/Lists/NotificationsList/AllItems.aspx RSS feed for the NotificationsList list. Wed, 15 Apr 2026 05:28:05 GMT Microsoft SharePoint Foundation RSS Generator 60 en-US Pharmacy Policy System: NotificationsList https://spmedpolicy-ba.ibx.com/ibc/pps/_layouts/15/images/siteIcon.png https://spmedpolicy-ba.ibx.com/ibc/pps/Lists/NotificationsList/AllItems.aspx Cholesterol Lowering Agents https://spmedpolicy-ba.ibx.com/ibc/pps/Lists/NotificationsList/DispForm.aspx?ID=538 EffectiveDate: 5/1/2026
PolicyNumber: Rx.01.131
LOB: Commercial
PolicyOwner: VanHorn, Lynnsey
QuarterlyCycle: C1-2026
Description:
Lomitapide a synthetic lipid-lowering agent, directly binds and inhibits microsomal triglyceride transfer protein, which resides in the lumen of the endoplasmic reticulum, thereby preventing the assembly of apo B-containing lipoproteins in enterocytes and hepatocytes. This inhibits the synthesis of chylomicrons and very low-density lipoprotein (VLDL). The inhibition of the synthesis of VLDL leads to reduced levels of plasma LDL-C.

Lomitapide (Juxtapid®) is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Proprotein convertase subtilisin/ kexin type 9 (PCSK9) is a serine protease synthesized primarily by the liver and intestines.  PCSK9 promotes the degradation of low density lipoprotein (LDL) receptors, thus preventing them from being recycled back to the plasma membrane where they can bind more LDL. Inhibitors of PCSK9 increase recycling of LDL receptors which in turn increases the capacity to remove LDL cholesterol (LDL-C) from the blood. These agents are monoclonal antibodies administered subcutaneously.

PRALUENT is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated: 
  • To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events.
  • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in : 
    • adults with hypercholesterolemia 
    • adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). 
    • adults with homozygous familial hypercholesterolemia (HoFH).
REPATHA is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor indicated: 
  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. 
  • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: 
    • adults with hypercholesterolemia. 
    • adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 
    • adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).

According to current guidelines, HMG-CoA reductase inhibitors (statins) are the mainstay of pharmacologic therapy for treating elevated LDL-C for both primary and secondary prevention of atherosclerotic cardiovascular disease.  Lifestyle modifications are a critical component of treating elevated LDL-C and should be used in conjunction with pharmacologic therapy.  

Clinical trials of PCSK9 inhibitors demonstrated reductions in LDL-C approximately 50-60%.  Reauthorization criteria will include a reduction from baseline of 25% or greater, which will assess adherence with the medication.

Bempedoic acid (Nexletol™) is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibition of cholesterol synthesis in the liver.  ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway.  Bempedoic ​acid and its active metabolite, ESP15228, require coenzyme A (CoA) activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA and ESP15228-CoA, respectively.  ACSVL1 is expressed primarily in the liver.  Inhibition of ACL by ETC-1002-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of low-density lipoprotein receptors.

Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine.  The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols.  Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver.  This causes a reduction of hepatic cholesterol stores and an increase in LDL receptors, resulting in clearance of cholesterol from the blood.

NEXLIZET, a combination of bempedoic acid, an adenosine triphosphate citrate lyase (ACL) inhibitor, and ezetimibe, a dietary cholesterol absorption inhibitor, is indicated: 
  • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). 
Bempedoic acid, a component of NEXLIZET, is indicated: 
  • To reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin). 
NEXLETOL, an adenosine triphosphate-citrate lyase (ACL) inhibitor, is indicated: 
  • to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin). 
  • as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Intent:
The intent of this policy is to communicate the medical necessity criteria for lomitapide (Juxtapid®), alirocumab (Praluent®), evolocumab (Repatha®), bempedoic acid (Nexletol™), and bempedoic acid/ezetimibe (Nexlizet™) as provided under the member's prescription drug benefit.

Policy:

INITIAL CRITERIA: Alirocumab (Praluent®) is medically necessary when ALL of the following are met:

  1. Diagnosis of ONE of the following:
    1. Member is 18 years of age or older with hypercholesterolemia; or
    2. Member is 8 years of age or older with heterozygous familial hypercholesterolemia (HeFH) ; or
    3. Member is 18 years of age or older with atherosclerotic cardiovascular disease (ASCVD); or 
    4. Member is 18 years of age or older and at increased risk for a major adverse cardiovascular event; and
  2. ONE of the following:
    1. While on maximally tolerated statin therapy within the last 120 days:
      1. Member has LDL-C greater than or equal to 70 mg/dL with atherosclerotic cardiovascular disease (ASCVD); or
      2. Member has LDL-C greater than or equal to 100mg/dL without atherosclerotic cardiovascular disease (ASCVD); or
      3. Member requires greater than or equal to 25% LDL-C reduction to achieve goal; or
    2. BOTH of the following:
      1. Member has been receiving PCSK9 therapy as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe); and
      2. LDL-C values drawn within the past 12 months while on maximally tolerated lipid lower therapy is within normal limits; and
  3. ONE of the following: 
    1. Member has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy; or
    2. Member is statin intolerant as evidenced by an inability to tolerate at least two statins, with at least one started at the lowest starting daily dose, due to intolerable symptoms or clinically significant biomarker changes of liver function or muscle function (e.g., creatine kinase); or
    3. Member has an FDA labeled contraindication to all statins; and
  4. Inadequate response or inability to tolerate evolocumab (Repatha®) for members 10 years of age or older

 

Initial authorization duration: 2 years

 

INITIAL CRITERIA: Alirocumab (Praluent®) is medically necessary when ALL of the following are met:

  1. Diagnosis of homozygous familial hypercholesterolemia (HoFH) and one of the following:
    1. Genetic confirmation of 2 mutations in the LDL receptor, ApoB, PCSK9, or LDL receptor adaptor protein 1 (i.e., LDLRAP1 or ARH); or
    2. Untreated LDL-C >400mg/dL with either of the following:
      1. Cutaneous or tendinous xanthoma prior to 10 years of age; or 
      2. Elevated LDL cholesterol prior to lipid-lowering therapy consistent with HeFH in both parents; and
  2. ONE of the following:
    1. Member is receiving other lipid-lowering therapy (e.g., statin, ezetimibe); or
    2. Member has a documented inability to take other lipid-lowering therapy (e.g., statin, ezetimibe); and
  3. Member is 18 years of age or older; and
  4. Inadequate response or inability to tolerate evolocumab (Repatha®)

Initial authorization duration: 2 years

 

REAUTHORIZATION CRITERIA: Alirocumab (Praluent®) is medically necessary when all of the following are met:

  1. Member demonstrates positive clinical response to therapy as evidence by a reduction in LDL-C levels from baseline; and
  2. ONE of the following:
    1. Member continues to receive other lipid-lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose; or
    2. Member has a documented inability to take other lipid-lowering therapy (e.g., statins, ezetimibe); and
  3. Inadequate response or inability tolerate evolocumab (Repatha®) for members 10 years of age or older

 

Reauthorization duration: 2 years

 

INITIAL CRITERIA: Evolocumab (Repatha®) is medically necessary when ALL of the following are met:

  1. Diagnosis of ONE of the following:
    1. Member is 18 years of age or older and at an increased risk of major adverse cardiovascular events with baseline LDL-C ≥ 70 mg/dL; or
    2. Member has clinical heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH) with baseline LDL-C ≥ 100mg/dL; or
    3. Member is 18 years of age or older with hypercholesterolemia with baseline LDL-C ≥ 70 mg/dL; and
  2. ONE of the following:
    1. Member has completed a trial of 12 consecutive weeks of one statin at the maximally tolerated dose; or
    2. Member is statin intolerant; or
    3. Member has an FDA labeled contraindication to all statins

 

Initial Authorization duration: 2 years

 

REAUTHORIZATION CRITERIA:  Evolocumab (Repatha®) is medically necessary when all of the following are met:

  1. Member demonstrates positive clinical response to therapy as evidenced by a reduction in LDL-C levels from baseline; and
  2. One of the following:
    1. Member continues to receive other lipid-lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose; or
    2. Member has a documented inability to take other lipid-lowering therapy (e.g., statins, ezetimibe)

 

Reauthorization duration: 2 years

 

INITIAL CRITERIA: Bempedoic acid (Nexletol™), bempedoic acid/ezetimibe (Nexlizet™) is medically necessary when ALL of the following are met:

  1. ONE of the following:
    1. Member is 18 years of age or older with heterozygous familial hypercholesterolemia (HeFH); or
    2. Member is 18 years of age or older with hypercholesterolemia; or 
    3. Member is 18 years of age or older and at increased risk for a major adverse cardiovascular event; and
  2. ONE of the following while on maximally tolerated statin therapy within the last 120 days:
    1. LDL-C greater than or equal to 55mg/dL with atherosclerotic cardiovascular disease (ASCVD) ; or
    2. LDL-C greater than or equal to 70 mg/dL without atherosclerotic cardiovascular disease (ASCVD); and
  3. ONE of the following:
    1. Member has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy; or
    2. Member is statin intolerant as evidenced by an inability to tolerate at least two statins, with at least one started at the lowest starting daily dose, due to intolerable symptoms or clinically significant biomarker changes of liver function or muscle function (e.g., creatine kinase); or
    3. Member has an FDA labeled contraindication to all statins

 

Initial Authorization duration: 2 years

 

REAUTHORIZATION CRITERIA: Bempedoic acid (Nexletol™), Bempedoic acid/ezetimibe (Nexlizet™) is medically necessary when member demonstrates positive clinical response to therapy (e.g., reduction in LDL-C levels)

 

Reauthorization duration: 2 years

 

Homozygous Familial Hypercholesterolemia (HoFH)

INITIAL CRITERIA: Lomitapide (Juxtapid®) is medically necessary when ALL of the following are met:

  1. Diagnosis of Homozygous Familial Hypercholesterolemia (HoFH); and
  2. Member is 2 years of age or older; and
  3. Used as an adjunct to lipid lowering treatments and a low-fat diet with ONE of the following:
    1. Genetic confirmation of 2 mutant alleles at the LDL receptor, Apo B, PCSK9, or LDL receptor adaptor protein 1 (i.e. LDLRAP1 or ARH); or
    2. Untreated LDL-C > 500mg/dL or treated LDL cholesterol ≥ 300mg/dL with either of the following:
      1. Cutaneous or tendinous xanthoma prior to 10 years of age, or
      2. Elevated LDL cholesterol prior to lipid-lowering therapy consistent with HeFH in both parents; and
  4. ONE of the following:
    1. Inadequate response to one of the following medications in combination with ezetimibe:
      1. Simvastatin (daily doses ≥ 40mg); or
      2. Atorvastatin (daily doses ≥ 20mg); or
      3. Rosuvastatin (daily doses ≥ 10mg); or
    2. Member has experience ONE of the following:
      1. Rhabdomyolysis or muscle symptoms with creatine kinase (CK) elevations > 10 times upper limit of normal (ULN) on any statin; or
      2. Myalgia (muscle symptoms without CK elevations) or myositis (muscle symptoms with CK elevations < 10 times ULN) with TWO statins; and
  5. Inadequate response or inability to tolerate evolocumab (Repatha®); and
  6. Not used in combination with a PCSK9 inhibitor; and
  7. Prescribed by or in consultation with one of the following:
    1. Cardiologist; or
    2. Endocrinologist; or
    3. Lipid specialist

 

Initial authorization duration: 2 years

 

REAUTHORIZATION CRITERIA: Lomitapide (Juxtapid®) is medically necessary when ALL of the following are met:

  1. One of the following:
    1. Member continues to receive other lipid-lowering therapy (e.g., statin, ezetimibe); or
    2. Member has an inability to take other lipid-lowering therapy (e.g., statin, ezetimibe); and
  2. Reduction in LDL-C of at least 25% from baseline while on therapy; and
  3. Prescribed by or in consultation with one of the following:
    1. Cardiologist; or
    2. Endocrinologist; or
    3. Lipid specialist; and
  4. Not used in combination with a PCSK9 inhibitor

 

Reauthorization duration: 2 years

BlackBoxWarning:

JUXTAPID® (lomitapide): WARNING: RISK OF HEPATOTOXICITY

JUXTAPID can cause elevations in transaminases. 

  • Measure alanine and aspartate aminotransferases (ALT, AST), alkaline phosphatase, and total bilirubin before initiating treatment and then ALT and AST regularly as recommended.
  • During treatment, adjust the dose of JUXTAPID if the ALT or AST is ≥3 times the upper limit of normal (ULN).
  • Discontinue JUXTAPID for clinically significant liver toxicity. 

JUXTAPID increases hepatic fat (hepatic steatosis) with or without concomitant increases in transaminases. 

  • Hepatic steatosis associated with JUXTAPID may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.
Because of the risk of hepatotoxicity, JUXTAPID is available only through a restricted program called the JUXTAPID REMS Program. Prescribe JUXTAPID only to patients with a clinical or laboratory diagnosis consistent with HoFH. The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH.
References:

Farnier M, Bruckert E. Severe familial hypercholesterolemia: Current and future management. Arch Cardiovasc Dis. 2012 Dec; 105(12):656-65. Accessed March 13, 2026.

Farnier M. PCSK9: From discovery to therapeutic applications. Arch Cardiovascular Dis. 2014; 107: 58-66. DOI: 10.1016/j.acvd.2013.10.007. Accessed March 13, 2026.

Goldberg AC, Hopkins PN, Toth PP, et al. Familial hypercholesterolemia: screening, diagnosis, and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidology. 2011;5:S1-S8. Accessed March 13, 2026.

Goldberg AC, Hopkins PN, Toth PP, et al. Familial hypercholesterolemia: screening, diagnosis, and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidology. 2011;5:S1-S8. Accessed December 6, 2025

Grundy SM, Cleeman JI, Merz NB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation. 2004; 110:227-39. Accessed March 13, 2026.

Grundy SM, Stone NJ, Bailey AL, Yeboah J, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018. Available from: https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000000624. Accessed March 13, 2026.

Jacobson TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for the patient-centered management of dyslipidemia: Part 1- full report. J Clin Lipidology. 2015;9:129-69. Accessed March 13, 2026.

Jacobson TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for the patient-centered management of dyslipidemia: Part 1- full report. J Clin Lipidology. 2015;9:129-69. Accessed March 13, 2026.

Juxtapid® (lomitapide) [prescribing information.] Cambridge, MA. Aegerion Pharmaceuticals. September 2020. Available at: http://juxtapidpro.com/prescribing-information. Accessed March 13, 2026.

Lambert G, Sjouke B, Choque B, Kastelein JJP, Hovingh GK. The PCSK9 decade. J Lipid Res. 2012; 53(12): 2515-24. DOI: 10.1194/jlr.R026658. Accessed March 13, 2026.

Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Daly Jr DD, DePalma SM, Minissian, MB, Orringer CE, Smith Jr SC, 2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Exper Decision Consensus Pathways. Journal of the American College of Cardiology (2017), doi: 10.1016/j.jacc.2017.07.745. Accessed March 13, 2026.

Nexletol™ (bempedoic acid) [prescribing information]. Ann Arbor, MI: Esperion Therapeutics, Inc.; January 2026. Available from: https://pi.esperion.com/nexletol/nexletol-pi.pdf. Accessed March 13, 2026.

Nexlizet™ (bempedoic acid and ezetimibe) [prescribing information]. Ann Arbor, MI: Esperion Therapeutics, Inc.; January 2026. Available from: https://pi.esperion.com/nexlizet/nexlizet-pi.pdf. Accessed March 13, 2026.

Praluent® (alirocumab) [package insert]. Bridgewater, NJ. Sanofi-Aventis US LLC. October 2025.  Available from: http://products.sanofi.us/praluent/praluent.pdf. Accessed March 13, 2026.

Raal FJ, Santos RD. Homozygous familial hypercholesterolemia: current perspectives on diagnosis and treatment. Atherosclerosis. 2012 Aug; 223(2):262-8. Accessed March 13, 2026.

Repatha® (evolocumab) [package insert]. Thousand Oaks, CA. Amgen Inc. August 2025. Available from: https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/repatha/repatha_pi_hcp_english.pdf. Accessed March 13, 2026.

Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce cardiovascular risk in adults: a report of the American College of Cardiology/ American Heart Association Task Force on practice guidelines. Circulation. 2013. https://doi.org/10.1161/01.cir.0000437738.63853.7a. Accessed March 13, 2026.

Varghese MJ. Familial hypercholesterolemia: a review. Ann Pediatr Cardiol. 2014;7:107-17. Accessed March 13, 2026.

Visser ME, Witztum JL, Stroes ES, et al. Antisense oligonucleotides for the treatment of dyslipidaemia. Eur Heart J. 2012 Jun; 33(12):1451-8. doi: 10.1093/eurheartj/ehs084. Epub 2012 May 24.

PolicyVersionNumber: 20
PTApprovalDate: 3/19/2026
NextReviewDate: 6/4/2026
CrossReferences:
Rx.01.33 Off Label Use

ApplicableDrugs:

Brand name

Generic name

Juxtapid®

Lomitapide

Praluent®

alirocumab

Repatha®

evolocumab

Nexletol™

Bempedoic acid

Nexlizet™

Bempedoic acid/ezetimibe


NotificationDate: 4/1/2026
NotificationDesc:
Off-cycle policy review: 
Reorganize policy 
Update drug indication verbiage 
Add indication specific age limit
Streamline criteria to bypass statin requirement when member is statin intolerant
Update authorization duration to 2 years
ProductName: n/a
GenericName: n/a
]]> srv_ppsgw_P Wed, 01 Apr 2026 04:39:54 GMT https://spmedpolicy-ba.ibx.com/ibc/pps/Lists/NotificationsList/DispForm.aspx?ID=538