013 Form

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Pharmacy Medical Policy Antihyperlipidemics Policy Table of Contents Authorization Information Coverage Criteria
Description
Appendix Policy History
Coding Information References Endnotes
Policy Number: 013 BCBSA Reference Number: N/A Related Policies • Quality Care Dosing guidelines may apply to the following medications and can be found in Medical Policy #621A. • Medical Benefit Prior Authorization Medication List, #034

Prior Authorization Information

Policy ☒ Prior Authorization ☐ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 3/15/2026 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☒ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason. We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.
See Appendix for additional information.

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Summary This is a comprehensive policy covering prior authorization and quantity limit requirements for anti- hyperlipidemic agents.
Policy No Requirements BCBSMA formulary coverage options for anti-hyperlipidemic agents that do not have any coverage requirements include: • Atorvastatin • Colesevelam
• Colestipol • Ezetimibe
• Ezetimibe-Simvastatin • Fenofibrate • Fluvastatin • Gemfibrozil • Icosapent Ethyl • Lovastatin
• Niacin ER • Omega-3 Ethyl Ester • Pravastatin
• Rosuvastatin • Simvastatin

Prior Authorization Criteria
Formulary status/requirements of the medications affected by this policy: Drug Formulary Status
(BCBSMA Commercial Plan) Special Considerations Evkeeza (evinacumab) Covered, PA

Juxtapid (lomitapide) Covered, PA, QCD Nexletol (bempedoic acid) Covered, PA, QCD

Nexlizet (bempedoic acid and ezetimibe) Covered, PA, QCD

Leqvio (inclisiran) Covered, PA SPBO Repatha (evolocumab)
Covered, PA, QCD

Praluent (alirocumab) NFNC, PA, QCD

Tryngolza™ (olezarsen) Covered, PA, QCD

PA – Prior Authorization; NFNC – Non-formulary, Non-Covered; QCD (Quality Care Dosing – refer to Policy 621b); SPBO: This medication is covered ONLY under the pharmacy benefit. (Refer to Policy 071) Approval Length: 12 months, unless otherwise specified in Clinical Guideline Coverage Criteria Clinical Guideline Coverage Criteria: Evkeeza Evkeeza may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met:

1. A confirmed diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) AND
2. Used as adjunct therapy to diet and maximally tolerated statin therapy in combination with ezetimibe AND
3. Recent cholesterol labs with values (<12 months ago) AND
4. Current treatment with Praluent or Repatha, unless clinically contraindicated to PCSK9s.

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Clinical Guideline Coverage Criteria: Juxtapid Juxtapid may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met:

1. A confirmed diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) AND
2. Used as adjunct therapy to diet and maximally tolerated statin therapy in combination with ezetimibe AND

3. Recent cholesterol labs (< 12 months) with values OR used LDL apheresis.

   Clinical Guideline Coverage Criteria: Leqvio Leqvio may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met: Initial Approval

4. A confirmed diagnosis of ONE of the following: a. Primary hyperlipidemia b. Heterozygous Familial Hypercholesterolemia (HeFH)
   c. Established cardiovascular disease AND
5. Age >18 years old AND
6. Evaluation in a lipid program staffed by a board-certified cardiologist or endocrinologist AND
7. Recent LDL labs with values (<12 months) AND
8. Used as adjunct therapy to diet and maximally tolerated statin therapy in combination with ezetimibe, OR Previous treatment failure with 3 statin medications (at least 2 of which are high potency) in combination with ezetimibe AND

9. Previous treatment failure with Repatha

   Continuation of therapy

10. Adherence to current therapy verified with claims data AND

11. Current (<3 months ago) submitted lab values show maintained improvement in LDL levels

    Clinical Guideline Coverage Criteria: Nexletol, Nexlizet Nexletol or Nexlizet may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met:

12. A confirmed diagnosis of ONE of the following:
    a. Heterozygous Familial Hypercholesterolemia (HeFH)
    Length of Approval: 3 months (encompassing one 6-month shot) initial approval. Length of Approval: 12 months.

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b. Established cardiovascular disease c. At high risk for cardiovascular disease (CVD) event but without established CVD AND

2. Age >18 years old AND
3. Evaluation in a lipid program staffed by a board-certified cardiologist or endocrinologist AND
4. Recent LDL labs with values (<12 months) AND
5. Used as adjunct therapy to diet and maximally tolerated statin therapy (Only applicable for with 1A as the diagnosis) Clinical Guideline Coverage Criteria: Praluent Praluent may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met: Initial Approval
6. A confirmed diagnosis of ONE of the following: a. Heterozygous Familial Hypercholesterolemia (HeFH)
   b. Homozygous Familial Hypercholesterolemia (HoFH)
   c. Established cardiovascular disease AND
7. Evaluation in a lipid program staffed by a board-certified cardiologist or endocrinologist AND
8. Recent LDL labs with values (<12 months) AND
9. Used as adjunct therapy to diet and maximally tolerated statin therapy in combination with ezetimibe AND
10. Previous treatment failure with Repatha Continuation of therapy
11. Adherence to current therapy verified with claims data, AND

12. Current (<3 months ago) submitted lab values show maintained improvement in LDL levels.

    Clinical Guideline Coverage Criteria: Repatha Repatha may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met: Initial Approval

13. A confirmed diagnosis of ONE of the following: a. Heterozygous Familial Hypercholesterolemia (HeFH)
    b. Homozygous Familial Hypercholesterolemia (HoFH) c. Established cardiovascular disease OR Length of Approval: 3 months. Length of Approval: 12 months.

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2. Patient is at increased risk for major adverse cardiovascular events (MACE) due to at least ONE of the following conditions: a. Coronary artery disease b. Peripheral arterial disease c. Atherosclerotic cerebrovascular disease d. Diabetes mellitus AND
3. Evaluation in a lipid program staffed by a board-certified cardiologist or endocrinologist AND
4. Recent LDL labs with values (<12 months) AND
5. Used as adjunct therapy to diet and maximally tolerated statin therapy in combination with ezetimibe Continuation of therapy
6. Adherence to current therapy verified with claims data AND

7. Current (<3 months ago) submitted lab values show maintained improvement in LDL levels

   Clinical Guideline Coverage Criteria: Tryngolza Tryngolza may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met: Initial Approval

8. A confirmed diagnosis of Familial chylomicronemia syndrome confirmation by a genetic mutation analysis AND
9. Evaluation in a lipid program staffed by a board-certified cardiologist or endocrinologist,
   AND
10. Fasting triglyceride levels of ≥880mg/dL within the last twelve (12) months AND

11. Used as adjunct therapy to a low-fat diet.

    Continuation of therapy

12. Adherence to current therapy verified with claims data AND
13. Current (<3 months ago) submitted lab values show maintained improvement in triglyceride levels. AND

14. Used as adjunct therapy to a low-fat diet.

    Length of Approval: 12 months. Length of Approval: 3 months. Length of Approval: 12 months. Length of Approval: 3 months.

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Appendix Formulary Status For non-covered medications, in addition to the prior authorization criteria, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient. Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug. Criteria Documentation Provider must submit supporting documentation (e.g., chart notes, lab results or other clinical information) to show that the member has met all approval criteria. Prior Use Criteria The plan uses prescription claim records to support criteria for prior use within previous 130 days or the trial and failure of formulary alternatives when available. Additional documentation will be required from the provider when historic prescription claim data is either not available or the medication fill history fails to establish criteria for prior use or trial and failure of formulary alternatives. Documentation will also be required to support any clinical reasons preventing the trial and failure of formulary alternatives. Please see the section on documentation requirements for more information.
Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical- policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434 Individual Consideration (for Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to: Blue Cross Blue Shield of Massachusetts

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Pharmacy Operations Department 25 Technology Place Hingham, MA 02043 Phone: 1-800-366-7778 Fax: 1-800-583-6289 Samples Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review. Specialty Blue Cross Blue Shield of Massachusetts (BCBSMA*) members (other than Medex®; Blue MedicareRx, Medicare Advantage plans that include prescription drug coverage) obtaining the medication from the Pharmacy benefit instead of the Medical benefit will be required to fill their prescriptions for medications listed as specialty at one of the providers in our retail specialty pharmacy network, see link below: Link to Specialty Pharmacy List

Policy History

Date Action 3/15/2026 Added expanded indication for Repatha. Updated formatting and references. 1/2026 QCD added to Juxtapid. 6/2025 Addition of Tryngolza 1/2025 Updated remove trial of three (3) statins for Praluent ® and Repatha ®. 8/2024 Updated to include Nexletol ™ & Nexlizet ™ new indication. 7/2024 Updated to add Repatha ® to the formulary and make Praluent NFNC 11/2023 Reformatted Policy. 10/2023 Reformatted Policy and updated IC to align with 118E MGL § 51A. Updated indication for Leqvio to include primary hyperlipidemia 7/2023 Reformatted Policy. 1/2023 Updated to remove Kynamro ® from the policy as it was withdrawn from the market. 4/2022 Updated to include Leqvio ® to the policy. 7/2021 Updated to add Evkeeza to the policy and included the new indication for Praluent ®. 8/2020 Updated to specify which meds are required to be filled at an in-network specialty pharmacy.
6/2020 Updated to include Nexletol ™ & Nexlizet ™ to the policy.
10/2019 Updated to Clarified Criteria. 7/2019 Updated new Praluent® indication. 11/2018 Updated to Clarified Criteria. 2/2018 Updated to include new Repatha Indication. 10/2017 Updated to change Walgreens Specialty Name. 7/2017 Updated to add AllCare to Pharmacy Specialty list. 6/2017 Updated address for Pharmacy Operations. 1/2017 Updated to remove Step from policy and add criteria for Juxtapid® and Kynamrotm. 6/2016 Updated to remove Advicor & Simcor due to loss of FDA approval & add Rosuvastatin to step 1. 4/2016 Updated to include PCSK9’s into the new Prior Authorization section of policy. 2/2014 Removal of Curascript name from specialty pharmacy section. 1/2014 Updated to add Juxtapid® & Kynamrotm to step 2 and reference 4, 5, 6, and 7. Also updated to include Liptruzettm* in step 3. Updated ExpressPAth language. 1/2013 Updated to move Lipitor to non-covered and consolidate Steps 3 & 4 into one Step 3 8/2012 Updated to add fluvastatin to Step 1 4/2012 Reviewed 4/2012 MPG-Cardiology and Pulmonology, no changes in coverage were made. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.

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No changes to policy statements.
1/2012 Updated to move Lipitor® 80mg from Step 1 to Step 3. 12/2011 Updated to add amlodipine/atorvastatin to step 1. 12/2011 Updated to add atorvastatin to step 1. 5/2011 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 4/2011 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 11/2011 Updated to move Vytorin® to Step 4 and non-covered status.
11/2010 Updated to include coverage criteria for new FDA approved product Livalo®.
4/2010 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 2/2010 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. No changes to policy statements. 2/2010 Updated with formulary change and Express PA information.
9/2009 Policy updated to change 180 day look back period to 130 days and to remove Medicare Part D criteria from Medical Policy.
4/2009 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 2/2009 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. No changes to policy statements. 1/2009 Updated to remove non-formulary designation of Step 4.
9/2008 Updated to include Simcor to medical policy. 4/2008 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 2/2008 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. No changes to policy statements. 7/2007 Updated to move Zocor and Pravachol brand names to Step 2 except Medicare HMO & PPO formulary and revision of request form.
4/2007 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 2/2007 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. No changes to policy statements. 2/2003 New policy, effective 2/2003, describing covered and non-covered indications.

Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434

References

1. Callister T. Q., Raggi P., Cooil B., Lippolis N. J., Russo D. J. Effect of HMG-CoA Reductase Inhibitors on Coronary Artery Disease as Assessed by Electron-Beam Computed Tomography N Engl J Med 1998; 339:1972-1978, Dec 31, 1998.
2. Chan, Queenie, Sakhuja, S, Ochs, A. et. all. Clinical Characteristics and Treatment of High-Risk Cardiovascular Patients without Prior Myocardial Infarction or Stroke: VERSALIUS-REAL – Results from US. Circulation. 2024; 150(1).
3. Charles R. Harper, MD; Terry A. Jacobson, MD New Perspectives on the Management of Low Levels of High-Density Lipoprotein Cholesterol Archives of Internal Medicine / volume:159 (page: 1049)
4. Thomas A. Pearson, MD, PhD, MPH; Irene Laurora, PharmD; Henry Chu, MS; Stephanie Kafonek, MD The Lipid Treatment Assessment Project (L-TAP): A Multicenter Survey to Evaluate the Percentages of Dyslipidemic Patients Receiving Lipid-Lowering Therapy and Achieving Low-Density Lipoprotein

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Cholesterol Goals Archives of Internal Medicine / volume:160 (page: 459)

5. Juxtapid® [package insert]. Cambridge, MA: Aeggerion Pharmaceutical, Inc.; December 2012.
6. J Atheroscler Thromb, 2012; 19:1043-1060 Mariko Harada-Shiba et al. Guidelines for the Management of Familial Hypercholesterolemia.
7. Liptruzettm [package insert]. Whitehouse Station, NJ: Merck & Co, Inc.; May 2013.
8. Kynamro [package insert]. Cambridge, MA: Genzyme Corporation.; 2013.
9. Praluent® [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC.; July 2015.
10. Repatha® [package insert]. Thousand Oaks, California: Amgen Inc.; Aug 2025.
11. Rao SV, O'Donoghue ML, Ruel M, et al. Circulation. 2025;151(13):e771-e862.
12. Nexletol [package insert]. Ann Arbor, MI: Esperion Therapeutics, Inc.; Mar 2020.
13. Nexlizet [package insert]. Ann Arbor, MI: Esperion Therapeutics, Inc.; Mar 2020.
14. Evkeeza [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; Feb 2021.
15. Leqvio ® [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.; Apr 2022.
16. Tryngolza ® [package insert]. Carlsbad, CA: IONIS Pharmaceuticals, Inc.; December 2024.