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Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1066
This program applies to Blue Partner, Commercial, SourceRx, and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Praluent® |
To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease |
|
1 |
Repatha® |
In adults with established cardiovascular disease (CVD) to reduce the risk of myocardial infarction, stroke, and coronary revascularization |
|
2 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
HeFH |
Criteria have been developed to aid in diagnosing heterozygous familial hypercholesterolemia (HeFH). These include the Simon Broome Register criteria and Dutch Lipid Clinic Network criteria.(5)
A possible diagnosis of HeFH according to Simon Broome diagnostic criteria requires the following:(3,5)
Dutch Lipid Clinic Network criteria for diagnosis of HeFH:(6)
|
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HoFH |
Homozygous familial hypercholesterolemia (HoFH) is a rare autosomal semi-dominant disease affecting males and females equally, characterized by markedly elevated levels of low-density lipoprotein cholesterol (LDL-C) from conception and accelerated atherosclerotic cardiovascular disease (ASCVD), often resulting in early death. Recent estimates indicate that about 30,000 people worldwide have HoFH but less than 5% are identified. Estimated global prevalence of HoFH by United Nations world region, based on 2020 population data and estimates of HoFH prevalence ranging from 1:250,000 to 1:360,000. Inadequate awareness and a disconnect between clinical diagnosis and interpretation of genetic results by health providers and payers contribute to underdiagnosis and undertreatment of HoFH. To address this, the European Atherosclerosis Society (EAS) has recently updated clinical guidance for HoFH care to improve education, early diagnosis, and improve cardiovascular health for patients with HoFH worldwide.(4) |
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ASCVD |
The most recent 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the management of Blood Cholesterol states that clinical atherosclerotic cardiovascular disease (ASCVD) includes the following, all of atherosclerotic origin:(9)
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Management |
The 2022 American College of Cardiology (ACC) Consensus Decision Pathway was designed to address current gaps in care for LDL-C lowering to reducing ASCVD risk. This effort relies extensively on the evidence established by the 2013 ACC/AHA and 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol, and provides further recommendations regarding the use of newer non-statin therapies. The key updates that the 2022 ACC Consensus Pathway recommends for patients with ASCVD on maximally tolerated statin therapy are a recommendation for a lower LDL-C threshold of 55 mg/dL(or non-HDL-C of 85 mg/dL) for adults with ASCVD at very high risk, and an LDL-C threshold of 70mg/dL (or non-HDL-C of 100 mg/dL) for adults with ASCVD not at very high risk when considering the addition of a non-statin therapy. If adults with clinical ASCVD at very high risk on a statin therapy for secondary prevention require >25% additional lowering of LDL-C, a PCSK9 inhibitor may be preferred as the initial non-statin therapy.(13)
CAC Agatston score in non-contrast CT can be used for patient risk classification for coronary heart disease:(11,12)
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Safety |
Praluent is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in Praluent. Hypersensitivity vasculitis, angioedema, and hypersensitivity reactions requiring hospitalization have occurred.(1) |
REFERENCES
Number |
Reference |
1 |
Praluent prescribing information. Regeneron Pharmaceuticals, Inc. April 2021. |
2 |
Repatha prescribing information. Amgen Inc. September 2021. |
3 |
National Institute for Health and Care Excellence. Appendix F Simon Broome Diagnostic Criteria for index individuals and relatives. Familial hypercholesterolaemia: identification and management (NICE Guideline No. 71). (2019, October 4). https://www.nice.org.uk/guidance/cg71/evidence/full-guideline-appendix-f-pdf-241917811 |
4 |
Cuchel, M., Raal, F. J., Hegele, R. A., Al-Rasadi, K., Arca, M., Averna, M., Bruckert, E., Freiberger, T., Gaudet, D., Harada-Shiba, M., Hudgins, L. C., Kayikcioglu, M., Masana, L., Parhofer, K. G., Roeters van Lennep, J. E., Santos, R. D., Stroes, E. S., Watts, G. F., Wiegman, A., ... Ray, K. K. (2023). 2023 Update on European Atherosclerosis Society Consensus Statement on Homozygous Familial Hypercholesterolaemia: new treatments and clinical guidance. European Heart Journal, 44(25), 2277-2291. https://doi.org/10.1093/eurheartj/ehad197 |
5 |
National Institute for Health and Care Excellence. (2019, October 4). Familial hypercholesterolaemia: identification and management (NICE Guideline No. 71). https://www.nice.org.uk/guidance/cg71 |
6 |
World Health Organization. Familial Hypercholesterolaemia (FH): Report of a second WHO consultation. Geneva, Switzerland: World Health Organization, 1999. |
7 |
National Organization for Rare Disorders (NORD). (2023, May 25). Familial Hypercholesterolemia. https://rarediseases.org/rare-diseases/familial-hypercholesterolemia/ |
8 |
Gidding, S. S., Champagne, M., de Ferranti, S. D., Defesche, J., Ito, M. K., Knowles, J. W., McCrindle, B., Raal, F., Rader, D., Santos, R. D., Lopes-Virella, M., Watts, G. F., & Wierzbicki, A. S. (2015). The Agenda for Familial Hypercholesterolemia. A Scientific Statement from the American Heart Association. Circulation, 132(22), 2167–2192. https://doi.org/10.1161/cir.0000000000000297 |
9 |
Grundy, S. M., Stone, N. J., Bailey, A. L., Beam, C., Birtcher, K. K., Blumenthal, R. S., Braun, L. T., de Ferranti, S., Faiella-Tommasino, J., Forman, D. E., Goldberg, R., Heidenreich, P. A., Hlatky, M. A., Jones, D. W., Lloyd-Jones, D., Lopez-Pajares, N., Ndumele, C. E., Orringer, C. E., Peralta, C. A., … Yeboah, J. (2019). 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APHA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation, 139, e1082–e1143. https://doi.org/10.1161/cir.0000000000000625 |
10 |
Robinson, J. G., Jayanna, M. B., Brown, A. S., Aspry, K., Orringer, C., Gill, E. A., Goldberg, A., Jones, L. K., Maki, K., Dixon, D. L., Saseen, J. J., & Soffer, D. (2019). Enhancing the Value of PCSK9 Monoclonal Antibodies by Identifying Patients Most Likely to Benefit. A Consensus Statement from the National Lipid Association. Journal of Clinical Lipidology, 13(4). https://doi.org/10.1016/j.jacl.2019.05.005 |
11 |
Hecht, H. S., Cronin, P., Blaha, M. J., Budoff, M. J., Kazerooni, E. A., Narula, J., Yankelevitz, D., & Abbara, S. (2017). 2016 SCCT/STR Guidelines for coronary artery calcium scoring of noncontrast noncardiac chest CT scans: A report of the Society of Cardiovascular Computed Tomography and Society of Thoracic Radiology. Journal of Cardiovascular Computed Tomography, 11, 74–84. https://doi.org/10.1016/j.jcct.2016.11.003 |
12 |
Blaha, M. J., Mortensen, M. B., Kianoush, S., Tota-Maharaj, R., & Cainzos-Achirica, M. (2017). Coronary Artery Calcium Scoring: Is It Time for a Change in Methodology? JACC: Cardiovascular Imaging, 10(8), 923–937. https://doi.org/10.1016/j.jcmg.2017.05.007 |
13 |
Lloyd-Jones, D., Morris, P. B., Ballantyne, C. M., Birtcher, K. K., Covington, A. M., DePalma, S. M., Minissian, M. B., Orringer, C. E., Smith, S. C., Waring, A. A., & Wilkins, J. T. (2022). 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk. Journal of the American College of Cardiology, 80(14), 1366–1418. https://doi.org/10.1016/j.jacc.2022.07.006 |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Praluent |
alirocumab subcutaneous solution auto-injector |
150 MG/ML ; 75 MG/ML |
M ; N ; O ; Y |
N |
|
|
Repatha sureclick |
evolocumab subcutaneous soln auto-injector |
140 MG/ML |
M ; N ; O ; Y |
N |
|
|
Repatha pushtronex system |
evolocumab subcutaneous soln cartridge/infusor |
420 MG/3.5ML |
M ; N ; O ; Y |
N |
|
|
Repatha |
evolocumab subcutaneous soln prefilled syringe |
140 MG/ML |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Repatha |
evolocumab subcutaneous soln prefilled syringe |
140 MG/ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
Repatha pushtronex system |
evolocumab subcutaneous soln cartridge/infusor |
420 MG/3.5ML |
2 |
Cartridges |
28 |
DAYS |
|
|
|
Repatha sureclick |
evolocumab subcutaneous soln auto-injector |
140 MG/ML |
2 |
Pens |
28 |
DAYS |
|
|
|
Praluent |
alirocumab subcutaneous solution auto-injector |
150 MG/ML ; 75 MG/ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Praluent |
alirocumab subcutaneous solution auto-injector |
150 MG/ML ; 75 MG/ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; SourceRx |
Repatha |
evolocumab subcutaneous soln prefilled syringe |
140 MG/ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; SourceRx |
Repatha pushtronex system |
evolocumab subcutaneous soln cartridge/infusor |
420 MG/3.5ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; SourceRx |
Repatha sureclick |
evolocumab subcutaneous soln auto-injector |
140 MG/ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Repatha |
evolocumab subcutaneous soln prefilled syringe |
140 MG/ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; SourceRx |
Repatha pushtronex system |
evolocumab subcutaneous soln cartridge/infusor |
420 MG/3.5ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; SourceRx |
Repatha sureclick |
evolocumab subcutaneous soln auto-injector |
140 MG/ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; SourceRx |
Praluent |
alirocumab subcutaneous solution auto-injector |
150 MG/ML ; 75 MG/ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||
PA |
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
ALBP _ Commercial _ CSReg _ PCSK9_Inhibitors_PAQL _ProgSum_ 10-01-2024 _
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